Open-label study of the long-term efficacy and safety of pramipexole in patients with Restless Legs Syndrome (extension of the PRELUDE study).
OBJECTIVE
To demonstrate the long-term efficacy and safety of pramipexole for Restless Legs Syndrome (RLS) using physician and patient RLS ratings, along with subjective assays of sleep parameters, in a 26-week, open-label trial.


METHODS
Among 107 Finnish adults with moderate to severe RLS, pramipexole initiated at 0.125 mg/day was titrated to a maximum 0.75 mg/day. Efficacy evaluations included the International RLS Study Group Rating Scale (IRLS), Patient Global Impression (PGI) scale, Clinical Global Impressions-Improvement (CGI-I) scale, Epworth Sleepiness Scale (ESS), and Short Form-36 (SF-36) Health Survey. Subjective Sleep Quality was assessed by patient ratings of sleep and morning tiredness. Safety was documented by Adverse Events reported in >5% of patients.


RESULTS
The mean reduction in IRLS score was 73.5% (P<0.05). The IRLS responder rate, defined by score reduction of >or= 50%, was 81.3%. On the PGI scale, 89.7% of patients rated themselves as "very much" or "much" better. By CGI-I assessment, 94.8% of patients were considered either "very much" or "much" improved. Mean ESS score showed a modest but statistically significant reduction (P<0.05) within the normal range, indicating that long-term pramipexole did not increase daytime sleepiness. On the SF-36 all 8 domains showed improvement, 5 of them statistically significant (P<0.05) and 4 of these 5 (role-physical, bodily pain, vitality, and role-emotional) by >10 points on a 100-point scale. Subjective Sleep Quality also improved. The most frequent Adverse Events were influenza (17.8%), headache (15.0%), and fatigue (10.3%).


CONCLUSIONS
Pramipexole is well tolerated and effective for long-term treatment of RLS.
Partinen
Markku
M
Skogby Sleep Clinic, Rinnekoti Research Centre, Kumputie 1, FI-02980 Espoo, Finland. markku.partinen@rinnekoti.fi
Hirvonen
Kari
K
Jama
Leni
L
Alakuijala
Anniina
A
Hublin
Christer
C
Tamminen
Ilkka
I
Koester
Juergen
J
Reess
Juergen
J
D000328:Adult; D000368:Aged; D052160:Benzothiazoles / Q000008:administration & dosage* / Q000009:adverse effects; D018491:Dopamine Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D000077487:Pramipexole; D012148:Restless Legs Syndrome / Q000188:drug therapy*; D012890:Sleep / Q000187:drug effects; D016896:Treatment Outcome; D055815:Young Adult
D052160:Benzothiazoles; D018491:Dopamine Agonists; D000077487:Pramipexole