Efficacy of Intravenous Iron Sucrose in Hemodialysis Patients with Restless Legs Syndrome (RLS): A Randomized, Placebo-Controlled Study

Deng, Yinghui; Jing-lin, WU; Jia, Qiang

doi:10.12659/msm.900520

Cited by 20 publications

(26 citation statements)

References 34 publications

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“…Nevertheless, short-term treatment with intravenous iron can alleviate RLS in patients on hemodialysis. 13 Our study is subject to some limitations. The crosssection analysis that does not confirm a cause-effect relationship, and the study also included a small sample size.…”

Section: Discussionmentioning

confidence: 94%

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Restless legs syndrome in patients on hemodialysis: Polysomnography findings

Bambini

Moysés

Batista

et al. 2019

Hemodialysis International

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Introduction: Restless legs syndrome (RLS) is a highly prevalent sleep movement disorder usually accompanied by periodic limb movements of sleep (PLMS). The incidence of RLS and PLMS in patients with end‐stage renal disease (ESRD) on dialysis is much higher. Clinically, RLS and PLMS can co‐occur. We hypothesized that patients with ESRD on dialysis would have a distinct presentation of RLS, with a higher prevalence of PLMS. Methods: We examined clinical, demographic, biochemical, and polysomnographic characteristics of RLS in patients on dialysis matched to control subjects with normal renal function based on age, sex, body mass index, and frequency of apneas and hypopneas per hour of sleep, defined by the apnea and hypopnea index (AHI), in a proportion of 3:1. Patients with ESRD were on hemodialysis three times per week. Polysomnography was performed overnight in the sleep laboratory. Findings: Patients on dialysis compared to control subjects had a lower amount of N3 sleep (77.6 ± 39.9 minutes vs. 94.8 ± 33.7 minutes, p = 0.037) and REM sleep (55.6 ± 27.5 minutes vs. 74.1 ± 28.4 minutes, p = 0.006), regardless of the presence of RLS. Among the patients on dialysis, those with RLS had higher PLMS. In the control group, patients with RLS had a lower ferritin level, which was not observed in the dialysis group. There was a significant interaction between PLMS and ESRD (p = 0.001), with a higher prevalence of PLMS in patients with ESRD on dialysis in a model adjusted for AHI, sex, arousals, and age. Factors that were associated with PLMS were RLS (p = 0.003), ESRD (p = 0.0001), and AHI (p = 0.041), with an adjusted R2 of 0.321. Conclusion: RLS in patients with ESRD on dialysis is independently associated with PLMS, regardless of the severity of sleep apnea, arousals, and age.

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Section: Discussionmentioning

confidence: 94%

“…We found no association between ferritin levels and RLS, in agreement with previous studies, which might indicate that RLS in patients on dialysis has a distinct physiopathology or at least has other causes. Nevertheless, short‐term treatment with intravenous iron can alleviate RLS in patients on hemodialysis …”

Section: Discussionmentioning

confidence: 99%

Restless legs syndrome in patients on hemodialysis: Polysomnography findings

Bambini

Moysés

Batista

et al. 2019

Hemodialysis International

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“…As summarized in Table 2, studies have consistently reported that iron sucrose is an effective treatment for iron deficiency/iron-deficiency anemia in patients with CKD, leading to increased Hb, serum ferritin, and TSAT in patients regardless of whether they are undergoing hemodialysis or receiving ESAs [40,[43][44][45][46][47][48][49][50][51][52][53][54].…”

Section: Chronic Kidney Diseasementioning

confidence: 99%

“…The safety profile is therefore well established in many different patient groups, including CKD, GI disorders, women's health disorders, oncology, cardiology, and for patient blood management (Tables 2, 3 , 4, 5, 6, 7). To date, more than 50 published clinical studies, covering numerous patient populations, have reported safety outcomes with administration of iron sucrose; 18 of these studies have been reported in the last 5 years [40,46,47,50,52,53,58,66,73,74,111,113,114,126,127,[129][130][131].…”

Section: Safety and Tolerability Of Iron Sucrosementioning

confidence: 99%

Iron Sucrose: A Wealth of Experience in Treating Iron Deficiency

et al. 2020

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Iron deficiency and iron-deficiency anemia are associated with increased morbidity and mortality in a wide range of conditions. In many patient populations, this can be treated effectively with oral iron supplementation; but in patients who are unable to take or who do not respond to oral iron therapy, intravenous iron administration is recommended. Furthermore, in certain conditions, such as end-stage kidney disease, chronic heart failure, and inflammatory bowel disease, intravenous iron administration has become first-line treatment. One of the first available intravenous iron preparations is iron sucrose (Venofer ® ), a nanomedicine that has been used clinically since 1949. Treatment with iron sucrose is particularly beneficial owing to its ability to rapidly increase hemoglobin, ferritin, and transferrin saturation levels, with an acceptable safety profile. Recently, important new data relating to the use of iron sucrose, including the findings from the landmark PIVOTAL trial in patients with end-stage kidney disease, have been reported. Several years ago, a number of iron sucrose similars became available, although there have been concerns about the clinical appropriateness of substituting the original iron sucrose with an iron sucrose similar because of differences in efficacy and safety. This is a result of the complex and unique physicochemical properties of nanomedicines such as iron sucrose, which make copying the molecule difficult and problematic. In this review, we summarize the evidence accumulated during 70 years of clinical experience with iron sucrose in terms of efficacy, safety, and cost-effectiveness.

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“…Nine compared iron to placebo and one compared iron to a dopamine agonist (Lee 2014). Resless legs syndrome (RLS) was defined using the 1995 International Restless Legs Syndrome Study Group criteria (IRLSSG) in three studies (Deng 2016;Sloand 2004;Walters 1995), the 2003 IRLSSG criteria in six studies Grote 2009; Lee 2014; Trenkwalder 2017; Wang 2009), the Hopkins telephone diagnostic interview for RLS in three studies Cho 2016;Earley 2009), and by clinical interview by a neurologist in one study (Davis 2000). In this latter study, 24 of 28 participants met all four diagnostic criteria for RLS using the 1995 criteria.…”

Section: Included Studiesmentioning

confidence: 99%

Iron for the treatment of restless legs syndrome

Trotti

Becker

2019

Cochrane Database of Systematic Reviews

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a We downgraded one level for publication bias for several reasons: 1) one study completed in 2012 (NCT00685815) for which published results could not be found in the search; 2) generally small sample sizes; and 3) the majority of participants were in trials funded by pharmaceutical companies. b We downgraded one level for the possibility of selective outcome reporting, as this outcome was infrequently reported across studies. c We downgraded one level because the Optimal Information Size (OIS) calculation suggests insu icient power for this outcome.

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Efficacy of Intravenous Iron Sucrose in Hemodialysis Patients with Restless Legs Syndrome (RLS): A Randomized, Placebo-Controlled Study

Cited by 20 publications

References 34 publications

Restless legs syndrome in patients on hemodialysis: Polysomnography findings

Restless legs syndrome in patients on hemodialysis: Polysomnography findings

Iron Sucrose: A Wealth of Experience in Treating Iron Deficiency

Iron for the treatment of restless legs syndrome

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