Evidence map›Paper›PMID 25545376›Full record

Trial reportInflammatory bowel diseases2015

Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program.

Christoph Gasche, Tariq Ahmad, Zsolt Tulassay, Daniel C Baumgart, Bernd Bokemeyer, Carsten Büning, Stefanie Howaldt, Andreas Stallmach, AEGIS Study Group

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Inflammatory bowel diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 59 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 7 pooled it
8.8field-weighted citation impact, top 2% 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.

NCT01340872 phase3completednot on this map

A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Ulcerative Colitis Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 1)

TypeinterventionalSponsorShield TherapeuticsRan2011 to 2014Enrolled128ConditionsIron Deficiency Anaemia, Inflammatory Bowel Disease, Ulcerative ColitisArmsST10-021, Placebo Comparator
NCT01352221 phase3completednot on this map

A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Crohn's Disease Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 2)

TypeinterventionalSponsorShield TherapeuticsRan2011 to 2014Enrolled128ConditionsIron Deficiency Anaemia, Inflammatory Bowel Disease, Crohn's DiseaseArmsST10, Placebo oral capsule
NCT02760940 phase4unknown statusnot on this mapstarted 2016, after this paper: background citation

Anemia Treatment in Inflammatory Bowel Disease: Predictive Factors of Response to Oral Iron Treatment

TypeinterventionalSponsorFederal University of Juiz de ForaRan2016 to 2018Enrolled200ConditionsAnemia, Bowel Diseases, InflammatoryArmsoral liposomal iron
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 7 syntheses or guidelines pooled it, 130 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Interventions for fatigue in inflammatory bowel disease.The Cochrane database of systematic reviews · 2020
    Pooled it
  6. Diet and inflammatory bowel disease: The Asian Working Group guidelines.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2019
    Guideline
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
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  20. Review
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

9 authors at 8 institutions in 4 countries.

Christoph Gasche*Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria; †University of Exeter Medical School, Exeter, United Kingdom; ‡Department of Medicine, Semmelweis University of Medicine, Budapest, Hungary; §Division of Gastroenterology and Hepatology, Department of Medicine, Charité Medical School, Humboldt-University of Berlin, Germany; ‖Gastroenterology Practice, Minden, Germany; ¶Department of Hepatology and Gastroenterology, Charite, University of Medicine, Berlin, Germany; **Division of Inflammatory Bowel Disease, Hamburg Institute of Research, Hamburg, Germany; and ††Department of Internal Medicine IV (Gastroenterology, Hepatology and Infectious Diseases), Jena University Hospital, Jena, Germany.
Tariq Ahmad
Zsolt Tulassay
Daniel C Baumgart
Bernd Bokemeyer
Carsten Büning
Stefanie Howaldt
Andreas Stallmach
AEGIS Study Group
Charité - Universitätsmedizin Berlin · DEHamburg Institut (Germany) · DEHumboldt-Universität zu Berlin · DEJena University Hospital · DEJohannes Wesling Klinikum Minden · DEMedical University of Vienna · ATSemmelweis University · HUUniversity of Exeter · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIron deficiency anemia (IDA) is frequently seen in inflammatory bowel disease. Traditionally, oral iron supplementation is linked to extensive gastrointestinal side effects and possible disease exacerbation. This multicenter phase-3 study tested the efficacy and safety of ferric maltol, a complex of ferric (Fe) iron with maltol (3-hydroxy-2-methyl-4-pyrone), as a novel oral iron therapy for IDA.

methodsAdult patients with quiescent or mild-to-moderate ulcerative colitis or Crohn's disease, mild-to-moderate IDA (9.5-12.0 g/dL and 9.5-13.0 g/dL in females and males, respectively), and documented failure on previous oral ferrous products received oral ferric maltol capsules (30 mg twice a day) or identical placebo for 12 weeks according to a randomized, double-blind, placebo-controlled study design. The primary efficacy endpoint was change in hemoglobin (Hb) from baseline to week 12. Safety and tolerability were assessed.

resultsOf 329 patients screened, 128 received randomized therapy (64 ferric maltol-treated and 64 placebo-treated patients) and comprised the intent-to-treat efficacy analysis: 55 ferric maltol patients (86%) and 53 placebo patients (83%) completed the trial. Significant improvements in Hb were observed with ferric maltol versus placebo at weeks 4, 8, and 12: mean (SE) 1.04 (0.11) g/dL, 1.76 (0.15) g/dL, and 2.25 (0.19) g/dL, respectively (P < 0.0001 at all time-points; analysis of covariance). Hb was normalized in two-thirds of patients by week 12. The safety profile of ferric maltol was comparable with placebo, with no impact on inflammatory bowel disease severity.

conclusionsFerric maltol provided rapid clinically meaningful improvements in Hb and showed a favorable safety profile, suggesting its possible use as an alternative to intravenous iron in IDA inflammatory bowel disease.

Indexed as

Administration, OralAdultAnemia, Iron-DeficiencyColitis, UlcerativeCrohn DiseaseDouble-Blind MethodFemaleFerric CompoundsHemoglobinsHumansMaleMaximum Tolerated DosePrognosisPyronesQuality of LifeFerric Compoundsferric maltolHemoglobinsPyrones

Identifiers

PMID25545376
PMCPMC4342319
OpenAlexW1987326742

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.