New Data Shows Pramipexole (Mirapexin(R)/Sifrol(R)) Can Significantly Reduce Limb Pain in Patients With Restless Legs Syndrome (RLS)

Ingelheim, Germany (ots/PRNewswire) -

- First Ever Study to Demonstrate Efficacy of Pramipexole in
Treating RLS-Associated Limb Pain

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

A new study demonstrating that pramipexole
(Mirapexin(R)/Sifrol(R)) can significantly reduce RLS-associated limb
pain in patients with Restless Legs Syndrome (RLS)(1) was presented
today at the SLEEP 2008 22nd Annual Meeting of the Associated
Professional Sleep Societies (APSS) in Baltimore, U.S.A. This effect
is in addition to delivering effective relief from the broad range of
RLS symptoms, including sleep disruption, daytime tiredness and mood
disturbance. Pain associated with RLS symptoms, such as leg pain, is
highly frequent in RLS patients (approximately 60 percent)(2) and has
been shown to have a negative impact on their health-related quality
of life.(3)

The results of a large, multi-national, randomised, double-blind,
placebo-controlled study showed for the first time that pramipexole,
a non-ergot dopamine agonist indicated to treat moderate to severe
RLS symptoms, significantly reduced limb pain as soon as after five
days of treatment and the reduction in pain continued to improve
throughout the study period (12 weeks). Improvements with placebo
were consistently lower than with pramipexole and were only observed
during the first weeks, and declined thereafter.(1)

"To date, clinical studies with available pharmacologic agents
for limb pain have not demonstrated longer term benefits for RLS
patients. These new findings with pramipexole will be well received
by both doctors and patients who are often looking for a fast-acting
and effective treatment for the characteristic RLS symptoms, while
seeking the added benefit of alleviating the uncomfortable and
painful sensations so often associated with RLS," said Professor
Markku Partinen, MD, PhD, Department of Neurology, University of
Helsinki, Finland.

In the study, limb pain was measured at baseline, after one day,
five days, nine days, two weeks, four weeks and 12 weeks using a
100-mm visual analogue scale (VAS)* where 0 equalled 'no pain' and
100 'unbearable pain'. At five days, limb pain was reduced by -15.5
points in the pramipexole group (n=178) versus -5.0 points in the
placebo group (n=179). At two weeks and 12 weeks the reductions were
-27.5 and -33.5 respectively in the pramipexole group versus -15.0
and -11.0 respectively in the placebo group. The difference versus
placebo was statistically significant already from day 5 on over the
entire study period.(1) Throughout the study period pramipexole was
well tolerated. The proportion of patients who discontinued due to
adverse events was similar between the treatment groups (8.6 percent
for placebo and 9.3 percent for pramipexole).(4)

The new data presented at APSS reaffirm pramipexole as a highly
effective treatment that addresses the broad range of RLS patient
needs. Pramipexole has been shown to rapidly alleviate the
characteristic symptoms of the condition(5), including relief from
limb pain which is so frequently associated with RLS.

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:

*Visual analogue scale (VAS)

The visual analogue scale (VAS) is a pain assessment tool to help
patients describe the intensity of their pain. The VAS consists of a
straight line with the left end of the line representing no pain and
the right end of the line representing the worst pain. Patients are
asked to mark where they think their pain is on this line.

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(6) and around one-third of sufferers
experience symptoms more than twice weekly causing moderate to severe
distress.(2) 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. Aarskog D et al. Pramipexole rapidly improves RLS-associated
limb pan. Presented 09 June 2008, 22nd Annual Meeting of the
Associated Professional Sleep Societies (APSS), Baltimore, U.S.A.;
Poster # 0827.

2. Allen RP et al. Restless Legs Syndrome prevalence and impact
REST general population study. Arch Int Medicine 2005; 165: 1286-92.

3. Kushida C et al. Burden of Restless Legs Syndrome on
health-related quality of life. Qual Life Res 2006; 16(4): 617-624.

4. 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.

5. 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.

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

ots Originaltext: Boehringer Ingelheim
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