Efficacy and tolerability of Stalevo® in patients with Parkinson's disease experiencing wearing-off

Background: Levodopa is still the most effective treatment for Parkinson's disease. However, its short half-life encourages the development of fluctuations in motor response during the course of the disease. The new preparation Stalevo (R) which combines levodopa, the dopa decarboxylase inhibitor carbidopa and the catechol-O-methyltransferase inhibitor entacapone in one tablet provides a longer levodopa half-life and more stable concentrations of plasma levodopa. A more continuous dopaminergic stimulation (CDS) can be achieved and motor complications such as wearing-off and dyskinesias are reduced. Methods: 840 Parkinson's disease patients experiencing wearing-off were enrolled in this prospective open-label multicentre trial to study efficacy and tolerability of Stalevo (R). Selection of patients as well as the dosage of each patient's study medication were carried out by the participating physicians. Duration of study was planned to be 5 weeks. Primary end point of the study was the improvement of wearing-off symptoms by Stalevo (R). Off-time, occurrence of dyskinesias, change in other antiparkinsonian medication as well as safety and tolerability were studied, too. Results: After switching to Stalevo (R) the severity of wearing-off symptoms was significantly reduced by an average of 46%. Mean daily off-time decreased from 115 min to 57 min. The number of patients experiencing dyskinesias was reduced from 35% to 24% at the end of the study. Total daily dose of levodopa decreased by 53 mg on average. In 16% of patients the treatment with a dopamine agonist was stopped or the dose was reduced. In 31% of patients the other antiparkinsonian medication was not required any longer or the dose was reduced. Adverse events occurred in 2.5% of patients. Tolerability of therapy was rated as "very good" or "good" in 85% of patients. Conclusion: This prospective open-label trial in 840 patients with Parkinson's disease experiencing wearing-off confirms the good efficacy and good tolerability of Stalevo (R) once again.