Boehringer Ingelheim

Efficacy of Boehringer Ingelheim's Pramipexole (Mirapexin(R)/Sifrol(R) Also Demonstrated in Patients With Daytime RLS Symptoms

    Ingelheim Am Rhein, Germany (ots/PRNewswire) -

    - Studies Reinforce the Benefits of Pramipexole From Daytime Symptom Control, Including Afternoon and Early Evening Onset

    - For Healthcare Media Outside the U.S.A.

    New data demonstrate that pramipexole (Mirapexin(R)/Sifrol(R)) is also efficacious and well-tolerated in Restless Legs Syndrome (RLS) patients with daytime RLS symptoms. The data was presented this week at the Movement Disorder Society's (MDS) 11th International Congress of Parkinson's Disease and Movement Disorders in Istanbul, Turkey. Pramipexole, taken once daily, was shown to relieve afternoon and early evening RLS symptom onset,(1) and improve the daytime symptoms of the condition,2 reinforcing the treatment's broad spectrum appeal for patients with moderate-to severe-RLS.(1),(2)

    Addressing afternoon and evening symptoms onset

    In the analysis1 conducted by Walters et al, results showed pramipexole to be statistically significantly superior to placebo in treating RLS symptoms in patients who experience symptoms in the afternoon or early evening. The primary efficacy endpoint (IRLS total score) in one double-blind multi-centre trial was analysed among patients with early-onset symptoms (47 percent of total study population). Patients with early-onset symptoms were defined as those with symptoms occurring from 3:00-9:00pm at baseline. Results showed that pramipexole was significantly effective in treating symptoms of RLS in patients who experience early-onset symptoms, results which were comparable to those seen in the total study population. This study highlights the range of patients that may benefit from pramipexole in treating RLS, which affects patients not only at night, but in some patients already in the early afternoon and evening, severely impacting activities of daily living and quality of life.

    Control of daytime symptoms

    The second project presented at MDS assessed the efficacy of pramipexole in improving daytime RLS symptoms.(2) Kushida et al presented new data pooled from a series of double-blind trials, demonstrating that pramipexole was generally effective in improving daytime symptoms. In this analysis, patients with a baseline Epworth Sleepiness Scale (ESS) score of greater than or equal  to 10 (defined as 'daytime impaired') were compared to the total study  population. Nearly a third of patients in these studies (31 percent) were considered 'daytime impaired'. Results showed a statistically significant  improvement from baseline on both IRLS scored daytime sleepiness (-0.46 in total population and -0.37 in daytime impaired) and visual analog scales (VAS) RLS severity during the day (-8.7 in total population and -10.8 in daytime impaired). In addition, ESS scores were significantly improved in patients who were the most impaired based on ESS baseline assessment.

    Impact of RLS symptoms on working life

    Finally, an analysis(3) by Lainey et al evaluated the impact of RLS symptoms on working life. In the course of enlisting RLS patients for a clinical trial, Lainey et al assessed the impact that symptoms of RLS may have on patients' working lives. In this 12-week double-blind RLS trial, the Johns Hopkins Restless Legs Syndrome Quality of Life (RLS-QOL) questionnaire was used to explore in 337 patients whether patients with moderate-to-severe RLS encountered difficulty in fulfilling work responsibilities. Study results found that a substantial number of workers reported that RLS interfered with work life, with 36 percent who had difficulty working a full day at least a few times during the preceding month and 32 percent sometimes worked fewer hours than they would have liked. Eight patients ascribed their absence of employment to RLS symptoms.

    The data presented at MDS demonstrate that pramipexole, taken once daily, can provide significant benefits to patients with RLS, even if these symptoms occur earlier in the evening or during the day.

    Please be advised

    This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for all international markets. This being the case, please be aware that there may be some differences between countries  regarding specific medical information including licensed uses. Please take  account of this when referring to the material.

    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 years(4) and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress.(5) 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.

    About pramipexole

    Pramipexole (known in Europe under the trade names Mirapexin(R) and Sifrol(R) and in the U.S.A. as Mirapex(R)) 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 April 2006 throughout the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS), in addition to other countries such as Australia, Brazil, Canada, Mexico, USA and others.

    The most commonly reported adverse reactions in early and late Parkinson's disease in clinical trials were dizziness, involuntary movement, postural hypotension, constipation, hallucinations, headache, difficulty falling asleep, sleepiness, nausea and fatigue. The most commonly reported adverse reactions in clinical trials for Restless Legs Syndrome were nausea, headache, and tiredness.

    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.

    Boehringer Ingelheim

    The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and 38,400 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 2006, Boehringer Ingelheim posted net sales of 10.6 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). Walters A., et al. Pramipexole is effective treatment for RLS patients suffering from afternoon or early evening RLS symptoms. Abstract #888. To be presented at MDS 2007, Istanbul, Turkey.

    (2). Kushida C., et al. Pramipexole improves daytime symptoms among patients with Restless Legs Syndrome (RLS) with impaired daytime function. Abstract #896. To be presented at MDS 2007, Istanbul, Turkey.

    (3). Lainey E., et al. Disruption of working life among persons with moderate to severe Restless Legs Syndrome. Abstract #885. To be presented at MDS 2007, Istanbul, Turkey.

    (4). Phillips B., et al. Epidemiology of Restless Legs symptoms in adults. Arch Intern Med 2000; 160(14): 2137-2141.

    (5). Allen RP., et al. Restless Legs Syndrome prevalence and impact: REST general population study. Arch Intern Med 2005; 165(11): 1286-1292.

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Contact: Ursula Bardon, Corporate Division Communications, Boehringer
Ingelheim/Germany, 55216 Ingelheim/Germany, E-mail:, +49-61-32-77-2622

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