In a nutshell
This study investigated the safety profile of opicapone (Ongentys) in the treatment of Parkinson's disease. Researchers suggested that this drug was safe and well-tolerated in these patients.
Parkinson's disease (PD) is a chronic disorder that attacks brain cells. These cells lose their abilities causing symptoms such as muscle weakness and tremors. Levodopa is the standard treatment for PD, however, its long-term use is associated with motor fluctuations. Motor fluctuations happen when PD symptoms come back, sometimes worst, before the next levodopa dose. New treatments are necessary to improve the outcomes of motor fluctuations in long-term levodopa users.
Opicapone is a newer drug approved to improve the motor fluctuations of patients with PD using levodopa. Prior studies showed the effectiveness and safety of opicapone for up to 1 year. However, it is not yet clear how this drug is associated with long-term side effects, such as off-symptoms.
Methods & findings
This study analyzed data from 2 other studies evaluating the safety of opicapone. It included a total of 1614 patients with PD. Of these, 766 patients were from a double-blind study. These patients received 3 to 8 daily doses of levodopa for at least 1 year. They also received 25 or 50 mg opicapone or a placebo. The remaining patients (848) were from the second study, which began the day after completing the first study. This continued until 52 weeks of treatment. Patients started with a dose of 25mg opicapone, which could be increased if needed.
In study 1, 63.3% of patients being treated with opicapone, and 57.2% having a placebo, reported side effects. The most common were dyskinesia (DYS; involuntary movements that the patient cannot control), constipation and insomnia. Serious side effects were seen in 3.5% of the patients receiving opicapone and 4.3% in the placebo group.
71.3% of patients from study 2 reported at least one side effect. Most occurred within the first 2 months and then decreased thereafter. Serious side effects, such as nausea and diarrhea were reported in less than 2% of patients.
The bottom line
This study concluded that long-term use of opicapone was safe and well-tolerated in the treatment of motor fluctuations in patients with PD.
The fine print
This study was funded by BIAL, Opicapone’s manufacturer.
Published By :
Journal of Parkinson’s disease
Sep 03, 2019
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