ROPINIROLE FOR THE TREATMENT OF EARLYPARKINSON-DISEASE - A 12-MONTH EXPERIENCE

Objective: To evaluate ropinirole hydrochloride as dopaminergic monoth erapy in patients with early Parkinson disease. Design: A 6-month exte nsion of a double-blind, placebo-controlled study. Setting: Ambulatory care at 22 different sites in the United States. Patients: Patients w ho successfully completed the initial 6-month study could enter the 6- month extension study (ropinirole, n=70; placebo, n=77). Intervention: Use of ropinirole or placebo therapy. Main Outcome measures: The effi cacy variables were the number of patients who successfully completed the 12-month study and did not require supplemental levodopa, the numb er of patients requiring supplemental levodopa, and the proportion of patients having an insufficient therapeutic response. Results: Signifi cantly fewer ropinirole-treated patients met criteria for insufficient therapeutic response (23 [19.8%] of 116) or required the initiation o f levodopa therapy (22 [19%] of 116) compared with placebo-treated pat ients (60 [48%] of 125 patients for insufficient therapeutic response; 57 [45.6%] of 125 patients for additional levodopa). Significantly mo re ropinirole-treated patients (51 [44.0%] of 116) successfully comple ted the 12-month study and did not require supplemental levodopa compa red with placebo-treated patients (28 [22.4%] of 125). The incidence o f adverse experiences and patient withdrawals was low. Conclusion: Rop inirole was effective and well tolerated as monotherapy for 12 months in patients with early Parkinson disease.