Evaluating rasagiline as add-on therapy in patients with Parkinson’s disease

This study evaluated the safety and effectiveness of rasagiline (Azilect) in patients with Parkinson’s disease (PD) and wearing-off effects (motor symptoms worsen as levodopa wears off before the next dose is taken). This study concluded that rasagiline improved symptoms and quality of life in these patients.

PD is a progressive disease caused by loss of brain cells that make dopamine. Dopamine is a chemical substance that sends signals to the cells that help coordinate movements. Levodopa is the cornerstone of PD therapy. Nerve cells use levodopa to make dopamine, which replenishes the brain’s reduced dopamine supply. At first, levodopa is effective in relieving PD symptoms. However, each dose becomes less effective as treatment continues. As a result, many patients experience wearing-off effects.

Wearing-off effects can negatively impact daily living and quality of life. Add-on therapy is commonly used to relieve these symptoms. This treatment is given with a primary treatment to improve its effects. The safety and effectiveness of rasagiline given as an add-on therapy with levodopa in PD patients with wearing-off effects remain under investigation.

This study compared rasagiline to placebo (a substance with no active effect) in patients with PD. This study involved 404 Japanese patients with PD. All patients were already taking levodopa at the time of this study. Patients received either rasagiline (65.1%) or placebo (34.9%) as an add-on therapy with levodopa for 26 weeks. Motor-related activities of daily living, motor symptoms, and quality of life were evaluated.

The average daily OFF-time (periods when medications are not working and PD symptoms return) decreased by 0.51 hours (placebo) versus 1.11 – 1.35 hours (rasagiline) from the start of treatment.

From the start of treatment, the average daily ON-time (good motor performance when medications work) without dyskinesia (involuntary jerky movements such as twisting or writhing) increased by 0.90 – 1.25 hours with rasagiline versus 0.36 hours with placebo. Motor symptom scores significantly decreased by 5.24 – 5.65 points (rasagiline) versus 3.50 (placebo). Quality of life scores significantly decreased by 1.00 points (rasagiline) versus increasing by 2.84 points (placebo).

Overall, side effects were reported by 50.4% (placebo) versus 69.9% – 73.6% (rasagiline) of patients. Most of these were mild or moderate. The common cold was the most common side effect (9 – 18%). Serious side effects were reported by 2.8% (placebo) versus 7.5 – 7.8% (rasagiline) of patients. 6.4% (placebo) versus 13.5 – 15.5% (rasagiline) of patients stopped the treatment due to side effects.

This study concluded that rasagiline is effective and well-tolerated in patients with PD. The authors suggest that rasagiline is a viable option for patients who develop wearing-off effects with levodopa.

This study only included Japanese patients, so the results may not be applied to all peoples. Also, the study only lasted for 26 weeks. Longer studies are needed to determine the long-term effectiveness of rasagiline.

This study received funding support from Takeda, the developer of rasagiline in Japan. 

Talk to your doctor about add-on therapies to help with wearing-off effects.