Avandia and the Risk of Heart Attack

Posted May 22, 2007

Yesterday Drs. Steven Nissen and Kathy Wolski published their concern that Avandia might increase the risk of heart attack and death from heart problems in the New England Journal of Medicine on line. The report is getting wide publicity.

Should you be worried?
Should you stop taking your Avandia, Avandamet or Avandaryl?

The short answer to both these questions is a definitive NO.

1). The report by Drs Nissen and Wolski does not present any new research. It is a “meta-analysis” of a collection of old studies. Meta-analysis is a technique in which a mish-mash of studies is combined and analyzed using statistics. Meta-analyses are considered poor quality science. Frequently the results found through meta-analysis are proven wrong. A minority of meta-analysis results stand the test of time.

2. The best studies of the effects of Avandia done to date—that is those studies carried out in the most high quality reliable ways, do NOT show any increased risk of heart attack or death.

For example, the study called ADOPT included over 4000 patients with diabetes followed up to 6 years. Other studies have shown that Avandia actually reduced heart blockage after angioplasty and stent placement.

3. In an ongoing fashion throughout the course of a clinical trial, safety-monitoring committees examine the results, as they are collected. At present thousands of patients are participating in studies of Avandia, studies that have already covered several years of experience with Avandia. The RECORD study and the ACCORD study sponsored by the NIH are designed to learn about how diabetes causes heart disease. There has been no evidence of increased risk of heart disease from Avandia in these high quality studies.

4. The fine-print of the New England Journal of Medicine article states that Dr. Nissen receives research funding from Takeda Pharmaceuticals. He does not receive funding from Glaxo Smith Kline, the makers of Avandia.

Takeda makes Actos, a medicine chemically related to Avandia. Both Avandia and Actos help control blood sugar in the same way. There are no major differences between the medical effects of Actos (Takeda) and Avandia (Glaxo Smith Kline).The two companies that make Avandia and Actos compete against each other.

We urge you not to listen to the TV or read the newspaper to make important decisions on your health. Check our website for updates or if you are a patient under our care, feel free to call our office with additional questions.