Avandia, a pill widely prescribed by doctors to treat type 2 diabetes, actually increases users' risk for heart attack by 43 percent, U.S. researchers reported Monday.
The findings on Avandia (generic name rosiglitazone) will appear in the June 14 issue of the New England Journal of Medicine, but were released early on Monday by the journal's editors due to their public health importance.
"In view of the potential cardiovascular risks and in the absence of evidence of other health advantages, except for laboratory measures of glycemic [blood sugar] control, the rationale for prescribing rosiglitazone at this time is unclear," concluded Drs. Bruce M. Psaty, of the University of Washington, and Curt D. Furberg, of Wake Forest University, two diabetes experts who co-authored an accompanying editorial in the journal.
Psaty and Furberg also said that, barring any new data to the contrary, the U.S. Food and Drug Administration should take regulatory action to restrict access to Avandia, which is made by GlaxoSmithKline.
However, the editorial noted the findings aren't conclusive. "A few events either way might have changed the findings for myocardial infarction or for death from cardiovascular causes. In this setting, the possibility that the findings were due to chance cannot be excluded. In their discussion, the authors properly emphasize the fragility of their findings."
GlaxoSmithKline responded by issuing a strongly worded press release defending the safety of the drug. In the statement, company officials said that GSK "strongly disagrees with the conclusions reached in the New England Journal of Medicine article, which are based on incomplete evidence and a methodology that the author admits has significant limitations."
The company said that several large scale, long-term clinical trials, overseen by safety monitoring boards, have yet to uncover any threats to patient safety. "GSK's long-term, landmark study ADOPT [A Diabetes Outcome Progression Trial] -- one of the longest clinical trials in people with type 2 diabetes to date -- directly compared both the safety and effectiveness of Avandia with other oral anti-diabetic medicines in over 4,300 patients studied for up to six years," the statement said.
"Data from ADOPT showed that the overall risk of serious, cardiovascular events [CV death, myocardial infarction, and stroke, or MACE endpoint] for patients on Avandia was comparable to metformin and sulfonylurea (glyburide) -- two of the most commonly used medicines to treat type 2 diabetes," the statement said.
A second long-term study, DREAM, which followed more than 5,200 patients at high risk of developing of type 2 diabetes for a period of three to five years, found that "Avandia monotherapy showed no increase in cardiovascular risk when compared to placebo," according to the statement.
More than 2 million people worldwide now take Avandia for type 2 diabetes, generating $3.2 billion in annual sales for the GlaxoSmithKline, according to The New York Times. Avandia was first approved for the treatment of type 2 diabetes in 1999.
For the new study, Dr. Steven Nissen and his colleague Kathy Wolski at the Cleveland Clinic evaluated 42 studies that compared patients taking Avandia with patients not using the drug. The studies included almost 28,000 patients, 15,560 of whom were taking Avandia.
The researchers found the risk of a heart attack was increased 43 percent among those taking Avandia, and there was a 64 percent increased risk of dying from cardiovascular causes, compared with patients not taking the drug.
Among patients taking Avandia, 86 had heart attacks compared with 72 among patients not on the drug. In addition, 39 patients taking Avandia died from cardiovascular causes compared with 22 patients not receiving the drug, Nissen and Wolski found.
"Rosiglitazone was associated with a significant increase in the risk of myocardial infarction [heart attack] and with an increase in the risk of death from cardiovascular causes that had borderline significance," the authors wrote.
"Until more precise estimates of cardiovascular risk of this treatment can be delineated in patients with diabetes, patients and providers should carefully consider the potential of rosiglitazone in the treatment of type 2 diabetes," they concluded.
In their editorial, Psaty and Furberg said the new data about Avandia highlights the failure of the FDA's drug-approval process.
"During the market life of rosiglitazone, tens of millions of prescriptions for the drug have been written for patients with type 2 diabetes," they wrote. "Insofar as the findings of Nissen and Wolski represent a valid estimate of the risk of cardiovascular events, rosiglitazone represents a major failure of the drug-use and drug-approval process in the United States."
But GlaxoSmithKline strongly refuted the study's claims.
"The totality of the data show that Avandia has a comparable cardiovascular profile to other oral anti-diabetic medicines," the company said. "GlaxoSmithKline stands firmly behind the safety of Avandia when used appropriately, and we believe its significant benefits continue to outweigh any treatment risks," they added.
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