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FDA Reviewing Stalevo for Cardiac Side Effects

Aug 20, 2010 | Parker Waichman LLP

The Food & Drug Administration (FDA) in conducting a safety review of the Parkinson’s disease drug Stalevo. In a notice posted to its Web site, the agency said it is evaluating clinical trial data that suggest patients taking Stalevo may be at an increased risk for cardiovascular events such as heart attacks and strokes compared to patients taking another Parkinson’s drug known as Sinemet.

Stalevo is a combination of carbidopa/levodopa and entacapone, while Sinemet contains only carbidopa/levodopa. Entacapone is also available as a single ingredient product (sold under the brand name Comtan) to be always administered in association with carbidopa/levodopa.

According to the FDA, it is estimated that 154,000 patients received prescription for Stalevo from its approval in June 2003 through October 2009.

The FDA decided to conduct a safety review after a meta-analysis called the Stalevo Reduction In Dyskinesia Evaluation – Parkinson’s Disease, or STRIDE-PD, found a small increased risk of cardiovascular events in subjects taking Stalevo, according to the FDA. STRIDE-PD combined the cardiovascular-related findings from 15 clinical trials comparing Stalevo to carbidopa/levodopa.

Based on those findings, the FDA conducted a meta-analysis that combined the cardiovascular findings from 15 clinical trials in approximately 4,800 patients comparing entacapone/carbidopa/levodopa to carbidopa/levodopa without entacapone. A composite endpoint of myocardial infarction, stroke, and cardiovascular death was used to represent cardiovascular events. Twenty-seven cardiovascular events were reported in the entacapone/carbidopa/levodopa group compared to 10 in the carbidopa/levodopa group. This resulted in a relative risk of 2.46. When the STRIDE-PD trial was removed from the analysis, the relative risk was 1.67.

The FDA said it has not yet concluded that Stalevo increases the risk of heart attack, strokes, or cardiovascular death. The agency said 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 said it is exploring additional ways to assess whether Stalevo increases the risk of cardiovascular events, and will update the public when its review is complete.


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