A Multicenter Single-Arm Study of Switching to Ferric Citrate Hydrate for Iron Deficiency Anemia in Patients Intolerant to Oral Iron: RIO-SWITCH

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-03-07 DOI:10.1007/s12325-025-03123-9

Osamu Wada-Hiraike, Aya Maruyama, Yuko Mitobe, Takayuki Iriyama, Mayuyo Mori-Uchino, Yutaka Osuga, RIO-SWITCH Consortium

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引用次数: 0

Abstract

Introduction

Treatment interruptions due to adverse drug reactions (ADRs) are common in iron deficiency anemia (IDA). We evaluated medication completion rates and quality of life (QoL) changes in patients with IDA after starting ferric citrate hydrate (FCH) treatment.

Methods

This multicenter, open-label, uncontrolled, single-arm comparative study included 30 Japanese female patients with IDA who experienced nausea and/or vomiting (N/V) with previous oral iron preparations. Patients received FCH 500 mg orally daily (< 1000 mg/day). Those with hemoglobin levels ≥ 11.0 g/dl completed the study at week 4; others continued until week 8. The primary endpoint was medication completion rate. Secondary endpoints included medication compliance rate, treatment satisfaction scores, and QoL scores and changes.

Results

Thirty patients initiated and completed treatment; 24 reached ≥ 11.0 g/dl hemoglobin at week 4 and ended treatment, while 6 continued until week 8. The medication compliance rate was 93.92% ± 8.11% (mean ± standard deviation [SD]), and the completion rate was 100.0% (95% confidence interval 88.4–100.0%). Questionnaire findings revealed that the most severe nausea score decreased from 5.7 ± 2.4 to 1.7 ± 2.1 (mean ± SD), N/V incidence decreased from 100.0 to 63.3%, and patients reporting that N/V did not interfere with daily life increased from 6.7 to 52.6% following the switch to FCH. Twenty-four patients (80.0%) reported a satisfactory experience with FCH versus their previous oral iron preparation. Scores for all eight subscales of the Short-Form 36-Item Health Survey v2 improved, with significant increases in six. Nine ADR events occurred in six patients (20.0%), including nausea in three (10.0%); none were serious or resulted in treatment discontinuation.

Conclusion

FCH treatment exhibited a satisfactory medication completion rate in patients with IDA. Switching to FCH reduced N/V incidence and improved N/V and QoL severity compared with previous oral iron preparations.

Trial Registration

jRCTs031210634. Registration date: March 01, 2022.

查看原文本刊更多论文

一项多中心单臂研究：对口服铁不耐受的缺铁性贫血患者改用柠檬酸铁水合物治疗：RIO-SWITCH。

由于药物不良反应（adr）导致的治疗中断在缺铁性贫血（IDA）中很常见。我们评估了IDA患者在开始水合柠檬酸铁（FCH）治疗后的药物完成率和生活质量（QoL）变化。方法：这项多中心、开放标签、非对照、单臂比较研究纳入了30名日本女性IDA患者，这些患者既往口服铁制剂后出现恶心和/或呕吐（N/V）。患者每日口服FCH 500 mg(结果：30例患者开始并完成治疗；24例患者第4周血红蛋白≥11.0 g/dl， 6例患者持续治疗至第8周。用药依从率为93.92%±8.11%（均数±标准差[SD]），完成率为100.0%（95%可信区间88.4 ~ 100.0%）。问卷调查结果显示，切换到FCH后，最严重的恶心评分从5.7±2.4下降到1.7±2.1 (mean±SD)， N/V发生率从100.0下降到63.3%，报告N/V不干扰日常生活的患者从6.7增加到52.6%。24名患者（80.0%）报告了FCH与先前口服铁制剂相比的满意体验。简表36项健康调查v2的所有8个子量表得分都有所提高，其中6个得分显著提高。6例（20.0%）患者发生9起不良反应事件，其中3例恶心（10.0%）；没有严重的或导致治疗中断。结论：FCH治疗对IDA患者有满意的药物完成率。与以前的口服铁制剂相比，改用FCH可降低N/V发生率，改善N/V和生活质量严重程度。试验注册：jRCTs031210634。报名日期：2022年3月1日。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.