Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease.

Abstract

BACKGROUND:

Ropinirole prolonged release (RPR) is a once-daily formulation. However, there may be individual pharmacokinetic differences so that multiple dosing may be preferred in some individuals. This study compares once-daily and twice-daily RPR in patients with Parkinson's disease.

METHODS:

This study was an open-label crossover study. We enrolled Parkinson's disease patients on dopamine agonist therapy with unsatisfactory control such as motor fluctuation, dyskinesia and sleep-related problems. Agonists were switched into equivalent dose of RPR. Subjects were consecutively enrolled into either once-daily first or twice-daily first groups, and received the same amount of RPR in a single and two divided dosing for 8 weeks respectively in a crossover manner without a washout period.The primary outcome was a questionnaire of the preference completed by patients in the last visit. The secondary outcome measures included the Unified Parkinson's Disease Rating Scale part 3 (mUPDRS), Hoehn and Yahr stage (H&Y); sleep questionnaire including overall quality of sleep, nocturnal off symptoms and early morning symptoms; Epworth Sleep Scale (ESS); compliances and patient global impression (PGI).

RESULTS:

A total of 82 patients were enrolled and 61 completed the study. 31 patients preferred twice-daily regimen, 17 preferred the once-daily regimen, and 13 had no preference. Their mean mUPDRS, H&Y, ESS, sleep quality, compliance and adverse events were not statistically different in both regimens. PGI-improvement on wearing off defined was better in twice-daily dosing regimen.

CONCLUSIONS:

RPR is a once-daily formulation, but multiple dosing was preferred in many patients. Multiple dosing of RPR might be a therapeutic option if once-daily dosing is unsatisfactory.

• Authors: Ji Young Yun, Han-Joon Kim, Jee-Young Lee, Young Eun Kim, Ji Seon Kim, Jong-Min Kim, Beom S Jeon
• Journal: BMC neurology (BMC Neurol) Vol. 13 Pg. 113 (Sep 02 2013) ISSN: 1471-2377 [Electronic] England
• PMID: 24004540 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antiparkinson Agents
• Benzothiazoles
• Indoles
• ropinirole
• Pramipexole

Topics

• Adult
• Aged
• Aged, 80 and over
• Antiparkinson Agents (administration & dosage)
• Benzothiazoles (therapeutic use)
• Cross-Over Studies
• Drug Administration Schedule
• Female
• Humans
• Indoles (administration & dosage)
• Male
• Middle Aged
• Outcome Assessment, Health Care
• Parkinson Disease (drug therapy)
• Pramipexole
• Retrospective Studies
• Surveys and Questionnaires