"How exactly can they establish the safety of rosiglitazone in a short-term study with less than 100 patients receiving the drug?" asked Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation, who was the first to report the risk of heart attack associated with Avandia. "This was an intravascular ultrasound study, not a morbidity-mortality study."
Dr. Gregg C. Fonarow, a professor of cardiology at the University of California, Los Angeles, agreed with Nissen that the study was too small to make any valid claims about the safety of Avandia.
"This study with only 193 patients is too small to draw any conclusions regarding the potential benefits and risk of rosiglitazone in this patient population," he said.
Dr. Paul Aftring, senior director of metabolic research at GlaxoSmithKline, said, "We recognize the limitation of the size of this study, but the safety data were very reassuring. They are consistent with other data in high-risk populations."
The safety data of any trial is never defined by a population of less than 100 patients, Aftring said. "But the longer-term data in longer-term studies in high-risk populations is actually quite reassuring," he added.
Aftring noted that the current labeling of Avandia says that the drug should be used with caution in high-risk populations. "Victory adds to the knowledge base that in well-managed populations, careful use of rosiglitazone is appropriate, and there are no safety issues," he said.
More information
For more on diabetes drugs, visit the U.S. Food and Drug Administration .
