Vioxx, a pain killer, was withdrawn from the market in 2004 after the APPROVe trial showed that it doubled the risk of heart attacks.
In a new study published in The Lancet, researchers contacted 84% of the people who took part in the original trial and confirmed the findings of previous study. They also found that a year after stopping the treatment, participants still had increased risk of heart attack, stroke or death comapred with those in the placebo group. The researchers raised the concern that long term use of of all non-aspirin NSAIDs may have a similar effect and suggested doctors to weigh up the benefits of these drugs in individual patients.
The drugmaker, Merck, issued a statement :"....this post-hoc analysis using limited data from a prematurely terminated study needs to be interpreted very cautiously......".
Source: Baron JA, Sandler RS, Bresalier RS et al. Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. The Lancet 2008; Oct 14 [Early online publication]
Showing posts with label vioxx. Show all posts
Showing posts with label vioxx. Show all posts
Friday, October 24, 2008
Friday, May 25, 2007
Avandia and myocardial infarction
A leading cardiologist, Steven Nissen, found that Avandia (generic name: rosiglitazone), a diabetes drug, "was associated with significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance."
The study concluded that despite the study's limitation, " patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes."
His findings were based on an analysis of 42 RCTs and published online on May 21 by NEJM. "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes". The article will appear in the June 14 issue of the Journal.
Avandia is a top-selling diabetes drug manufacturered by GlaxoSmithKline, introduced in 1999 and is widely used to lower blood glucose levels in patients with type 2 diabetes mellitus. Nissen’s analysis on Avandia has caused the Glaxo stock down more than 6% in midday trading.
Dr. Nissen is a strong critic on drug safety, he and colleague, Eric Topol, a well-known cardiologist, raised concerns about the safety of Vioxx in JAMA in 2001 that led to the withdrawal of the drug from the market in 2004. Dr Topol lost his job after testimony against the drug manufacturer Merck in federal trial.
The study concluded that despite the study's limitation, " patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes."
His findings were based on an analysis of 42 RCTs and published online on May 21 by NEJM. "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes". The article will appear in the June 14 issue of the Journal.
Avandia is a top-selling diabetes drug manufacturered by GlaxoSmithKline, introduced in 1999 and is widely used to lower blood glucose levels in patients with type 2 diabetes mellitus. Nissen’s analysis on Avandia has caused the Glaxo stock down more than 6% in midday trading.
Dr. Nissen is a strong critic on drug safety, he and colleague, Eric Topol, a well-known cardiologist, raised concerns about the safety of Vioxx in JAMA in 2001 that led to the withdrawal of the drug from the market in 2004. Dr Topol lost his job after testimony against the drug manufacturer Merck in federal trial.
Subscribe to:
Comments (Atom)