By Maggie Schwarz
WASHINGTON, DC — October 11, 2007 — In a trial of patients with advanced Parkinson’s disease who were not optimally controlled with levodopa, prolonged-release ropinirole significantly reduced off time, and improved motor symptoms, according to research presented here at the 132nd Annual Meeting of the American Neurological Association (ANA).
Researchers enrolled patients with Parkinson’s disease who were not controlled optimally with levodopa and randomised 202 patients to adjunctive treatment with prolonged-release ropinirole and 191 to placebo. Treatment was administered once daily for 24 weeks.
Lead author Rajesh Pahwa, MD, Director, Parkinson’s Disease and Movement Disorder Center, and Laverne and Joyce Rider Professor of Neurology, University of Kansas School of Medicine, Kansas City, Kansas, United States, presented the study results in a poster session on.
The initial dose of ropinirole was 2.0 mg daily and was titrated to a maximum of 24.0 mg daily. At 8.0 mg daily and at each subsequent increase, levodopa dose reduction was required.
The primary endpoint was a mean change in daily off time at week 24 (last observation carried forward [LOCF]). Post hoc analyses assessed mean changes from baseline in tremor, rigidity, and bradykinesia components of the Unified Parkinson’s Disease Rating Scale (UPDRS) at week 24 LOCF.
Prolonged-release ropinirole reduced daily off time significantly compared with placebo at week 24 LOCF (P <.0001). At week 24 LOCF, significantly greater improvements were seen with ropinirole 24-hour compared with placebo, for changes in tremor (P =.0001), rigidity (P =.0003) and bradykinesia (P <.0001) from baseline.
Mean dose of ropinirole at the last assessment was 18.8 mg +- 6.3 mg daily.
Dr. Pahwa concluded that the dopamine agonist ropinirole, in a prolonged-release formulation, can improve difficult-to-control symptoms of advanced Parkinson’s disease, a stage of the disease notable for suboptimal control using levodopa.
