Requip(R) (ropinirole HCl) significantly improves symptoms of Restless Legs Syndrome (RLS) and is a generally well-tolerated treatment, according to the results of a study presented at the 55th American Academy of Neurology (AAN) annual meeting in Honolulu. The study is the first large, international, randomized, double blind, placebo controlled trial to examine the efficacy, safety, tolerability and patient reported outcomes of Requip for the treatment of RLS.
RLS is a potentially debilitating neurological disorder characterized by an uncontrollable urge to move the legs. The condition is characterized by painful or distressing sensations in the legs that are described as creeping or twitching and that occur during rest and are relieved through movement.
Because symptoms often appear during rest in the evening or at night, RLS can lead to appreciable sleep disturbances. No medicines have been approved by the U.S. Food and Drug Administration for treatment of RLS.
“This is the largest controlled trial of ropinirole in RLS conducted to date and the results affirm the efficacy and tolerability findings from previous small studies. The results are therefore very favorable,” said Diego Garcia-Borreguero, a key study investigator and director of the sleep disorders unit within the Department of Neurology at Fundacion Jimenez Diaz in Madrid, Spain. “As a physician who treats patients with RLS, I’m very excited about the improvement of symptoms like the irresistible urge to move and positive impact on sleep in this study.”
The 12-week study, sponsored by GlaxoSmithKline, was conducted in 43 hospitals in 10 European countries(i), and enrolled 284 adults with RLS(ii). It compared the effectiveness and tolerability of placebo (an inactive tablet) with Requip at doses ranging from 0.25 mg up to 4 mg (mean daily dose at 12 weeks was 1.9 plus or equals 1.13 mg), taken one to three hours prior to bedtime.
Results showed that RLS symptoms improved significantly more in the patients taking Requip (n=146) as compared to patients taking placebo (n=138)(iii). Patients treated with Requip experienced a decrease in their RLS symptom scores that were almost a third greater than those seen with patients taking placebo (27%, 11 points vs. 8 points). When asked by their doctor about their overall well-being (as measured by the CGI-I scale(iv)), patients taking Requip were significantly more likely to report being “much improved” or “very much improved” compared with placebo treated patients.
Requip was generally well-tolerated by patients. Nausea, headache and vomiting were the most common adverse events. (Nausea was 37.7% Requip vs. 6.5% placebo; headache was 19.9% Requip vs. 16.7% placebo and vomiting was 13% Requip vs. 1.4% placebo). Events were generally mild to moderate and transient. Serious adverse events were uncommon and none were considered to be treatment related or caused a patient to withdraw from the study.
This study is part of GlaxoSmithKline’s clinical development program for Requip in RLS. Requip has not been approved by the FDA for the treatment of RLS. It has been approved and is currently marketed for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.
In the treatment of Parkinson’s disease, Requip is generally well tolerated. In studies for Parkinson’s disease, the most commonly reported side effects are nausea, somnolence, dizziness, headache and dyskinesia. Patients are advised to talk to their doctor about whether they have the potential to develop the sedating effects associated with ropinirole, which include somnolence, and the possibility of falling asleep while engaged in activities of daily living, including operation of a motor vehicle. Fainting or low blood pressure may occur during initial treatment or with an increase in dose. Hallucinations may occur at anytime during treatment. Requip may potentiate the side effects of L-dopa and may cause and/or exacerbate pre-existing dyskinesias.
GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and healthcare companies. For more information on Requip, including full prescribing information, visit http://www.Requip.com.
(i) Austria, Belgium, France, Germany, Italy, The Netherlands, Norway, Spain, Sweden, UK. 43 hospitals and neurology clinics participated.
(ii) Men and women ages 18-79 years and diagnosed with RLS using the International RLS Study Group diagnostic criteria; Walters, 1995. Patients had a score of at least 15 on the International Restless Legs Scale (IRLS) and had experienced either at least 15 nights with RLS symptoms in the previous month or, in the investigators’ opinion, would have had symptoms with this frequency if they had not been receiving treatment.
(iii) All participants scored greater than or equal to 15 on the International Restless Legs Scale (IRLS). Requip was associated with significantly greater mean (SE) improvements on the IRLS at week 12 than placebo (-11.04 points versus -8.03 points respectively).
(iv) CGI-I Scale — Clinical Global Impression ‘Global Improvement’ Scale
SOURCE GlaxoSmithKline. Web Site: http://www.gsk.com http://www.Requip.com