Latest Data Demonstrate Boehringer Ingelheim's Pramipexole (Mirapexin®/Sifrol®) Improves Broad Spectrum Of Symptoms Of Restless Legs Syndrome

New data presented today show patients taking pramipexole (Mirapexin®/ Sifrol®) can experience significant improvements in a broad range of symptoms associated with Restless Legs Syndrome (RLS).1 In an additional study presented today, pramipexole was also shown to be well tolerated in RLS patients affected by concomitant diseases, which are commonly experienced in this patient group.2 The results of the studies were presented at the 10th International Congress of Parkinson's Disease and Movement Disorders (MDS) in Kyoto, Japan.

In all studies presented, patients taking pramipexole rated clinically meaningful improvements to their night and day-time symptoms, as measured on the International Restless Legs Scale (IRLS). The IRLS measures several aspects of the condition, ranging from discomfort, the need to move around, and relief by moving around, to specific RLS symptoms such as sleep disturbance, day-time tiredness, mood disorder, as well as addressing overall severity, weekly frequency, daily severity, and impact on daily activities.1

"Patients with Restless Legs Syndrome need treatment that will help to improve all of their symptoms in the night and day-time. The new evidence presented today gives both clinicians and patients the confidence that pramipexole can be used to address the key aspects of this chronic condition," said Professor John W. Winkelman, MD, PhD, Medical Director of the Sleep Health Centre of Brigham and Women's Hospital, Boston, Massachusetts/USA and Harvard Medical School.

IRLS data were pooled from a total of 564 pramipexole recipients and 220 placebo recipients, all of whom had participated in one of three placebo-controlled double-blind randomised trials of pramipexole in RLS. Pramipexole improved symptoms across all IRLS subscores (range 0 to 4 points), versus placebo. The mean improvement in the pramipexole arm ranged from 0.9 points for 'impact on daily activities' and 1.0 for 'mood disturbance' to 1.8 points for 'need to move due to discomfort'.1 These results, confirmed by patients themselves, reinforce the overall benefits of pramipexole.

Broad range of patients

According to another study presented today at MDS, RLS patients with concomitant diseases, or who are taking additional therapies, benefited from treatment with pramipexole.2 It is very common for RLS patients to suffer from additional conditions, including seasonal allergy, hypertension and gastroesophageal reflux.2 Furthermore, patients frequently take medication for other conditions, including analgesics, anti-inflammatory and anti-rheumatic drugs, and agents affecting cardiovascular function.2

Results from a 12-week randomised, double-blind, placebo-controlled trial show that even with the high frequencies of concomitant diagnoses and therapies, pramipexole was associated with a significant 12-week reduction of IRLS by an adjusted mean of -13.5, compared with -9.3 for placebo (P<0.0001) .2 Therefore, patients with concomitant diseases or who are taking additional therapies can be effectively treated with pramipexole for their RLS symptoms.

"When you consider RLS is a chronic condition for which patients may need to take treatment over a long period of time, it is crucial that we explore how a drug clinically interacts with other treatments," Dr Winkelman added. "The data presented today add to our extensive knowledge on the safety of pramipexole and provide us with the reassurance that it can be used in the broadest range of patients."

Sustained symptom relief

The advantages of using pramipexole over an extended length of time were also demonstrated by data from three trials presented today at MDS.3,4,5 The results demonstrate that, over a 6-month period, pramipexole showed a substantial improvement in symptoms of RLS compared to placebo. This improvement was judged by both patients and their treating clinicians using specific RLS rating tools. Across all three trials at least 67 percent of patients judged themselves to be much better, or very much better, after completing 6 months of therapy.3,4,5 Additionally, clinicians rated improvements between 12.5 points3 and 16.9 points5 on the IRLS scale.

The data presented at MDS demonstrate that pramipexole addresses the broad range of RLS symptoms, can provide significant benefits to patients with RLS and comorbid conditions, and can also offer sustained relief from this chronic condition.

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 years6 and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress7. 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 Sifrol® and Mirapexin® and in the U.S.A. as Mirapex®) is a compound from Boehringer Ingelheim research first licenced in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s Disease, as monotherapy or in combination with levodopa. Pramipexole was licenced in April 2006 throughout the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) and is also licenced in Australia, Brazil, Canada, 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.

References:

1 -- Winkelman JW et al. Pramipexole improves a broad range of facets of restless legs syndrome. Abstract #P374. Presented at MDS 2006, Kyoto, Japan.

2 -- Winkelman JW et al. Pramipexole is not affected by therapy for concomitant disease in patients with restless legs syndrome. Abstract #P400. Presented at MDS 2006, Kyoto, Japan.

3 -- Oertel WH et al. Six-month efficacy of pramipexole for restless legs syndrome: results from a 20-week extension of a 6-week study. Abstract #P405. Presented at MDS 2006, Kyoto, Japan.

4 -- Kupsch A., et al. Six-month efficacy of pramipexole in restless legs syndrome: results from a run-in phase for a 12-week study. Abstract #P373. Presented at MDS 2006, Kyoto, Japan.

5 -- Partinen M., et al. Sustained efficacy of pramipexole in restless legs syndrome: results from a 6-month extension of a 3-week trial. Abstract #P390. Presented at MDS 2006, Kyoto, Japan.

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

7 -- 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.

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