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First ever study to demonstrate efficacy of pramipexole in treating RLS-associated limb pain
For medical media, outside the US only
Ingelheim, Germany, 10 June 2008 – A new study demonstrating that pramipexole (Mirapexin®/Sifrol®) can significantly reduce RLS-associated limb pain in patients with Restless Legs Syndrome (RLS)1 was presented today at the SLEEP 2008 22nd Annual Meeting of the Associated Professional Sleep Societies (APSS) in Baltimore, U.S.A., This effect is in addition to delivering effective relief from the broad range of RLS symptoms, including sleep disruption, daytime tiredness and mood disturbance. Pain associated with RLS symptoms, such as leg pain, is highly frequent in RLS patients (approximately 60 percent)2 and has been shown to have a negative impact on their health-related quality of life.3
The results of a large, multi-national, randomised, double-blind, placebo-controlled study showed for the first time that pramipexole, a non-ergot dopamine agonist indicated to treat moderate to severe RLS symptoms, significantly reduced limb pain as soon as after five days of treatment and the reduction in pain continued to improve throughout the study period (12 weeks). Improvements with placebo were consistently lower than with pramipexole and were only observed during the first weeks, and declined thereafter.1
“To date, clinical studies with available pharmacologic agents for limb pain have not demonstrated longer term benefits for RLS patients. These new findings with pramipexole will be well received by both doctors and patients who are often looking for a fast-acting and effective treatment for the characteristic RLS symptoms, while seeking the added benefit of alleviating the uncomfortable and painful sensations so often associated with RLS,” said Professor Markku Partinen, MD, PhD, Department of Neurology, University of Helsinki, Finland.
In the study, limb pain was measured at baseline, after one day, five days, nine days, two weeks, four weeks and 12 weeks using a 100-mm visual analogue scale (VAS)* where 0 equalled ‘no pain’ and 100 ‘unbearable pain’. At five days, limb pain was reduced by -15.5 points in the pramipexole group (n=178) versus -5.0 points in the placebo group (n=179). At two weeks and 12 weeks the reductions were -27.5 and -33.5 respectively in the pramipexole group versus -15.0 and -11.0 respectively in the placebo group. The difference versus placebo was statistically significant already from day 5 on over the entire study period.1 Throughout the study period pramipexole was well tolerated. The proportion of patients who discontinued due to adverse events was similar between the treatment groups (8.6 percent for placebo and 9.3 percent for pramipexole).4
The new data presented at APSS reaffirm pramipexole as a highly effective treatment that addresses the broad range of RLS patient needs. Pramipexole has been shown to rapidly alleviate the characteristic symptoms of the condition5, including relief from limb pain which is so frequently associated with RLS.
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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:
*Visual analogue scale (VAS)
The visual analogue scale (VAS) is a pain assessment tool to help patients describe the intensity of their pain. The VAS consists of a straight line with the left end of the line representing no pain and the right end of the line representing the worst pain. Patients are asked to mark where they think their pain is on this line.
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 years6 and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress.2 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.
Pramipexole (known in Europe under the trade names Mirapexin® and Sifrol® and in the U.S.A. as Mirapex®) 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 currently registered in over 80 countries across the globe.
The most commonly reported adverse reactions in clinical trials for Restless Legs Syndrome were nausea, headache, dizziness and fatigue. The most commonly reported adverse reactions in early and late Parkinson’s disease in clinical trials were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Pramipexole may cause patients 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. It should be noted that impulse control disorders/compulsive behaviours may occur while taking medicines to treat Parkinson`s disease, including pramipexole.
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 135 affiliates in 47 countries and 39,800 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 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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1 Aarskog D et al. Pramipexole rapidly improves RLS-associated limb pan. Presented 09 June 2008, 22nd Annual Meeting of the Associated Professional Sleep Societies (APSS), Baltimore, U.S.A.; Poster # 0827.
2 Allen RP et al. Restless Legs Syndrome prevalence and impact REST general population study. Arch Int Medicine 2005; 165: 1286-92.
3 Kushida C et al. Burden of Restless Legs Syndrome on health-related quality of life. Qual Life Res 2006; 16(4): 617-624.
4 Ferini-Strambi L et al. Pramipexole for Restless Legs Syndrome and associated sleep disturbance. Presented 16 April 2008, 60th Annual Meeting of the American Academy of Neurology (AAN), Chicago (IL), U.S.A.; Poster # P05.172.
5 Ferini-Strambi L et al. Rapid onset and sustained efficacy of pramipexole in Restless Legs Syndrome. Presented 16 April 2008, 60th Annual Meeting of the American Academy of Neurology (AAN), Chicago (IL), U.S.A.; Poster # P05.164.
6 Phillips B et al. Epidemiology of Restless Legs symptoms in adults. Arch Intern Med 2000; 160(14): 2137-2141.