Requip(reg) (Ropinirole Hcl) significantly improves symptoms of Restless Legs Syndrome at 1 week

Main Category: Sleep / Sleep Disorders / Insomnia
Article Date: 07 Jun 2004 - 16:00 PDT

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Over a third of patients taking GlaxoSmithKline's Requip (ropinirole HCl) for Restless Legs Syndrome (RLS) in clinical trials experienced significant improvement in their symptoms at one week, according to the results presented at the Associated Professional Sleep Societies 18th Annual Meeting in Philadelphia.

The results were from combined data from three double-blind, placebo-controlled trials of Requip in RLS, which included 618 patients, ages 18 to 79 years. 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 results show that over one-third of patients experienced significant improvement in their symptoms at one week of treatment with Requip. Only one in seven patients showed some improvement on placebo," said Philip Becker, M.D., Clinical Professor of Psychiatry at Southwestern Medical Center of Dallas and Medical Director of the Sleep Medicine Institute at Presbyterian Hospital of Dallas, who was the lead investigator of the study. "These results are encouraging because most of these patients previously suffered the disruptive and uncomfortable sensations of RLS for years."

Restless Legs Syndrome is a neurologic movement disorder characterized by an uncontrollable urge to move the legs and by uncomfortable or sometimes painful sensations in the legs often described as creeping, 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.

Symptom Relief at One Week

At one week, more patients receiving Requip reported significant improvement in their RLS symptoms than patients receiving placebo. In the three double-blind trials, 618 patients were randomized to receive Requip or placebo, taken once a day for 12 weeks one to three hours before bedtime. During weeks one to seven, Requip was titrated upwards (range: 0.25 - 4 mg/day) until patients reached their individual effective doses.

The maximum dose by the end of week one was a low dose of 0.5 mg/day. At one week of treatment, significantly more patients receiving Requip were rated as "much improved" or "very much improved" using the Clinical Global Impression Improvement (CGI-I) scale compared to patients taking placebo (35.3% [109/309] vs 14.8% [45/304]; p<0.0001).

Additionally, the mean improvement in the International Restless Legs Scale (IRLS) total score at one week was significantly greater in patients receiving Requip (n=299) than placebo (n=290) (-8.1 vs -4.6; p<0.0001).

During treatment over a twelve-week period and over the dose range of 0.25 - 4 mg/day, the most commonly reported adverse events of Requip versus placebo were nausea (37.9% vs. 8.1%); headache (22.3% vs. 20.8%) and vomiting (12.9% vs. 1.6%).

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%), dizziness (40% vs. 22%) and somnolence (40% vs. 6%).

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 http://www.Requip.com or by calling Holly Russell at GlaxoSmithKline at (919) 483-2839. For more information on GlaxoSmithKline visit http://www.gsk.com.