Effective cabergoline treatment in idiopathic restless legs syndrome.
OBJECTIVE
To assess the efficacy and safety of the dopamine agonist cabergoline (CAB) in patients with restless legs syndrome (RLS).


METHODS
Patients with moderate to severe RLS were randomized into four groups receiving placebo, 0.5 mg, 1 mg, or 2 mg CAB once daily in a double-blind, placebo-controlled, multicenter dose-finding trial followed by an open long-term extension trial of 47 weeks. Efficacy was assessed with the RLS-6 scales and International RLS Study Group severity scale (IRLS).


RESULTS
A total of 85 patients (age 56 +/- 10 years, 71% females) were treated. Severity of RLS-6 scale symptoms during the night (the primary endpoint) was markedly improved by all CAB doses compared to placebo (placebo: -1.4 +/- 3.1, 0.5 mg CAB: -4.2 +/- 3.0 [p = 0.0082], 1.0 mg CAB: -4.0 +/- 2.9 [p = 0.0040], 2.0 mg CAB: -4.8 +/- 3.7 [p = 0.0026]). Similar results were found for the RLS severity at bedtime and during the day, IRLS, and satisfaction with sleep. A stable, clinically relevant improvement was achieved in all efficacy measures (severity during the night: change between last assessment and baseline: -5.6 +/- 2.5, rate of remission: 71.2%) throughout 1 year with a mean CAB dose of 2.2 mg per day. During long-term treatment, 6 of 66 treated patients were affected (n = 2) or possibly affected (n = 4) by mild augmentation. Under CAB therapy up to 1 year, 11 of 85 patients discontinued treatment due to a drug-related adverse event.


CONCLUSIONS
Cabergoline is an efficacious and well-tolerated option for the treatment of restless legs symptoms during the night and the day.
Stiasny-Kolster
K
K
Department of Neurology, Philipps-University, Marburg, Germany. stiasny@staff.uni-marburg.de
Benes
H
H
Peglau
I
I
Hornyak
M
M
Holinka
B
B
Wessel
K
K
Emser
W
W
Leroux
M
M
Kohnen
R
R
Oertel
W H
WH
D000368:Aged; D000077465:Cabergoline; D018491:Dopamine Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004873:Ergolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006212:Hallucinations / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000139:chemically induced; D011446:Prospective Studies; D012148:Restless Legs Syndrome / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D018491:Dopamine Agonists; D004873:Ergolines; D000077465:Cabergoline