Schmidt C, Ahmad T, Tulassay Z, Baumgart D C, Bokemeyer B, Howaldt S, Stallmach A, Büning C
Clinic of Internal Medicine IV, Jena University Hospital, Jena, Germany.
University of Exeter Medical School, Exeter, UK.
Aliment Pharmacol Ther. 2016 Aug;44(3):259-70. doi: 10.1111/apt.13665. Epub 2016 May 29.
Ferric maltol was effective and well-tolerated in iron deficiency anaemia patients with inflammatory bowel disease during a 12-week placebo-controlled trial.
To perform a Phase 3 extension study evaluating long-term efficacy and safety with ferric maltol in inflammatory bowel disease patients in whom oral ferrous therapies had failed to correct iron deficiency anaemia.
After 12 weeks of randomised, double-blind treatment, patients with iron deficiency anaemia and mild-to-moderate ulcerative colitis or Crohn's disease received open-label ferric maltol 30 mg b.d. for 52 weeks.
111 patients completed randomised treatment and 97 entered the open-label ferric maltol extension. In patients randomised to ferric maltol ('continued'; n = 50), mean ± s.d. haemoglobin increased by 3.07 ± 1.46 g/dL between baseline and Week 64. In patients randomised to placebo ('switch'; n = 47), haemoglobin increased by 2.19 ± 1.61 g/dL. Normal haemoglobin was achieved in high proportions of both continued and switch patients (89% and 83% at Week 64, respectively). Serum ferritin increased from 8.9 μg/L (baseline) to 26.0 μg/L (Week 12) in ferric maltol-treated patients, and to 57.4 μg/L amongst all patients at Week 64. In total, 80% of patients reported ≥1 adverse event by Week 64. Adverse events considered related to ferric maltol were recorded in 27/111 (24%) patients: 8/18 discontinuations due to adverse events were treatment-related. One patient was withdrawn due to increased ulcerative colitis activity.
Normal haemoglobin was observed in ≥80% of patients from weeks 20-64 of long-term ferric maltol treatment, with concomitant increases in iron storage parameters. Ferric maltol was well-tolerated throughout this 64-week study.
在一项为期12周的安慰剂对照试验中，麦芽糖铁对患有炎症性肠病的缺铁性贫血患者有效且耐受性良好。
进行一项3期扩展研究，评估麦芽糖铁对口服铁剂治疗未能纠正缺铁性贫血的炎症性肠病患者的长期疗效和安全性。
经过12周的随机双盲治疗后，缺铁性贫血且患有轻至中度溃疡性结肠炎或克罗恩病的患者接受开放标签的麦芽糖铁，每日两次，每次30mg，持续52周。
111名患者完成了随机治疗，97名进入开放标签的麦芽糖铁扩展治疗阶段。随机接受麦芽糖铁治疗的患者（“继续治疗组”；n = 五十），从基线到第64周，血红蛋白均值±标准差增加了3.07±1.46g/dL。随机接受安慰剂治疗的患者（“转换治疗组”；n = 47），血红蛋白增加了2.19±1.61g/dL。继续治疗组和转换治疗组中均有高比例患者实现了血红蛋白正常化（第64周时分别为89%和83%）。麦芽糖铁治疗的患者血清铁蛋白从8.9μg/L（基线）升至26.0μg/L（第12周），到第64周时，所有患者血清铁蛋白升至57.4μg/L。到第64周时，总计80%的患者报告了≥1次不良事件。27/111（24%）的患者记录到被认为与麦芽糖铁相关的不良事件：因不良事件而停药的18例中有8例与治疗相关。1例患者因溃疡性结肠炎活动增加而退出。
在长期麦芽糖铁治疗的第20 - 64周，≥80%的患者观察到血红蛋白正常，同时铁储存参数增加。在这项为期64周的研究中，麦芽糖铁耐受性良好。
