RLS & Requip

[Guest guest]

Requip Significantly Reduces Periodic Leg Movements in Patients With

Restless Legs Syndrome ImmuneSupport.com

GlaxoKline's Requip® (ropinirole HCl) Significantly Reduces Periodic

Leg Movements in Patients With Restless Legs Syndrome

New Study Also Demonstrates Improved Sleep Adequacy Among RLS

Patients

RESEARCH TRIANGLE PARK, N.C., Aug. 1 /PRNewswire-FirstCall/ -- New

data published in the August issue of SLEEP shows that patients with primary

Restless Legs Syndrome (RLS) and with periodic leg movements during

sleep (PLMS), have fewer awakenings resulting from involuntary kicks when

treated with GlaxoKline's Requip (ropinirole HCl). Patients also reported

better sleep adequacy as defined by feeling rested upon waking in the

morning. Objective measurements showed that PLMS significantly decreased

from nearly 49 per hour to 12 per hour in the group treated with Requip

compared to a decrease of 36 per hour to 34 per hour in the placebo group (P

< 0.0001).

In the study, patients treated with Requip also experienced a significant

reduction in the number of times PLMS woke them from sleep, termed PLMA

(PLM with arousal), from 7 per hour to 2.5 per hour (p = 0.0096). Requip is

under review by the U.S. Food and Drug Administration (FDA) for the

treatment of RLS. There is no currently approved treatment for RLS in the

United States.

" The RLS patients in our study suffered from involuntary movements of their

legs that often disrupted their sleep. These leg movements are often

associated with RLS, " stated Clete A. Kushida, M.D., Director of the Stanford

University Center for Human Sleep Research and an author of the study.

" These new study results show that patients who were given Requip had

significant reductions in the number of leg movements, resulting in fewer

awakenings from sleep. "

PLMS are involuntary movements of the legs during sleep and are a feature

seen in over 80 percent of patients with RLS. Restless Legs Syndrome, a

condition that affects up to ten percent of the population, is a neurologic

movement disorder characterized by an irresistible urge to move the legs and

by uncomfortable or sometimes unpleasant sensations in the legs often

described as creeping-crawling, burning or twitching.

These symptoms generally occur at rest, such as when sitting, lying or

sleeping, and are temporarily relieved by movement. As a result, people with

RLS have difficulty falling asleep and staying asleep and often avoid activities

such as movies, long car rides or airline flights.

Requip® Shown to Improve Sleep and Reduce PLMS

In this study, 65 patients with at least moderately severe RLS and PLMS who

met the International RLS Study Group criteria for RLS and had 5 PLMS per

hour on a screening polysomnogram were included in the study.

Patients aged 18 to 79 were enrolled from 15 referral centers and were

randomized to receive Requip (0.25 to 4mg per day) or placebo. Participants

were titrated to their effective dose of medication and received treatment for

12 weeks. Polysomnography simultaneously records multiple physiologic

parameters related to sleep and wakefulness and is used to objectively

evaluate abnormalities in sleep.

At 12 weeks, Requip significantly improved patients' ability to sleep. Both the

primary endpoint (PLMS per hour) and secondary endpoint variable (PLMA

per hour) showed large and statistically significant differences in favor of

Requip over placebo. With Requip, PLMS per hour were significantly

decreased from 48.5 per hour to 11.8 per hour, compared with a decrease

from 35.7 per hour to 34.2 per hour in the placebo group (p < 0.0001).

Further, at a mean dose of 1.8 mg per day, Requip effectively reduced PLMS

to normal levels (less than or equal to 5 per hour) for more than half of the

patients (53.6 percent) versus 14.8 percent of patients on placebo. Among

other sleep variables, the ability to initiate sleep (known as sleep latency)

was

significantly improved in patients receiving Requip compared to the placebo

group. Average sleep latency in the group treated with Requip decreased

from 16.7 to 6.6 minutes compared with an increase in the placebo group

from 8.9 to 14.4 minutes (p < 0.01).

No serious adverse events occurred in either group. The most common

adverse events reported with Requip versus placebo were headache (34.4

vs. 18.2 percent), nausea (31.3 vs. 15.2 percent) and dizziness (18.8 vs. 3

percent).

About Requip®

Requip is a second-generation dopamine agonist that directly stimulates

post-synaptic dopamine receptors in the brain. It is believed that RLS may be

caused by a dopamine dysfunction.

Requip is indicated for the treatment of the signs and symptoms of idiopathic

Parkinson's disease and is generally well tolerated in this population. In

placebo-controlled studies for early treatment in this patient population on

monotherapy, the most commonly reported side effects for Requip versus

placebo were nausea (60 vs. 22 percent), dizziness (40 vs. 22 percent) and

somnolence (40 vs. 6 percent). Patients are advised to talk to their doctor

about whether they have the potential to develop the sedating effects

associated with Requip, which include somnolence, and the possibility of

falling asleep while engaged in activities of daily living, including operation

of

a motor vehicle. Fainting or low blood pressure may occur during initial

treatment or with an increase in dose. Hallucinations may occur at anytime

during treatment. Requip may potentiate the side effects of L-dopa and may

cause and/or exacerbate pre-existing dyskinesias.