Evidence map›Paper›PMID 33719027›Full record

Trial reportInternational journal of hematology2021

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.

Norio Komatsu, Kojo Arita, Hironori Mitsui, Takanori Nemoto, Koji Hanaki

Erratum issuedOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of hematology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.6field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 17 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Norio KomatsuDepartment of Hematology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan. komatsun@juntendo.ac.jp.ORCID http://orcid.org/0000-0003-1880-9126
Kojo AritaPharmaceutical Division, Japan Tobacco Inc., 3-4-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-0023, Japan.
Hironori MitsuiPharmaceutical Division, Japan Tobacco Inc., 3-4-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-0023, Japan.
Takanori NemotoPharmaceutical Division, Japan Tobacco Inc., 3-4-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-0023, Japan.
Koji HanakiPharmaceutical Division, Japan Tobacco Inc., 3-4-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-0023, Japan.
Japan Tobacco (Japan) · JPJuntendo University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 dosages of ferric citrate hydrate (FC) compared with sodium ferrous citrate (SF) in patients with IDA. FC at both 500 and 1000 mg/day was non-inferior to SF at 100 mg/day in terms of the change in the hemoglobin concentration at Week 7 from baseline. Logistic regression analysis suggested that the cumulative proportion of patients who achieved the target hemoglobin concentration (≥ 13.0 g/dL in male patients and ≥ 12.0 g/dL in female patients) at Week 7 was highest among those treated with FC at 1000 mg/day, followed by SF at 100 mg/day and FC at 500 mg/day. Both dosages of FC were well tolerated in patients with IDA. The incidences of nausea and vomiting were significantly lower in the FC treatment groups than in the SF group. In conclusion, FC has potential to be an oral iron preparation with sufficient efficacy for the treatment of IDA and a lower risk of nausea and vomiting.

Indexed as

AdultAnemia, Iron-DeficiencyCitric AcidDouble-Blind MethodFerric CompoundsFerrous CompoundsHumansJapanMiddle AgedTreatment OutcomeCitric Acidferric citrateFerric Compoundsferrous citrateFerrous CompoundsFerric citrate hydrateGastrointestinal side effectsIron deficiency anemiaJapanOral iron preparation

Identifiers

PMID33719027
PMCPMC10917848
OpenAlexW3139033187

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.