The U.S. Food and Drug Administration (FDA) has notified healthcare professionals that it is evaluating clinical trial data that suggest patients taking Stalevo® may be at an increased risk for cardiovascular events – including strokes – compared to those taking rival product Sinemet.
What is Stalevo?
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.
It is estimated that 154,000 patients were dispensed a prescription for Stalevo from its approval in June 2003 through October 2009.
Stalevo Linked to Increased Risk for Stroke
The FDA’s review of the potential stroke risk with Stalevo is ongoing. The data being evaluated are from a meta-analysis that combined the cardiovascular-related findings from 15 clinical trials comparing Stalevo to carbidopa/levodopa. In the meta-analysis, an increased risk of cardiovascular events in the Stalevo group was found.
US FDA alerts healthcare professionals to regularly evaluate the cardiovascular status of patients who are taking Stalevo, especially if they have a history of cardiovascular disease.
STRIDE-PD Stalevo Trial
In STRIDE-PD, 373 patients received Stalevo and 372 received carbidopa/levodopa. Treatment lasted between 2.6 years and 4 years. The average age of patients in the trial was approximately 60 years. During the trial, seven myocardial infarctions and one cardiovascular death were reported in the Stalevo group and no myocardial infarctions or cardiovascular deaths were reported in the carbidopa/levodopa group.