Source:Sleep Medicine
Author(s): Yong Won Cho, Richard P. Allen, Christopher J. Earley
IntroductionThere have been four randomized, placebo-controlled, double-blinded studies of intravenous (IV) iron in Restless Legs Syndrome (RLS), all of which delivered a final total dose of 1000 mg of iron. The purpose of this study was to evaluate effects of a lesser total dose (500 mg of iron).MethodsSubjects with idiopathic RLS were enrolled in a randomized, double-blinded, placebo-controlled study. Subjects received either 500 mg ferric carboxymaltose (FCM) or placebo as a single infusion (Phase I). Subjects who were previously on medication were off any RLS medications for at least two weeks prior to baseline assessment. The primary outcome variable was a change-from-baseline at week-6 on the International RLS Severity Scale (IRLSS) and a subject-completed Visual Analog Scale of Severity (VAS). Phase II of the study involved long-term (30 weeks) follow-up after completing the 6-week efficacy phase.ResultsAt week-6 post infusion, FCM, compared to placebo recipients, showed no significantly greater change-from-baseline for both primary outcome measures (IRLSS scale, FCM 500mg vs. placebo: -8.3±7.5 vs. -4.8±8.7, p=0.100; VAS, FCM 500mg vs. placebo: -23.4±24.1 vs. -13.3±23.1, p=0.077). None of the secondary outcome variables showed a significant difference at week-6. Seven (21.9%) of the 32 subjects treated with iron in Phase I remained free from further RLS medications at 30 weeks. There were no serious adverse effects found in this study.ConclusionsThis study did not show a significant benefit of a single 500mg FCM treatment for RLS symptoms. The two previous, well-controlled, trials of 1000 mg FCM showed significant treatment benefits suggesting that there may be a clinically relevant total dose required to achieve a clinical response.
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