Following the findings of the STRIDE-PD trial of a combination drug, Stalevo (Novartis), which is utilized in the treatment for Parkinson’s disease, the FDA is reviewing the drug. The report hinted that the drug might put the patients at a higher risk of cardiovascular diseases.
The FDA has said that the patients can continue taking the drug unless their doctor asks them to discontinue. However, the physicians should check and review the CV status of the patients, who are on the drug, which is an amalgamation of carbidopa/levodopa and entacapone.
Administration of the drug should be considered in those who have had CV disease, before.
In the STRIDE-PD (Stalevo Reduction In Dyskinesia Evaluation – Parkinson's Disease) examination, 373 patients were involved who were given Stalevo. On the other hand, 372 patients took carbidopa/levodopa combination
It was found that those who were administered Stalevo, had a higher occurrence rate of MI, than those who were in the Sinemet group.
In order to find out cardiovascular rates, FDA carried out a meta-analysis of 15 medical experiments, wherein Stalevo and Sinemet were compared with each other.
It was seen that there was a minor risk of CV in patients who were given Stalevo. But, the agency said that “several factors make evaluation of these findings difficult”.