Decade-old Novartis Parkinson's drug redeemed as FDA sees no CVD risk
- After examining safety data from recently completed clinical trials, the FDA determined that Novartis' Parkinson's med Stalevo (carbidopa, levodopa, entacapone) does not increase the risk of cardiovascular (CV) events.
- Stalevo was first approved in 2003.
- In 2010, the FDA published a warning about possible CV risks associated with Stalevo after looking at data from a post-marketing study—Stalevo Reduction in Dyskinesia Evaluation in Parkinson’s Disease (STRIDE-PD), as well as a meta-analysis.
Stalevo represents a good treatment option for many patients with Parkinson’s disease (PD), because it combines levodopa and carbidopa, which control the main symptoms of PD, such as muscle stiffness, tremors, spasms, and poor muscle control, with entacapone, which reduces the end of dose "wearing off" effect associated with treatment.
Also, it should be noted that the drugs are combined in a dose-appropriate way to facilitate dosing. Therefore, when the FDA issued a warning about this combination in 2010, it was difficult from a treatment perspective. Fortunately, the issue has been resolved with the latest clinical trial—a trial that truly reflects the value of postmarketing studies.