Kathryn M. Andolsek, MD, MPH
What are the efficacy and safety of dopamine agonists for the restless legs syndrome (RLS)?
Included studies compared dopamine agonists with placebo or other drugs given for ≥ 7 days in patients ≥ 18 years of age with primary or secondary RLS (International RLS Study Group criteria). Outcomes included International RLS Severity Rating Scale (IRLS) score, Periodic Limb Movements in Sleep Index (PLMSI), sleep efficiency (time sleeping when in bed), number of dropouts due to adverse events, Clinical Global Impressions-Improvement (CGI-I) score, and self-rated sleep quality and disease-specific quality of life.
MEDLINE, EMBASE/Excerpta Medica, CINAHL, PsycINFO (1985 to 2008); Cochrane Central Register of Controlled Trials (Cochrane Library, 2008, Issue 4); reference lists; and online clinical trial and drug company registers were searched for double-blind, randomized, controlled trials (RCTs). Authors and drug companies were contacted. 38 RCTs (n = 7365, mean age 55 y, mean 64% women) met the selection criteria: 35 were placebo-controlled. 13 RCTs evaluated ropinirole, 10 pramipexole, 5 pergolide, 5 rotigotine, 3 cabergoline, 2 lisuride, and 1 sumanirole. The most frequent treatment duration was 12 weeks (range 1 wk to 7 mo). Results of 23 RCTs were published in their entirety. 37 RCTs were fully or partly funded by drug companies.
The main results for placebo-controlled RCTs are shown in the Table. Meta-analysis showed that dopamine agonists were better than levodopa for reducing symptom severity (2 RCTs, n = 422, mean difference [MD] in reduction of IRLS score −5.3, 95% CI −8.4 to −2.1). Cabergoline improved quality of life more than levodopa (1 RCT, n = 314, MD in RLS quality of life scale −5.5, CI −8.4 to −2.7). Dopamine agonists and levodopa did not differ for other outcomes.
Dopamine agonists improve outcomes more than placebo in the restless legs syndrome, but patients are more likely to discontinue treatment because of adverse events.
Dopamine agonists vs placebo for the restless legs syndrome*
*CGI-I = Clinical Global Impressions-Improvement scale; IRLS = International Restless Legs Syndrome Severity Rating Scale; PLMSI = Periodic Limb Movements in Sleep Index; other abbreviations defined in Glossary. RBI, RRI, NNT, NNH, and CI calculated from data in article using a random-effects model.
†Negative differences favor dopamine agonists.
‡Positive differences favor dopamine agonists.
Andolsek KM. Review: Dopamine agonists are effective for the restless legs syndrome but may be discontinued due to adverse events. Ann Intern Med. ;155:JC1–9. doi: 10.7326/0003-4819-155-2-201107190-02009
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Published: Ann Intern Med. 2011;155(2):JC1-9.
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