Evidence map›Paper›PMID 30039442›Full record

Trial reportInternational journal of hematology2019

Comparison of efficacy and safety between intravenous ferric carboxymaltose and saccharated ferric oxide in Japanese patients with iron-deficiency anemia due to hypermenorrhea: a multi-center, randomized, open-label noninferiority study.

Katsuya Ikuta, Hideki Hanashi, Kozo Hirai, Yoshiaki Ota, Yutaka Matsuyama, Asami Shimura, Masaru Terauchi, Mikio Momoeda

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 16% 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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 1 country.

Katsuya IkutaDivision of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, 2-1-1-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan. ikuta@asahikawa-med.ac.jp.
Hideki HanashiNew Medical Research System Clinic, Tokyo, Japan.
Kozo HiraiMinamimorimachi Ladies' Clinic, Osaka, Japan.
Yoshiaki OtaDepartment of Gynecology, Kurashiki Medical Center, Okayama, Japan.
Yutaka MatsuyamaDepartment of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Asami ShimuraClinical Research 2, Zeria Pharmaceutical Co., Ltd., Chuo-ku, Tokyo, Japan.
Masaru TerauchiClinical Research 2, Zeria Pharmaceutical Co., Ltd., Chuo-ku, Tokyo, Japan.
Mikio MomoedaDepartment of Integrated Women's Health, St. Luke's International Hospital, Tokyo, Japan.
Zeria Pharmaceutical (Japan) · JPAsahikawa Medical University · JPKurashiki Medical Center · JPOsaka Minami Medical Center · JPSt. Luke's International Hospital · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The intravenous formulation for supplementing iron currently available in Japan requires frequent administration. In contrast, ferric carboxymaltose (FCM) can improve iron-deficiency anemia (IDA) with only a small number of administrations; however, its efficacy and safety have not been established in Japanese patients. In this randomized, open-label study, we verified the noninferiority of FCM to saccharated ferric oxide (SFO) in Japanese patients with IDA due to hypermenorrhea, with the mean change from baseline to the highest observed hemoglobin level as the primary endpoint. Two hundred and thirty-eight eligible subjects (119 in FCM group, 119 in SFO group) were administered the investigational medicinal product and included in the analysis. The adjusted mean change from baseline to the highest observed hemoglobin level (95% CI) was 3.90 g/dL (3.77, 4.04) in the FCM group and 4.05 g/dL (3.92, 4.19) in the SFO group, and the difference between the groups (95% CI) was - 0.15 g/dL (- 0.35, 0.04). The noninferiority of FCM was verified. Incidence of adverse events was < 60% in both groups, and no significant difference was observed between the treatment groups. These results indicate that FCM can be a new, well-tolerated, and rapid treatment option for Japanese patients with IDA.

Indexed as

AdultAnemia, Iron-DeficiencyFemaleFerric CompoundsFerric Oxide, SaccharatedHemoglobinsHumansJapanMaltoseMenorrhagiaMiddle AgedTreatment OutcomeYoung Adultferric carboxymaltoseFerric CompoundsFerric Oxide, SaccharatedHemoglobinsMaltoseFerric carboxymaltose (FCM)HypermenorrheaIntravenous ironIron-deficiency anemia (IDA)Japan

Identifiers

PMID30039442
OpenAlexW2884235408

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.