The FDA cautions about heart risk with Parkinson’s drug Stalevo
The Food and Drug Administration on Friday cautioned that it is investigating the possibility that the combination Parkinson’s drug Stalevo may increase the risk of heart attack, stroke and death in elderly patients who are taking it. The agency urged patients not to stop taking the drug, but warned them to let their physicians know if the patients have risk factors for cardiovascular disease.
Stalevo, sold by Novartis, is a combination of three drugs: carbidopa, levodopa and entacapone. The combination of carbidopa and levodopa is sold separately under the brand name Sinemet and is a standard therapy for Parkinson’s, while entacapone is sold individually under the brand name Comtan. Comtan has no anti-Parkinson’s activity of its own, but it improves the efficacy of carbidopa/levodopa.
The first indication of risk for Stalevo, the agency said, came from a clinical trial called STRIDE-PD, in which 373 patients took Stalevo and 372 received carbidopa/levodopa. The average age of the patients was 60, and the trial lasted an average of 2.7 years. That study found seven heart attacks and one death in the Stalevo group and none in the carbidopa/levodopa group.
Concerned, the agency combined results from that study with those from 14 other trials totaling about 4,800 patients. That analysis showed 27 heart attacks, strokes or deaths in the Stalevo group compared with 10 in the carbidopa/levodopa group, for a statistically significant increased risk of 146%. But when the data from STRIDE-PD was not included, the increased risk was only 67% and it was not statistically significant.
There are several limitations to the study, the agency said. Parkinson’s patients have an increased risk of cardiovascular events, the studies were not designed to examine cardiovascular risks, and most of the studies had a duration less than six months. The FDA said it is now trying to find additional ways to quantify the potential risk.
Thomas H. Maugh II / Los Angeles Times
