Steve is formally known as Dr. Steven Nissen, chief of cardiology at one of the country’s leading cardiology establishments, the Cleveland Clinic. He is one of the country’s most prominent cardiologists, and he concentrates more and more on drug safety. His tools of choice are statistics and meta-analyses, which pool data from previous studies. He is also an expert at searching the Web.
Together with researcher Kathy Wolski, they threw the diabetes world into a tizzy with yesterday’s online publication with an article linking Avandia to a risk of heart attacks and death. The article, “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” will appear in the June 14 print issue of the prestigious New England Journal of Medicine.
The analysis, based on a review of 42 clinical studies involves nearly 28,000 patients, found that Avandia raises the risk of heart attack by 43 percent. That is statistically significant (with a p value of 0.03). Avandia also increases in the risk of death from all cardiovascular causes by 64 percent, although the finding was not statisically significant (a p value of 0.06).
Patients taking Avandia had 86 heart attacks and 39 deaths. By comparison, patients in the studies who didn’t take Avandia had 72 heart attacks and 22 deaths.
These findings are especially frightening to many people with diabetes and their doctors because two-thirds of those of us with diabetes die from heart problems. “If you find a diabetes drug increases the risk of heart attacks, the consequences are so grave that it warrants urgent action,” Dr. Nissen told The Wall Street Journal.
If Avandia threatens the heart, no one knows just how it does this. But Avandia is one of a class of drugs known as peroxisome proliferator-activated receptor-γ (PPAR-γ) agonists, which has multiple effects on the body. The notorious drug Rezulin, which Warner-Lambert withdrew from the market in 2000 after it killed at least 63 people from liver and heart disease, is a class member. David Willman of The Los Angeles Times won the 2001 Pulizer Prize for investigative reporting of that scandal.
And it’s not that there aren’t alternatives. Avandia has been the nation’s No. 2 diabetes drug. American doctors wrote more than 13 million prescriptions for Avandia last year, according to data that USA Today cited in its front-page article today. Avandia sales last year were $1.7 billion in the United States, just a bit behind another drug in the same class, Actos, with $1.9 billion, according to data cites in today’s New York Times.