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FDA finds no evidence of cardiovascular risk in Parkinson’s drug


 

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Entacapone, a drug used in the treatment of Parkinson’s disease, does not cause cardiovascular events such as heart attack or stroke, according to a safety review from the Food and Drug Administration.

In 2010, a possible cardiovascular event risk alert was issued by the FDA for two drugs, Comtan (entacapone) and Stalevo (entacapone, levodopa, and carbidopa), based on findings from the STRIDE-PD trial and a meta-analysis combining results from 15 other studies. As levodopa and carbidopa are used in other Parkinson’s medications without risk of cardiovascular events, entacapone was thought to be responsible for the abnormal study findings.

To verify the study results, the FDA required Novartis, manufacturer of Stalevo, to conduct a study investigating the cardiovascular risk of entacapone. The Novartis study found no increased risk, and further FDA analysis of STRIDE-PD, a study not meant to assess cardiovascular risk, indicated the results were an anomaly.

“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 said in the press release.

Find the full press release on the FDA website.

lfranki@frontlinemedcom.com

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