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Requip (Ropinirole HCl) Significantly Improves Symptoms of Restless Legs Syndrome: Presented at APSS

CHICAGO, IL -- June 9, 2003 -- Requip® (ropinirole HCl) significantly improves symptoms of Restless Legs Syndrome (RLS), and is generally well tolerated, according to the results of a study presented at the 17^th Associated Professional Sleep Societies annual meeting in Chicago. A second study also showed that Requip reduced periodic leg movements during sleep (PLMS), a primary motor symptom of the condition. No medicines have been approved by the U.S. Food and Drug Administration for treatment of RLS.

RLS is a neurological disorder that affects about 5-10 percent of the general adult population. It is characterized by an uncontrollable urge to move the legs and painful or distressing sensations in the legs that are described as creeping or twitching 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. Additionally, approximately 90 percent of RLS patients experience PLMS (periodic leg movements of sleep), which are repetitive movements that occur about every 20-40 seconds in one or both legs and often cause sleep disruption.

"As a physician who regularly treats patients with Restless Legs Syndrome, I have seen how serious this condition can be, particularly with regard to impact on sleep. The chronic sleep depravation that some RLS patients experience as a result of their symptoms has a significant impact on daytime functioning," said Arthur Walters, M.D., New Jersey Neuroscience Institute and a key investigator in the first study. "I am very encouraged by the results of this trial."

Study Conducted in Six Countries
The results of the first study show that Requip taken at a single daily dose of up to 4 mg one to three hours before bedtime is effective in the treatment of RLS and significantly improves symptoms as measured by The International RLS (IRLS) and Clinical Global Impression (CGI) scales compared with placebo. Nearly 20 percent more patients taking Requip reported themselves "much improved" or "very much improved" as compared to those taking placebo.

Requip was generally well tolerated by patients in this study. A total of 5.3 percent of patients in the Requip group withdrew from the study before completion due to adverse events, as compared to 6.6 percent of the placebo group. Nausea (39.7%), headache (22.1%), fatigue (15.3%) and dizziness (15.3%) were the adverse events reported most commonly. The study was a 12-week randomized, double blind and placebo controlled study conducted in 47 centers in six countries, with an enrollment of 267 patients with primary RLS. It compared the safety, efficacy and tolerability of Requip with placebo at doses ranging from 0.25 mg up to 4 mg (mean daily dose at 12 weeks was 1.9 plus or minus 1.19 mg) once daily.

U.S. Study Results Explained
In the second study presented at the meeting, the results indicate that Requip in doses up to 4 mg per day is an effective treatment for PLMS in patients with primary RLS and significantly reduces the number of PLMS that cause a patient to wake up. Specifically, patients treated with Requip demonstrated a significantly better PLMSI (PLMS per hour index) and PLMSA/hr (PLMS with arousal per hour of sleep) at week 12 than the placebo group (PLMSI: Requip -32.94, placebo, -5.71; PLMSA/hr: Requip -3.28, placebo 1.05).

The study was also a 12-week double-blind randomized placebo controlled study enrolling 65 patients with primary RLS and PLMS. It compared the effectiveness, safety and tolerability of Requip versus placebo at doses ranging from 0.25 mg up to 4 mg (mean daily dose at 12 weeks was 1.8 plus or minus 1.10 mg) one to three hours before bedtime. Patients' nighttime leg movements were recorded by a nocturnal polysomnogram to compare change in PLMSI and PLMSA/hr.

Requip was generally well tolerated with only one patient withdrawing from the study because of an adverse event. Headache (34.4%), nausea (31.3%) and dizziness (18.8%) were the adverse events reported most commonly in the ropinirole group.

"This study provides real, objective evidence that ropinirole has a positive effect on patients' nighttime leg movements," said Richard P. Allen, Ph.D., Research Associate in Neurology, Johns Hopkins University, and key study investigator who presented the data.

These two studies are 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.


SOURCE: GlaxoSmithKline

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