Ropinirole Prolonged-Release Reduces Parkinson's 'Off' Time

KANSAS CITY, Kan., April 2 -- For patients with Parkinson's disease poorly controlled by levodopa alone, the addition of ropinirole (Requip) both reduced "off" time and allowed for lower doses of levodopa, found a multicenter international study.

Among 393 patients in the randomized study, prolonged-release ropinirole as an adjunct to levodopa led to a mean reduction in daily "off" time of 2.1 hours, compared with 0.3 hours for patients on placebo, reported Rajesh Pahwa, M.D,, of University of Kansas here, and colleagues, in the April 3 issue of Neurology.

"We also found the drug helped improve quality of life and motor function," said Dr. Pahwa and colleagues.

Ropinirole is a non-ergot dopamine agonist used as both monotherapy and adjunctively for early and advanced Parkinson's disease. The drug is also approved for restless legs syndrome.

In a double-blind study, Dr. Pahwa and colleagues in the Efficacy And Safety Evaluation in PD-Adjunct (EASE-PD Adjunct) study evaluated the efficacy of ropinirole 24-hour prolonged release as an adjunct to levodopa. They randomly assigned 393 Parkinson's disease patients to ropinirole 24-hour (202 patients) or placebo (191 patients) or placebo as an adjunct to levodopa for 24 weeks.

Ropinirole was titrated at a starting dose of 2 mg/day, to a minimum of 6 mg/day, or up to 24 mg/day as necessary, until an optimal therapeutic dose was reached.

The primary study outcome was a mean change from baseline to week 24 in hours of daily "off" time as recorded in patient diaries. Secondary outcomes included mean change from baseline in the hours of "on" time, percentages of "on" and "off" time, and hours and percentages of "on" time without troublesome dyskinesias.

The authors found that at week 24, the mean ropirinole dose was 18.6 mg/day, and there was a mean reduction in daily levodopa of 278 mg. The mean reduction in daily "off" time was 2.1 hours in the ropinirole 24-hour group, and 0.3 hours in the placebo group. The mean difference was 1.7 hours (95% confidence interval, -2.34, -1.09, P

Dr. Pahwa and six of the co-authors have also received "personal compensation" (in three cases exceeding ,000/year) from GSK. One of the co-authors is a GSK employee.