- FRIDAY, May 30 (HealthDay News) — Skin patches that contain the
drug rotigotine help relieve restless legs syndrome (RLS), according to a
German study.

Dopaminergic drugs — which stimulate the body's dopamine system — are
currently used as a first-line treatment for RLS, and rotigotine is
already used to treat Parkinson's disease. This study of 458 people with
moderate to severe RLS examined the efficacy of rotigotine skin
patches.

The patients were randomly assigned to apply skin patches with 1
milligrams of rotigotine (115 patients), 2 milligrams (112), or 3
milligrams (114) once a day for six months. A fourth group of 117 patients
received a placebo.

The patients were assessed using the International Restless Leg
Syndrome study group severity rating scale (IRLS) and the clinical global
impressions (CGI) item 1 score, which measures severity of symptoms. At
the start of the study, the patients' average IRLS score was 28.1, and
their average CGI item 1 score was four or more.

At the end of the study, mean changes in IRLS score were: -13.7 in the
1 mg group; -16.2 in the 2 mg group; -16.8 in the 3 mg group; and -8.6 in
the placebo group. Changes in the CGI item 1 score were: -2.09 in the 1 mg
group; -2.41 in the 2 mg group; -2.55 in the 3 mg group; and -1.34 in the
placebo group.

Of the 341 patients who used the rotigotine skin patches, 145 (43
percent) experienced skin reactions (mostly mild or moderate), compared to
two of 117 (2 percent) of those who received the placebo.

Ten patients suffered serious side effects related to rotigotine:
elevation of liver enzymes (1 patient); worsening of tinnitus (1);
non-response to anticoagulation (1); electrocardiogram changes (1); and
skin patch application site reactions (6). All the skin reactions resolved
within a short time after the patch was removed.

“The results of this 6-month trial indicate that transdermal delivery
of low doses of rotigotine for 24 h per day are more effective than
placebo at relieving symptoms of RLS in patients who are moderately to
severely affected. This trial, together with a pilot study and
dose-finding trial, suggest that, despite differences in treatment
duration and other design features, there exists a clear therapeutic
window in terms of dose of rotigotine to treat restless legs syndrome
between 1 mg over 24 h to 3 mg over 24 h,” the study authors wrote.

The study was published online in The Lancet Neurology and was
expected to be in the July print issue of the journal.

“The introduction of a patch with a constant delivery of a dopamine
agonist is a welcome addition to the armamentarium. Unfortunately, the
rotigotine patch has been temporarily withdrawn from the U.S. market
because of problems with manufacturing and the unreliable delivery of the
drug,” Dr. Kapil Sethi, of the Medical College of Georgia, wrote in an
accompanying commentary.

“RLS causes significant discomfort and adversely affects the quality of
life of patients. Whether it has more ominous consequences is unclear. A
recent study showed that RLS is associated with a greater risk of
cardiovascular disease, particularly in patients with greater frequency or
severity of RLS symptoms. Whether treatment of RLS will reduce this risk
is unknown, and further studies should help answer this question,” Sethi
wrote.

More information

The U.S. National Institute of Neurological Disorders and Stroke has
more about restless legs syndrome.