New Study Finds No Significant Heart Attack Risk From Diabetes Drug

Finding conflicts with previous research on Avandia; experts still express concern

By Steven Reinberg
HealthDay Reporter

Related Encyclopedia • Addison's Disease • Carcinoid Syndrome • Congenital Adrenal Hyperplasia • Cushing's Syndrome More... Related Healthscout Videos Hope for Diabetes and Lou Gehrig's Preventing Type 1 Diabetes Medicine's Next Big Thing? Diabetes Discoveries Continuous Glucose Monitoring System More... Related Animations • Diabetes More... Related Drug Information • Actonel • Actos • Amaryl • Avandamet More... Related News Articles • Panel Calls for Better Diabetes Screening • Mediterranean Diet May Ward Off Type 2 Diabetes • Anti-Rejection Drug May Boost Diabetes in Kidney Transplant Patients • Enriched Cocoa Improves Blood Flow in Diabetics More...

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.

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.

Text Continues Below

---

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.

Page:  1 | 2 | Next >>