Objective: To evaluate ropinirole hydrochloride as dopaminergic monotherapy in patients with early Parkinson disease.
Design: A 6-month extension of a double-blind, placebo-controlled study.
Setting: Ambulatory care at 22 different sites in the United States.
Patients: Patients who 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 efficacy variables were the number of patients who successfully completed the 12-month study and did not require supplemental levodopa, the number of patients requiring supplemental levodopa, and the proportion of patients having an insufficient therapeutic response.
Results: Significantly fewer ropinirole-treated patients met criteria for insufficient therapeutic response (23 [19.8%] of 116) or required the initiation of levodopa therapy (22 [19%] of 116) compared with placebo-treated patients (60 [48%] of 125 patients for insufficient therapeutic response; 57 [45.6%] of 125 patients for additional levodopa). Significantly more ropinirole-treated patients (51 [44.0%] of 116) successfully completed the 12-month study and did not require supplemental levodopa compared with placebo-treated patients (28 [22.4%] of 125). The incidence of adverse experiences and patient withdrawals was low.
Conclusion: Ropinirole was effective and well tolerated as monotherapy for 12 months in patients with early Parkinson disease.