Efficacy and safety of pramipexole in restless legs syndrome

J. W. Winkelman, K. D. Sethi, C. A. Kushida, P. M. Becker, J. Koester, J. J. Cappola, J. Reess

Research output: Contribution to journalArticle

163 Citations (Scopus)

Abstract

OBJECTIVE: To evaluate the efficacy and safety of pramipexole in patients with moderate to severe restless legs syndrome (RLS) METHODS: The authors conducted a 12-week, double-blind, randomized, placebo-controlled trial of fixed doses of pramipexole (0.25, 0.50, and 0.75 mg/day). Patients (N = 344) were up-titrated to their randomized dose over 3 weeks. The primary efficacy endpoints were patient ratings of symptom severity on the International RLS Study Group Rating Scale (IRLS) and clinician ratings of improvement on the Clinical Global Impressions-Improvement (CGI-I) scale. Secondary efficacy endpoints included visual analogue ratings of sleep and quality of life (QOL) RESULTS: By both primary measures, pramipexole was superior to placebo. For IRLS, the adjusted mean (SE) change from baseline to week 12 was -9.3 (1.0) for placebo, -12.8 (1.0) for 0.25 mg/day, -13.8 (1.0) for 0.50 mg/day, and -14.0 (1.0) for 0.75 mg/day (all p < 0.01). Similarly, pramipexole increased the percentage of patients with a CGI-I rating of "very much improved" or "much improved" at the end of the trial (51.2% for placebo and 74.7%, 67.9%, and 72.9% for pramipexole; all p < 0.05). Pramipexole significantly improved ratings of symptom severity, day and night, and also ratings of sleep satisfaction and QOL. Pramipexole was well tolerated: The most frequent adverse events with higher occurrence in the pramipexole group were nausea (19.0% vs 4.7%) and somnolence (10.1% vs 4.7%) CONCLUSION: As rated by patients and by clinicians, pramipexole was efficacious and safe in reducing the symptoms of restless legs syndrome.

Original languageEnglish (US)
Pages (from-to)1034-1039
Number of pages6
JournalNeurology
Volume67
Issue number6
DOIs
StatePublished - Sep 1 2006

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Restless Legs Syndrome
Safety
Placebos
Sleep
Quality of Life
pramipexole
Nausea
Randomized Controlled Trials

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Winkelman, J. W., Sethi, K. D., Kushida, C. A., Becker, P. M., Koester, J., Cappola, J. J., & Reess, J. (2006). Efficacy and safety of pramipexole in restless legs syndrome. Neurology, 67(6), 1034-1039. https://doi.org/10.1212/01.wnl.0000231513.23919.a1

Efficacy and safety of pramipexole in restless legs syndrome. / Winkelman, J. W.; Sethi, K. D.; Kushida, C. A.; Becker, P. M.; Koester, J.; Cappola, J. J.; Reess, J.

In: Neurology, Vol. 67, No. 6, 01.09.2006, p. 1034-1039.

Research output: Contribution to journalArticle

Winkelman, JW, Sethi, KD, Kushida, CA, Becker, PM, Koester, J, Cappola, JJ & Reess, J 2006, 'Efficacy and safety of pramipexole in restless legs syndrome', Neurology, vol. 67, no. 6, pp. 1034-1039. https://doi.org/10.1212/01.wnl.0000231513.23919.a1
Winkelman JW, Sethi KD, Kushida CA, Becker PM, Koester J, Cappola JJ et al. Efficacy and safety of pramipexole in restless legs syndrome. Neurology. 2006 Sep 1;67(6):1034-1039. https://doi.org/10.1212/01.wnl.0000231513.23919.a1
Winkelman, J. W. ; Sethi, K. D. ; Kushida, C. A. ; Becker, P. M. ; Koester, J. ; Cappola, J. J. ; Reess, J. / Efficacy and safety of pramipexole in restless legs syndrome. In: Neurology. 2006 ; Vol. 67, No. 6. pp. 1034-1039.
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AU - Kushida, C. A.

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