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Rotigotine Skin Patch May Ease Restless Legs Symptoms
Date:5/30/2008

But one expert notes problems with manufacturing, unreliable delivery of the drug

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.'/>"/>

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