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From the Departments of Neurology of the Mayo Clinic, Scottsdale (Dr. Adler), the Medical College of Georgia (Dr. Sethi), the University of South Florida (Dr. Hauser), Vanderbilt University Hospital (Dr. Davis), Oregon Health Sciences University (Dr. Hammerstad), Creighton University Medical Center (Dr. Bertoni), Taylor Medical Group (Dr. Taylor), the University of Miami (Dr. Sanchez-Ramos), and the Colorado Neurological Institute (Dr. O'Brien). A complete listing of the members of this group will be found at the end of this paper, preceding the references.
Address correspondence and reprint requests to Dr. Charles Adler, Mayo Clinic Scottsdale, Department of Neurology, 13400 E. Shea Blvd., Scottsdale, AZ 85259.
A prospective, randomized, placebo-controlled, double-blind, parallel-group, 6-month study assessed the efficacy and safety of ropinirole, a nonergoline D2-dopamine agonist, in patients with early Parkinson's disease (n = 241; Hoehn & Yahr stages I to III) with limited or no prior dopaminergic therapy. Patients (mean age, 62.8 years), stratified by concomitant use of selegiline, were randomized to ropinirole (n= 116) or placebo (n = 125). The starting dose of ropinirole was 0.25 mg tid with titration to at least 1.5 mg tid (maximum dose, 8 mg tid). Primary efficacy endpoint was the percentage improvement in Unified Parkinson's Disease Rating Scale (UPDRS) motor score. Ropinirole-treated patients had a significantly greater percentage improvement in UPDRS motor score than patients who received placebo (+24% vs -3%; p < 0.001). Ropinirole was well tolerated and patient withdrawals were infrequent. Most adverse experiences were related to peripheral dopaminergic activity. Ropinirole monotherapy is an effective and well-tolerated therapeutic option for treatment of early Parkinson's disease.
Supported by a grant from SmithKline Beecham Pharmaceuticals.
Presented in part at the 48th Annual Meeting of the American Academy of Neurology, San Francisco, CA, March, 1996.
Received January 21, 1997. Accepted in final form February 20, 1997.
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