New data shows pramipexole (Mirapexin®/Sifrol®) can significantly reduce limb pain in patients with Restless Legs Syndrome (RLS)
First ever study to demonstrate efficacy of pramipexole in treating RLS-associated limb pain
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New data shows pramipexole (Mirapexin®/Sifrol®) can significantly reduce limb pain in patients with Restless Legs Syndrome (RLS) First ever study to demonstrate efficacy of pramipexole in treating RLS-associated limb pain 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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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.
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.
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