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Cabergoline for RLS

Clinical bottom line

About 45% of patients treated with cabergoline over five weeks were symptom free, significantly higher than with placebo. There were no serious adverse events. The amount of evidence, though, is slight.


Reference

K Stiasny-Kolster et al. Effective cabergoline treatment in idiopathic restless legs syndrome. Neurology 2004 63: 2272-2279.

Clinical trial

This properly randomised and double-blind trial compared three doses of cabergoline at 0.5, 1.0 and 2.0 mg daily (achieved by titration) with placebo over five weeks. There was an open-label extension also.

Outcomes were subjective ratings of RLS symptoms by questionnaire, and sleep using diaries.

Results

Eighty-five patients were recruited. Cabergoline at any dose provided better improvement in RLS symptoms than placebo. Responders, that is patients without symptoms during the night, comprised 45% with cabergoline at any dose compared with 9% in placebo (Table 1).

Table 1: Clinical trial of cabergoline
Reference
Design
Treatments and Outcomes
Patient details
Efficacy
Adverse Events
Stiasny-Kolster et al. Neurology 2004 63: 2272-2279 R = 2
DB = 2
WD = 1
QS = 5
Parallel group
Duration = five weeks dose ranging study, with open label extension
Treatments
1 Cabergoline 0.5, 1, 2 mg daily (63)
2 Placebo (22)
Outcomes
Questionnaires for symptoms and sleep diaries
Mean age about 56 years, mostly women, with duration of RLS over 10 years in most. All doses were superior to placebo, without much evidence of dose-response, for RLS severity scales. After five weeks with cabergoline, 28/62 (45%) had no symptoms, compared with 2/22 (9%) with placebo during the night. There was some improvement in sleep onset times There were no serious adverse events in any group, with 1/21 and 3/20 discontinuing because of AEs with 0.5 mg and 1.0 mg respectively.
About a third of all patients had a drug-related adverse event

During the open-label titration study about 70% of patients were symptom free at night.

Adverse events occurred frequently, but not more often with cabergoline (60% had an adverse event) than with placebo (55%).

Comment

This single trial provides some evidence that cabergoline may be of value in treating RLS.