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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.

Contact:

Contact (Please direct all enquiries via email in the first
instance): Ursula Bardon, Corporate Division Communications,
Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, E-mail:
press@boehringer-ingelheim.com, Phone: +49-6132-77-2622

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