Avandia should be pulled from the market because of the "serious" cardiovascular risk the diabetes drug poses, which exceeds that of
competitor pioglitazone (
Actos),
FDA staff reviewers again recommended.Rosiglitazone is no more effective at improving
glycemic control in
type 2 diabetes than pioglitazone and provides no known unique
health benefits, and while both drugs increase the risk of
congestive heart failure,
rosiglitazone's effect is "substantially greater," FDA reviewers wrote in a massive briefing document released Friday
In the FDA reviewers' analysis, the hazard ratios with rosiglitazone versus placebo were:
- 1.42 for MI (95% lower confidence limit 0.93, 95% upper confidence limit 2.16)
- 0.96 for strokes (95% LCL 0.60, 95% UCL 1.54)
- 0.95 for cardiovascular death (95% LCL 0.57, 95% UCL 1.60)
- 1.13 for major adverse cardiovascular events (95% LCL 0.85, 95% UCL 1.50)
More
here.
