Efficacy and safety of pramipexole in chinese patients with restless legs
syndrome: results from a multi-center, randomized, double-blind,
placebo-controlled trial.
Author(s): Ma JF, Wan Q, Hu XY, Sun SG, Wang WZ, Zhao ZX, Wang YJ, Liu CF, Li JM, Jiang YP,
Chen SD.
Affiliation(s): Department of Neurology & Institute of Neurology, Ruijin Hospital Affiliated to
the Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Publication date & source: 2012, Sleep Med. , 13(1):58-63
BACKGROUND: We performed a six-week study of pramipexole vs. a placebo in Chinese
restless legs syndrome patients.
METHODS: Overall, 305 enrolled patients were assigned randomly in a 2:1 ratio to
the pramipexole group (N=202) and the placebo group (N=103).
RESULTS: Of 287 patients in the full analysis set, the pramipexole group showed
significant improvement compared with the placebo group in the change of their
International Restless Legs Syndrome Study Group Rating Scale of Severity (IRLS)
total score from baseline to week 6 after adjustment of centers and baseline
characters (-15.87±0.66 vs. -11.35±0.92, p<0.0001) and in the proportion of
patients who were "much improved" and "very much improved" when measured by
Clinical Global Impressions-Improvement (81.9% vs. 54.3%, p<0.0001). At week 6,
the IRLS responder rate was 73.8% (pramipexole) and 48.9% (placebo) (p<0.0001)
and the patient global impression responder rate was 68.6% (pramipexole) and
43.5% (placebo) (p<0.0001). The proportion of adverse events was 62.9% in the
pramipexole group and 43.7% in the placebo group, respectively. No deaths
occurred.
CONCLUSION: Pramipexole was effective and well-tolerated in Chinese patients with
restless legs syndrome.
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