lunes, 23 de agosto de 2010

A reviewing CV risk of Novartis/Orion’s Stalevo


US regulators have notified healthcare professionals of an ongoing safety review of Novartis and Orion’s Parkinson’s disease drug Stalevo, on fears that the drug may be linked to cardiovascular risks.
The agency said it is currently evaluating data from 15 clinical trials to determine whether patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for CV events such as heart attack and stroke and death) compared to those taking Merck’s Sinemet (carbidopa/levodopa) alone.
The meta-analysis was spurred by findings from the Stalevo Reduction In Dyskinesia Evaluation – Parkinson's Disease (or STRIDE-PD) trial, in which an imbalance in the number of myocardial infarctions in patients treated with Stalevo compared to those taking only Sinemet was observed.
The US Food and Drug Administration stressed, however, that it has not yet drawn any conclusions from its assessment, and also noted that many of the CV events occurred in a single study, and that they “are not uncommon in people with Parkinson's disease in the age range studied in these trials”.




**Published in "Pharma Times"