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Background <p>The optimal dosing strategy for intravenous (IV) iron in patients undergoing hemodialysis (HD) with iron-deficiency anemia remains uncertain. While high-dose IV iron is commonly used, concerns exist regarding its potential risks. This systematic review and meta-analysis aims to assess the efficacy and safety of high-dose IV iron in this population.</p> Methods <p>PubMed, Embase, and Cochrane databases were searched for randomized controlled trials (RCTs) comparing high-dose with low-dose IV iron or no iron in patients undergoing HD with iron-deficiency anemia. Risk ratios (RR), mean differences (MD), and standardized mean differences (SMD) with 95% confidence intervals (CI) were pooled across studies. Heterogeneity was assessed using <i>I</i><sup>2</sup> statistics.</p> Results <p>This analysis included five RCTs involving 2614 patients, of whom 1326 (50.7%) received high-dose IV iron. Mean follow-up ranged from 1.5 to 52.8&#xa0;months. There was no significant difference between groups in the change from baseline in hemoglobin (MD 0.15&#xa0;g/dL; 95% CI − 0.26 to 0.57; <i>p</i> = 0.47). In contrast, ferritin levels (SMD 0.98; 95% CI 0.71–1.26; <i>p</i> &lt; 0.001) and transferrin saturation were significantly increased in the high-dose IV iron group compared with control (MD 5.02%; 95% CI 3.17–6.87; <i>p</i> &lt; 0.001). No statistically significant differences were observed between groups for cardiac adverse events (<i>p</i> = 0.064), cardiovascular mortality (<i>p</i> = 0.440), vascular disorders (<i>p</i> = 0.487), or infections (<i>p</i> = 0.948).</p> Conclusions <p>High-dose IV iron demonstrated a safety profile comparable to that of low-dose or no IV iron and was associated with significant increases in transferrin saturation and ferritin levels, despite no improvements in hemoglobin levels.</p>

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Efficacy and safety of high-dose intravenous iron in the treatment of iron-deficiency anemia in patients undergoing hemodialysis: a systematic review and meta-analysis of randomized controlled trials

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月9日

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  • Clara Campoverde,
  • Alanis Yael Szyferman,
  • Federico Napoli,
  • Ifunanya Peculiar Nnajiofor,
  • Henrique Alexsander Ferreira Neves,
  • Maria Luiza Rodrigues Defante,
  • Ana Beatriz Valverde Ramos,
  • Paula Dibo

摘要

Background

The optimal dosing strategy for intravenous (IV) iron in patients undergoing hemodialysis (HD) with iron-deficiency anemia remains uncertain. While high-dose IV iron is commonly used, concerns exist regarding its potential risks. This systematic review and meta-analysis aims to assess the efficacy and safety of high-dose IV iron in this population.

Methods

PubMed, Embase, and Cochrane databases were searched for randomized controlled trials (RCTs) comparing high-dose with low-dose IV iron or no iron in patients undergoing HD with iron-deficiency anemia. Risk ratios (RR), mean differences (MD), and standardized mean differences (SMD) with 95% confidence intervals (CI) were pooled across studies. Heterogeneity was assessed using I2 statistics.

Results

This analysis included five RCTs involving 2614 patients, of whom 1326 (50.7%) received high-dose IV iron. Mean follow-up ranged from 1.5 to 52.8 months. There was no significant difference between groups in the change from baseline in hemoglobin (MD 0.15 g/dL; 95% CI − 0.26 to 0.57; p = 0.47). In contrast, ferritin levels (SMD 0.98; 95% CI 0.71–1.26; p < 0.001) and transferrin saturation were significantly increased in the high-dose IV iron group compared with control (MD 5.02%; 95% CI 3.17–6.87; p < 0.001). No statistically significant differences were observed between groups for cardiac adverse events (p = 0.064), cardiovascular mortality (p = 0.440), vascular disorders (p = 0.487), or infections (p = 0.948).

Conclusions

High-dose IV iron demonstrated a safety profile comparable to that of low-dose or no IV iron and was associated with significant increases in transferrin saturation and ferritin levels, despite no improvements in hemoglobin levels.