Boehringer Ingelheim

No Increased Risk of Treatment-Induced Augmentation in Restless Legs Syndrome (RLS) Demonstrated in Long-Term Placebo-Controlled Study With Mirapexin(R)
Sifrol(R) (Pramipexole)

Ingelheim, Germany (ots/PRNewswire) - - For Healthcare Media outside the U.S.A. New data presented today at the 61st Annual Meeting of the American Academy of Neurology (AAN), in Seattle, U.S.A. show that augmentation did not significantly differ in RLS patients treated with Mirapexin(R) /Sifrol(R) (pramipexole*) versus the group receiving placebo.(1) Augmentation, i.e. the worsening of RLS symptoms due to pharmacological treatment, has been frequently observed in patients treated with levodopa, a dopaminergic agent sometimes used to treat RLS.(2-4) Existing data for pramipexole, a non-ergot dopamine agonist, suggested that augmentation is less frequent and less severe than with levodopa,(3) however, until now there had been no well designed study to compare the frequency of augmentation under pramipexole versus placebo. "Although the phenomenon of augmentation in RLS has been widely recognised by RLS experts, there was a lack of placebo-controlled studies to differentiate the potential impact of the active drug in causing symptoms worsening. Because of its already established safety and efficacy profile in the treatment of RLS, pramipexole was used as study drug for this trial. The results showed that the risk of developing augmentation for RLS patients using pramipexole was comparable to that of those who received a placebo," said Birgit Högl, MD, assistant professor of neurology, head of the Sleep Disorders Clinic at the Medical University of Innsbruck, Austria and lead author of the study. "Diagnosing augmentation is a demanding task, even for experts familiar with the subject. The results from this trial, however, are quite reassuring and can support physicians and patients in their treatment decisions." Further results from this study presented at AAN reaffirmed sustained efficacy for pramipexole over a long-term period (26 weeks).(5) Positive response to treatment in this randomised, placebo-controlled, double-blind clinical trial was significantly higher for pramipexole compared to placebo measured on the International RLS Study Group Rating scale (58.6% vs. 42.8%, P=0.0044), the Clinical Global Impressions-Improvement scale (68.5% vs. 50.3%, P=0.0010), and the Patient Global Impression scale (62.3% vs. 44.0%, P=0.0011).(5) Overall, the data presented at AAN reaffirm the favourable safety, efficacy and tolerability profile of pramipexole over the long term for the treatment of Restless Legs Syndrome in patients with moderate to severe symptoms. *) See Notes to Editor for further trade names. Please be advised This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A. Notes to the Editor: Study Design A 26-week randomised, double-blind, placebo-controlled trial to assess the incidence of augmentation in RLS among recipients of flexible-dose pramipexole versus placebo. Among the 152 pramipexole- and 149 placebo- recipients treated for (greater than or equal to) 4 weeks, 47 (30.9%) and 40 (26.8%) qualified for expert-panel review. Of these, 11.8% of pramipexole recipients and 9.4% of placebo recipients were classified as augmentation. There was no statistically significant difference between the two groups in time to augmentation (P=0.8060).(1) About Restless Legs Syndrome (RLS) Restless Legs Syndrome is a neurological disorder characterised by an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs. Restless Legs Syndrome affects up to ten percent of the population worldwide aged between 30 and 79 years(6) and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress.(7) The motor-restlessness worsens during the evening and night causing difficulty initiating and maintaining sleep. The sleep disruption can lead to excessive daytime sleepiness and compromise work performance. Restless Legs Syndrome also has considerable impact on social activities that require immobility. More information on Restless Legs Syndrome can be found under http://www.rlsunderthecovers.com. About Mirapexin(R)/Sifrol(R) (pramipexole) Pramipexole (known under the trade names Mirapexin(R), Sifrol(R), Mirapex(R) and Pexola(R)) is a compound from Boehringer Ingelheim research first approved in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson's disease, as monotherapy or in combination with levodopa. Pramipexole was approved in 2006 for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS). Pramipexole is available in over 70 countries across the globe. The most commonly ([greater than or equal to] 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with pramipexole were nausea, headache, dizziness and fatigue. The most commonly ([greater than or equal to] 5%) reported adverse drug reactions in patients with Parkinson's disease treated with pramipexole were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue. Pramipexole may cause patients, particularly with Parkinson's disease, to fall asleep without any warning even while doing normal daily activities such as driving. When taking pramipexole hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. Patients and caregivers should be aware of the fact that abnormal behaviour (reflecting symptoms of impulse control disorders and compulsive behaviours) such as binge eating, compulsive shopping, hypersexuality and pathological gambling have been reported in patients treated with dopaminergic drugs, including pramipexole. Dose reduction/tapered discontinuation should be considered. About Boehringer Ingelheim The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 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 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. For more information please visit http://www.boehringer-ingelheim.com. References 1. Högl B et al. Similar incidences of augmentation during 26 weeks of double-blind pramipexole treatment for Restless Legs Syndrome in comparison to placebo. Oral presentation # S07.003 presented on 28 April 2009 at the 61st Annual Meeting of the American Academy of Neurology, Seattle, U.S.A. 2. Allen R et al. Augmentation of the Restless Legs Syndrome with carbidopa/levodopa. Sleep 1996; 19(3): 205-213. 3. Trenkwalder C et al. Treatment of Restless Legs Syndrome: an evidence-based review and implications for clinical practice. Mov Dis 2008; 23(16): 2267-2302. 4. Garcia-Borreguero D et al. Diagnostic standards for dopaminergic augmentation of Restless Legs Syndrome: report from a World Association of Sleep Medicine - International Restless Legs Syndrome Study Group consensus conference at the Max Planck Institute. Sleep Med 2007; 8(5): 520-530. 5. Högl B et al. Efficacy and safety of pramipexole for Restless Legs Syndrome: a 26 Week randomised, placebo-controlled clinical trial in the European Union. Poster # P07.056 presented on 30 April 2009 at the 61st Annual Meeting of the American Academy of Neurology, Seattle, U.S.A. 6. Phillips B et al. Epidemiology of Restless Legs Symptoms in adults. Arch Intern Med 2000; 160(14): 2137-2141. 7. Hening W et al. Impact, diagnosis and treatment of Restless Legs Syndrome in a primary care population: REST (RLS epidemiology, symptoms and treatment) primary care study. Sleep Med 2004; 5(3): 237-246. Contact: Ursula Bardon Corporate Division Communications Boehringer Ingelheim GmbH 55216 Ingelheim/Germany E-mail: press@boehringer-ingelheim.com Phone: +49-6132-77-2622 ots Originaltext: Boehringer Ingelheim Im Internet recherchierbar: http://www.presseportal.ch Contact: Contact: Ursula Bardon, Corporate Division Communications, Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, E-mail: press@boehringer-ingelheim.com, Phone: +49-6132-77-2622

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