Aspirin, ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs) remain the most common treatment to relieve symptoms of arthritis and other inflammatory disorders. But despite their widespread use (around 2.5 million Canadians have osteoarthritis) these medications are also known to cause severe, sometimes life-threatening adverse effects within the body, particularly in the gastrointestinal tract.
A novel anti-inflammatory drug being developed and commercialized by an inflammation expert at McMaster University has shown promise in relieving symptoms of inflammation, while substantially reducing the incidence of bleeding and intestinal damage often caused by NSAIDs.
The research is published in the March issue of the British Journal of Pharmacology.
John Wallace, a pharmacologist and director of the Farncombe Family Digestive Health Research Institute at McMaster University, compared naproxen, a commonly used NSAID, to a novel anti-inflammatory drug, ATB-346, which he developed in collaboration with a team of Italian chemists and is now commercializing through his company, Antibe Therapeutics Inc.
ATB-346 is a derivative of naproxen which releases hydrogen sulfide. Evidence from animal studies suggests that in small quantities, hydrogen sulfide can protect the stomach from injury and can accelerate the healing of pre-existing ulcers.
"I've been working on NSAIDs for over 20 years," said Wallace, a professor of medicine in the Michael G. DeGroote School of Medicine at McMaster University. "This particular drug is, by far, the shining star. We've tested it in every model where it should fail, and it has performed exceptionally well."
To examine the gastrointestinal safety and anti-inflammatory effectiveness of ATB-346, Wallace and his co-investigators tested the drug in healthy rats as well as those with arthritis and inflammation. The researchers also examined the impact of the drug on rats with compromised gastrointestinal tracts, a model which mimicked the clinical scenario in which NSAIDs are frequently used and have caused damage such as bleeding and ulcers.
"From the beginning, we decided that we were going to do the most rigorous testing of any NSAID that's ever been done," Wallace said. "We very deliberately tested the drug in models where NSAIDs fail."
The researchers found that ATB-346 was at least as effective as naproxen in relieving inflammation in animal models. They also discovered that ATB-346 was in the order of 100 times safer than naproxen, causing little or no damage to the stomach and small intestine.
When given to rats with impaired gastrointestinal tracts, ATB-346 did not cause any gastric damage. Moreover, the researchers observed that it enhanced, rather than inhibited, healing of pre-existing ulcers.
Finally, unlike naproxen, ATB-346 had no effect on blood pressure in rats with hypertension, suggesting the drug may have less cardiovascular risks than conventional NSAIDs.
The researchers concluded that H2S-releasing NSAIDs appear to represent a promising alternative to existing therapies for the treatment of inflammation and pain. Future research will focus on the potential cardiovascular benefits of these drugs.
Source:
Veronica McGuire
McMaster University
вторник, 28 июня 2011 г.
суббота, 25 июня 2011 г.
New Treatment For Early To Mid-Stage Osteoarthritis May Provide Better Precision During Surgery
A robotic arm device developed to assist orthopedic surgeons with performing partial knee replacement surgery for early to mid-stage osteoarthritis is now available at NewYork-Presbyterian Hospital/Columbia University Medical Center. The technology was approved by the FDA in 2005, and to date nearly 5,000 cases have been performed in the U.S.
"Robotic technology is particularly well-suited to partial knee replacement surgery, which requires a high degree of precision. This device is making it possible to treat patients early and with more precision in order to more quickly and effectively eliminate their pain and get their lives back on track," says Dr. William Macaulay, director of the Center for Hip and Knee Replacement at NewYork-Presbyterian Hospital/Columbia University Medical Center and the Nas S. Eftekhar Professor of Clinical Orthopaedic Surgery and chief of the Division of Adult Reconstructive Surgery of the Hip and Knee at Columbia University College of Physicians and Surgeons.
According to a report by the Journal of the American Medical Association, more than 10 million adults in the United States suffer with osteoarthritis of the knee, which is characterized by the breakdown and eventual loss of cushioning joint cartilage. The result is debilitating pain while standing or walking short distances, climbing up or going down stairs, or getting in and out of a chair.
Surgical treatment is either a total knee replacement or, less commonly, partial knee replacement for patients whose damaged cartilage is restricted to one or more areas. Both procedures alleviate the problem by removing the damaged areas of cartilage and replacing these surfaces with an implant.
Total knee replacement is an invasive surgery and requires extensive rehabilitation. But some surgeons shy away from the partial replacement procedure because good outcomes depend on positioning and aligning the implants precisely.
According to Dr. Macaulay, the robotic arm gives the surgeon a pre-surgical plan that details the technique for bone preparation and customized implant positioning using a CT scan of the patient's knee. During the procedure, the system creates a three-dimensional virtual view of the patient's bone surface and correlates the image to the pre-programmed surgical plan. As the surgeon uses the robotic arm, its tactile, acoustic and visual feedback limits the bone preparation to the diseased areas and provides for optimal implant positioning and placement.
"Patients report being without pain and are comfortable with the feel of their partially reconstructed knee. The potential advantages are a shorter hospital stay, typically one to three days, as well as a quicker overall recovery," says Dr. Macaulay. "In most cases, patients can walk soon after surgery, drive a car within two weeks and return to regular daily activities shortly thereafter."
Typical surgical candidates experience knee pain with activity, usually on the inner knee, under the kneecap or the outer knee; knee pain or stiffness when activities are initiated from a sitting position; and have failed to respond to non-surgical treatments or non-steroidal anti-inflammatory medication such as ibuprofen.
The robotic arm being used at NewYork-Presbyterian/Columbia is the RIO® Robotic Arm Interactive Orthopedic System by MAKO Surgical Corp.
Source:
Robotic Surgery at NewYork-Presbyterian
NewYork-Presbyterian Hospital/Columbia University Medical Center
"Robotic technology is particularly well-suited to partial knee replacement surgery, which requires a high degree of precision. This device is making it possible to treat patients early and with more precision in order to more quickly and effectively eliminate their pain and get their lives back on track," says Dr. William Macaulay, director of the Center for Hip and Knee Replacement at NewYork-Presbyterian Hospital/Columbia University Medical Center and the Nas S. Eftekhar Professor of Clinical Orthopaedic Surgery and chief of the Division of Adult Reconstructive Surgery of the Hip and Knee at Columbia University College of Physicians and Surgeons.
According to a report by the Journal of the American Medical Association, more than 10 million adults in the United States suffer with osteoarthritis of the knee, which is characterized by the breakdown and eventual loss of cushioning joint cartilage. The result is debilitating pain while standing or walking short distances, climbing up or going down stairs, or getting in and out of a chair.
Surgical treatment is either a total knee replacement or, less commonly, partial knee replacement for patients whose damaged cartilage is restricted to one or more areas. Both procedures alleviate the problem by removing the damaged areas of cartilage and replacing these surfaces with an implant.
Total knee replacement is an invasive surgery and requires extensive rehabilitation. But some surgeons shy away from the partial replacement procedure because good outcomes depend on positioning and aligning the implants precisely.
According to Dr. Macaulay, the robotic arm gives the surgeon a pre-surgical plan that details the technique for bone preparation and customized implant positioning using a CT scan of the patient's knee. During the procedure, the system creates a three-dimensional virtual view of the patient's bone surface and correlates the image to the pre-programmed surgical plan. As the surgeon uses the robotic arm, its tactile, acoustic and visual feedback limits the bone preparation to the diseased areas and provides for optimal implant positioning and placement.
"Patients report being without pain and are comfortable with the feel of their partially reconstructed knee. The potential advantages are a shorter hospital stay, typically one to three days, as well as a quicker overall recovery," says Dr. Macaulay. "In most cases, patients can walk soon after surgery, drive a car within two weeks and return to regular daily activities shortly thereafter."
Typical surgical candidates experience knee pain with activity, usually on the inner knee, under the kneecap or the outer knee; knee pain or stiffness when activities are initiated from a sitting position; and have failed to respond to non-surgical treatments or non-steroidal anti-inflammatory medication such as ibuprofen.
The robotic arm being used at NewYork-Presbyterian/Columbia is the RIO® Robotic Arm Interactive Orthopedic System by MAKO Surgical Corp.
Source:
Robotic Surgery at NewYork-Presbyterian
NewYork-Presbyterian Hospital/Columbia University Medical Center
среда, 22 июня 2011 г.
Improving Sleep Quality Could Ease Disability In Rheumatoid Arthritis Patients
A study in the Feb. 15 issue of the Journal of Clinical Sleep Medicine found that poor sleep quality correlated with higher levels of depressive symptoms, greater pain severity, increased fatigue, and greater functional disability in patients with Rheumatoid Arthritis (RA). The study suggests that addressing sleep problems via pharmacological or behavioral interventions may have a critical impact on the health and lives of patients with RA.
The study represents a cross-sectional examination of the relationship between sleep quality and functional disability in 162 patients with RA. The sample had an average age of 58.5 years, and 76 percent were female. All patients had been diagnosed with RA for at least two years; on average, patients had RA for 14 years.
Participants completed the following questionnaires: Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory-II, Medical Outcomes Study Short Form - 36, and the Health Assessment Questionnaire. The results provided input on their sleep quality, depression, fatigue, and functional disability and pain severity, respectively. Patients also provided sociodemographic information and their medical history.
Results show that sleep quality has an indirect effect on functional disability after controlling for age, gender and number of comorbities. According to the PSQI results, 61 percent of patients were poor sleepers and 33 percent reported having pain that disturbed their sleep three or more times per week.
"The primary finding of our study is that poor sleep quality is associated with greater functional disability among patients with RA and this relationship may be explained by pain severity and fatigue," said lead author Dr. Faith S. Luyster, research assistant professor at the University of Pittsburgh School of Nursing in Pittsburgh, Pa. "These results highlight the importance of addressing sleep complaints among patients with RA. By treating sleep problems either pharmacologically or behaviorally, symptoms and activity limitations associated with RA may be reduced."
The study's finding that poorer sleep quality is associated with greater pain severity is consistent with recent evidence suggesting that sleep disruption may lower pain threshold and enhance pain in RA and otherwise healthy adults.
According to the National Institute of Health, RA is an inflammatory disease affecting about 1.3 million U.S. adults, and causes pain, swelling, stiffness, and loss of function in the joints. Disturbed sleep has been found to be a major concern among persons with RA.
Physical disability resulting from polyarticular joint disease in patients with RA may limit their ability to carry out daily activities such as dressing, walking, grooming, and writing - tasks that can be further restricted by fatigue, pain severity, and depression.
It is possible that functional disability may affect depression, pain severity and fatigue, which in turn may affect sleep quality. It is likely that the relationships are bidirectional to some extent.
"Not sleeping well at night can contribute to greater pain sensitivity and fatigue during the day which in turn can limit a patient's ability to engage in activities of daily living and discretionary activities," Luyster said.
Luyster noted that treating sleep disturbances in RA patients might have beneficial effects beyond improving sleep.
The study, "Sleep Quality and Functional Disability in Patients with Rheumatoid Arthritis," was supported by grants from the National Institute of Health.
Source:
Emilee McStay
American Academy of Sleep Medicine
The study represents a cross-sectional examination of the relationship between sleep quality and functional disability in 162 patients with RA. The sample had an average age of 58.5 years, and 76 percent were female. All patients had been diagnosed with RA for at least two years; on average, patients had RA for 14 years.
Participants completed the following questionnaires: Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory-II, Medical Outcomes Study Short Form - 36, and the Health Assessment Questionnaire. The results provided input on their sleep quality, depression, fatigue, and functional disability and pain severity, respectively. Patients also provided sociodemographic information and their medical history.
Results show that sleep quality has an indirect effect on functional disability after controlling for age, gender and number of comorbities. According to the PSQI results, 61 percent of patients were poor sleepers and 33 percent reported having pain that disturbed their sleep three or more times per week.
"The primary finding of our study is that poor sleep quality is associated with greater functional disability among patients with RA and this relationship may be explained by pain severity and fatigue," said lead author Dr. Faith S. Luyster, research assistant professor at the University of Pittsburgh School of Nursing in Pittsburgh, Pa. "These results highlight the importance of addressing sleep complaints among patients with RA. By treating sleep problems either pharmacologically or behaviorally, symptoms and activity limitations associated with RA may be reduced."
The study's finding that poorer sleep quality is associated with greater pain severity is consistent with recent evidence suggesting that sleep disruption may lower pain threshold and enhance pain in RA and otherwise healthy adults.
According to the National Institute of Health, RA is an inflammatory disease affecting about 1.3 million U.S. adults, and causes pain, swelling, stiffness, and loss of function in the joints. Disturbed sleep has been found to be a major concern among persons with RA.
Physical disability resulting from polyarticular joint disease in patients with RA may limit their ability to carry out daily activities such as dressing, walking, grooming, and writing - tasks that can be further restricted by fatigue, pain severity, and depression.
It is possible that functional disability may affect depression, pain severity and fatigue, which in turn may affect sleep quality. It is likely that the relationships are bidirectional to some extent.
"Not sleeping well at night can contribute to greater pain sensitivity and fatigue during the day which in turn can limit a patient's ability to engage in activities of daily living and discretionary activities," Luyster said.
Luyster noted that treating sleep disturbances in RA patients might have beneficial effects beyond improving sleep.
The study, "Sleep Quality and Functional Disability in Patients with Rheumatoid Arthritis," was supported by grants from the National Institute of Health.
Source:
Emilee McStay
American Academy of Sleep Medicine
воскресенье, 19 июня 2011 г.
New Data Reveals Tocilizumab Is The First And Only Biologic Drug To Show Superiority Over Current Standard Of Care In Rheumatoid Arthritis
The innovative rheumatoid arthritis drug tocilizumab has shown superiority over the current standard of care, methotrexate (MTX), by achieving a greater reduction of signs and symptoms at 6 months in patients suffering from rheumatoid arthritis(RA). This new data, presented today at The European League Against Rheumatism (EULAR) meeting in Paris, makes tocilizumab the first and only biologic therapy to have achieved superiority over MTX.
Furthermore, nearly three times as many patients treated with the therapy achieved disease remission (34% vs. 12%) as defined by the globally recognised measure DAS28
In the AMBITION study, 70%, 44% and 28% of patients in the tocilizumab (8 mg/kg) monotherapy arm achieved ACR20, ACR50 and ACR70 compared, respectively, with 53%, 34% and 15%, respectively, of patients treated with MTX alone.1 Disease remission (DAS28
Furthermore, nearly three times as many patients treated with the therapy achieved disease remission (34% vs. 12%) as defined by the globally recognised measure DAS28
In the AMBITION study, 70%, 44% and 28% of patients in the tocilizumab (8 mg/kg) monotherapy arm achieved ACR20, ACR50 and ACR70 compared, respectively, with 53%, 34% and 15%, respectively, of patients treated with MTX alone.1 Disease remission (DAS28
четверг, 16 июня 2011 г.
Knee Replacement Surgery? AAOS Says Get Two At The Same Time
Significantly fewer prosthetic joint infections as well as other revision knee operation complications occurred within one year after surgery if a person gets both knees replaced at the same time instead of stretching out the operations over time. Simultaneous replacement may be the way to go according to a new study, instead of doing one at a time on separate occasions.
According to the American Academy of Orthopedic Surgeons (AAOS), there are about 270,000 knee replacement operations performed each year in the United States. Although about 70% of these operations are performed in people over the age of 65, a growing number of knee replacements are being done in younger patients. Orthopedic surgeons evaluate patients individually. Recommendations for surgery are based on a patient's pain and disability, not age. Total knee replacements have been performed successfully at all ages, from the young teenager with juvenile arthritis to the elderly patient with degenerative arthritis.
However, simultaneous replacement was associated with a moderately higher risk of adverse cardiovascular outcomes within 30 days, according to a study presented this week at the 2011 Annual Meeting of the American Academy of Orthopedic Surgeons (AAOS).
John P. Meehan, MD, study author and orthopedic surgeon from the University of California, Davis explains:
"Our study found that the risk of developing a serious joint infection that required an additional knee revision surgery was two times higher in patients who had staged knee replacements compared to the patients who had both knees replaced at the same time (2.2% after staged knee replacements and 1.2 percent after bilateral knee replacements). These findings indicate that performing simultaneous knee replacements would significantly reduce the incidence of major orthopedic complications, and at the same time reduce the number of hospitalizations and the number of operating room sessions."
11,445 patients who underwent simultaneous bilateral knee replacement and 23,715 patients who had both knees replaced in two stages several months apart were compared in the new study.
The results were interesting to say the least. Those persons having both knees replaced at the same time demonstrated a higher risk of heart attack and pulmonary embolism, similar risk of death and stroke, but lower risk of major joint infection or major mechanical malfunction.
The knee is the largest joint in the body. Normal knee function is required to perform most everyday activities. The knee is made up of the lower end of the thighbone (femur), which rotates on the upper end of the shin bone (tibia), and the kneecap (patella), which slides in a groove on the end of the femur. Large ligaments attach to the femur and tibia to provide stability. The long thigh muscles give the knee strength.
The joint surfaces where these three bones touch are covered with articular cartilage, a smooth substance that cushions the bones and enables them to move easily. All remaining surfaces of the knee are covered by a thin, smooth tissue liner called the synovial membrane. This membrane releases a special fluid that lubricates the knee, reducing friction to nearly zero in a healthy knee. Normally, all of these components work in harmony. But disease or injury can disrupt this harmony, resulting in pain, muscle weakness, and reduced function.
This particular study also found that the risk of adverse cardiovascular events such as having a heart attack or developing a blood clot that travels to the lungs was higher after undergoing simultaneous knee replacements, but there was no significant difference in overall mortality.
Source: American Academy of Orthopedic Surgeons News Release
Written by Sy Kraft, B.A.
According to the American Academy of Orthopedic Surgeons (AAOS), there are about 270,000 knee replacement operations performed each year in the United States. Although about 70% of these operations are performed in people over the age of 65, a growing number of knee replacements are being done in younger patients. Orthopedic surgeons evaluate patients individually. Recommendations for surgery are based on a patient's pain and disability, not age. Total knee replacements have been performed successfully at all ages, from the young teenager with juvenile arthritis to the elderly patient with degenerative arthritis.
However, simultaneous replacement was associated with a moderately higher risk of adverse cardiovascular outcomes within 30 days, according to a study presented this week at the 2011 Annual Meeting of the American Academy of Orthopedic Surgeons (AAOS).
John P. Meehan, MD, study author and orthopedic surgeon from the University of California, Davis explains:
"Our study found that the risk of developing a serious joint infection that required an additional knee revision surgery was two times higher in patients who had staged knee replacements compared to the patients who had both knees replaced at the same time (2.2% after staged knee replacements and 1.2 percent after bilateral knee replacements). These findings indicate that performing simultaneous knee replacements would significantly reduce the incidence of major orthopedic complications, and at the same time reduce the number of hospitalizations and the number of operating room sessions."
11,445 patients who underwent simultaneous bilateral knee replacement and 23,715 patients who had both knees replaced in two stages several months apart were compared in the new study.
The results were interesting to say the least. Those persons having both knees replaced at the same time demonstrated a higher risk of heart attack and pulmonary embolism, similar risk of death and stroke, but lower risk of major joint infection or major mechanical malfunction.
The knee is the largest joint in the body. Normal knee function is required to perform most everyday activities. The knee is made up of the lower end of the thighbone (femur), which rotates on the upper end of the shin bone (tibia), and the kneecap (patella), which slides in a groove on the end of the femur. Large ligaments attach to the femur and tibia to provide stability. The long thigh muscles give the knee strength.
The joint surfaces where these three bones touch are covered with articular cartilage, a smooth substance that cushions the bones and enables them to move easily. All remaining surfaces of the knee are covered by a thin, smooth tissue liner called the synovial membrane. This membrane releases a special fluid that lubricates the knee, reducing friction to nearly zero in a healthy knee. Normally, all of these components work in harmony. But disease or injury can disrupt this harmony, resulting in pain, muscle weakness, and reduced function.
This particular study also found that the risk of adverse cardiovascular events such as having a heart attack or developing a blood clot that travels to the lungs was higher after undergoing simultaneous knee replacements, but there was no significant difference in overall mortality.
Source: American Academy of Orthopedic Surgeons News Release
Written by Sy Kraft, B.A.
понедельник, 13 июня 2011 г.
Amgen And Wyeth Announce Updates To U.S. Prescribing Information For Enbrel(R)
Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced updates to the U.S. Food and Drug Administration (FDA)-approved U.S. Prescribing Information (PI) for Enbrel(R) (etanercept).
The U.S. PI now contains a boxed warning relating to the risk of infections, including tuberculosis, which is similar to labeling for other medicines in the tumor necrosis factor (TNF) inhibitor class. The PI had previously included a bolded warning regarding the risk of infections and tuberculosis. This information is now in a boxed warning and includes additional language regarding screening and monitoring patients for tuberculosis, including patients who tested negative for latent tuberculosis infection. In addition, the boxed warning states that tuberculosis has been observed in patients receiving TNF-blocking agents, including ENBREL, and that tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection. The boxed warning notes that data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with ENBREL than with TNF-blocking monoclonal antibodies. The boxed warning further notes that, nonetheless, post-marketing cases of tuberculosis reactivation have been reported for TNF blockers, including ENBREL.
The risks defined in the boxed warning are consistent with the risk of tuberculosis and infections that have been included in previous versions of the U.S. PI. The primary concern of both Amgen and Wyeth is for the safety of patients, and both companies maintain an ongoing pharmacovigilance program to analyze and evaluate all safety reports from clinical and open-label trials as well as post-marketing surveillance. As always, it is important that physicians and patients fully understand the benefits and risks of ENBREL treatment.
Other PI updates include the addition of reported incidence of tuberculosis infection observed in clinical studies in the Adverse Reactions section. In global clinical studies of more than 20,000 patients, tuberculosis was observed in approximately 0.01 percent of patients. In more than 15,000 patients from clinical studies in the U.S. and Canada, tuberculosis was observed in approximately 0.007 percent of patients. The Adverse Reaction Information from Spontaneous Reports section was also updated based on post-marketing surveillance reports. Additional information was added regarding antibody assays in the immunogenicity section.
The indication within the U.S. PI for juvenile idiopathic arthritis (JIA) - formerly called juvenile rheumatoid arthritis (JRA) - also was changed. ENBREL now has an updated JIA indication for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.
In addition to these U.S. PI updates, the current patient package insert (PPI) for ENBREL will be replaced with a Medication Guide when it becomes available. Patients will receive the Medication Guide when a prescription for ENBREL is dispensed in the U.S. As with the current PPI, Amgen and Wyeth will distribute the Medication Guide in conjunction with any company-sponsored patient communications about ENBREL.
Amgen and Wyeth are informing healthcare professionals about the revisions to the U.S. PI through a "Dear Healthcare Professional" letter, and will post the letter and updated PI on enbrel.
ABOUT ENBREL
ENBREL is a fully human soluble tumor necrosis factor (TNF) receptor. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and has more than 15 years of collective clinical experience.
ENBREL indications in the U.S.:
-- ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.
-- ENBREL is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.
-- ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
-- ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
-- ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Important Safety Information
What important safety information do I need to know about taking prescription ENBREL?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of active TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections.
Serious infections, including tuberculosis (TB), have happened in patients taking ENBREL. Some of these serious infections have been fatal. Many serious infections occurred in people prone to infection. Serious infections have also occurred in patients with advanced or poorly-controlled diabetes. Do not start Enbrel if you have an infection or are allergic to ENBREL or its components. Once on ENBREL, if you get an infection or have any sign of an infection, including fever, cough, or flu-like symptoms or have open sores on your body, tell your doctor. Your doctor should test you for TB before starting Enbrel and should monitor you closely for signs and symptoms of TB.
Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes have been reported. There have been rare reports of serious blood disorders (some fatal).
In medical studies, more cases of lymphoma (a type of cancer) were seen in patients taking TNF blockers compared to similar patients who were not taking TNF blockers. The risk of lymphoma may be several-fold higher in people with rheumatoid arthritis and psoriasis; the role of TNF blockers in the development of malignancies is unknown.
Tell your doctor if you:
-- Think you have, are being treated for, have signs of, or are prone to infection
-- Have any open sores
-- Have or have had TB or hepatitis B
-- Have ever been treated for heart failure
-- Have ever had or develop a serious nervous system disorder
-- Develop symptoms such as persistent fever, bruising, bleeding or paleness while taking ENBREL
Common side effects in adult clinical trials were injection site reactions, infection and headache.
In a medical study of patients with JIA, infections, headaches, abdominal pain, vomiting, and nausea occurred more frequently than in adults. The kinds of infections reported were generally mild and similar to those usually seen in children. Other serious adverse reactions were reported, including serious infections, depression/personality disorder.
If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA.
About Amgen and Wyeth
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Wyeth markets ENBREL outside of North America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit amgen.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. To learn more, visit wyeth.
Amgen Forward Looking Statement
This news release contains forward-looking statements that are based on Amgen's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen's business. Unless otherwise noted, Amgen is providing this information as of March 17, 2008, and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen's products after they are on the market. Amgen's business may be impacted by government investigations, litigation and products liability claims. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.
In addition, sales of Amgen's products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of Amgen's products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen routinely obtain patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's ability to obtain or maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen's business and results of operations.
The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
Wyeth Forward Looking Statement
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
View drug information on Enbrel.
The U.S. PI now contains a boxed warning relating to the risk of infections, including tuberculosis, which is similar to labeling for other medicines in the tumor necrosis factor (TNF) inhibitor class. The PI had previously included a bolded warning regarding the risk of infections and tuberculosis. This information is now in a boxed warning and includes additional language regarding screening and monitoring patients for tuberculosis, including patients who tested negative for latent tuberculosis infection. In addition, the boxed warning states that tuberculosis has been observed in patients receiving TNF-blocking agents, including ENBREL, and that tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection. The boxed warning notes that data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with ENBREL than with TNF-blocking monoclonal antibodies. The boxed warning further notes that, nonetheless, post-marketing cases of tuberculosis reactivation have been reported for TNF blockers, including ENBREL.
The risks defined in the boxed warning are consistent with the risk of tuberculosis and infections that have been included in previous versions of the U.S. PI. The primary concern of both Amgen and Wyeth is for the safety of patients, and both companies maintain an ongoing pharmacovigilance program to analyze and evaluate all safety reports from clinical and open-label trials as well as post-marketing surveillance. As always, it is important that physicians and patients fully understand the benefits and risks of ENBREL treatment.
Other PI updates include the addition of reported incidence of tuberculosis infection observed in clinical studies in the Adverse Reactions section. In global clinical studies of more than 20,000 patients, tuberculosis was observed in approximately 0.01 percent of patients. In more than 15,000 patients from clinical studies in the U.S. and Canada, tuberculosis was observed in approximately 0.007 percent of patients. The Adverse Reaction Information from Spontaneous Reports section was also updated based on post-marketing surveillance reports. Additional information was added regarding antibody assays in the immunogenicity section.
The indication within the U.S. PI for juvenile idiopathic arthritis (JIA) - formerly called juvenile rheumatoid arthritis (JRA) - also was changed. ENBREL now has an updated JIA indication for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.
In addition to these U.S. PI updates, the current patient package insert (PPI) for ENBREL will be replaced with a Medication Guide when it becomes available. Patients will receive the Medication Guide when a prescription for ENBREL is dispensed in the U.S. As with the current PPI, Amgen and Wyeth will distribute the Medication Guide in conjunction with any company-sponsored patient communications about ENBREL.
Amgen and Wyeth are informing healthcare professionals about the revisions to the U.S. PI through a "Dear Healthcare Professional" letter, and will post the letter and updated PI on enbrel.
ABOUT ENBREL
ENBREL is a fully human soluble tumor necrosis factor (TNF) receptor. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and has more than 15 years of collective clinical experience.
ENBREL indications in the U.S.:
-- ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.
-- ENBREL is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.
-- ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
-- ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
-- ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Important Safety Information
What important safety information do I need to know about taking prescription ENBREL?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of active TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections.
Serious infections, including tuberculosis (TB), have happened in patients taking ENBREL. Some of these serious infections have been fatal. Many serious infections occurred in people prone to infection. Serious infections have also occurred in patients with advanced or poorly-controlled diabetes. Do not start Enbrel if you have an infection or are allergic to ENBREL or its components. Once on ENBREL, if you get an infection or have any sign of an infection, including fever, cough, or flu-like symptoms or have open sores on your body, tell your doctor. Your doctor should test you for TB before starting Enbrel and should monitor you closely for signs and symptoms of TB.
Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes have been reported. There have been rare reports of serious blood disorders (some fatal).
In medical studies, more cases of lymphoma (a type of cancer) were seen in patients taking TNF blockers compared to similar patients who were not taking TNF blockers. The risk of lymphoma may be several-fold higher in people with rheumatoid arthritis and psoriasis; the role of TNF blockers in the development of malignancies is unknown.
Tell your doctor if you:
-- Think you have, are being treated for, have signs of, or are prone to infection
-- Have any open sores
-- Have or have had TB or hepatitis B
-- Have ever been treated for heart failure
-- Have ever had or develop a serious nervous system disorder
-- Develop symptoms such as persistent fever, bruising, bleeding or paleness while taking ENBREL
Common side effects in adult clinical trials were injection site reactions, infection and headache.
In a medical study of patients with JIA, infections, headaches, abdominal pain, vomiting, and nausea occurred more frequently than in adults. The kinds of infections reported were generally mild and similar to those usually seen in children. Other serious adverse reactions were reported, including serious infections, depression/personality disorder.
If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA.
About Amgen and Wyeth
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Wyeth markets ENBREL outside of North America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit amgen.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. To learn more, visit wyeth.
Amgen Forward Looking Statement
This news release contains forward-looking statements that are based on Amgen's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen's business. Unless otherwise noted, Amgen is providing this information as of March 17, 2008, and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen's products after they are on the market. Amgen's business may be impacted by government investigations, litigation and products liability claims. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.
In addition, sales of Amgen's products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of Amgen's products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen routinely obtain patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's ability to obtain or maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen's business and results of operations.
The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
Wyeth Forward Looking Statement
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
View drug information on Enbrel.
пятница, 10 июня 2011 г.
Generics as Effective for Arthritis and Pain as Brand Drugs - Consumer Reports
Ibuprofen and Salsalate Chosen as Consumer Reports Best Buy Drugs -
Two generic drugs - ibuprofen and salsalate - cost significantly less and are as effective as brand name medicines for most
people needing treatment for osteoarthritis and mild to moderate pain, according to a report released today by the Consumer
Reports Best Buy Drugs Project. This is particularly good news for people with arthritis who are now looking for an
alternative to Vioxx, which has been withdrawn from the market for safety reasons.
CRBestBuyDrugs
The two generics, selected as the Best Buy Drugs in the category known as non-steroidal anti-inflammatory drugs (NSAIDs),
cost $24 to $30 a month on average. Some brand name NSAIDs cost more than $150 a month and up to $300 a month.
Thus, the savings possible from a prescription for one of the Best Buy medicines compared to an expensive brand can be
substantial.
The report indicates that all the prescription NSAIDs are equally as effective at typical and comparable dose levels. It
recommends that people who have health insurance talk with their doctor about finding the NSAID that has the lowest possible
out-of-pocket cost under their health insurance plan. Other relatively low-cost generic NSAIDs are available in addition to
ibuprofen and salsalate.
CRBestBuyDrugs
The report also notes that all NSAIDs can have dangerous side effects, especially at higher doses. It recommends that people
who have had a stomach ulcer or gastrointestinal (GI) bleeding, or are at risk of either, consider avoiding the drugs
altogether if possible.
A newer type of NSAID - called Cox-2 inhibitors - have been marketed to help protect against stomach ulcers and GI bleeding.
The report notes that the Cox-2 drugs - Celebrex and Bextra - do not protect against this risk completely. In addition, these
medicines are being closely scrutinized in light of the recent removal from the market of Vioxx, also a Cox-2 drug. Vioxx was
linked to a higher risk of heart attacks and strokes.
"The ubiquitous ads for Vioxx and Celebrex over the last few years have led many consumers to think these costly drugs are
better for everyone. They are not." says Gail Shearer, director of health policy analysis for Consumers Union and project
manager for Consumer Reports Best Buy Drugs. "Our analysis indicates that millions of consumers could get the same symptom
relief and save a lot of money by taking one of the Best Buy drugs we recommend, or another generic, especially if they must
pay for their own medicines out-of-pocket."
Consumer Reports Best Buy Drugs is an educational and outreach initiative that compares a variety of prescription drugs on
cost, effectiveness and safety to help consumers and their doctors identify the most effective and affordable medicines.
Consumers can download reports from the free website, CRBestBuyDrugs, of the first three drug categories reviewed: cholesterol-lowering statins,
heartburn and acid reflux treatments, and anti-inflammatories. Each month, Consumer Reports Best Buy Drugs will feature a
report on best buys in commonly used drug categories.
Consumer Reports Best Buy Drugs combines evidence-based research on the comparative effectiveness and safety of prescription
drugs with national-level data on drug prices. The information on drug effectiveness is derived from the Drug Effectiveness
Review Project (DERP), a 12-state initiative. Drug cost information reflects average retail prices paid in cash by consumers
at the pharmacy. The CU reports are peer-reviewed by medical experts in the particular drug category.
Consumer Reports Best Buy Drugs is funded in part with a grant from the Engelberg Foundation, a charitable trust that
supports a wide range of activities in the fields of health care, science and education. The project is also partially funded
through a grant from the National Library of Medicine of the National Institutes of Health.
©Consumers Union 2004. The material above is intended for legitimate news entities only; it may not be used for commercial or
promotional purposes. Consumers Union, the publisher of Consumer Reports®, is an expert, independent nonprofit organization
whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect
themselves. To achieve this mission, we test, inform, and protect. To maintain our independence and impartiality, CU accepts
no outside advertising, no free test samples, and has no agenda other than the interests of consumers. CU supports itself
through the sale of our information products and services, individual contributions, and a few noncommercial grants.
CRBestBuyDrugs
View drug information on Bextra; Vioxx.
Two generic drugs - ibuprofen and salsalate - cost significantly less and are as effective as brand name medicines for most
people needing treatment for osteoarthritis and mild to moderate pain, according to a report released today by the Consumer
Reports Best Buy Drugs Project. This is particularly good news for people with arthritis who are now looking for an
alternative to Vioxx, which has been withdrawn from the market for safety reasons.
CRBestBuyDrugs
The two generics, selected as the Best Buy Drugs in the category known as non-steroidal anti-inflammatory drugs (NSAIDs),
cost $24 to $30 a month on average. Some brand name NSAIDs cost more than $150 a month and up to $300 a month.
Thus, the savings possible from a prescription for one of the Best Buy medicines compared to an expensive brand can be
substantial.
The report indicates that all the prescription NSAIDs are equally as effective at typical and comparable dose levels. It
recommends that people who have health insurance talk with their doctor about finding the NSAID that has the lowest possible
out-of-pocket cost under their health insurance plan. Other relatively low-cost generic NSAIDs are available in addition to
ibuprofen and salsalate.
CRBestBuyDrugs
The report also notes that all NSAIDs can have dangerous side effects, especially at higher doses. It recommends that people
who have had a stomach ulcer or gastrointestinal (GI) bleeding, or are at risk of either, consider avoiding the drugs
altogether if possible.
A newer type of NSAID - called Cox-2 inhibitors - have been marketed to help protect against stomach ulcers and GI bleeding.
The report notes that the Cox-2 drugs - Celebrex and Bextra - do not protect against this risk completely. In addition, these
medicines are being closely scrutinized in light of the recent removal from the market of Vioxx, also a Cox-2 drug. Vioxx was
linked to a higher risk of heart attacks and strokes.
"The ubiquitous ads for Vioxx and Celebrex over the last few years have led many consumers to think these costly drugs are
better for everyone. They are not." says Gail Shearer, director of health policy analysis for Consumers Union and project
manager for Consumer Reports Best Buy Drugs. "Our analysis indicates that millions of consumers could get the same symptom
relief and save a lot of money by taking one of the Best Buy drugs we recommend, or another generic, especially if they must
pay for their own medicines out-of-pocket."
Consumer Reports Best Buy Drugs is an educational and outreach initiative that compares a variety of prescription drugs on
cost, effectiveness and safety to help consumers and their doctors identify the most effective and affordable medicines.
Consumers can download reports from the free website, CRBestBuyDrugs, of the first three drug categories reviewed: cholesterol-lowering statins,
heartburn and acid reflux treatments, and anti-inflammatories. Each month, Consumer Reports Best Buy Drugs will feature a
report on best buys in commonly used drug categories.
Consumer Reports Best Buy Drugs combines evidence-based research on the comparative effectiveness and safety of prescription
drugs with national-level data on drug prices. The information on drug effectiveness is derived from the Drug Effectiveness
Review Project (DERP), a 12-state initiative. Drug cost information reflects average retail prices paid in cash by consumers
at the pharmacy. The CU reports are peer-reviewed by medical experts in the particular drug category.
Consumer Reports Best Buy Drugs is funded in part with a grant from the Engelberg Foundation, a charitable trust that
supports a wide range of activities in the fields of health care, science and education. The project is also partially funded
through a grant from the National Library of Medicine of the National Institutes of Health.
©Consumers Union 2004. The material above is intended for legitimate news entities only; it may not be used for commercial or
promotional purposes. Consumers Union, the publisher of Consumer Reports®, is an expert, independent nonprofit organization
whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect
themselves. To achieve this mission, we test, inform, and protect. To maintain our independence and impartiality, CU accepts
no outside advertising, no free test samples, and has no agenda other than the interests of consumers. CU supports itself
through the sale of our information products and services, individual contributions, and a few noncommercial grants.
CRBestBuyDrugs
View drug information on Bextra; Vioxx.
вторник, 7 июня 2011 г.
Metabolic Syndrome And Disease Costly In Working Population
Employees with Metabolic Syndrome (MetS) has greater health care costs and productivity losses and is more likely to report arthritis, chronic pain, diabetes and heart disease.
This study examined the health care, pharmacy and short term disability costs of employees (N=3285) of a manufacturing corporation in 2004 and 2006 who did and did not have MetS and disease.
The prevalence of MetS increased in this population from 29.8% in 2004 to 32.1% in 2006 and MetS was significantly associated with the incidence of arthritis, chronic pain, diabetes, and heart disease with odds ratios ranging from 1.607 for chronic pain to 13.191 for diabetes. The costs of those with MetS and disease were 3.66 times greater than those without MetS and without disease.
MetS includes the risk factors of blood pressure, triglycerides, overweight, HDL cholesterol and elevated glucose. Those with the syndrome are at increased risk of morbidity and mortality from a variety of health conditions, thus making MetS an important trait to recognize and treat.
Alyssa B. Schultz PhD, first author of the paper from the University of Michigan Health Management Research Center says: "MetS is associated with disease and increased costs in this working population. There is an opportunity for health promotion to prevent MetS risk factors from progressing to disease status which may improve vitality for employees as well as limit the economic impact to the corporation."
This will be discussed in Value in Health, the official journal of the International Society for Pharmacoeconomics and outcomes Research.
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 4,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
Source
ISPOR
This study examined the health care, pharmacy and short term disability costs of employees (N=3285) of a manufacturing corporation in 2004 and 2006 who did and did not have MetS and disease.
The prevalence of MetS increased in this population from 29.8% in 2004 to 32.1% in 2006 and MetS was significantly associated with the incidence of arthritis, chronic pain, diabetes, and heart disease with odds ratios ranging from 1.607 for chronic pain to 13.191 for diabetes. The costs of those with MetS and disease were 3.66 times greater than those without MetS and without disease.
MetS includes the risk factors of blood pressure, triglycerides, overweight, HDL cholesterol and elevated glucose. Those with the syndrome are at increased risk of morbidity and mortality from a variety of health conditions, thus making MetS an important trait to recognize and treat.
Alyssa B. Schultz PhD, first author of the paper from the University of Michigan Health Management Research Center says: "MetS is associated with disease and increased costs in this working population. There is an opportunity for health promotion to prevent MetS risk factors from progressing to disease status which may improve vitality for employees as well as limit the economic impact to the corporation."
This will be discussed in Value in Health, the official journal of the International Society for Pharmacoeconomics and outcomes Research.
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 4,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
Source
ISPOR
суббота, 4 июня 2011 г.
High vitamin D intake linked to reduced risk of rheumatoid arthritis
A new study has found that women with the highest levels of vitamin D are 30% less likely to develop rheumatoid arthritis than women with the lowest levels of vitamin D.
We all know that vitamin D helps build bones. However, it seems that vitamin D plays a crucial role in our immune system, says team leader, Dr. Kenneth Saag (University of Alabama, Birmingham, USA). His study is reported in the medical journal Arthritis and Rheumatism.
He analysed data from nearly 30,000 women (aged 55-69). At the beginning of the study (1986) all the thirty thousand women were arthritis free. They were monitored for vitamin D intake during the 11-year period (with food frequency questionnaires).
During the period of this study they found 152 confirmed cases of rheumatoid arthritis.
There was a direct link between dietary and supplemental vitamin D intake and a reduced risk of rheumatoid arthritis (i.e. both ways, getting your vitamin D from food or supplements 400 IU/Day reduced rheumatoid arthritis risk).
Dietary intake reduced the risk by 28% while supplemental intake reduced risk by 34%.
Researchers found that supplemental intake reduced rheumatoid arthritis risk significantly. They found no single food which was strongly linked to rheumatoid arthritis risk. They did find, however, that those who consumed the most milk has a lower risk of developing rheumatoid arthritis.
Although we are not yet sure what role vitamin D plays on our immune system 'the results from this study suggest a possible role for vitamin D in reducing the risk of an immunologic disorder', the researchers say. They added that further studies were needed to verify these findings.
SOURCE: Arthritis and Rheumatism, January 2004.
We all know that vitamin D helps build bones. However, it seems that vitamin D plays a crucial role in our immune system, says team leader, Dr. Kenneth Saag (University of Alabama, Birmingham, USA). His study is reported in the medical journal Arthritis and Rheumatism.
He analysed data from nearly 30,000 women (aged 55-69). At the beginning of the study (1986) all the thirty thousand women were arthritis free. They were monitored for vitamin D intake during the 11-year period (with food frequency questionnaires).
During the period of this study they found 152 confirmed cases of rheumatoid arthritis.
There was a direct link between dietary and supplemental vitamin D intake and a reduced risk of rheumatoid arthritis (i.e. both ways, getting your vitamin D from food or supplements 400 IU/Day reduced rheumatoid arthritis risk).
Dietary intake reduced the risk by 28% while supplemental intake reduced risk by 34%.
Researchers found that supplemental intake reduced rheumatoid arthritis risk significantly. They found no single food which was strongly linked to rheumatoid arthritis risk. They did find, however, that those who consumed the most milk has a lower risk of developing rheumatoid arthritis.
Although we are not yet sure what role vitamin D plays on our immune system 'the results from this study suggest a possible role for vitamin D in reducing the risk of an immunologic disorder', the researchers say. They added that further studies were needed to verify these findings.
SOURCE: Arthritis and Rheumatism, January 2004.
среда, 1 июня 2011 г.
Differences In Orthopedic Surgical Outcomes Revealed By Medicare Data
The more specialized a hospital is in orthopedic surgical care, the better the outcomes appear to be for patients undergoing hip and knee replacement surgery, University of Iowa researchers report in a new study of Medicare patients.
Among more specialized hospitals, there were fewer serious post-surgical complications such as blood clots, infections and heart problems, as well as fewer deaths.
The findings, which were published online Feb. 11 by the British Medical Journal, were based on data for nearly 1.3 million patients who received hip or knee replacement surgeries between 2001 and 2005 at 3,818 hospitals in the United States.
"The findings suggest that more specialized hospitals have better outcomes even after we account for the type of patients each hospital cares for and the number of hip and knee replacement surgeries that each hospital performs," said the study's lead author Tyson Hagen, M.D., fellow in rheumatology at the UI Roy J. and Lucille A. Carver College of Medicine and UI Hospitals and Clinics.
"While specialization appears to be an important indicator of quality, it is just one factor that patients might want to consider along with other important factors, such as how close the hospital is to home," Hagen added.
By using Medicare data from 2001 to 2005, the study was limited to the experience of patients age 65 and older. The study authors used Medicare data since it is available for almost all hospitals in the United States. While the study focused on people age 65 and older, the researchers said the findings indicate trends that could be relevant to the larger population.
The study adjusted for differences in the types of patient seen at each hospital, as well as the number of surgeries that each hospital performed. Compared to the least specialized hospitals, the more specialized hospitals treated a lower proportion of women and African-Americans. These hospitals also treated patients who had better health overall.
The results grouped hospitals into five levels of specialization. At the average hospital, orthopedic surgeries, which include back surgery and fracture repair in addition to joint replacements, represented 10.5 percent of admissions. The most specialized group in the current study included hospitals that had 14.5 percent or more admissions for orthopedic care. These hospitals had fewer complications or deaths within the first 90 days after a surgery than less specialized hospitals did.
For example, the rate of death for patients who had hip and knee replacements was twice as high at the least specialized hospitals compared to patients treated at the most specialized hospital -- 1.4 percent compared to .7 percent within the first 90 days after surgery.
In addition, the rate of post-surgery infection for patients who got hip and knee replacements decreased from 2.6 percent at the least specialized hospitals to 1.6 at the most specialized hospitals.
The study's senior author Peter Cram, M.D., UI associate professor of internal medicine, noted that larger hospitals might do a relatively high volume of orthopedic surgical cases but often were categorized as less specialized because they do so many other types of surgeries besides orthopedics.
"Learning more about orthopedic specialization could help us to better understand how to organize care and take ideas from more specialized hospitals to less specialized hospitals, and result in better outcomes all around," Cram said.
The study also involved the Center for Research in the Implementation of Innovative Strategies at the Iowa City Veterans Affairs Medical Center.
The study was supported in part by funding from the National Institutes of Health. In addition, Cram is supported through the Robert Wood Johnson Faculty Scholars Program.
Source:
Becky Soglin
University of Iowa - Health Science
Among more specialized hospitals, there were fewer serious post-surgical complications such as blood clots, infections and heart problems, as well as fewer deaths.
The findings, which were published online Feb. 11 by the British Medical Journal, were based on data for nearly 1.3 million patients who received hip or knee replacement surgeries between 2001 and 2005 at 3,818 hospitals in the United States.
"The findings suggest that more specialized hospitals have better outcomes even after we account for the type of patients each hospital cares for and the number of hip and knee replacement surgeries that each hospital performs," said the study's lead author Tyson Hagen, M.D., fellow in rheumatology at the UI Roy J. and Lucille A. Carver College of Medicine and UI Hospitals and Clinics.
"While specialization appears to be an important indicator of quality, it is just one factor that patients might want to consider along with other important factors, such as how close the hospital is to home," Hagen added.
By using Medicare data from 2001 to 2005, the study was limited to the experience of patients age 65 and older. The study authors used Medicare data since it is available for almost all hospitals in the United States. While the study focused on people age 65 and older, the researchers said the findings indicate trends that could be relevant to the larger population.
The study adjusted for differences in the types of patient seen at each hospital, as well as the number of surgeries that each hospital performed. Compared to the least specialized hospitals, the more specialized hospitals treated a lower proportion of women and African-Americans. These hospitals also treated patients who had better health overall.
The results grouped hospitals into five levels of specialization. At the average hospital, orthopedic surgeries, which include back surgery and fracture repair in addition to joint replacements, represented 10.5 percent of admissions. The most specialized group in the current study included hospitals that had 14.5 percent or more admissions for orthopedic care. These hospitals had fewer complications or deaths within the first 90 days after a surgery than less specialized hospitals did.
For example, the rate of death for patients who had hip and knee replacements was twice as high at the least specialized hospitals compared to patients treated at the most specialized hospital -- 1.4 percent compared to .7 percent within the first 90 days after surgery.
In addition, the rate of post-surgery infection for patients who got hip and knee replacements decreased from 2.6 percent at the least specialized hospitals to 1.6 at the most specialized hospitals.
The study's senior author Peter Cram, M.D., UI associate professor of internal medicine, noted that larger hospitals might do a relatively high volume of orthopedic surgical cases but often were categorized as less specialized because they do so many other types of surgeries besides orthopedics.
"Learning more about orthopedic specialization could help us to better understand how to organize care and take ideas from more specialized hospitals to less specialized hospitals, and result in better outcomes all around," Cram said.
The study also involved the Center for Research in the Implementation of Innovative Strategies at the Iowa City Veterans Affairs Medical Center.
The study was supported in part by funding from the National Institutes of Health. In addition, Cram is supported through the Robert Wood Johnson Faculty Scholars Program.
Source:
Becky Soglin
University of Iowa - Health Science
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