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Ropinirole (Requip) More Effective than Placebo in Reducing Drug-Related Motor Complications of Parkinson's Disease: Presented at MDS

By Paula Moyer

ROME, ITALY -- June 21, 2004 -- Ropinirole (Requip) is more effective than placebo at reducing the motor complications of Parkinson's disease that are associated with long-term treatment with levodopa, according to findings presented here June 15th at the 8th International Congress of Parkinson's Disease and Movement Disorders.

"A higher number of ropinirole-treated patients had reduced motor disability and reduced time in the 'off' state than those treated with placebo," according to principal investigator Yoshikuni Mizuno, MD, Head, Neurology Department, Juntendo University, Tokyo, Japan. "The groups had similar rates of withdrawals due to adverse events, a finding which suggests that ropinirole is well tolerated."

Ropinirole, a non-ergotamine dopamine-2 (D2) and D3 receptor agonist, has been used both as an initial therapy and as an adjunct to levodopa in the treatment of Parkinson's disease, primarily as a levodopa-sparing agent. In the current study, the investigators wanted to see if ropinirole could reduce the motor complications associated with long-term levodopa therapy.

They designed a 16-week, double blind, randomized, placebo-controlled, parallel-group study in which 35 centers in Japan recruited 243 patients with Parkinson's disease that had been assessed to be at Hoehn and Yahr stages II to IV. The patients were receiving some form of levodopa and required the addition of a dopamine agonist to relieve motor fluctuations or to improve symptom control.

The study design required that the patients' levodopa dose be stable for at least 4 weeks before study entry. The dose was either kept unchanged or lowered due to levodopa-related adverse events. Patients took either ropinirole from 0.25 mg to 1 mg daily or matching placebo tablets 3 times daily, increased to a maximum of 15 mg daily.

The investigators wanted to see if patients underwent a change from baseline in their Unified Parkinson's Disease Rating Scale (UPDRS) motor score part III, in the "on" state. They also assessed the efficacy of treatment by the percentage of patients who had more than a 20% reduction in the "off" state and the Clinical Global Impression of Efficacy (CGIE) scale score. They used the percentage of patients who completed the study as a gauge of treatment tolerability.

The data for 121 patients in the ropinirole group and 120 in the placebo patients were used for the full analysis data set. Among these, 98 in the ropinirole group (81%) and 96 patients in the placebo group (80%) completed the study.

At the end of 16 weeks of treatment, the mean daily dose of ropinirole was 7.1 mg (standard deviation [SD] 2.9 mg) and the placebo equivalent was 7.8 mg (SD 3.1mg). The mean daily dose of levodopa was 325 mg in the ropinirole group and 317 mg in the placebo group.

The mean reduction in the UPDRS motor score was 9.5 points in the ropinirole group and 4.5 points in the placebo group (P =.00001). The investigators observed that 70.8% of patients in the ropinirole group were classified as responders, or patients with a reduction of more than 20% in the UPDRS motor score, compared to 44.5% of the placebo group (P =.00005).

Among these patients, 58.7% in the ropinirole group had at least a 20% reduction in the "off" state, compared to 38.6% of those in the placebo group (P =.030). On the CGIE scale, 55.0% of the ropinirole group improved, compared with 28.3% of the placebo group (P =.00004).

The ropinirole-treated patients were more likely to report adverse events (84.3%) than were placebo patients (65.6%; P =.001). The most common of these events was nausea, experienced by 24.8% and 11.5%, respectively). The groups had similar incidences of withdrawals due to adverse events (10.7% and 11.5%, respectively).


[Presentation title: "Ropinirole is Highly Effective on Motor Function as Adjunct Therapy to L-Dopa in Japanese Patients With Parkinson's Disease. Abstract #P467]

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