The FDA is looking into safety data on the Novartis drug Stalevo, a combination treatment for Parkinson's disease. The agency said the drug may increase the risk of heart attack, stroke and death in elderly patients, and that it's working to check out that possibility.
The safety review was touched off by data from a trial known as STRIDE-PD, which compared treatment with Stalevo, a combination of entacapone with carbidopa/levodopa, to treatment with Merck's Sinemet, a carbiopa/levodopa drug. In that trial, seven heart attacks and one death were observed in Stalevo patients, but none in the Sinemet group.
Pooling that data with 14 other trials covering some 4,800 patients, the FDA found 27 heart attacks, strokes or deaths in the Stalevo group compared with 10 in the Sinemet group. But, as the agency points out, this data isn't exactly perfect; the studies weren't designed to measure cardiovascular risks, for one thing. So the FDA is looking for other ways to assess Stalevo safety. In the meantime, patients should keep taking Stalevo, the agency says, but should tell their doctors if they have CV risk factors.