FDA weighs safety of Parkinson's therapy after possible CV risk found
The FDA is investigating the combination drug Stalevo (Novartis), used to treat Parkinson’s disease, after results of the STRIDE-PD trial reported results that showed the drug may have the potential to increase cardiovascular risk in patients.
While FDA said patients administered the drug--a combination of carbidopa/levodopa and entacapone--should not stop taking it unless told to do so by physicians, they said physicians should monitor and evaluate the CV status of patients taking the drug, particularly in those who have had prior CV disease.
The STRIDE-PD (Stalevo Reduction In Dyskinesia Evaluation – Parkinson's Disease) trial evaluated 373 patients administered Stalevo and 372 patients administered a carbidopa/levodopa combination (Sinemet, Merck). Results showed that patients administered Stalevo had an increased incidence rate of MI compared to patients in the Sinemet arm.
After these results, FDA performed a meta-analysis of 15 clinical trials that compared Stalevo to Sinemet to examine cardiovascular findings. The agency found a “small” increased risk for CV events in the Stalevo study arm; however, it said that “several factors make evaluation of these findings difficult.”
Limitations of the meta-analysis were present because the trials were not designed to evaluate cardiovascular events or safety. Additionally, the FDA said most of the adverse events occurred during a single trial, STRIDE-PD.
While an estimated 154,000 patients have been administered Stalevo since June 2003, despite recent findings, the FDA said the review is ongoing and the agency has not concluded that the drug increases a patients’ CV risk.
While FDA said patients administered the drug--a combination of carbidopa/levodopa and entacapone--should not stop taking it unless told to do so by physicians, they said physicians should monitor and evaluate the CV status of patients taking the drug, particularly in those who have had prior CV disease.
The STRIDE-PD (Stalevo Reduction In Dyskinesia Evaluation – Parkinson's Disease) trial evaluated 373 patients administered Stalevo and 372 patients administered a carbidopa/levodopa combination (Sinemet, Merck). Results showed that patients administered Stalevo had an increased incidence rate of MI compared to patients in the Sinemet arm.
After these results, FDA performed a meta-analysis of 15 clinical trials that compared Stalevo to Sinemet to examine cardiovascular findings. The agency found a “small” increased risk for CV events in the Stalevo study arm; however, it said that “several factors make evaluation of these findings difficult.”
Limitations of the meta-analysis were present because the trials were not designed to evaluate cardiovascular events or safety. Additionally, the FDA said most of the adverse events occurred during a single trial, STRIDE-PD.
While an estimated 154,000 patients have been administered Stalevo since June 2003, despite recent findings, the FDA said the review is ongoing and the agency has not concluded that the drug increases a patients’ CV risk.