Efficacy of Boehringer Ingelheim's Pramipexole (Mirapexin(R)/Sifrol(R) Also Demonstrated in Patients With Daytime RLS Symptoms

Ingelheim Am Rhein, Germany (ots/PRNewswire) -

- Studies Reinforce the Benefits of Pramipexole From Daytime
Symptom Control, Including Afternoon and Early Evening Onset

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

New data demonstrate that pramipexole (Mirapexin(R)/Sifrol(R)) is
also efficacious and well-tolerated in Restless Legs Syndrome (RLS)
patients with daytime RLS symptoms. The data was presented this week
at the Movement Disorder Society's (MDS) 11th International Congress
of Parkinson's Disease and Movement Disorders in Istanbul, Turkey.
Pramipexole, taken once daily, was shown to relieve afternoon and
early evening RLS symptom onset,(1) and improve the daytime symptoms
of the condition,2 reinforcing the treatment's broad spectrum appeal
for patients with moderate-to severe-RLS.(1),(2)

Addressing afternoon and evening symptoms onset

In the analysis1 conducted by Walters et al, results showed
pramipexole to be statistically significantly superior to placebo in
treating RLS symptoms in patients who experience symptoms in the
afternoon or early evening. The primary efficacy endpoint (IRLS total
score) in one double-blind multi-centre trial was analysed among
patients with early-onset symptoms (47 percent of total study
population). Patients with early-onset symptoms were defined as those
with symptoms occurring from 3:00-9:00pm at baseline. Results showed
that pramipexole was significantly effective in treating symptoms of
RLS in patients who experience early-onset symptoms, results which
were comparable to those seen in the total study population. This
study highlights the range of patients that may benefit from
pramipexole in treating RLS, which affects patients not only at
night, but in some patients already in the early afternoon and
evening, severely impacting activities of daily living and quality of
life.

Control of daytime symptoms

The second project presented at MDS assessed the efficacy of
pramipexole in improving daytime RLS symptoms.(2) Kushida et al
presented new data pooled from a series of double-blind trials,
demonstrating that pramipexole was generally effective in improving
daytime symptoms. In this analysis, patients with a baseline Epworth
Sleepiness Scale (ESS) score of greater than or equal to 10 (defined
as 'daytime impaired') were compared to the total study population.
Nearly a third of patients in these studies (31 percent) were
considered 'daytime impaired'. Results showed a statistically
significant improvement from baseline on both IRLS scored daytime
sleepiness (-0.46 in total population and -0.37 in daytime impaired)
and visual analog scales (VAS) RLS severity during the day (-8.7 in
total population and -10.8 in daytime impaired). In addition, ESS
scores were significantly improved in patients who were the most
impaired based on ESS baseline assessment.

Impact of RLS symptoms on working life

Finally, an analysis(3) by Lainey et al evaluated the impact of
RLS symptoms on working life. In the course of enlisting RLS patients
for a clinical trial, Lainey et al assessed the impact that symptoms
of RLS may have on patients' working lives. In this 12-week
double-blind RLS trial, the Johns Hopkins Restless Legs Syndrome
Quality of Life (RLS-QOL) questionnaire was used to explore in 337
patients whether patients with moderate-to-severe RLS encountered
difficulty in fulfilling work responsibilities. Study results found
that a substantial number of workers reported that RLS interfered
with work life, with 36 percent who had difficulty working a full day
at least a few times during the preceding month and 32 percent
sometimes worked fewer hours than they would have liked. Eight
patients ascribed their absence of employment to RLS symptoms.

The data presented at MDS demonstrate that pramipexole, taken once
daily, can provide significant benefits to patients with RLS, even if
these symptoms occur earlier in the evening or during the day.

Please be advised

This release is from the Corporate Headquarters of Boehringer
Ingelheim and is intended for all international markets. This being
the case, please be aware that there may be some differences between
countries regarding specific medical information including licensed
uses. Please take account of this when referring to the material.

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 April 2006 throughout the European
Union for the symptomatic treatment of moderate to severe idiopathic
Restless Legs Syndrome (RLS), in addition to other countries such as
Australia, Brazil, Canada, Mexico, USA 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 137 affiliates in 47 countries and 38,400
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 2006, Boehringer Ingelheim posted net sales of 10.6 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 www.boehringer-ingelheim.com.

References

(1). Walters A., et al. Pramipexole is effective treatment for RLS
patients suffering from afternoon or early evening RLS symptoms.
Abstract #888. To be presented at MDS 2007, Istanbul, Turkey.

(2). Kushida C., et al. Pramipexole improves daytime symptoms
among patients with Restless Legs Syndrome (RLS) with impaired
daytime function. Abstract #896. To be presented at MDS 2007,
Istanbul, Turkey.

(3). Lainey E., et al. Disruption of working life among persons
with moderate to severe Restless Legs Syndrome. Abstract #885. To be
presented at MDS 2007, Istanbul, Turkey.

(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.

ots Originaltext: Boehringer Ingelheim
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Contact:
Contact: Ursula Bardon, Corporate Division Communications, Boehringer
Ingelheim/Germany, 55216 Ingelheim/Germany, E-mail:
press@boehringer-ingelheim.com, +49-61-32-77-2622