Ferric Maltol Is Effective in Correcting Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease: Results from a Phase-3 Clinical Trial Program
Ferric Maltol Is Effective in Correcting Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease: Results from a Phase-3 Clinical Trial Program
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DOI：
10.1097/mib.0000000000000314
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发表时间：
2015-03-01
影响因子：
4.9
通讯作者：
Stallmach, Andreas
中科院分区：
文献类型：
--
作者：
Gasche, Christoph;Ahmad, Tariq;Stallmach, Andreas
背景：缺铁性贫血（IDA）是常见于炎症性肠病。传统上，口服铁补充剂与广泛的胃肠道副作用和可能的疾病恶化有关。这项多中心III期研究测试了麦芽酚铁（一种三价铁（Fe 3+）与麦芽酚的复合物）的疗效和安全性（3-羟基-2-甲基-4-吡喃酮）作为IDA的新型口服铁疗法。静止期或轻中度溃疡性结肠炎或克罗恩病、轻中度IDA成人患者（女性和男性分别为9.5-12.0 g/dL和9.5-13.0 g/dL），并且记录了既往口服亚铁产品失败的患者接受了口服麦芽酚铁胶囊（30 mg，每日两次）或相同的安慰剂治疗12周，根据随机、双盲、安慰剂对照研究设计。主要疗效终点为血红蛋白（Hb）从基线至第12周的变化。结果：筛选的329例患者中，128例接受随机治疗（64例麦芽酚铁治疗和64例安慰剂治疗的患者），包括意向治疗疗效分析：55例麦芽酚铁患者（86%）和53例安慰剂患者（83%）完成了试验。在第4、8和12周，麦芽酚铁组与安慰剂组相比，Hb显著改善：平均值（SE）分别为1.04（0.11）g/dL、1.76（0.15）g/dL和2.25（0.19）g/dL（所有时间点P < 0.0001;协方差分析）。到第12周，三分之二的患者Hb恢复正常。麦芽酚铁的安全性与安慰剂相当，没有影响炎症性肠病severity.Conclusions：麦芽酚铁提供了快速的临床有意义的改善血红蛋白，并表现出良好的安全性，这表明其可能作为一种替代静脉注射铁在IDA炎症性肠病。
Background:Iron deficiency anemia (IDA) is frequently seen in inflammatory bowel disease. Traditionally, oral iron supplementation is linked to extensive gastrointestinal side effects and possible disease exacerbation. This multicenter phase-3 study tested the efficacy and safety of ferric maltol, a complex of ferric (Fe3+) iron with maltol (3-hydroxy-2-methyl-4-pyrone), as a novel oral iron therapy for IDA.Methods:Adult patients with quiescent or mild-to-moderate ulcerative colitis or Crohn's disease, mild-to-moderate IDA (9.5-12.0 g/dL and 9.5-13.0 g/dL in females and males, respectively), and documented failure on previous oral ferrous products received oral ferric maltol capsules (30 mg twice a day) or identical placebo for 12 weeks according to a randomized, double-blind, placebo-controlled study design. The primary efficacy endpoint was change in hemoglobin (Hb) from baseline to week 12. Safety and tolerability were assessed.Results:Of 329 patients screened, 128 received randomized therapy (64 ferric maltol-treated and 64 placebo-treated patients) and comprised the intent-to-treat efficacy analysis: 55 ferric maltol patients (86%) and 53 placebo patients (83%) completed the trial. Significant improvements in Hb were observed with ferric maltol versus placebo at weeks 4, 8, and 12: mean (SE) 1.04 (0.11) g/dL, 1.76 (0.15) g/dL, and 2.25 (0.19) g/dL, respectively (P < 0.0001 at all time-points; analysis of covariance). Hb was normalized in two-thirds of patients by week 12. The safety profile of ferric maltol was comparable with placebo, with no impact on inflammatory bowel disease severity.Conclusions:Ferric maltol provided rapid clinically meaningful improvements in Hb and showed a favorable safety profile, suggesting its possible use as an alternative to intravenous iron in IDA inflammatory bowel disease.