The Food and Drug Administration (FDA) has notified healthcare professionals that it is evaluating clinical trial data suggesting that patients taking Stalevo™ (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events  compared with those taking carbidopa/levodopa (sold as the combination product, Sinemet™).

Both Stalevo and Sinemet have been shown to be effective treatments for the symptoms of Parkinson’s disease. The addition of entacapone to carbidopa/levodopa has been shown to lead to a greater degree of improvement in some of the symptoms of Parkinson disease than treatment with carbidopa/levodopa alone. Entacapone is also available as a single-ingredient product (sold under the brand name Comtan®), which is always administered in association with carbidopa/levodopa, as entacapone has no antiparkinsonian effect of its own. It is estimated that 154,000 patients were dispensed a prescription for Stalevo from its approval in June 2003 through October 2009.

The agency’s decision to conduct a meta-analysis was based on findings from the Stalevo Reduction In Dyskinesia Evaluation – Parkinson’s Disease (STRIDE-PD) trial, which reported an imbalance in the number of myocardial infarctions in patients treated with Stalevo compared with those receiving only carbidopa/levodopa. Although myocardial infarction, cardiac irregularities, hypertension, and palpitations have been reported with levodopa, previous clinical trials with Stalevo did not show an imbalance in cardiovascular events.

At this time, the FDA’s review of the potential cardiovascular risk with Stalevo is ongoing. Healthcare professionals should regularly evaluate the cardiovascular status of patients who are taking Stalevo, especially if they have a history of cardiovascular disease. Patients should not stop taking Stalevo unless told to do so by their healthcare professional.

The FDA is exploring additional ways to assess whether Stalevo increases the risk of cardiovascular events, and will update the public when this review is complete.

1. Food and Drug Administration (FDA). Drugs. Drug Safety and Availability. FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk. Updated August 23, 2010. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm223060.htm. Accessed August 24, 2010.

Posted in News Service
This entry was posted on Tuesday, August 24th, 2010 at 12:00 pm.