Boehringer Ingelheim GmbH

Boehringer Ingelheim's pramipexole (Sifrol(R)/Mirapexin(R)) Can

Provide Benefit of Improved Mood Disturbance for People With Restless Legs Syndrome

    GLASGOW, Scotland (ots) -

        (For media outside the US only)

    - New Data Shows pramipexole is an Effective Treatment Option for
        the  Broad Range of RLS Symptoms During Both the Night and  

      New data indicate that when treated with pramipexole
(Sifrol(R)/Mirapexin(R)), patients affected by Restless Legs Syndrome
(RLS) can experience significant improvement in mood disturbance - a
frequent and debilitating symptom of the condition(1,2) which
adversely affects the lives of millions of people worldwide. Findings
were presented today at the 10th Congress of the European Federation
of Neurological Societies (EFNS).

      Restless Legs Syndrome is a complex condition, in that physical
symptoms, such as an uncontrollable urge to move the legs and
difficulty falling or staying asleep, are coupled with psychological
symptoms which can profoundly impact the patient's quality of life
and can contribute to a patient becoming depressed.(3)

      According to the internationally renowned expert in the field of
RLS, Luigi Ferini Strambi, MD, Assistant Professor of Neurology,
State University of Milan, and Professor of Psychobiology of Sleep,
University Vita-Salute, Milan, Italy: "We need to tackle the multiple
facets of this complex condition. Because RLS not only affects
patients' sleep, it is important to consider treatment options that
are effective in treating the night-time symptoms as well as also
improving the daytime symptoms many RLS patients experience. The
management of RLS-related mood symptoms and the role of central
dopaminergic mechanisms are extremely important considerations that
influence therapeutic decisions."

      Additional findings from the data presented at the Congress
highlight that with pramipexole, improvements of RLS symptoms are
already possible at very low doses. Data for pramipexole also show
rapid and sustained symptom relief, improved sleep quality, and
reduction in daytime tiredness.(4,5,6)

      Overcoming mood disturbance and daytime symptoms

      According to one study presented at this Congress, mood
disturbance is an important symptom in RLS, that goes beyond the
cardinal sensorimotor RLS symptoms and that requires examination in
large scale trials to fully evaluate a drug's effect.(2)

    In this study presented by Leissner et al., among the total population studied, 55.6 percent initially described their mood as moderately to very severely disturbed. Within this subset, 72.7 percent of the pramipexole recipients improved to none or mild disturbance of mood, compared with 52.2 percent for placebo recipients (p=0.0064). From their responses to a single question from the International Restless Legs Syndrome Study Group's severity rating scale, International Restless Legs Scale (IRLS), RLS patients with moderate to very severe mood disturbance found pramipexole to have significant benefit against disturbed mood in RLS.(2)

    In another study presented, the sustained effects of pramipexole on mood in patients with RLS were examined. This study consisted of two phases: a 6-month open-label period with titration of pramipexole, followed by a 12-week randomised, double-blind placebo-controlled withdrawal period within the open-label responder group. At baseline, at randomisation, and at the end of the 12-week double-blind phase patient ratings of their mood disturbance were assessed.(1)

    At baseline 83.3 percent of patients reported mood disturbance of any kind. After open-label pramipexole this figure improved to 39.6 percent. Additionally, during the double-blind phase pramipexole recipients maintained their improvement: 20.5 percent reported mood disturbances at randomisation and 25.6 percent at trial's end. (1)

    By contrast, patients switched to double-blind placebo after the open-label treatment period with pramipexole experienced a worsening from 29 percent with mood disturbance at randomisation to 71 percent at the trial's end after withdrawal of pramipexole (p<0.0001). (1)

    For a total follow-up of nine months, pramipexole maintained its relief of mood disturbance in the setting of this RLS study. (1)

    Efficacy and tolerability

    In other studies presented at the EFNS, pramipexole's efficacy, tolerability and overall effects across the broad symptom spectrum were presented. In these studies, key findings included:

    - A study exploring the efficacy of different dosages demonstrated that almost all pramipexole responders (88.1 percent) did so at 0.50mg/day or less, supporting a simple low dose regime.(7)

    - Both short term (six weeks) and long term (one year) the safety profile of pramipexole for RLS was favourable. (8)

    - In clinicians' judgement almost no treatment-related events caused any substantial impairment of a patient's daily life, regardless of whether the treatment was open-label or double-blind.(8)

    - Pramipexole was proven to be effective across both night and daytime RLS symptoms. In a six week period using visual analogue scales (VAS) to express their perceptions of RLS symptoms, 72.8 percent of the pramipexole recipients improved to none or mild symptom severity compared with 50 percent for placebo recipients (p=0.0030). By two different methods of patient self-rating, pramipexole showed significant capacity to reduce the severity of RLS not only through the night but also through the day, a time when the syndrome's sensorimotor features often abate. (5)

    - In a polysomnography study assessing pramipexole's impact on sleep including its effects on periodic limb movements (PLMs), pramipexole improved PLMs with statistically significant decreases in all four PLM indices (PLMI, PLMSI, PLMAI, PLMWI) at the lowest dose tested (0.125mg/day). Overall the PLMI showed a range of mean percent drop for pramipexole dose groups studied from 75 to 84 percent, while the mean percent drop for placebo was 15 percent. Pramipexole also tended to improve sleep latency and total sleep time.(5)

    About Restless Legs Syndrome (RLS)

    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 population worldwide aged between 30 and 79 years(9) and 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.

    About pramipexole

    Pramipexole (known in Europe under the trade names Sifrol(R) and Mirapexin(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) and is also approved in Australia, Brazil, Mexico 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 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.

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    Disclaimer: Press Release for international use. As to the registration status in individual countries, please check with the contact address indicated below or liaise with the country-specific Boehringer Ingelheim affiliate.


    (1). Trenkwalder C. et al. Sustained effects of pramipexole on mood in patients with Restless Legs Syndrome. EFNS 2006; Glasgow, UK. Poster presentation P1156. To be presented 3 September 2006.

    (2). Leissner L et al. Effect of pramipexole on mood in patients with Restless Legs Syndrome. EFNS 2006; Glasgow, UK. Poster presentation P1186. To be presented 3 September 2006.

    (3). 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.

    (4). Oertel WH et al. Daytime symptoms of Restless Legs Syndrome during pramipexole therapy. EFNS 2006; Glasgow, UK. Poster presentation P1147. To be presented 3 September 2006.

    (5). Partinen M et al. Effects of pramipexole on polysomnographic measures of Restless Legs Syndrome. EFNS 2006; Glasgow, UK. Poster presentation P2129. To be presented 4 September 2006.

    (6). Trenkwalder C et al. Sustained effects of individually optimised open-label pramipexole on sleep quality in Restless Legs Syndrome. EFNS 2006; Glasgow, UK. Poster presentation P2146. To be presented 4 September 2006.

    (7). Stiasny-Kolster K et al. Incremental responder rates to flexibly up-titrated pramipexole in Restless Legs Syndrome. EFNS 2006; Glasgow, UK. Poster presentation P2185. To be presented 4 September 2006.

    (8). Oertel WH et al. Safety of pramipexole during 52-week treatment of Restless Legs Syndrome. EFNS 2006; Glasgow, UK. Poster presentation P1191. To be presented 3 September 2006.

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

ots Originaltext: Boehringer Ingelheim

Ursula Bardon
Corporate Division Communications
Boehringer Ingelheim GmbH
55216 Ingelheim/Germany
Phone: +49-6132-77-2622
Fax: +49-6132-72-2622

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