Comparison of ropinirole controlled‐ and immediate‐release in Japanese patients with advanced Parkinson's disease

Abstract

AbstractBackgroundIn Japan, ropinirole controlled‐release tabletsrecently became available for Parkinson's disease.AimWe compared the efficacy and safety of ropinirole controlled‐release with ropinirole immediate‐release.MethodsWe carried out a phase III clinical trial (randomized, double‐blind, double‐dummy), in which controlled‐release (n = 156) or immediate‐release (n = 146) was given to Japanese patients with advanced Parkinson's disease under L‐dopa treatment. First, we assessed the non‐inferiority of ropinirole controlled‐release to immediate‐release at week 24 by measuring change from week 0 in total score of the Unified Parkinson's Disease Rating Scale Part III. Then, during weeks 26–32, we evaluated the safety and efficacy of patients’ switching from ropinirole immediate‐release to controlled‐release, and a subset of patients continued on ropinirole controlled‐release though week 54.ResultsThe change in the Unified Parkinson's Disease Rating Scale Part III total score at week 24 was −10.8 for the controlled‐release group and −11.1 for the immediate‐release group (adjusted mean difference: 0.34, two‐sided 95% confidence interval −1.41 to 2.09), and the upper limit of the confidence interval was less than the predefined margin of 2.5, showing the non‐inferiority of ropinirole controlled‐release to immediate‐release. The efficacy did not change after overnight switching from ropinirole immediate‐release to controlled‐release, and lasted until week 54. Adverse events were comparable between the two groups during the whole study period.ConclusionsAs adjunctive therapy to L‐dopa, ropinirole controlled‐release improved motor symptoms in Japanese patients with advanced Parkinson's disease. The overnight switch from immediate‐release to controlled‐release did not result in any unexpected adverse event.