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Ropinirole Patch Versus Placebo, Ropinirole Extended‐Release Tablet in Advanced Parkinson's Disease
Author(s) -
Hattori Nobutaka,
Mochizuki Hideki,
Hasegawa Kazuko,
Nomoto Masahiro,
Uchida Eiji,
Terahara Takaaki,
Okawa Koji,
Fukuta Hiroyuki
Publication year - 2020
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.28071
Subject(s) - ropinirole , placebo , medicine , confidence interval , anesthesia , clinical endpoint , randomized controlled trial , levodopa , parkinson's disease , disease , pathology , alternative medicine
Background A dopamine agonist patch is an important treatment option for PD. Objectives A randomized, double‐blind, parallel‐group, placebo‐controlled trial was conducted to evaluate superiority of ropinirole hydrochloride patch over placebo and noninferiority to ropinirole hydrochloride extended‐release tablet. Methods PD patients using levodopa received ropinirole patch (up to 64 mg/d), ropinirole tablets (up to 16 mg/d), or placebo once‐daily (double‐dummy technique). The primary endpoint was the change from baseline in the total score for the UPDRS Part III ( on state) at week 16. Results The change of the least squares mean (95% confidence interval) in the UPDRS Part III total score was –9.8 (–10.8 to –8.7) with ropinirole patch, –4.3 (–5.8 to –2.8) with placebo, and –10.1 (–11.2 to –9.1) with ropinirole tablet. The difference between the ropinirole patch and placebo groups was –5.4 (–7.3 to –3.6), demonstrating superiority of the patch over placebo. The difference between the ropinirole patch and tablet groups was 0.3 (–1.2 to 1.8). The upper limit of the 95% confidence interval was smaller than the noninferiority limit of 2.5, demonstrating noninferiority of ropinirole patch to ropinirole tablet. In all three groups, most adverse events were mild or moderate and there were no serious safety concerns. Conclusions Once‐daily ropinirole patch was effective in advanced PD patients, having demonstrated superiority over placebo and noninferiority to ropinirole tablet, without causing serious safety problems. Ropinirole patch can be an alternative option for PD patients. © 2020 International Parkinson and Movement Disorder Society