Evidence map›Paper›PMID 19951979›Full record

Trial reportHaematologica2010

Tailoring iron chelation by iron intake and serum ferritin: the prospective EPIC study of deferasirox in 1744 patients with transfusion-dependent anemias.

Maria Domenica Cappellini, John Porter, Amal El-Beshlawy, Chi-Kong Li, John F Seymour, Mohsen Elalfy, Norbert Gattermann, Stéphane Giraudier, Jong-Wook Lee, Lee Lee Chan and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Haematologica, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00171821 (A One Year, Open-label, Single-arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670), which is not on this map. Cited by 88 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 6 pooled it
14.1field-weighted citation impact, top 1% 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.

NCT00171821 phase3completednot on this map

A One Year, Open-label, Single-arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/Day) in Patients Diagnosed With Transfusion-dependent Iron Overload

TypeinterventionalSponsorNovartis PharmaceuticalsRan2005 to 2010Enrolled1,784ConditionsTransfusion-dependent Iron OverloadArmsDeferasirox
3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 6 syntheses or guidelines pooled it, 285 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Deferasirox for managing iron overload in people with thalassaemia.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Pooled it
  5. Guideline
  6. Guideline
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Article
  19. Article
  20. Review

28 more citing papers are in PubMed but not listed here.

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

20 authors at 15 institutions in 13 countries.

Maria Domenica CappelliniUniversità di Milano, Policlinico Foundation IRCCS, Milan, Italy. maria.cappellini@unimi.it
John Porter
Amal El-Beshlawy
Chi-Kong Li
John F Seymour
Mohsen Elalfy
Norbert Gattermann
Stéphane Giraudier
Jong-Wook Lee
Lee Lee Chan
Kai-Hsin Lin
Christian Rose
Ali Taher
Swee Lay Thein
Vip Viprakasit
Dany Habr
Gabor Domokos
Bernard Roubert
Antonis Kattamis
EPIC Study Investigators
Novartis (Switzerland) · CHAmerican University of Beirut · LBCairo University · EGCatholic University of Korea · KRChinese University of Hong Kong · CNFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITGroupe Francophone des Myélodysplasies · FRHeinrich Heine University Düsseldorf · DEMahidol University · THNational and Kapodistrian University of Athens · GRNational Taiwan University · TWNovartis (France) · FRPeter MacCallum Cancer Centre · AUUCL Australia · AUUniversity of Malaya · MY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledBackground Following a clinical evaluation of deferasirox (Exjade) it was concluded that, in addition to baseline body iron burden, ongoing transfusional iron intake should be considered when selecting doses. The 1-year EPIC study, the largest ever investigation conducted for an iron chelator, is the first to evaluate whether fixed starting doses of deferasirox, based on transfusional iron intake, with dose titration guided by serum ferritin trends and safety markers, provides clinically acceptable chelation in patients (aged >or=2 years) with transfusional hemosiderosis from various types of anemia. DESIGN AND

methodsThe recommended initial dose was 20 mg/kg/day for patients receiving 2-4 packed red blood cell units/month and 10 or 30 mg/kg/day was recommended for patients receiving less or more frequent transfusions, respectively. Dose adjustments were based on 3-month serum ferritin trends and continuous assessment of safety markers. The primary efficacy end-point was change in serum ferritin after 52 weeks compared with baseline.

resultsThe 1744 patients enrolled had the following conditions; thalassemia (n=1115), myelodysplastic syndromes (n=341), aplastic anemia (n=116), sickle cell disease (n=80), rare anemias (n=43) and other transfused anemias (n=49). Overall, there was a significant reduction in serum ferritin from baseline (-264 ng/mL; P<0.0001), reflecting dosage adjustments and ongoing iron intake. The most common (>5%) adverse events were gastrointestinal disturbances (28%) and skin rash (10%). Conclusions Analysis of this large, prospectively collected data set confirms the response to chelation therapy across various anemias, supporting initial deferasirox doses based on transfusional iron intake, with subsequent dose titration guided by trends in serum ferritin and safety markers (clinicaltrials.gov identifier: NCT00171821).

Indexed as

Blood TransfusionAdolescentAdultAgedAged, 80 and overAnemiaBenzoatesChildChild, PreschoolDeferasiroxFemaleFerritinsHumansIron Chelating AgentsIron, DietaryIron OverloadBenzoatesDeferasiroxFerritinsIron Chelating AgentsIron, DietaryTriazoles

Identifiers

PMID19951979
PMCPMC2857545
OpenAlexW2100714797

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.