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Requip (Ropinirole HCl) Maintains Symptom Control, Improves Sleep, In Patients With Restless Legs Syndrome: Presented at AAN

SAN FRANCISCO, CA -- April 28, 2004 -- Requip® (ropinirole HCl) was associated with long-term improvements in symptoms of Restless Legs Syndrome (RLS) and health-related quality of life (HRQoL) for patients, according to the results of a study presented at the 56^th American Academy of Neurology annual meeting in San Francisco. In addition, a combined analysis of three double-blind, placebo-controlled studies found that Requip significantly improved the subjective quality and quantity of sleep in RLS patients compared with placebo. Requip is not approved for RLS and is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of RLS. Currently, there is no approved treatment for RLS in the U.S.

"The results of this trial are significant because they show that Requip had a positive effect on symptoms of RLS and health-related quality of life scores. This suggests that by treating the symptoms of RLS, patients may experience a better health-related quality of life," said Jacques Montplaisir, M.D, Ph.D., Centre d'Étude du Sommeil, Hôpital du Sacré-Coeur de Montréal, Québec, Canada and Associate Professor of Psychiatry and Neuroscience, Université du Montréal. "Research has shown that the HRQoL of RLS patients is considerably impaired as compared to the general population."

RLS affects approximately 10 percent of the general population. Also known as Ekbom's syndrome, RLS is a neurological disorder characterized by an intense and often uncontrollable urge to move the legs. The symptoms of RLS generally occur during periods of rest or inactivity and are worse in the evening or at night. These symptoms can significantly disrupt a patient's sleep and daily activities. People with RLS often have difficulty falling and staying asleep and, as a result, can experience daytime fatigue. Many people with RLS report that their job, personal relationships and activities of daily living are impacted because of these sleep disruptions.


Requip Controls Symptoms and Improves HRQoL in RLS Patients
Results from a 36-week study of the efficacy and safety of Requip in the treatment of RLS showed positive results in symptom control and HRQoL. In the study, patients (18-79 years) with primary RLS received 24 weeks' single-blind treatment with Requip. Patients who responded to treatment and who met study requirements for treatment were then randomized to 12 weeks' double-blind treatment with either Requip or placebo. The primary end-point of the study was the proportion of patients relapsing during the double-blind phase between weeks 24 and 36. Relapse was defined as significant worsening of RLS symptoms based on the International Restless Legs Rating Scale or of sufficient severity to require withdrawal from the study. Of 202 enrolled patients, 106 completed the single-blind phase; 92 entered the double-blind phase. Results showed that the odds of a patient relapsing while receiving placebo were three times greater than those of a patient receiving Requip (odds ratio 0.33, p = 0.02).

Secondary end-points included scores on two HRQoL measures, the Short Form-36 (SF-36), a well-recognized and validated QoL measure, and the RLS Quality of Life Questionnaire (RLSQoL), a disease-specific measure. A significant treatment difference in favor of Requip was reported on the RLSQoL questionnaire and in four of the eight SF-36 domains, which were: vitality, role limitations due to physical health, social functioning and mental health. The differences observed in the remaining domains (physical functioning, bodily pain role limitations due to emotional health and general health) were not significant. In the double-blind phase of the long-term relapse prevention study the most common adverse events for Requip versus placebo were nausea (17.8% vs. 2.1%), headache (11.1% vs. 6.4%). Most adverse events were mild or moderate in severity.

Requip Provides Sleep Benefits in RLS Patients
The combined results from three double-blind, placebo-controlled studies with Requip showed that Requip (up to 4 mg/day) had a positive effect on aspects of sleep in patients suffering from RLS. Patients (at least 18 years of age) with primary RLS were randomized to Requip or placebo for 12 weeks. The Medical Outcomes Study (MOS) sleep scale was completed at baseline and week 12 by 304/309 patients randomized to Requip and by 301/306 patients randomized to placebo.

At 12 weeks, improvements in each of the four MOS sleep scale domains assessed (sleep adequacy p < 0.0001, sleep quantity p= 0.002, sleep disturbance p< 0.0001 and daytime somnolence p=0.0006) showed significant improvement for those treated with Requip compared to those on placebo, including an increased sleep time of 42 minutes. The most common adverse events for Requip versus placebo were nausea (37.9% vs. 8.1%) and headache (22.3% vs. 20.8%) and vomiting (12.9% vs. 1.6%).

"Results of our research are important because they demonstrate that Requip is effective in alleviating motor symptoms of RLS and consequently providing sleep benefits," said Richard P. Allen, Ph.D., DABSM, Research Associate in Neurology at Johns Hopkins. "By treating the symptoms of RLS, patients may thereby experience improved sleep."

About Requip
Requip is a second-generation dopamine agonist that directly stimulates the 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. A diagnosis of RLS does not indicate the onset of Parkinson's disease.

In the treatment of Parkinson's disease, Requip is generally well tolerated. In placebo-controlled studies for early Parkinson's disease in patients 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.


SOURCE: GlaxoSmithKline

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