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Boehringer Ingelheim Pharmaceuticals, Inc. Release: Pramipexole Significantly Improved Symptoms Of Restless Legs Syndrome, New Studies Show

Published: Apr 05, 2006

SAN DIEGO, April 5 /PRNewswire/ -- Data presented this week at the 58th Annual Meeting of the American Academy of Neurology (AAN) demonstrated that treatment with pramipexole significantly improved the symptoms of Restless Legs Syndrome (RLS) in multiple studies involving nearly 500 patients. It is estimated that up to one in ten adults suffer from RLS.

These data, from two pivotal studies of pramipexole in the treatment of RLS, were presented in four poster sessions. In a study by Winkelman et al, all doses of pramipexole produced statistically significant improvements versus placebo on patient- and clinician-rated RLS improvement scales over a twelve week period. Furthermore in a separate presentation of data from the same study, pramipexole-treated patients also showed up to a 56 percent quality of life improvement versus placebo, a finding that was highly significant. Evaluation of quality of life was one of several secondary endpoints from the study. A second study, by Trenkwalder et al, demonstrated that treatment with pramipexole was associated with sustained improvement of RLS symptoms, and additionally that withdrawal of the pramipexole treatment resulted in significant worsening of RLS symptoms.

"These studies provide evidence that supports the efficacy and safety of pramipexole for RLS across a range of symptoms which were sustained over time," said lead investigator, John W. Winkelman, MD, PhD, Medical Director, Sleep Health Center, Brigham and Women's Hospital.

About the Studies

Winkelman et al, aa double-blind, placebo-controlled, parallel-group study, involved 344 RLS patients (129 male; 215 female) who were randomly assigned to treatment groups (0.25 mg, 0.50 mg, and 0.75 mg of pramipexole). Of those patients, data from 339 were analyzed to evaluate the effect of 12 weeks of treatment with pramipexole on efficacy and quality of life. The mean age of patients was 51.4 years and the mean duration of RLS symptoms was 5.1 years.

Trenkwalder et al was a multicenter, placebo-controlled, double-blind withdrawal trial that included 150 RLS patients who had previously completed a 6-month, open-label, run-in with pramipexole. Patients were randomly assigned to three months of treatment with pramipexole or placebo. Data from 147 patients were analyzed to evaluate the effects of pramipexole on clinician and patient ratings of RLS symptom severity. The mean age of patients was 59.6 years (72 percent female) and the mean duration of symptoms was 5.6 years.

To assess RLS symptom severity and/or improvement, both studies utilized the patient- and clinician-rated improvement scales - the Clinical Global Impressions-Global Improvement scale (CGI-I) and the International RLS Study Group Rating Scale (IRLS). In Winkelman et al, quality of life was assessed by the Johns Hopkins RLS Quality of Life questionnaire (RLS-QOL), an 18-item, self-report instrument, specifically developed to assess the impact of RLS on patients' quality of life.

About Restless Legs Syndrome (RLS)

RLS is a common, yet often undiagnosed, neurological sensorimotor disorder. Current estimates suggest that 10 percent of adults suffer from RLS, with the true percentage possibly higher due to underdiagnosis of the condition. Patients with RLS often experience an urge to move their legs at night due to uncomfortable leg sensations that worsen during periods of rest or inactivity, often interfere with the ability to sleep, and are partially or totally relieved with movement, such as walking or stretching. While symptoms can vary from person to person, they are generally described as burning, creeping, crawling, aching, tingling, or tugging sensations in the legs. Additionally, people with RLS will often have disruptions in sleeping caused by periodic limb movements (PLMS). Approximately one-third of sufferers experience symptoms at least twice weekly, causing moderate to severe distress.

RLS embodies a broad range of symptoms, such as daytime tiredness, mood disturbance, and inability to perform daily activities. These symptoms can have a substantial negative impact on patients' quality of life (QOL). Leg discomfort, sleep disturbance, and fatigue can, in turn, impact daily functioning by affecting a patient's ability to work and participate in social activities and family life. A recent study indicated that more than one third of RLS patients reported that their symptoms had a high negative impact on their QOL. In a subanalysis of another study, RLS patients had lower QOL scores than patients with diabetes, hypertension, other cardiovascular conditions, and osteoarthritis.

About Pramipexole

Pramipexole, a compound from Boehringer Ingelheim research, is currently approved for the treatment of the signs and symptoms of idiopathic Parkinson's disease, as monotherapy or in combination with levodopa. A supplemental New Drug Application (sNDA) has also been filed with the U.S. Food and Drug Administration for the treatment of restless legs syndrome (RLS). The most common side effects in people taking pramipexole for RLS were nausea, sleepiness and headache. The most commonly reported adverse events in early and late Parkinson's disease in clinical trials were dizziness, dyskinesia, extrapyramidal syndrome, headache, insomnia, somnolence, and nausea. Hallucinations and postural (orthostatic) hypotension may occur. Patients have reported falling asleep without perceived warning signs during activities of daily living, including operation of a motor vehicle, which sometimes resulted in accidents. Patients and caregivers should be informed that impulse control disorders/compulsive behaviors can occur while taking medicines to treat Parkinson's disease, including pramipexole.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and approximately 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2005, Boehringer Ingelheim posted net sales of US $11.8 billion (9.5 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

Boehringer Ingelheim Pharmaceuticals, Inc.

CONTACT: Kate O'Connor, Public Relations, Boehringer IngelheimPharmaceuticals, Inc., +1-203-791-6250,koconno4@rdg.boehringer-ingelheim.com

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