Evidence map›Paper›PMID 32557181›Full record

Observational studyDrug safety2020

Association Between Intravitreal Aflibercept and Serious Non-ocular Haemorrhage Compared with Intravitreal Ranibizumab: A Multicentre Observational Cohort Study.

Janet Sultana, Francesco Giorgianni, Giulia Scondotto, Valentina Ientile, Pasquale Cananzi, Olivia Leoni, Sebastiano Walter Pollina Addario, Giovanbattista De Sarro, Adele De Francesco, Maria Rosa Puzo and 2 more

Abstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 37% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. 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

12 authors at 6 institutions in 2 countries.

Janet SultanaDepartment of Biomedical and Dental Sciences and of Morphological and Functional Images, University of Messina, Messina, Italy. jsultana@unime.it.
Francesco GiorgianniU.O.S.D. Farmacologia Clinica, A.O.U. Policlinico "G. Martino", Messina, Italy.
Giulia ScondottoU.O.S.D. Farmacologia Clinica, A.O.U. Policlinico "G. Martino", Messina, Italy.
Valentina IentileU.O.S.D. Farmacologia Clinica, A.O.U. Policlinico "G. Martino", Messina, Italy.
Pasquale CananziRegional Pharmacovigilance Centre, Palermo, Italy.
Olivia LeoniRegional Pharmacovigilance Centre, Lombardy, Italy.
Sebastiano Walter Pollina AddarioDepartment of Public Health and Epidemiology, Sicilian Regional Healthcare Centre, Palermo, Italy.
Giovanbattista De SarroDepartment of Healthcare Science, Catanzaro University, Catanzaro, Italy.
Adele De FrancescoMater Domini Hospital, Catanzaro, Italy.
Maria Rosa PuzoRegional Pharmacovigilance Centre, Potenza, Italy.
Christel RenouxCentre for Clinical Epidemiology, Jewish General Hospital-Lady Davis Institute, Montreal, Canada.
Gianluca TrifiròDepartment of Biomedical and Dental Sciences and of Morphological and Functional Images, University of Messina, Messina, Italy.
Azienda Ospedaliera Universitaria Policlinico "G. Martino" · ITJewish General Hospital · CAAzienda Ospedaliero Universitario Mater Domini · ITMagna Graecia University · ITRegione Siciliana · ITUniversity of Messina · IT

Funding

Agenzia Italiana del Farmaco, Ministero della Salute CUP-H56D16000070005
6 · The paper itself

Abstract

introductionIntravitreal anti-vascular endothelial growth factor (VEGF) drugs aflibercept and ranibizumab are used in neovascular retinal diseases but may be associated with non-ocular haemorrhage.

aimsOur objective was to compare the risk of non-ocular haemorrhage with intravitreal aflibercept versus intravitreal ranibizumab and with individual intravitreal anti-VEGFs versus intravitreal dexamethasone.

methodsA retrospective cohort study was conducted using four Italian claims databases, covering 18 million inhabitants from 2011 to 2016. Incident aflibercept users were matched 1:4 to incident ranibizumab users. The outcome was incident non-ocular haemorrhage requiring hospitalisation. Incidence per 1000 person-years (PYs) was estimated. Patients were followed for 180 days using an intention-to-treat (ITT) approach. An as-treated (AT) approach was also employed, using grace periods of 60 or 90 days. Analyses were repeated for aflibercept versus dexamethasone and ranibizumab versus dexamethasone. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Cox proportional hazards models.

resultsWe identified incident users of intravitreal ranibizumab (n = 21,766), aflibercept (n = 3150) and dexamethasone (n = 3900). The incidence of haemorrhage was four events per 1000 PYs for each drug. Aflibercept was not associated with increased risk versus ranibizumab at 180 days (HR 0.97 [95% CI 0.37-2.56]). Results were consistent in the AT analysis (HR 1.19 [95% CI 0.52-2.75]). No increased risk was found for aflibercept and ranibizumab at 180 days versus dexamethasone (HR 0.70 [95% CI 0.30-2.60] and HR 0.67 [95% CI 0.33-1.38], respectively).

conclusionNo association was identified between intravitreal aflibercept and non-ocular haemorrhage versus ranibizumab. A comparable risk for these intravitreal anti-VEGFs and intravitreal dexamethasone was observed.

Indexed as

Angiogenesis InhibitorsCohort StudiesDatabases, FactualDrug-Related Side Effects and Adverse ReactionsFemaleHemorrhageHumansIntravitreal InjectionsItalyMaleMiddle AgedProportional Hazards ModelsRanibizumabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsRetinal DiseasesafliberceptAngiogenesis InhibitorsRanibizumabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion Proteins

Identifiers

PMID32557181
OpenAlexW3036284444

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.