By Ed Susman
CHICAGO -- April 18, 2008 -- Sleep disturbance scores were reduced nearly 50% in patients with restless legs syndrome treated with pramipexole, doctors reported here at the 60th Annual Meeting of the American Academy of Neurology (AAN 2008).
"Most people with restless legs syndrome who seek medical advice have often suffered for a long time from sleep deprivation due to the debilitating impact of restless legs syndrome," said Luigi Ferini-Strambi, MD, Professor of Neurology, Sleep Disorders Centre, Università Vita-Salute, San Raffaele, Milan, Italy. "To feel the benefit of a simple, effective treatment right from the start is a huge step forward for these patients."
In the randomised, double-blind, placebo-controlled clinical trial, Dr. Ferini-Strambi and colleagues assigned 179 patients to placebo and 178 to pramipexole. Individuals were eligible for the trial if they scored greater than 15 points on the International Restless Legs Syndrome Study Group Rating Scale and had symptoms at least 2 to 3 times per week.
After 12 weeks, sleep disturbance scores for the patient group treated with pramipexole were reduced from 52.5 to 27.8, and from 55.6 to 38.5 in the placebo group (P = .0001). A score of 24.5 is considered normal, Dr. Ferini-Strambi said in a poster presentation on April 16.
"Beyond enabling patients to sit comfortably through an evening, patients taking pramipexole can look forward to a night of sleep without being disturbed by the uncontrollable urge to move their legs. For many people with restless legs syndrome, this means that they can finally start regaining their quality of life."
He noted that the effects of pramipexole on sleep have not previously been evaluated with a well-validated, multi-dimensional, patient-reported instrument.
"This trial confirms the efficacy and good tolerability of pramipexole for the treatment of the essential features of restless legs syndrome. Additionally, pramipexole significantly reduced sleep disturbance -- the most burdensome problem in restless legs syndrome -- to near-normal levels," he concluded.
Funding for this study was provided by Boehringer Ingelheim GmbH.
[Presentation title: Pramipexole for Restless Legs Syndrome and Associated Sleep Disturbance. Abstract P05.172]
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