Stalevo levodopa/carbidopa/entacapone regulatory update

FDA is reviewing the cardiovascular safety of Stalevo levodopa/carbidopa/entacapone from Orion after a meta-analysis of 15 trials showed an increased incidence of cardiovascular events in patients receiving the Parkinson's disease (PD) drug compared to patients receiving carbidopa/levodopa. The analysis, which included about 4,800 patients, showed there were significantly more cardiovascular events in the Stalevo group vs. the carbidopa/levodopa group (27 vs. 10). However, the agency said that if data from the Phase III STRIDE-PD trial were removed from the analysis the difference in cardiovascular events would no longer be statistically significant. FDA also noted several limitations of the analysis, including that the trials were not specifically designed to evaluate Stalevo's cardiovascular risk, most patients had preexisting cardiovascular risk factors and 11 of the trials had a duration of fewer than six months, which the agency said was possibly not long enough to evaluate cardiovascular risk.

FDA is already reviewing the safety of Stalevo after data from STRIDE-PD showed an increased incidence of prostate cancer in patients receiving the drug compared to carbidopa/levodopa (see BioCentury, April 5). ...