{"title":"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。","authors":"Osamu Wada-Hiraike, Aya Maruyama, Yuko Mitobe, Takayuki Iriyama, Mayuyo Mori-Uchino, Yutaka Osuga, RIO-SWITCH Consortium","doi":"10.1007/s12325-025-03123-9","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p><h3>Methods</h3><p>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.</p><h3>Results</h3><p>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.</p><h3>Conclusion</h3><p>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.</p><h3>Trial Registration</h3><p>jRCTs031210634. Registration date: March 01, 2022.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2150 - 2167"},"PeriodicalIF":3.4000,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03123-9.pdf","citationCount":"0","resultStr":"{\"title\":\"A Multicenter Single-Arm Study of Switching to Ferric Citrate Hydrate for Iron Deficiency Anemia in Patients Intolerant to Oral Iron: RIO-SWITCH\",\"authors\":\"Osamu Wada-Hiraike, Aya Maruyama, Yuko Mitobe, Takayuki Iriyama, Mayuyo Mori-Uchino, Yutaka Osuga, RIO-SWITCH Consortium\",\"doi\":\"10.1007/s12325-025-03123-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>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.</p><h3>Methods</h3><p>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.</p><h3>Results</h3><p>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.</p><h3>Conclusion</h3><p>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.</p><h3>Trial Registration</h3><p>jRCTs031210634. Registration date: March 01, 2022.</p></div>\",\"PeriodicalId\":7482,\"journal\":{\"name\":\"Advances in Therapy\",\"volume\":\"42 5\",\"pages\":\"2150 - 2167\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-03-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://link.springer.com/content/pdf/10.1007/s12325-025-03123-9.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://link.springer.com/article/10.1007/s12325-025-03123-9\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Therapy","FirstCategoryId":"3","ListUrlMain":"https://link.springer.com/article/10.1007/s12325-025-03123-9","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
A Multicenter Single-Arm Study of Switching to Ferric Citrate Hydrate for Iron Deficiency Anemia in Patients Intolerant to Oral Iron: RIO-SWITCH
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.
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.
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