Movement Disorders (revue)

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A randomized, double‐blind, placebo controlled, multi‐center study of intravenous iron sucrose and placebo in the treatment of restless legs syndrome

Identifieur interne : 000A48 ( Istex/Corpus ); précédent : 000A47; suivant : 000A49

A randomized, double‐blind, placebo controlled, multi‐center study of intravenous iron sucrose and placebo in the treatment of restless legs syndrome

Auteurs : Ludger Grote ; Lena Leissner ; Jan Hedner ; Jan Ulfberg

Source :

RBID : ISTEX:89BCBB5535CC93038CC43B6AEA9EC23D367BB2C5

English descriptors

Abstract

Iron deficiency may exacerbate symptoms in the Restless Legs Syndrome (RLS). We investigated the effect of intravenous iron sucrose or placebo on symptoms in patients with RLS and mild to moderate iron deficit. Sixty patients with primary RLS (seven males, age 46 (9) years, S‐ferritin ≤45 μg/L) recruited from a cohort of 231 patients were randomly assigned in a 12‐months double‐blind, multi‐centre study of iron sucrose 1000 mg (n = 29) or saline (n = 31). The primary efficacy variable was the RLS severity scale (IRLS) score at week 11. Median IRLS score decreased from 24 to 7 (week 11) after iron sucrose and from 26 to 17 after placebo (P = 0.123, N.S. for between treatment comparison). The corresponding scores at week 7 were 12 and 20 in the two groups (P = 0.017). Drop out rate because of lack of efficacy at 12 months was 19/31 after placebo and 5/29 patients after iron sucrose (Kaplan–Meier estimate, log rank test P = 0.0006) suggesting an iron induced superior long term RLS symptom control. Iron sucrose was well tolerated. This study showed a lack of superiority of iron sucrose at 11 weeks but found evidence that iron sucrose reduced RLS symptoms both in the acute phase (7 weeks) and during long‐term follow up in patients with variable degree of iron deficiency. Further studies on target patient groups, dosing and dosing intervals are warranted before iron sucrose could be considered for treatment of iron deficient patients with RLS. © 2009 Movement Disorder Society

Url:
DOI: 10.1002/mds.22562

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ISTEX:89BCBB5535CC93038CC43B6AEA9EC23D367BB2C5

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<p> Additional Supporting Information may be found in the online version of this article. </p>
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<caption>Supporting Figure 1: Short‐, intermediate‐, and long‐term effects of iron sucrose and placebo on RLS symptoms. Shown as the median values of the IRLS score at baseline (week 0) and at follow up weeks 3, 7, 11, and months 5, 8, and 12. (ITT analysis, n=29 for the iron sucrose group and n=31 for the placebo group)</caption>
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<caption>Supporting Table 1: Adverse reactions during the study. Number of adverse reactions and percentage of all reported reactions listed in certain categories. Different events may have occurred in one individual patient and at repeated occasions.</caption>
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<p>Iron deficiency may exacerbate symptoms in the Restless Legs Syndrome (RLS). We investigated the effect of intravenous iron sucrose or placebo on symptoms in patients with RLS and mild to moderate iron deficit. Sixty patients with primary RLS (seven males, age 46 (9) years, S‐ferritin ≤45 μg/L) recruited from a cohort of 231 patients were randomly assigned in a 12‐months double‐blind, multi‐centre study of iron sucrose 1000 mg (n = 29) or saline (n = 31). The primary efficacy variable was the RLS severity scale (IRLS) score at week 11. Median IRLS score decreased from 24 to 7 (week 11) after iron sucrose and from 26 to 17 after placebo (
<i>P</i>
= 0.123, N.S. for between treatment comparison). The corresponding scores at week 7 were 12 and 20 in the two groups (
<i>P</i>
= 0.017). Drop out rate because of lack of efficacy at 12 months was 19/31 after placebo and 5/29 patients after iron sucrose (Kaplan–Meier estimate, log rank test
<i>P</i>
= 0.0006) suggesting an iron induced superior long term RLS symptom control. Iron sucrose was well tolerated. This study showed a lack of superiority of iron sucrose at 11 weeks but found evidence that iron sucrose reduced RLS symptoms both in the acute phase (7 weeks) and during long‐term follow up in patients with variable degree of iron deficiency. Further studies on target patient groups, dosing and dosing intervals are warranted before iron sucrose could be considered for treatment of iron deficient patients with RLS. © 2009 Movement Disorder Society</p>
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<title>A randomized, double‐blind, placebo controlled, multi‐center study of intravenous iron sucrose and placebo in the treatment of restless legs syndrome</title>
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<title>A randomized, double‐blind, placebo controlled, multi‐center study of intravenous iron sucrose and placebo in the treatment of restless legs syndrome</title>
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<name type="personal">
<namePart type="given">Jan</namePart>
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<abstract lang="en">Iron deficiency may exacerbate symptoms in the Restless Legs Syndrome (RLS). We investigated the effect of intravenous iron sucrose or placebo on symptoms in patients with RLS and mild to moderate iron deficit. Sixty patients with primary RLS (seven males, age 46 (9) years, S‐ferritin ≤45 μg/L) recruited from a cohort of 231 patients were randomly assigned in a 12‐months double‐blind, multi‐centre study of iron sucrose 1000 mg (n = 29) or saline (n = 31). The primary efficacy variable was the RLS severity scale (IRLS) score at week 11. Median IRLS score decreased from 24 to 7 (week 11) after iron sucrose and from 26 to 17 after placebo (P = 0.123, N.S. for between treatment comparison). The corresponding scores at week 7 were 12 and 20 in the two groups (P = 0.017). Drop out rate because of lack of efficacy at 12 months was 19/31 after placebo and 5/29 patients after iron sucrose (Kaplan–Meier estimate, log rank test P = 0.0006) suggesting an iron induced superior long term RLS symptom control. Iron sucrose was well tolerated. This study showed a lack of superiority of iron sucrose at 11 weeks but found evidence that iron sucrose reduced RLS symptoms both in the acute phase (7 weeks) and during long‐term follow up in patients with variable degree of iron deficiency. Further studies on target patient groups, dosing and dosing intervals are warranted before iron sucrose could be considered for treatment of iron deficient patients with RLS. © 2009 Movement Disorder Society</abstract>
<note type="content">*Potential conflict of interest: Nothing to report.</note>
<note type="funding">Renapharma Ltd, Uppsala, Sweden</note>
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<topic>iron sucrose</topic>
<topic>restless legs syndrome</topic>
<topic>treatment</topic>
<topic>iron deficiency</topic>
<topic>clinical trial</topic>
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<note type="content"> Additional Supporting Information may be found in the online version of this article.Supporting Info Item: Supporting Information - Supporting Figure 1: Short‐, intermediate‐, and long‐term effects of iron sucrose and placebo on RLS symptoms. Shown as the median values of the IRLS score at baseline (week 0) and at follow up weeks 3, 7, 11, and months 5, 8, and 12. (ITT analysis, n=29 for the iron sucrose group and n=31 for the placebo group) - Supporting Table 1: Adverse reactions during the study. Number of adverse reactions and percentage of all reported reactions listed in certain categories. Different events may have occurred in one individual patient and at repeated occasions. - </note>
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