TUESDAY, June 5 (HealthDay News) -- Results of a new drug-company funded study show no significant increased risk for heart attack or death from heart disease associated with Avandia, the widely used diabetes drug.
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The British study, released Tuesday by the New England Journal of Medicine, follows last month's study in the same journal by Dr. Steven E. Nissen and Kathy Wolski of the Cleveland Clinic, which found a significant -- up to 43 percent-- increased risk of cardiovascular deaths and heart attack from the drug.
The latest study was released by the journal early to coincide with a Congressional hearing Wednesday that will focus on the drug's safety risks.
The British researchers saw no increased risk for cardiac events among those taking Avandia (generic name rosiglitazone) and those not taking it.
"Overall, there was no significant difference between those on rosiglitazone and those not on rosiglitazone," said study co-author Stuart J. Pocock, of the London School of Hygiene & Tropical Medicine. "The concern about cardiovascular death, I think we have clearly deflated. The concern on heart attack -- our data are modifying that concern, but it's still inconclusive," he said.
But one expert thinks that any risk is too great, and there is no need to use the drug.
"These current data do not reassure me; in fact, they make me more concerned that there may be a problem here," said Dr. David M. Nathan, of Massachusetts General Hospital, and author of an accompanying editorial in the journal.
On May 21, the U.S. Food and Drug Administration responded to concerns in the Nissen-Wolski study by issuing a safety alert for the drug. But it stopped short of asking for a stronger warning label, saying more analysis was needed.
The hearing Wednesday, by the House Committee on Oversight and Government Reform, will focus in part on the FDA's actions. The committee is chaired by Rep. Henry Waxman, D-Calif., a frequent critic of the agency.
In Pocock's trial, researchers randomly selected 4,447 people with type 2 diabetes to receive rosiglitazone or metformin plus other drugs. During 3.75 years of follow-up, 217 people taking rosiglitazone and 202 patients taking metformin either died or were hospitalized due to heart disease.
"If you look at deaths, including cardiovascular deaths, there were slightly more deaths in the control group than among those taking rosiglitazone," Pocock said. "That's very assuring."
While there was no "significant" difference in heart attacks between the two groups, there were slightly more heart attacks among people taking rosiglitazone, Pocock said.
Comparing these results with the Nissen-Wolski study, Pocock said his findings "lie somewhere between no cardiovascular effect and the Nissen effect. We have to say, at present, given ours is an ongoing study, our findings are inconclusive."
Nathan pointed out, however, that the original goal of the new study was to show a benefit of rosiglitazone in preventing heart disease.
"When you get a finding that is against the hypothesis, it makes me sit up and take note," he said. "None of the data is reassuring. You don't give the drug the benefit of the doubt -- you give safety the benefit of the doubt."
There are lots of other choices for diabetes medications, Nathan added. "I don't see the advantage of rosiglitazone compared with its potential disadvantages," he said. "When you have drugs that may not be safe, you try to use the ones that are safe."
GlaxoSmithKline, the makers of Avandia, said in a prepared statement that the British study should reassure type 2 diabetes patients that the product is safe.
"The interim findings do not show evidence of a significant difference in cardiovascular death and heart attack between Avandia and the control groups, and therefore do not confirm the hypothesis generated by the recently published meta-analysis in the New England Journal of Medicine that raised concerns about these events with Avandia," said Moncef Slaoui, chairman for research and development at GlaxoSmithKline.
"They [the findings] add to the weight of evidence, from both previously published long-term clinical trials and other studies, that the overall ischemic cardiovascular safety profile of Avandia is comparable to the traditional anti-diabetes treatments. Patients and physicians should find these data reassuring," Slaoui added.
SOURCES: Stuart J. Pocock, Ph.D., London School of Hygiene & Tropical Medicine, London, England; David M. Nathan, M.D., Massachusetts General Hospital, Boston; June 5, 2005, statement, GlaxoSmithKline United States, Philadelphia; June 5, 2007, online release, New England Journal of Medicine
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