Long-term open-label study of pramipexole in patients with primary restless legs syndrome.

Abstract

A phase III, open-label, long-term clinical study was performed to evaluate the safety and efficacy of pramipexole in a cohort of 141 Japanese patients with primary restless legs syndrome (RLS). The patients were started on pramipexole 0.25 mg/day and were subsequently maintained on that dose or switched to 0.125, 0.5, or 0.75 mg/day to achieve optimal efficacy and tolerability. The International Restless Legs Syndrome Study Group Rating Scale for restless legs syndrome (IRLS) score improved from 22.3+/-4.7 at baseline to 11.1+/-7.7 at week 8 and 4.9+/-5.9 at week 52. IRLS responders, defined as patients whose IRLS total score decreased by > or =50% from baseline, accounted for 67.4% at week 12 and 86.6% at week 52. Over 90% of patients were Clinical Global Impression-global improvement (CGI-I) and Patient Global Impression (PGI) responders. The Pittsburgh Sleep Quality Index (PSQI) score decreased from 7.9+/-3.1 at baseline to 4.6+/-2.9 at week 52. Similarly, the Japanese version of the Epworth Sleepiness Scale score decreased from 9.3+/-5.2 to 4.9+/-3.8. Baseline IRLS score < or =20 was significantly associated with a complete IRLS response in this long-term study. Adverse events were typical of nonergot dopamine agonists, mild in intensity, and decreased in frequency as the study progressed. RLS augmentation was not observed. Pramipexole 0.25-0.75 mg/day is efficacious, safe, and well tolerated in patients with RLS. Pramipexole showed good efficacy, particularly in patients with an IRLS total score <20.

• Authors: Yuichi Inoue, Kenji Kuroda, Koichi Hirata, Naohisa Uchimura, Tatsuo Kagimura, Tetsuo Shimizu
• Journal: Journal of the neurological sciences (J Neurol Sci) Vol. 294 Issue 1-2 Pg. 62-6 (Jul 15 2010) ISSN: 1878-5883 [Electronic] Netherlands
• PMID: 20451927 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2010 Elsevier B.V. All rights reserved.

Chemical References

• Benzothiazoles
• Dopamine Agonists
• Pramipexole
• Ferritins

Topics

• Benzothiazoles (administration & dosage, adverse effects, therapeutic use)
• Body Mass Index
• Cohort Studies
• Dopamine Agonists (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Ferritins (blood)
• Follow-Up Studies
• Humans
• Japan
• Male
• Middle Aged
• Pramipexole
• Proportional Hazards Models
• Restless Legs Syndrome (blood, drug therapy)
• Severity of Illness Index
• Sex Factors
• Sleep (drug effects)
• Time Factors
• Treatment Outcome