In a nutshell
This study investigated the long-term effectiveness and safety of selegiline (Zelapar) in Japanese patients with early Parkinson's disease. Researchers suggested that selegiline improved the outcomes of these patients with manageable side effects.
Some background
Parkinson's disease (PD) is a chronic disease that affects the brain cells. These cells lose the abilities controlled by them. This causes symptoms such as tremors and muscle weakness. The standard treatment is levodopa. However, this treatment is associated with significant side effects if used long-term. New therapies with less side effects are necessary.
In Japan, selegiline was approved for combination use with levodopa in 1998. However, selegiline alone has been approved to use in other countries, but not for patients with early PD. Therefore, the effectiveness and safety of selegiline alone remain under investigation.
Methods & findings
This study included 134 patients with early PD. All patients received selegiline alone for 56 weeks. These patients received an increasing dose of selegiline up to 10mg per day.
91 patients (67.9%) completed the 56-week study. The treatment significantly improved the outcomes of these patients from week 4 to week 56. The best effects were seen at week 20.
58 patients (44.3%) had side effects associated with the treatment. However, the negative effects did not increase with the increasing doses. The most common side effects included back pain, high blood pressure, vomiting, and increased blood levels of creatine kinase (an enzyme that shows damage to the muscles).
The bottom line
This study concluded that long-term treatment with selegiline alone improved the outcomes of patients with early PD with manageable side effects.
The fine print
This study only included Japanese patients. Further studies in more diverse populations are needed. This study was funded by FP Pharmaceutical, the manufacturer of selegiline in Japan.
Published By :
Clinical neuropharmacology
Date :
Apr 30, 2019