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Efficacy and safety of ferric citrate hydrate compared with sodium ferrous citrate in Japanese patients with iron deficiency anemia: a randomized, double-blind, phase 3 non-inferiority study.

Author: AritaKojo, HanakiKoji, KomatsuNorio, MitsuiHironori, NemotoTakanori

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Overview

Ferric citrate hydrate (FC) at both 500 and 1000 mg/day was non-inferior to sodium ferrous citrate (SF) at 100 mg/day in terms of the change in hemoglobin concentration at Week 7. FC at 1000 mg/day had the highest proportion of patients achieving the target hemoglobin concentration, followed by SF at 100 mg/day and FC at 500 mg/day. Both dosages of FC were well tolerated, with significantly lower incidences of nausea and vomiting compared to SF.
Paper Details　
Original Abstract of the Article :
Oral iron preparations are used as first-line treatment for iron deficiency anemia (IDA), but their gastrointestinal side effects prevent patients from appropriate adherence. We recently conducted a randomized, double-blind, phase 3 non-inferiority study to evaluate the efficacy and safety of two do...See full text at original site
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引用元：
https://doi.org/10.1007/s12185-021-03123-9

データ提供：米国国立医学図書館（NLM）

Ferric Citrate Hydrate: A Refreshing Oasis in the Desert of Iron Deficiency Anemia

The desert of iron deficiency anemia can be a challenging landscape, often leaving individuals feeling weak and fatigued. This research explores the efficacy and safety of ferric citrate hydrate (FC) compared to sodium ferrous citrate (SF) in treating iron deficiency anemia (IDA) in Japanese patients. The study involved a randomized, double-blind, phase 3 non-inferiority trial, evaluating the effectiveness of two FC dosages (500 mg/day and 1000 mg/day) compared to SF (100 mg/day). The results demonstrated that both FC dosages were non-inferior to SF in terms of hemoglobin concentration improvement at week 7. The study also found that FC was associated with a significantly lower incidence of nausea and vomiting compared to SF, suggesting that it may be a more tolerable option for patients with IDA.

A New Route in the Desert of Iron Deficiency Anemia

The research suggests that FC has the potential to be a valuable treatment option for IDA, offering an effective and well-tolerated alternative to SF. The findings highlight the importance of considering patient-specific factors, such as gastrointestinal tolerance, when choosing an oral iron preparation. The study encourages further research to evaluate the long-term efficacy and safety of FC in managing IDA.

Navigating the Desert of Iron Deficiency Anemia with FC

This research offers a refreshing oasis in the desert of iron deficiency anemia. It underscores the importance of exploring new and effective treatment options that prioritize patient comfort and well-being. Remember, like a camel caravan seeking a reliable source of water in the desert, finding the right treatment for IDA is crucial for regaining energy and vitality.

Dr.Camel's Conclusion

This research reminds us that the desert of iron deficiency anemia can be navigated with a variety of treatment options. It's a reminder that like a desert oasis, we should seek out solutions that bring relief and enhance our overall health and well-being.

Date :
  1. Date Completed 2021-06-28
  2. Date Revised 2021-06-28
Further Info :

Pubmed ID

33719027

DOI: Digital Object Identifier

10.1007/s12185-021-03123-9

SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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