Evidence map›Paper›PMID 28585152›Full record

ReviewDrug safety2017

Overview of the Safety of Anti-VEGF Drugs: Analysis of the Italian Spontaneous Reporting System.

Paola Maria Cutroneo, Claudia Giardina, Valentina Ientile, Simona Potenza, Laura Sottosanti, Carmen Ferrajolo, Costantino J Trombetta, Gianluca Trifirò

Abstract readReview
PubMed Publisher
In one paragraph

Review in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
2.3field-weighted citation impact, top 12% 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

20 citing papers in PubMed, 26 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Anti-VEGF and Other Novel Therapies for Neovascular Age-Related Macular Degeneration: An Update.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021
    Review
  14. Article
  15. Observational
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article
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 4 institutions in 1 country.

Paola Maria CutroneoSicilian Regional Pharmacovigilance Center, Messina, Italy. pmcutroneo@unime.it.
Claudia GiardinaClinical Pharmacology Unit, University Hospital G. Martino, Messina, Italy.
Valentina IentileClinical Pharmacology Unit, University Hospital G. Martino, Messina, Italy.
Simona PotenzaPharmacovigilance Office, Italian Medicines Agency, Rome, Italy.
Laura SottosantiPharmacovigilance Office, Italian Medicines Agency, Rome, Italy.
Carmen FerrajoloDepartment of Experimental Medicine, Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, University of Campania, Naples, Italy.
Costantino J TrombettaDepartment of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy.
Gianluca TrifiròClinical Pharmacology Unit, University Hospital G. Martino, Messina, Italy.
Azienda Ospedaliera Universitaria Policlinico "G. Martino" · ITItalian Medicines Agency · ITUniversity of Messina · ITRegione Siciliana · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAnti-vascular endothelial growth factor (anti-VEGF) drugs are widely used for the treatment of several cancers and retinal diseases. The systemic use of anti-VEGF drugs has been associated with an increased risk of serious adverse reactions. Whether this risk is also related to intravitreal administration of anti-VEGF drugs is unclear.

objectiveThe aim of this study was to provide an overview of the safety of anti-VEGF drugs in oncology and ophthalmology settings using the Italian Spontaneous Reporting System (SRS).

methodsWe selected all suspected adverse drug reaction (ADR) reports attributed to anti-VEGF drugs and conducted descriptive frequency analyses stratified by indication of use. As a measure of disproportionality, we calculated the proportional reporting ratio with 95% confidence intervals at the level of standardized Medical Dictionary for Regulatory Activities (MedDRA

resultsOf a total of 2472 anti-VEGF drug-related reports, 2173 (87.9%) and 299 (12.1%) were attributed to systemic and intravitreal use of these drugs, respectively. The frequency of serious ADRs reported was higher for intravitreal administration of anti-VEGF drugs than for systemic use in patients with cancer (58.9 vs. 34.1%) (p < 0.001) and were disproportionally associated with ischemic heart disease and thromboembolic and cerebrovascular events. Most serious ADRs related to anti-VEGF drugs in patients with cancer are known and clinically relevant (e.g., gastrointestinal and vascular disorders).

conclusionsThis study documented that serious ADRs and systemic toxicity may occur not only with systemic use of anti-VEGF drugs in patients with cancer but also with intravitreal administration. Close monitoring of cardio/cerebrovascular adverse events should be considered during treatment with all anti-VEGF drugs.

Indexed as

Adverse Drug Reaction Reporting SystemsAngiogenesis InhibitorsDatabases, FactualDrug-Related Side Effects and Adverse ReactionsHumansItalyVascular Endothelial Growth Factor AAngiogenesis InhibitorsVascular Endothelial Growth Factor A

Identifiers

PMID28585152
OpenAlexW2622551543

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.