Ropinirole Patch Versus Placebo, Ropinirole Extended‐Release Tablet in Advanced Parkinson's Disease

Abstract

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

Newly Approved and Investigational Drugs for Motor Symptom Control in Parkinson's Disease

“…ICDs were not reported in the study, and there were no differences in dyskinesia or sleep issues between the groups. Exploratory efficacy analyses revealed significantly reduced OFF time, ON-WoTD, and good ON time relative to placebo [ 126 ]. A 52-week open-label study demonstrated long-term safety and did assess ICDs, with no increased incidence reported.…”

Ropinirole patch treatment of nocturnal violent tremor in Parkinson's disease

“…6 Moreover, a comparative study of ropinirole transdermal patches versus tablets revealed no significant differences in motor or sleep scores. 7 In our patient, the dosage of rotigotine was low and other anti-parkinsonian medications were not consistent when each using ropinirole patch and rotigotine. The reason for the differing effectiveness in nocturnal tremor treatment between ropinirole patch and rotigotine may be due to differences in dopamine D1 or D2 receptor affinity.…”

“…A more recent systematic review and network meta‐analysis evaluating the comparative efficacy of non‐ergot dopamine agonists showed that the improvement rate of UPDRS part II + III was higher with immediate‐ or prolonged‐release ropinirole tablets than with rotigotine 6 . Moreover, a comparative study of ropinirole transdermal patches versus tablets revealed no significant differences in motor or sleep scores 7 . In our patient, the dosage of rotigotine was low and other anti‐parkinsonian medications were not consistent when each using ropinirole patch and rotigotine.…”

The effect and safety of ropinirole in the treatment of Parkinson disease

“…Ropinirole is a non-ergot dopamine receptor agonist that is selective for D2 and D3 dopamine receptors. [34] It has negligible affinity for a wide range of central non-dopaminergic receptors, including a and b adrenergic receptors, serotonin receptor type 1, serotonin receptor type 2, benzodiazepines, and g-GABA receptor. [35] In PD patients with exercise fluctuations, ropinirole, as an adjunct to L-DA, has been proven in early trials to improve the symptoms of PD.…”