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New data suggest pramipexole can significantly improve quality of life (QoL) for people with Restless Legs Syndrome (RLS)

Pressmeddelande   •   Apr 05, 2006 13:44 CEST

By treating the broad range of RLS symptoms, pramipexole can reduce the significant QoL burden of the condition
05 April 2006
For medical media, outside the US only

Ingelheim/Germany, 5 April 2006 – Data reported today, at the 58th Annual Meeting of the American Academy of Neurology, in San Diego, U.S.A., indicate that when treated with pramipexole, patients affected by Restless Legs Syndrome (RLS) can experience a significantly improved quality of life.1

Restless Legs Syndrome is a common neurological disorder characterised by an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs which worsen during the evening and night. RLS, however, not only affects sufferers’ ability to sleep, but is also associated with debilitating daytime symptoms, such as tiredness and depression.2

“RLS goes beyond the night-time symptoms. The consequences of the constant sleep interruptions are devastating. For me it means being tired in the day, not being able to concentrate in my work and therefore feeling very depressed,” explains Katrin S., a patient from Sweden who has been suffering from RLS for more than 25 years.

The latest data, presented today at the AAN, are from a study involving 344 patients who were randomised to receive either pramipexole or placebo over a 12 week period. At the start of the study, the mean QoL score (as assessed by the John Hopkins RLS Quality of Life questionnaire (RLS-QoL)) was 69.1. After 12 weeks of treatment with pramipexole, the total mean change in the score from baseline was 19.8 (+/- 16.6), with a mean difference from placebo of 6.4 (+/- 1.6), p = 0.0001. The RLS-QoL is a self-completion questionnaire, specifically developed to assess the impact of RLS on patients’ quality of life. It includes criteria such as disruption to routine daily activities, ability to concentrate during the daytime, ability to make decisions and to work normal hours.3

"It’s important to remember that Restless Legs Syndrome is much more than disturbed sleep. Patients experience a broad range of consequences, such as daytime tiredness, and depressive and anxiety symptoms, such that their quality of life can be dramatically impacted. These latest data are important in that they indicate that, by addressing the underlying RLS symptoms, pramipexole can help patients to regain the quality of life that many of them feel that they have lost,” explained Professor John W Winkelman, MD PhD, Medical Director of the Sleep Health Centre of Brigham and Women’s Hospital, Boston, Massachusetts/USA, Harvard Medical School, and lead author of the study.

Pramipexole, currently the most prescribed dopamine agonist used for the treatment of Parkinson’s Disease (PD), recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) recommending its approval for the treatment of Restless Legs Syndrome (RLS) in the European Union.

Significant burden of the condition
Patients who suffer from Restless Legs Syndrome commonly report that their quality of life is significantly compromised and studies have shown that the impact on quality of life is comparable to conditions such as diabetes, hypertension and osteoarthritis.2,4 In addition to the sleep disturbance, RLS can result in daytime tiredness, exhaustion, difficulty concentrating, depression and anxiety.2 A recent study5 indicated that over one third of RLS patients reported that their symptoms had a high negative impact on their quality of life.

Clinical guidelines6 recommend dopamine agonists as first-line treatment for moderate to severe RLS and these new data add to the growing body of clinical evidence indicating that pramipexole is a well-tolerated treatment that can deliver rapid, sustained and significant relief from the symptoms of RLS and bring about significant improvements in patients’ quality of life.

Efficacy in treating RLS
The registration programme for pramipexole included more than 1,000 patients in Europe and the United States. These study results have confirmed that pramipexole provides rapid relief from symptoms after just one week of starting treatment. Pramipexole is highly efficacious at the starting dose of 0.125mg single dose per day and up to 0.75mg single dose per day7 and is well tolerated.8,9,10

The efficacy and tolerability of pramipexole in RLS continues to be investigated in a comprehensive clinical trials programme with more than 1,000 patients, to further assess the therapeutic potential in this condition.

About Restless Legs Syndrome (RLS)
RLS affects up to ten percent of the population aged between 30 and 79 years11 and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress.12 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. RLS also has considerable impact on social activities that require immobility.

About pramipexole
Pramipexole (known in Europe under the trade names Sifrol® and Mirapexin® and in the U.S.A. as Mirapex®), is a compound from Boehringer Ingelheim research currently approved for the treatment of the signs and symptoms of idiopathic Parkinson`s Disease, as monotherapy or in combination with levodopa. On 24 February 2006, the Committee for Medicinal Products for Human Use (CHMP) issued a Positive Opinion recommending approval of pramipexole for the treatment of Restless Legs Syndrome in the European Union. An application has also been filed with the U.S. Food and Drug Administration to include treatment of RLS in the US label.

The most commonly reported adverse reactions in early and late Parkinson’s disease in clinical trials were dizziness, dyskinesia, headache, insomnia, somnolence, constipation, nausea, hallucinations visual, orthostatic hypotension and fatigue. 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.It should be noted that impulse control disorders/compulsive behaviours can occur while taking medicines to treat Parkinson`s disease, including pramipexole.

Boehringer Ingelheim
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 almost

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 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Note to Editor:
Johns Hopkins RLS-QoL questionnaire:
An 18-item self-report questionnaire that evaluates the impact of RLS on daily life, sleep, emotional well-being, social life, and work life in the past 4 weeks. The maximum RLS-QoL summary score is 100 and high scores indicate a better quality of life.


Contact:
Boehringer Ingelheim GmbH
Ursula Bardon
55216 Ingelheim am Rhein
GERMANY
Phone: +49/6132/77 26 22
E-mail

References:
1 Winkelman J W. Pramipexole improves quality of life in patients with RLS. Poster No: 02.022. Presented at the American Association of Neurology Annual Meeting, April 2006
2 Allen RP et al. Restless Legs Syndrome Prevalence and impact REST general Population Study. Arch Int Medicine 2005, 165:1286-92
3 Abetz L et al. The reliability, validity and responsiveness of the Restless legs Syndrome Quality of Life Questionnaire (RLSQoL) in a trial population. Health and Quality of Life Outcomes 2005,3:79
4 Abetz L et al Evaluating the quality of life of patients with restless legs syndrome Clin Ther 2004; 26(6) 925-935
5 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
6 AASM Standards of Practice: Sleep. 2004
7 Oertel W, Stiasny-Kolster K. Early and persistent effect of pramipexole in RLS patients already with the starting dose. Movement Disorders 2005, 20 (Suppl 10): S58
8 Winkelman J; Sethi K; Kushida C; Becker P; Mahowald M. Pramipexole is efficacious and safe in treating RLS patients: results of a 12 weeks placebo controlled, fixed dose study. Sleep Med 2005; 6 (Suppl 2): S74
9 Partinen M; Hirvonen K; Alakuijala A; Jama L; Terttunen J. Rapid relief from RLS symptoms with pramipexole: results of a large polysomnographic study. Neurology 2004; 63 (8):1545
10 C. Trenkwalder, K. Stiasny-Kolster and the German RLS-Pramipexole Study Group. Sustained efficacy of Pramipexole in Restless Legs Syndrome. Sleep Med 2005; 6 (Suppl 2): S73
11 Phillips B et al Epidemiology of restless legs symptoms in adults. Arch Intern Med 2000; 160(14): 2137-2141
12 Allen RP, Walters AS, Montplaisir J, Hening W, Myers A, Bell TJ, et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med 2005; 165:1286 -1292