[Efficacy and safety of ropinirole in the treatment of Parkinson's disease: a multi-center, randomized, double-blind and bromocriptine-controlled trial].

Abstract

OBJECTIVE:

To explore the efficacy and safety of ropinirole in the treatment of Parkinson's disease.

METHODS:

From November 2005 to April 2007, a total of 221 subjects from 7 hospitals of Beijing, Lanzhou and Wuhan participated in a 12-week multi-center, randomized, bromocriptine-controlled, double-blind, double-dummy and parallel-group trial. The efficacy of ropinirole was assessed with the unified Parkinson's disease rating scale (UPDRS) score, "off" time according to the patient's diary and the overall evolution of clinical efficacy. The safety was assessed on the basis of adverse events, blood pressure, pulse, laboratory measurement and electrocardiographic recordings. And the statistical analyses were performed with t, paired t, χ(2) and covariance tests.

RESULTS:

In the intent-to-treat population, the average UPDRSIII score decreased to (11 ± 9) in ropinirole group and (11 ± 10) in bromocriptine group while the UPDRSIIscore decreased to (4 ± 4) and (3 ± 5) respectively at Week 12 versus baseline. It showed that ropinirole was non-inferior to bromocriptine. The "off" time at Week 12 [(3.0 ± 1.2)h, (3.8 ± 1.6)h] versus baseline [(4.2 ± 2.0)h, (4.4 ± 1.7)h] decreased (t = 10.772, t = 5.746, P = 0.000) in ropinirole and bromocriptine groups. Ropinirole offered a better overall improvement rate (q = 7.241, P = 0.007). The adverse events occurring at a ratio of over 5% caused by ropinirole included orthostatic hypotension, nausea, dizziness, upper abdominal discomfort, insomnia and palpitation. No significant difference existed in the frequency of adverse events between two groups.

CONCLUSIONS:

Ropinirole is both effective and safe in the treatment of Chinese patients with Parkinson's disease.

• Authors: Shu-hua Li, Hai-bo Chen, Zhen-fu Wang, Rong-hua Tang, Xiao-ying Zhang, Jin-sheng Yang, Wei-qin Zhao, Xiang-ru Sun, Jun Ma
• Journal: Zhonghua yi xue za zhi (Zhonghua Yi Xue Za Zhi) Vol. 93 Issue 25 Pg. 1952-7 (Jul 02 2013) ISSN: 0376-2491 [Print] China
• PMID: 24169242 (Publication Type: English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Indoles
• ropinirole
• Bromocriptine

Topics

• Adult
• Aged
• Aged, 80 and over
• Bromocriptine (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Indoles (adverse effects, therapeutic use)
• Male
• Middle Aged
• Parkinson Disease (drug therapy)