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Meta-analysis of the efficacy and tolerability of pramipexole versus ropinirole in the treatment of restless legs syndrome.
Sleep Med. 2008 Oct; 9(7):715-26.SM

Abstract

OBJECTIVE

In the absence of comparative trials a meta-analysis was performed to compare the efficacy and tolerability of the non-ergot derived dopamine agonists, pramipexole and ropinirole, in restless legs syndrome (RLS).

METHODS

Frequentist fixed and random-effects models were pre-specified for the direct comparisons and a Bayesian approach for the indirect comparison. Efficacy outcomes included the mean change from baseline in the International RLS Study Group Rating Scale (IRLS) score and the percentage of responders on the clinical global impressions - improvement scale (CGI-I). Safety outcomes included the incidence of withdrawal and adverse events.

RESULTS

The direct meta-analysis confirmed superior efficacy for both treatments versus placebo for the IRLS (pramipexole: -5.45; 95% CI: -7.70; -3.20; ropinirole: -3.16; 95% CI: -4.26; -2.05) and the CGI-I (pramipexole: OR=2.98; 95% CI: 2.08; 4.26; ropinirole: OR=1.99; 95% CI: 1.52; 2.60). Placebo comparisons showed a significantly higher incidence of nausea for pramipexole (p<0.01), whereas nausea, vomiting, dizziness, and somnolence were significantly higher for ropinirole (all p<0.01). The indirect comparison showed with a probability of > or = 95%, a superior reduction in the mean IRLS score (-2.33; 95% credibility interval [CrI]: -4.23; -0.41), higher CGI-I response rate (OR=1.50; 95% CrI: 0.97; 2.32) and significantly lower incidence of nausea, vomiting, and dizziness for pramipexole compared to ropinirole.

CONCLUSION

Differences in efficacy and tolerability favouring pramipexole over ropinirole can be observed. These findings should be further confirmed in head-to-head clinical trials.

Authors+Show Affiliations

i3 Innovus, 3rd floor, Beaufort House Cricket Field Road, Uxbridge UB8 1QG, United Kingdom. sibilia.quilici@i3innovus.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18226947

Citation

Quilici, S, et al. "Meta-analysis of the Efficacy and Tolerability of Pramipexole Versus Ropinirole in the Treatment of Restless Legs Syndrome." Sleep Medicine, vol. 9, no. 7, 2008, pp. 715-26.
Quilici S, Abrams KR, Nicolas A, et al. Meta-analysis of the efficacy and tolerability of pramipexole versus ropinirole in the treatment of restless legs syndrome. Sleep Med. 2008;9(7):715-26.
Quilici, S., Abrams, K. R., Nicolas, A., Martin, M., Petit, C., Lleu, P. L., & Finnern, H. W. (2008). Meta-analysis of the efficacy and tolerability of pramipexole versus ropinirole in the treatment of restless legs syndrome. Sleep Medicine, 9(7), 715-26. https://doi.org/10.1016/j.sleep.2007.11.020
Quilici S, et al. Meta-analysis of the Efficacy and Tolerability of Pramipexole Versus Ropinirole in the Treatment of Restless Legs Syndrome. Sleep Med. 2008;9(7):715-26. PubMed PMID: 18226947.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Meta-analysis of the efficacy and tolerability of pramipexole versus ropinirole in the treatment of restless legs syndrome. AU - Quilici,S, AU - Abrams,K R, AU - Nicolas,A, AU - Martin,M, AU - Petit,C, AU - Lleu,P-L, AU - Finnern,H W, Y1 - 2008/01/28/ PY - 2007/04/04/received PY - 2007/09/17/revised PY - 2007/11/16/accepted PY - 2008/1/30/pubmed PY - 2009/2/3/medline PY - 2008/1/30/entrez SP - 715 EP - 26 JF - Sleep medicine JO - Sleep Med. VL - 9 IS - 7 N2 - OBJECTIVE: In the absence of comparative trials a meta-analysis was performed to compare the efficacy and tolerability of the non-ergot derived dopamine agonists, pramipexole and ropinirole, in restless legs syndrome (RLS). METHODS: Frequentist fixed and random-effects models were pre-specified for the direct comparisons and a Bayesian approach for the indirect comparison. Efficacy outcomes included the mean change from baseline in the International RLS Study Group Rating Scale (IRLS) score and the percentage of responders on the clinical global impressions - improvement scale (CGI-I). Safety outcomes included the incidence of withdrawal and adverse events. RESULTS: The direct meta-analysis confirmed superior efficacy for both treatments versus placebo for the IRLS (pramipexole: -5.45; 95% CI: -7.70; -3.20; ropinirole: -3.16; 95% CI: -4.26; -2.05) and the CGI-I (pramipexole: OR=2.98; 95% CI: 2.08; 4.26; ropinirole: OR=1.99; 95% CI: 1.52; 2.60). Placebo comparisons showed a significantly higher incidence of nausea for pramipexole (p<0.01), whereas nausea, vomiting, dizziness, and somnolence were significantly higher for ropinirole (all p<0.01). The indirect comparison showed with a probability of > or = 95%, a superior reduction in the mean IRLS score (-2.33; 95% credibility interval [CrI]: -4.23; -0.41), higher CGI-I response rate (OR=1.50; 95% CrI: 0.97; 2.32) and significantly lower incidence of nausea, vomiting, and dizziness for pramipexole compared to ropinirole. CONCLUSION: Differences in efficacy and tolerability favouring pramipexole over ropinirole can be observed. These findings should be further confirmed in head-to-head clinical trials. SN - 1389-9457 UR - https://www.unboundmedicine.com/medline/citation/18226947/Meta_analysis_of_the_efficacy_and_tolerability_of_pramipexole_versus_ropinirole_in_the_treatment_of_restless_legs_syndrome_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(07)00432-7 DB - PRIME DP - Unbound Medicine ER -