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Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks

Including Comtan (entacapone) and Stalevo (entacapone, carbidopa, and levodopa)

AUDIENCE: Neurology

ISSUE: An FDA safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson's disease. As a result, recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the drug labels.

FDA alerted patients and health care professionals about a possible increased risk for cardiovascular events and death with Stalevo in August 2010. This possible safety issue was observed in a clinical trial called the Stalevo Reduction in Dyskinesia Evaluation in Parkinson's Disease (STRIDE-PD) and in a meta-analysis that combined the cardiovascular-related findings from 15 clinical trials comparing Stalevo to carbidopa/levodopa. Carbidopa and levodopa have been used extensively and have not been shown to have an increased cardiovascular risk. FDA was concerned that the entacapone in Stalevo was responsible for these cardiovascular risks because the comparison drugs do not contain this ingredient.

To better understand the significance of these findings, FDA required the Stalevo manufacturer, Novartis, to study the potential for cardiovascular risk with the entacapone component of the drug. FDA examined the results from this required study and from one additional study and concluded they do not show an increased risk of cardiovascular adverse events with entacapone. 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. 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.

BACKGROUND: Entacapone-containing products, Comtan and Stalevo, have been shown to be effective in treating symptoms of Parkinson's disease, such as muscle stiffness, tremors, spasms, and poor muscle control. The combination of entacapone with carbidopa and levodopa in Stalevo has been shown to reduce end-of-dose “wearing-off” in patients with Parkinson's disease to a greater degree than with entacapone alone or with the two-drug combination of carbidopa and levodopa.

RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program

Read the MedWatch safety alert, including a link to the FDA drug safety communication, at:

ComtanR 和StalevoR 皆為含有entacapone成份之藥品,用於治療帕金森氏症之症狀,如肌肉僵硬、顫抖、痙攣和肌肉控制不佳等。StalevoR為entacapone、carbidopa及levodopa之三合一製劑,可有效改善當levodopa藥效減退時病人產生的運動功能障礙。

2010年8月美國FDA曾發布藥物安全警訊,依據15項臨床試驗的統合分析顯示,服用StalevoR (entacapone, carbidopa和levodopa) 與單獨服用carbidopa/levodopa的病人相比,發生心血管疾病之風險較高。

美國FDA要求廠商進行entacapone與心血管風險之相關研究,結果未發現使用entacapone治療帕金森氏症會增加心臟病發、中風或其他心血管疾病風險。故美國FDA擬維持目前對ComtanR (entacapone)及StalevoR (entacapone, carbidopa和levodopa)的使用建議,也呼籲醫療人員應持續追蹤並回報有關此藥品之不良反應報告。



[Posted 10/26/2015]