The New England of Journal recently published a scathing report on the adverse cardiovascular effects of Avandia. Avandia has been used since 1999 to treat diabetes II, and was approved by the FDA with the knowledge that minimal cardiovascular effects existed, but not more than with any other diabetic drug which existed. However, the risk for people with congestive heart failure was slightly higher.
The fact that a drug, any drug, has adverse effects should not come as a surprise to any of us. Asprin, tylenol, vitamins, etc.; all have their side effects, including death. Have any of these drugs been pulled from the market place? Of course not! However, physicians when they prescribe, and consumers when they buy, are educated on the effects and how to minimize.
However, the NEJM's article indicated that the risk of a CV event increased by 43% with Avandia. This news caused a real panic, to the point of stupor, in a public that had only recently been recovering from the Vioxx catastrophe.
So, the question now is, are those frightening statistics true, and if so, how could the FDA approve this drug to an unknowing public?
Several well known and respected physicians took to the field to respond to this question. Their answer, as a whole, was that the statistics used in the NEJM were skewed. One physician even stated that the NEJM is becoming no better than a British tabloid, minus the bare chested women. Bad news makes news, and news makes money!
The real statistics on Avandia are a lot less shocking:
- MI rates of 0.6% for rosiglitazone group vs 0.3% for controls
- MI/stroke/cardiovascular composite occurred in 1.2% of rosiglitazone vs 0.9% of control patients
- congestive heart failure episodes for rosiglitazone-treated patients compared with glyburide 22 vs 9 events
The only statistic that is really significant in the above three was the slightly higher rate of congestive heart failure episodes for some patients.
No one is saying Avandia is cardioprotective, as the manufacturer initially had reported. However, with the appropriate use of Avandia and careful monitoring, adverse effects are minimized. The FDA has always cited this side effect as one that would need careful monitoring; now it will emphasize this side effect by including it on the label of the medication.
Additionally, scientists are awaiting the conclusion of a much better designed research than published by the NEJM to evaluate the full effects of this drug. This much is know for sure; if the adverse effects were even half as high as that portended by the NEJM the research would have been halted immediately. The public's safety is always the most important factor in any research.
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