Boehringer Ingelheim

New Data Confirm Pramipexole Delivers Sustained Efficacy For Patients With Restless Legs Syndrome

    Berlin, Germany (ots/PRNewswire) -

    - For Healthcare Professional Journalists - Not for distribution to US media

    - Randomised, Placebo-Controlled Study Shows Discontinuation of Pramipexole Leads to Rapid Worsening of Symptoms -

    Two new, randomised, placebo-controlled studies presented this week at the inaugural conference of the World Association of Sleep Medicine (WASM), demonstrate that pramipexole - the number one dopamine agonist prescribed for Parkinson's Disease in the world - can deliver powerful and sustained efficacy in treating patients suffering from Restless Legs Syndrome  (RLS)[1,2] ew data from a randomised, placebo-controlled pramipexole  'withdrawal' study[1], report that when pramipexole is discontinued in  patients who have been responding well for six months, this leads to rapid  worsening of RLS symptoms - confirming for the first time, in a placebo- controlled trial, that pramipexole can deliver sustained, long-term symptom  improvement for RLS patients beyond six months. New data from a 12-weeks,  double-blind, fixed-dose study of 345 patients further confirm pramipexole  can provide significantly greater improvement in symptoms of RLS, when  measured by two standard clinical assessment tools, when compared to  placebo[2].

    These new data add to the growing body of clinical evidence that pramipexole is a well tolerated treatment that can deliver rapid and significant relief from the symptoms of RLS and bring about significant improvements in patients' quality of life. Clinical guidelines recommend dopamine agonists as first-line treatment for RLS, yet there has been limited data to confirm how long the treatments continue to relieve symptoms. Restless Legs Syndrome is a common, but poorly recognized and under-treated neurological disease that predominantly affects adults.

    Proven for the first time: pramipexole delivers sustained efficacy

    Although previous clinical evidence has provided a strong indication that pramipexole has the potential to deliver sustained efficacy, this evidence has been based on open-label or retrospective data. Professor Claudia Trenkwalder (Kassel, Germany) et al presented results from a prospective, placebo-controlled 'randomised withdrawal' study with pramipexole, which has shown for the first time that blinded discontinuation of pramipexole in RLS patients who are responding well, led to rapid worsening of symptoms in most patients[1]. The study set out to determine how 147 patients with moderate to severe RLS, who had already been receiving pramipexole treatment and who had responded well for six months, fared when they were randomised after six months to receive either a placebo treatment or to continue to receive pramipexole treatment. The primary endpoint of the study was assessment of 'Time to Worsening' of RLS symptoms measured using the International RLS Rating Scale (IRLS) and the Clinical Global Impressions - Global Improvement (CGI-I) scale. The results showed:

BERLIN, Germany, October 17 /PRNewswire/ --

    - RLS patients who were randomised to continue treatment with

    pramipexole experienced a significantly longer time before their

    symptoms worsened than those patients who were randomised on to placebo

    (p<0.0001)

    - The proportion of patients that experienced worsening of their

    RLS symptoms in the pramipexole group was statistically significantly

    smaller compared to those randomized to receive placebo (pramipexole

    20.5 percent vs. placebo 85.5 percent; p<0.0001)

    - After just one week more than 70.0 percent of patients on placebo

    worsened as compared to just 9.0 percent of patients in the pramipexole

    group.

    - In addition to the outstanding efficacy on RLS symptoms,

    pramipexole also significantly improved the disease-specific quality of

    life score to 90 percent (70 percent for placebo; p<0.0001)

    "This is an important study as it represents the first time that pramipexole has been confirmed in a placebo-controlled RLS trial to deliver sustained efficacy beyond six months. We have known from previous studies that pramipexole can provide marked and rapid relief from RLS symptoms - which is important for patients who want their treatment to work quickly - but what we could not confirm until now was whether pramipexole keeps working over a long period of time. This is good news for people suffering from the distressing symptoms of Restless Legs Syndrome," commented Professor Trenkwalder.

    Reinforcing previously reported efficacy with pramipexole

    A second study presented this week at WASM confirms the excellent short-term efficacy and tolerability of pramipexole in a 12-week, placebo-controlled, randomised study[2]. This study sought to compare the efficacy and safety of pramipexole at different doses (0.25mg; 0.5mg and 0.75mg) when compared to placebo. After 12 weeks, patients who received pramipexole - across all three doses - experienced significantly greater improvements in symptoms of RLS compared to placebo. Three hundred and forty five patients were randomised and 339 patients were assessed at the end of 12 weeks for improvement in RLS symptoms using the IRLS and CGI-I scales.

@@start.t1@@      - IRLS scores at week 12 demonstrated that across all three
         pramipexole doses the IRLS score was significantly improved for
         patients when compared to placebo
      - CGI-I scores also demonstrated that significantly more patients
         who received pramipexole treatment reported themselves as 'much
         improved ' or 'very much improved' at the end of 12 weeks of treatment
         compared to patients treated with placebo.@@end@@

    In both studies pramipexole was generally well tolerated and the most frequent adverse events were nausea, headache and fatigue. Pramipexole is currently approved for the treatment of early and advanced Parkinson's Disease and is being evaluated in clinical trials as a treatment for reducing the severity and symptoms of RLS.

    About pramipexole

    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. The most commonly reported adverse events in early and late Parkinson's disease in clinical trials were dizziness, dyskinesia, extrapyramidal syndrome, headache, insomnia, somnolence, and nausea. Hallucinations and postural (orthostatic) hypotension may occur. As described in the literature for dopamine agonists, patients have been reported as showing compulsive behavior. 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.

    Boehringer Ingelheim

    The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 45 countries and nearly 36,000 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 2004, Boehringer Ingelheim posted net sales of 8.2 billion euro while spending nearly one fifth of net sales in its largest business segment Prescription Medicines on research and development.

    For more information please visit www.boehringer-ingelheim.com

    Notes to Editors

@@start.t2@@      RLS         Restless Legs Syndrome
                    RLS is a neurological disorder characterised by an
                    uncontrollable urge to move the legs, usually accompanied by
                    unpleasant and sometimes painful sensations in the legs. RLS
                    affects up to ten percent of the adult population aged between
                    30 and 79 years [3] and around one-third of sufferers experience
                    symptoms more than twice weekly causing moderate to severe
                    distress[4]. 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[5,6].
      IRLS        International RLS Rating Scale
      CGI         Clinical Global Impression Scale
                    The CGI scale is a clinical-rated instrument that
                    consists of four subscales. The CGI-Improvement is
                    traditionally used as an endpoint in clinical trials for
                    responder analyses while the other subscales are less
                    used. The global assessment of overall severity of
                    illness, of the overall therapeutic effect and of
                    interference of side effects with functioning, provides
                    additional information of the overall effectiveness of a
                    drug treatment@@end@@

    References

    [1]. C. Trenkwalder, K. Stiasny-Kolster and the German RLS-Pramipexole Study Group. Sustained efficacy of Pramipexole in Restless Legs Syndrome. WASM 2005; Berlin, Germany; Oral presentation, Abstract # 057; 16 Oct 2005

    [2]. 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. WASM 2005; Berlin, Germany; Oral  presentation, Abstract # 058; 16 Oct 2005

    [3]. Phillips B et al Epidemiology of restless legs symptoms in adults  Arch Intern Med 2000; 160(14): 2137-2141

    [4]. 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

    [5]. Allen RP Earley CJ Restless legs syndrome: a review of clinical and pathophysiologic features J Clin Neurophysiol 2001; 18(2): 128-147

    [6]. Earley CJ Clinical practice. Restless legs syndrome New Engl J Med 2003: 348(21) ; 2103-2109

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