Long-term open-label study of pramipexole in patients with primary restless legs syndrome.
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.
Inoue
Yuichi
Y
Japan Somnology Center, Neuropsychiatric Research Institute, Shibuya-ku, Tokyo, Japan. inoue@somnology.com
Kuroda
Kenji
K
Hirata
Koichi
K
Uchimura
Naohisa
N
Kagimura
Tatsuo
T
Shimizu
Tetsuo
T
D052160:Benzothiazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015992:Body Mass Index; D015331:Cohort Studies; D018491:Dopamine Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005293:Ferritins / Q000097:blood; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D000077487:Pramipexole; D016016:Proportional Hazards Models; D012148:Restless Legs Syndrome / Q000097:blood / Q000188:drug therapy*; D012720:Severity of Illness Index; D012737:Sex Factors; D012890:Sleep / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome
D052160:Benzothiazoles; D018491:Dopamine Agonists; D000077487:Pramipexole; D005293:Ferritins