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Experts highlight the impact of Restless Legs Syndrome on patients` lives and call for better diagnosis

Pressmeddelande   •   Okt 15, 2004 14:11 CEST

Cannes/France, 15 October 2004 - Restless Legs Syndrome (RLS) remains among the most poorly recognized and under-treated neurological diseases despite the fact that it is one of the most common complaints among the adult population. Leading international experts met today at the 3rd International Scientific Symposium on Parkinson’s Disease and Restless Legs Syndrome1 in Cannes to hear leading experts discuss new advances in the field. Professor Jacques Montplaisir (Université de Montréal, Québec, Canada), reported on progress in clinical investigations and discussed new and effective treatments for RLS.

Restless Legs Syndrome – a neurological disorder characterised by an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs - affects up to ten percent of the adult population.2 Around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress.3 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.4,5

Gunnel Ståhl, a 59-year-old RLS patient from Sweden, described her condition as "…an overwhelming desire to move the legs, which began about fifteen years ago and then became progressively worse. In addition to the urge to move my legs, I experienced something I would describe as creepy sensation in my thighs. Getting to sleep has been a major problem and that inevitably impacted on my ability to concentrate at work and my overall energy levels, apart from affecting my family life. Eventually, I consulted a neurologist, who diagnosed me with Restless Legs Syndrome. I have heard of new treatment options on the horizon and am very excited about finding an effective pharmaceutical treatment for my condition."

A recent assessment of its impact using the Medical Outcomes Study 36-Item Short Form health survey, revealed that patients with Restless Legs Syndrome had significantly lower quality of life than patients with hypertension, and lower scores on six (out of eight scales) than patients with other cardiovascular diseases such as congestive heart failure, recent myocardial infarction and angina.6

"There is a great need among physicians and specialists for a better understanding of the causes of Restless Legs Syndrome and possible treatment options. Raising awareness among the medical community and patients about the symptoms and treatment of this highly prevalent condition will significantly contribute to improving disease management and bring hope to the millions of people affected by this disorder.", said Professor Montplaisir.

Recent clinical guidelines state that dopamine agonists are the drugs of choice in most patients with Restless Legs Syndrome.7, 8 Since the first placebo-controlled cross-over trial involving pramipexole in 1999,9 several open-label, retrospective studies on the efficacy and safety of pramipexole in RLS patients have been reported.10-12 These studies suggest that pramipexole is highly efficacious at doses in the range of 0.5 to 0.75 mg per day, well tolerated and has a low risk of augmentation (a worsening or new onset of symptoms during the day). It has also been shown to be effective in patients who have failed other treatments.13

While studies in the early 1980`s described the persistent efficacy of levodopa in RLS, a requirement for increased doses due to loss of efficacy (tolerance), re-emergence of symptoms in the second half of the night (rebound), or augmentation became apparent.14 These complications led to the need to switch treatment to a dopaminergic agonist or a non-dopaminergic drug in a substantial subset of patients, and explain why dopamine agonists have now replaced levodopa as first-line treatment for RLS.

The dopamine agonist pramipexole is currently being investigated in a broad clinical development program to further assess the therapeutic potential of pramipexole in this indication. Boehringer Ingelheim, the discoverer of the molecule, aims to achieve international approval of pramipexole in Restless Legs Syndrome. The size of the currently ongoing clinical development program - which includes more than 1000 patients - is unprecedented in this area.

“Encouraging results to date in trials with this dopamine agonist suggest that pramipexole can bring substantial relief to the millions of patients suffering from Restless Legs Syndrome”, said Professor Montplaisir. "It can be expected that pramipexole can offer tangible benefits over levodopa in terms of reduced risk of augmentation”, he added.

Pramipexole, a compound from Boehringer Ingelheim research, was jointly developed by Boehringer Ingelheim and Pharmacia Corp. (today Pfizer). Currently, Pramipexole is approved for the treatment of the signs and symptoms of idiopathic Parkinson`s Disease, as monotherapy or in combination with levodopa. Internationally it is marketed by Boehringer Ingelheim as Mirapex®, Mirapexin® or Sifrol® for the treatment of Parkinson’s Disease.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 152 affiliates in 45 countries and more than 34,000 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 2003, Boehringer Ingelheim posted net sales of 7.4 billion euro while spending more than one fifth of net sales in its largest business segment Prescription Medicines on research and development.


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References:
1 The 3rd International Scientific Symposium on Parkinson`s Disease and Restless Legs Syndrome took place in Cannes France (14-15th October). Over 350 neurologists from around the world attended the meeting which is accredited by the European Federation of Neurological Societies (EFNS).
2 Phillips B et al Epidemiology of restless legs symptoms in adults Arch Intern Med 2000; 160(14): 2137-2141
3 Hening W et al Impact, diagnosis and treatment of restless legs syndrome in a primary care population: the REST (RLS epidemiology, symptoms and treatment) primary care study Sleep Med 2004; 5(3): 237-246
4 Allen RP Earley CJ Restless legs syndrome: a review of clinical and pathophysiologic features J Clin Neurophysiol 2001; 18(2): 128-147
5 Earley CJ Clinical practice. Restless legs syndrome New Engl J Med 2003: 348(21) ; 2103-2109
6 Abetz L et al Evaluating the quality of life of patients with restless legs syndrome Clinical Therapeutics 2004; 26(6); 925-935
7 Silber MH et al An algorithm for the management of restless legs syndrome Mayo Clin Proc 2004; 79(7) : 916-922
8 Hening WA et al An update on the dopaminergic treatment of restless legs syndrome and periodic limb movement disorder Sleep 2004; 27: 560-583
9 Montplaisir J et al B Restless legs syndrome improved by pramipexole: a double-blind randomized trial. Neurology 1999; 52 (5) , 938-943
10 Silber MH et al Pramipexole in the management of restless legs syndrome Sleep 2003; 26(7): 819-821
11 Winkelman JW; Johnston L Augmentation and tolerance with long-term pramipexole treatment of restless legs syndrome (RLS). Sleep Med 2004; 5 (1), 9-14
12 Ferini-Strambi L Restless legs syndrome augmentation and pramipexole treatment Sleep Medicine 2002; 3(1): S23-S25.
13 Stiasny-Kolster K Oertel WH Low-dose pramipexole in the management of restless legs syndrome. An open-label trial Neuropsychobiol 2004; 50(1): 65-70.
14 Allen RP, Earley CJ Augmentation of the restless legs syndrome with carbidopa/levodopa Sleep 1996; 19(3): 205-213