New arthritis drugs carry unacceptable risks and expense for most patients
Merck to Withdraw Vioxx Because of Heart Risks
Sept. 30 (Bloomberg) -- Merck & Co. withdrew its Vioxx painkiller, which generated $2.5 billion in sales last year, because of a link to heart attacks and strokes. The company's shares slid as much as 28 percent, wiping out $28 billion in market value.
New three-year data from Merck suggested that patients taking Vioxx for more than 18 months faced twice the risk of a heart attack compared with those taking a placebo.
Drug companies are really promoting the new arthritis drugs such as Vioxx and Celebrex. These drugs are known collectively as "coxibs" because they inhibit an enzyme called COX-2. Sales of Coxib drugs in the US exceeds $7 BILLION per year even though these drugs are generally less effective for pain than is aspirin. they are associated with increased risk for heart attack, stroke, hypertension, renal failure, kidney failure and sudden unexplained death.
Got joint pain? Be sure your doctor uses safe and effective natural treatment. Just say "No" to drugs that cause heart attack, stroke, and sudden death. Arthritis drugs and "antidepressant" drugs may be more dangerous than beneficial. Treat the underlying cause of the problem: naturopathic medicine is the only healthcare paradigm that emphasizes treating the cause of the problem. Dr. Vasquez is the only licensed (Oregon and Washington) naturopathic doctor in Fort Worth, Texas.
Vioxx increases risk of heart attack, stroke, and sudden death
Risk of cardiovascular events associated with selective COX-2 inhibitors.
Journal of the American Medical Association 2001 Aug 22-29;286(8):954-9
Mukherjee D, Nissen SE, Topol EJ. Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, F 25, 9500 Euclid Ave , Cleveland , OH 44195 , USA .
Atherosclerosis is a process with inflammatory features and selective cyclooxygenase 2 (COX-2) inhibitors may potentially have antiatherogenic effects by virtue of inhibiting inflammation. However, by decreasing vasodilatory and antiaggregatory prostacyclin production, COX-2 antagonists may lead to increased prothrombotic activity. To define the cardiovascular effects of COX-2 inhibitors when used for arthritis and musculoskeletal pain in patients without coronary artery disease, we performed a MEDLINE search to identify all English-language articles on use of COX-2 inhibitors published between 1998 and February 2001. We also reviewed relevant submissions to the US Food and Drug Administration by pharmaceutical companies. Our search yielded 2 major randomized trials, the Vioxx Gastrointestinal Outcomes Research Study (VIGOR; 8076 patients) and the Celecoxib Long-term Arthritis Safety Study (CLASS; 8059 patients), as well as 2 smaller trials with approximately 1000 patients each. The results from VIGOR showed that the relative risk of developing a confirmed adjudicated thrombotic cardiovascular event (myocardial infarction, unstable angina, cardiac thrombus, resuscitated cardiac arrest, sudden or unexplained death, ischemic stroke, and transient ischemic attacks) with rofecoxib treatment compared with naproxen was 2.38 (95% confidence interval, 1.39-4.00; P =.002). There was no significant difference in cardiovascular event (myocardial infarction, stroke, and death) rates between celecoxib and nonsteroidal anti-inflammatory agents in CLASS. The annualized myocardial infarction rates for COX-2 inhibitors in both VIGOR and CLASS were significantly higher than that in the placebo group of a recent meta-analysis of 23 407 patients in primary prevention trials (0.52%): 0.74% with rofecoxib (P =.04 compared with the placebo group of the meta-analysis) and 0.80% with celecoxib (P =.02 compared with the placebo group of the meta-analysis). The available data raise a cautionary flag about the risk of cardiovascular events with COX-2 inhibitors. Further prospective trial evaluation may characterize and determine the magnitude of the risk.
A coxib a day won't keep the doctor away
The first agents to block cyclo-oxygenase 2 (COX2) were commercially introduced 5 years ago as new alternatives to existing non-steroidal anti-inflammatory drugs (NSAIDs). However, the pivotal trials of the first two COX2 inhibitors, rofecoxib and celecoxib, led to much consternation about their efficacy and safety profiles. In particular, rofecoxib [Vioxx] was associated with an unanticipated five-fold increase in myocardial infarctions [heart attacks] compared with naproxen.
THE LANCET Volume 364, Number 9435 21 August 2004
Coxibs not cost-effective for arthritis in most patients
Selective cyclooxygenase-2 (COX-2) inhibitors such as rofecoxib and celecoxib might not be cost-effective for first-line treatment of arthritis pain in patients at average risk for gastrointestinal bleeding, say US researchers.
Brennan Spiegel (University of California, Los Angeles, CA, USA) and colleagues report that, except for a subset of patients with a previous history of an ulcer bleed, the drugs--also known as "coxibs"--are not as cost-effective as non-steroidal anti-inflammatory drugs (NSAIDs) in treating an average patient with chronic arthritis, and both work equally well in controlling symptoms.
"In terms of doing better for gastrointestinal bleeding and very serious complications, there's a very small benefit for taking coxibs, and it's certainly a significant benefit when you look at the large studies", says Spiegel. "But in terms of how much we're paying for it, it doesn't seem to fulfill the basic criteria of what is cost-effective."
The researchers used decision-analysis software to analyse two strategies for managing a hypothetical cohort of 60-year-old patients with osteoarthritis or rheumatoid arthritis, who are not taking concurrent aspirin, and who need long-term NSAID therapy for moderate-to-severe arthritis pain.
Patients were initially treated with either a coxib or a non-selective NSAID, and over a lifetime developed either a gastrointestinal complication or remained free of gastrointestinal adverse events. In the average patient without prior gastrointestinal problems, using a coxib instead of a non-selective NSAID cost an additional US$275 809 a year to gain an extra quality-adjusted life-year. This fell to $55 803 when the analysis was limited to the subset of patients with a previous history of an ulcer bleed, thus proving potentially cost-effective (Ann Int Med 2003; 138: 795-806).
The researchers even biased the model in several ways to favour coxibs, such as excluding aspirin users from the cohort. The data suggest that concurrent aspirin use attenuates the gastrointestinal protective effects of coxibs, but even by being conservative, Spiegel says, they were not cost-effective.
Got joint pain? Be sure your doctor uses safe and effective natural treatment. Just say "No" to drugs that cause heart attack, stroke, and sudden death. Arthritis drugs and "antidepressant" drugs may be more dangerous than beneficial. Treat the underlying cause of the problem: naturopathic medicine is the only healthcare paradigm that emphasizes treating the cause of the problem. Dr. Vasquez is the only licensed (Oregon and Washington) naturopathic doctor in Fort Worth, Texas.
