After issuing a warning back in 2010 that Stalevo might increase risk of heart attack, stroke, and death in patients with Parkinson’s disease, the FDA has concluded that entacapone-containing drugs, which also include Comtan (entacapone), pose no increased risk of cardiovascular events.
The drug safety review was conducted after findings from a clinical trial and meta-analysis indicated that Stalevo may have an increased cardiovascular risk compared to carbidopa/levodopa. Stalevo is a combination of entacapone, carbidopa, and lovodopa, and researchers were concerned that entacapone was responsible for the increased cardiovascular risk since the comparison drugs do not contain the ingredient.
Stalevo manufacturer Novartis conducted a study to assess the risk of myocardial infarction (MI) in Parkinson’s patients taking entacapone. Researchers found that the risk for MI was not significantly increased in patients treated with entacapone compared to a control group treated with other Parkinson’s drugs. Notably, no participants from either group died from MI.
In a second study conducted by Graham et al, researchers found no evidence for an association between entacapone use and increased risk of MI, stroke, or death in Medicare patients with Parkinson’s disease compared to those treated with other Parkinson’s drugs.
Based on the study results, the FDA concluded that there is no evidence of a increased risk of cardiovascular events with use of entacapone, including Stalevo and Comtan. The FDA noted that the results behind the original safety concern came from a single study (STRIPE-PD) that was not designed to assess cardiovascular risks. Those results likely represent chance findings and are not a true representation of risk of entacapone use, the FDA said.
As a result of the investigation, the drug labels for Stalevo and Comtan will go unchanged.