BOSTON—For patients with restless legs syndrome (RLS), the rotigotine transdermal patch improved scores on all but one of the items in the International RLS (IRLS) scale by approximately the same magnitude, researchers reported at the 26th Annual Meeting of the Associated Professional Sleep Societies.
Compared with placebo, the rotigotine patch consistently decreased patients’ frequency of symptoms, symptom severity, and amount of time with symptoms, but, in one of two studies, did not increase the amount of relief that patients had from moving around. The latter item is “perhaps the most controversial” in the IRLS scale, according to Richard Allen, PhD, FAASM, Associate Professor of Neurology at Johns Hopkins University in Baltimore. Symptom relief with movement is required for the RLS diagnosis, and thus this scale item cannot improve much with treatment.
The rotigotine patch also reduced the impact of RLS, as measured by the IRLS scale. Compared with placebo, the patch improved patients’ reported sleep, decreased daytime fatigue, improved patients’ ability to carry out daily activities, and decreased the severity of RLS-associated mood disturbance.
A Post Hoc Analysis of Two Trials
To determine whether the rotigotine patch provided consistent improvement on all items of the IRLS scale, Dr. Allen and his colleagues performed post hoc analysis of data from two major studies of the drug. The investigators carried out standard statistical analysis using intention to treat and a maintenance treatment in patients with RLS. The researchers examined individual items on the IRLS scale at the end of maintenance and compared rotigotine to placebo using 1-, 2-, and 3-mg doses of the drug.
A total of 843 patients were included in the studies. Demographics were similar in the two studies, but American patients were slightly younger on average than European patients. De novo patients were more common in the American group than in the European group. The severity of RLS was different between the groups, but mild in both groups.
Decreased Symptom Frequency and Severity
Patients who received placebo had no significant improvement on any item of the IRLS scale. In contrast, the rotigotine patch “dramatically” decreased symptom frequency, severity of mood disturbance, and impact on the ability to perform daily activities, said Dr. Allen.
“The conclusion we reached from this post hoc analysis was that all of the items in the IRLS scale show successful improvement at about the same magnitude,” except for the amount of relief patients get from moving around, said Dr. Allen. The analysis reassured the investigators that the rotigotine patch addressed every aspect of RLS that is commonly measured.
Approximately 30% of patients who use the patch experience slight skin irritation, Dr. Allen told Neurology Reviews. The irritation improves, however, if the patient moves the patch to another part of the body that previously was unexposed to the patch.
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Tzonova D, Larrosa O, Calvo E, et al. Breakthrough symptoms during the daytime in patients with restless legs syndrome (Willis-Ekbom disease). Sleep Med. 2012;13(2):151-155.