Parkinson's Drug Does Not Increase Risk of Cardiovascular Events

The FDA has determined that entacapone (Comtan), a drug used in the treatment of Parkinson’s disease, does not increase patients’ risk of heart attacks, stroke, or other cardiovascular events.

As a result of these findings, recommendations for using Comtan and another treatment made up of entacapone, carbidopa, and levodopa (Stalevo) will remain the same.

Originally, the FDA had alerted patients and health care professionals that there may be a risk following a death linked to Stalevo in August 2010.

The FDA considered that Stalevo may be responsible for higher cardiovascular risks, as comparison drugs did not contain entacapone. The possible safety issue was observed in a clinical trial called Stavelo Reduction in Dyskinesia Evaluation in Parkinson’s Disease (STRIDE-PD) and in a meta-analysis involving 15 clinical trials comparing Stalevo with carbidopa/levodopa.

Novartis, the manufacturer of Stalevo, worked with the FDA to determine that the drug did not carry an increased risk of cardiovascular events.

“The results observed in the original meta-analysis were driven by results of a single study (STRIDE-PD), which was not designed to assess cardiovascular risks,” the FDA wrote in its recent statement. “[The] FDA believes that the meta-analysis and STRIDE-PD results are chance findings and do not represent a true increase in risk due to entacapone.”

The FDA recommends that patients and professionals continue to report any adverse events related to their medications to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.