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

Autor: Claudia Giardina, Laura Sottosanti, Simona Potenza, Valentina Ientile, Carmen Ferrajolo, Costantino John Trombetta, Gianluca Trifirò, Paola Maria Cutroneo
Přispěvatelé: Cutroneo, Paola Maria, Giardina, Claudia, Ientile, Valentina, Potenza, Simona, Sottosanti, Laura, Ferrajolo, Carmen, Trombetta, Costantino J., Trifirã², Gianluca
Rok vydání: 2017
Předmět:
Risk
Vascular Endothelial Growth Factor A
medicine.medical_specialty
Databases
Factual
Drug-Related Side Effects and Adverse Reactions
MedDRA
Events
MEDLINE
Angiogenesis Inhibitors
Disease
Pharmacology
Toxicology
03 medical and health sciences
Macular Degeneration
Myocardial-Infarction
0302 clinical medicine
Endothelial Growth-Factor
Angiogenesis Inhibitor Bevacizumab
Macular Degeneration
Myocardial-Infarction
Cancer-Patients
Antiangiogenic Therapy
Risk
Metaanalysis
Ranibizumab
Events
Internal medicine
Ranibizumab
medicine
Adverse Drug Reaction Reporting Systems
Humans
Pharmacology (medical)
Endothelial Growth-Factor
030212 general & internal medicine
Adverse effect
business.industry
Cancer
Intravitreal administration
Metaanalysis
medicine.disease
Confidence interval
Antiangiogenic Therapy
Cancer-Patients
Italy
030221 ophthalmology & optometry
business
Adverse drug reaction
Angiogenesis Inhibitor Bevacizumab
Zdroj: Drug safety. 40(11)
ISSN: 1179-1942
Popis: Introduction: Anti-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. Objective: The 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). Methods: We 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®) queries (SMQs). Results: Of 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). Conclusions: This 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.
Databáze: OpenAIRE
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