To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: AAN: Requip (Ropinirole HCl) Shows Promise for Restless Legs Syndrome URL: http://www.pslgroup.com/dg/1FA18E.htm Doctor's Guide May 7, 2001
RESEARCH TRIANGLE PARK, NC -- May 7, 2001 -- The first double-blind, placebo-controlled study of Requip® (ropinirole HCl) in patients with restless legs syndrome (RLS) demonstrated a significant improvement in the periodic leg movements (PLMs) of sleep compared to placebo. The study results were presented at the 53rd American Academy of Neurology annual meeting in Philadelphia, Pennsylvania. RLS is a potentially debilitating medical condition that affects approximately 16 million Americans. It is associated with the irresistible urge to move one's legs and involuntary jerking limb movements that can interfere with sleep. "Although there are no FDA approved treatments for RLS, this double-blind, placebo-controlled study of ropinirole in RLS involving 22 patients showed a significant improvement in the ropinirole-treated group versus the placebo-treated group," said Ray L. Watts, professor and vice chairman of the Department of Neurology at Emory University, Atlanta, Georgia. According to the Restless Legs Syndrome Foundation, RLS is characterized by prickly, burning, itching, pulling or tugging sensations that occur typically deep within the legs, occasionally in the arms and infrequently in other body parts. These sensations result in an irresistible urge to move the extremities that can eventually become completely involuntary. RLS can often be a debilitating condition leading to severe sleep difficulties and thereby feelings of unrest during the daytime. RLS can also prevent patients from conducting daily activities such as sitting for extended periods of time or riding in a car. Many sufferers are unaware these symptoms are a result of a medical condition. "As both a foundation board member and as a patient, I think research is critical because RLS affects so many people's lives in such a profound way," said Bob Waterman, Chairman of the Board, RLS Foundation. "I think we desperately need to continue the research." In this study, the effectiveness and tolerability of Requip were assessed for the treatment of RLS. The effectiveness was measured by the number of periodic leg movements (during poly-somnography) and by the International RLS Rating Scale. Patients with primary RLS were recruited for participation in the study. All patients underwent an extensive telephone interview regarding their RLS history, treatment and other medical problems prior to enrollment. Thirty-one patients were enrolled with 22 patients completing both the open-label and subsequent double-blind, placebo-controlled phases. The primary outcome measure was to determine whether the number of leg movements per hour in NREM sleep was reduced (using the Periodic Leg Movement Sleep Index, or PLMSI) in the patients treated with Requip versus the placebo-treated group. The secondary outcome measure was to determine if overall RLS symptoms as measured by the RLS rating scale were decreased in the patients treated with Requip vs. the placebo-treated group. Patients with primary RLS (n=31) were started on 0.25mg/dose of Requip administered in the evening. Once the patients reached their appropriate dose for maximum therapeutic effect, they were maintained at that dosage for two weeks during the open-label phase. The dose of Requip ranged from 0.25 to 6mg/day with an average of 1.7mg/day. Patients were evaluated at baseline and weekly using the RLS rating scale (range 0-40; 40 being severe disease) and by PLMS throughout the study. The mean age of the patients who completed the entire study (n=22) was 51 years of age. These patients averaged 26 years of suffering from RLS. At the end of the open label phase, patients underwent a 1:1 double-blind randomization to either placebo or continuation at the effective dosage of Requip for two additional weeks. Twenty-two of the thirty-one patients successfully completed both phases of the study. There was a statistically significant difference in the primary outcome variable (the PLMSI) between patients treated with Requip and the placebo-treated group in the double-blinded phase. Data for the secondary endpoint, using the RLS rating scale, also demonstrated improvement with Requip. The average RLS rating score at baseline was 23.2 for all patients compared to 13.5 for patients on Requip and 17.7 for patients on placebo following the double-blinded portion. Requip was generally well tolerated. Side effects reported from the 26 patients in the open label phase included drowsiness (11/26), gastrointestinal discomfort (11/26) and headache (10/26). Complete data on adverse events are not yet available from the double-blinded phase of the trial. Two patients dropped out due to drug related side effects (nausea and possible allergic reaction).
SOURCE: GlaxoSmithKline --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.