Boehringer Ingelheim

New Data Confirm Pramipexole (Mirapexin(R)/Sifrol(R)) Can Significantly Reduce Sleep Disturbance for People With Restless Legs Syndrome (RLS)

    Ingelheim, Germany (ots/PRNewswire) -

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

    - Studies Demonstrate Positive and Rapid Impact of Pramipexole on the Core Symptoms of Restless Legs Syndrome and Sleep Disturbance

    A new study has shown that pramipexole (Mirapexin(R)/Sifrol(R)) can significantly reduce sleep disturbance, often the most troublesome symptom experienced by people with Restless Legs Syndrome (RLS).(1) The important finding, presented today at the 60th Annual Meeting of the American Academy of Neurology (AAN) in Chicago, U.S.A., highlights the benefit of an RLS treatment which effectively targets the core symptoms of the condition, such as an uncontrollable urge to move the legs, as well as secondary symptoms including sleep disturbance. For the many people affected by RLS, this means that overall sleep patterns and quality of life can be greatly improved with pramipexole - a fast-acting treatment which has been shown to bring relief already after one night.(2)

    According to Professor Luigi Ferini-Strambi from the Sleep Disorders Center, Università Vita-Salute, San Raffaele, Milan (Italy) and lead author of the study: "Most people with RLS who seek medical advice have often suffered for a long time from sleep deprivation due to the debilitating impact of RLS. To feel the benefit of a simple, effective treatment right from the start, is a huge step forward for these patients. Beyond enabling them to sit comfortably through an evening, they can look forward to a night of sleep without being disturbed by the uncontrollable urge to move their legs. For many people with RLS, this means that they can finally start regaining their quality of life."

    In the study, a randomised, double blind and placebo controlled trial in adults with scores >15 on the International RLS Study Group Rating Scale (IRLS) and symptoms at least 2-3 times per week, improvements were assessed based on the MOS* sleep scale. The study was the first ever evaluating the effect of pramipexole on sleep, using a multi-dimensional patient-reported instrument. Sleep disturbance scores for the patient group treated with pramipexole were reduced from 52.5 to 27.8 after 12 weeks from baseline compared to 55.6 to 38.5 in the placebo group (p=0.0001), i.e. the pramipexole treated patient group reaching a near to normal level, and in some instances already after the first night of treatment(2) (a score of 24.5 is considered normal).(1)

    Although worsening of symptoms at night is a hallmark of RLS, many people with RLS also experience bothersome symptoms during the day. Furthermore, daytime function is disrupted by somnolence due to sleep disturbance, further heightening the need for fast-acting treatment options that effectively treat both the night and daytime symptoms of the condition.

    In a study assessing the rapid onset and sustained efficacy of pramipexole, rapid symptom improvements were shown after the first intake, reached their peak after four weeks and were maintained throughout the 12 week trial. Adjusted mean changes from baseline on IRLS were greater for pramipexole at all item points: day 9, day 14, week 4 and week 12 (p<0.0001 for all versus placebo). Patient Global Impression (PGI) responder rates were improved over placebo at day 1 (16.4% vs 8%), day 5 (36.2% vs 15.2%), day 9 (44.1% vs 19.6%), day 14 (53.1% vs 34.1%), week 4 (65.7% vs 39.7%) and week 12 (62.9% vs 38%).(2)

    The effect of pramipexole on daytime symptoms of RLS was shown in another study. This study showed a median baseline of 4.0 in both severity of daytime symptoms at rest and daytime sleepiness, as measured with the RLS-6 scale (0 = none/not at all, 10 = very severe). At week 12, the median reduction was - 2.0 (pramipexole) versus -1.0 (placebo) for daytime RLS severity (p = 0.0017) and -2.0 versus -1.0 (p = 0.0024) for daytime sleepiness.(3)

    Overall, the data presented at AAN reaffirm pramipexole as a highly effective and fast-acting treatment for RLS, in many cases even at the lowest dose and already after one night. Pramipexole not only alleviates the very unpleasant and sometimes painful feelings in the legs experienced by patients with RLS during periods of rest, but can also improve daytime RLS symptoms.

    Please be advised

    This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.

    Notes to the Editor:

    *Medical Outcomes Study (MOS) sleep scale

    The MOS Sleep Scale is a self-administered scale measuring specific aspects of sleep (problems with sleep disturbance [initiation and maintenance], adequacy, somnolence, quantity, respiratory impairments and snoring). It was designed for use in patients who may have varying co-morbidities. The frequency with which each problem has been experienced during the previous four weeks is rated on a 6-point scale ranging from 'none of the time' to 'all of the time', except sleep quantity, which is reported in hours. All scores are transformed linearly to range from 0 to 100 with the exception of the sleep quantity subscale, which is scored in hours. Higher scores indicate more of the attribute implied by the scale name (e.g. more sleep disturbance, more adequate sleep, greater sleep quantity).

    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 2006 for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS). Pramipexole is currently registered in over 80 countries across the globe.

    The most commonly reported adverse reactions in clinical trials for Restless Legs Syndrome were nausea, headache, dizziness and fatigue. The most commonly reported adverse reactions in early and late Parkinson's disease in clinical trials were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.

    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.

    About Boehringer Ingelheim

    The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 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 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

    For more information please visit http://www.boehringer-ingelheim.com.

    References

    1. 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.

    2. 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.

    3. Partinen M et al. Effects of pramipexole on daytime symptoms of Restless Legs Syndrome. Presented 16 April 2008, 60th Annual Meeting of the American Academy of Neurology (AAN), Chicago (IL), U.S.A.; Poster # P05.165.

    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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