GSK'S Requip(R) (ropinirole HCl) significantly reduces periodic leg movements in patients with RLS

07/30/04

Philadelphia, PA (August 1, 2004) – New data published in the August issue of SLEEP shows that patients with primary Restless Legs Syndrome (RLS) and with periodic leg movements during sleep (PLMS), have fewer awakenings resulting from involuntary kicks when treated with GlaxoSmithKline's Requip (ropinirole HCl). Patients also reported better sleep adequacy as defined by feeling rested upon waking in the morning. Objective measurements showed that PLMS significantly decreased from nearly 49 per hour to 12 per hour in the group treated with Requip compared to a decrease of 36 per hour to 34 per hour in the placebo group (P < 0.0001). In the study, patients treated with Requip also experienced a significant reduction in the number of times PLMS woke them from sleep, termed PLMA (PLM with arousal), from 7 per hour to 2.5 per hour (p = 0.0096). Requip is under review by the U.S. Food and Drug Administration (FDA) for the treatment of RLS. There is no currently approved treatment for RLS in the United States.

"The RLS patients in our study suffered from involuntary movements of their legs that often disrupted their sleep. These leg movements are often associated with RLS," stated Clete A. Kushida, M.D., Director of the Stanford University Center for Human Sleep Research and an author of the study. "These new study results show that patients who were given Requip had significant reductions in the number of leg movements, resulting in fewer awakenings from sleep."

PLMS are involuntary movements of the legs during sleep and are a feature seen in over 80 percent of patients with RLS. Restless Legs Syndrome, a condition that affects up to ten percent of the population, is a neurologic movement disorder characterized by an irresistible urge to move the legs and by uncomfortable or sometimes unpleasant sensations in the legs often described as creeping-crawling, burning or twitching.

These symptoms generally occur at rest, such as when sitting, lying or sleeping, and are temporarily relieved by movement. As a result, people with RLS have difficulty falling asleep and staying asleep and often avoid activities such as movies, long car rides or airline flights.

Requip® Shown to Improve Sleep and Reduce PLMS
In this study, 65 patients with at least moderately severe RLS and PLMS who met the International RLS Study Group criteria for RLS and had 5 PLMS per hour on a screening polysomnogram were included in the study. Patients aged 18 to 79 were enrolled from 15 referral centers and were randomized to receive Requip (0.25 to 4mg per day) or placebo. Participants were titrated to their effective dose of medication and received treatment for 12 weeks. Polysomnography simultaneously records multiple physiologic parameters related to sleep and wakefulness and is used to objectively evaluate abnormalities in sleep.

At 12 weeks, Requip significantly improved patients' ability to sleep. Both the primary endpoint (PLMS per hour) and secondary endpoint variable (PLMA per hour) showed large and statistically significant differences in favor of Requip over placebo. With Requip, PLMS per hour were significantly decreased from 48.5 per hour to 11.8 per hour, compared with a decrease from 35.7 per hour to 34.2 per hour in the placebo group (p < 0.0001). Further, at a mean dose of 1.8 mg per day, Requip effectively reduced PLMS to normal levels (≤5 per hour) for more than half of the patients (53.6 percent) versus 14.8 percent of patients on placebo. Among other sleep variables, the ability to initiate sleep (known as sleep latency) was significantly improved in patients receiving Requip compared to the placebo group. Average sleep latency in the group treated with Requip decreased from 16.7 to 6.6 minutes compared with an increase in the placebo group from 8.9 to 14.4 minutes (p < 0.01).

No serious adverse events occurred in either group. The most common adverse events reported with Requip versus placebo were headache (34.4 vs. 18.2 percent), nausea (31.3 vs. 15.2 percent) and dizziness (18.8 vs. 3 percent).

About Requip®
Requip is a second-generation dopamine agonist that directly stimulates post-synaptic dopamine receptors in the brain. It is believed that RLS may be caused by a dopamine dysfunction.

Requip is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease and is generally well tolerated in this population. In placebo-controlled studies for early treatment in this patient population on monotherapy, the most commonly reported side effects for Requip versus placebo were nausea (60 vs. 22 percent), dizziness (40 vs. 22 percent) and somnolence (40 vs. 6 percent). Patients are advised to talk to their doctor about whether they have the potential to develop the sedating effects associated with Requip, 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.

About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. Please consult full prescribing information for Requip, available at www.Requip.com or by calling Holly Russell at GlaxoSmithKline at (919) 483-2839. For more information on GlaxoSmithKline visit www.gsk.com.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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