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- Title
Cardiovascular Adverse Events With Intravitreal Anti-Vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Clinical Trials.
- Authors
Ngo Ntjam, Nadège; Thulliez, Marie; Paintaud, Gilles; Salvo, Francesco; Angoulvant, Denis; Pisella, Pierre-Jean; Bejan-Angoulvant, Theodora
- Abstract
<bold>Importance: </bold>Systemic safety of intravitreal anti-vascular endothelial growth factor (anti-VEGF) is a matter of debate and regular updates are necessary.<bold>Objective: </bold>To evaluate systemic adverse events (SAEs) associated with intravitreal anti-VEGF drugs compared with non-anti-VEGF treatments in patients with ocular diseases.<bold>Data Sources: </bold>Electronic searches were conducted in MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases from inception to July 7, 2020.<bold>Study Selection: </bold>Randomized clinical trials conducted in adults with retinal diseases who received intravitreal anti-VEGF drugs.<bold>Data Extraction and Synthesis: </bold>Studies and treatment characteristics and outcome data were extracted and analyzed, and study quality was evaluated.<bold>Main Outcomes and Measures: </bold>Main outcomes were major cardiovascular events (MACEs) and total mortality. Secondary outcomes included nonocular hemorrhage, components of MACEs, other cardiovascular outcomes, serious SAEs, and all SAEs.<bold>Results: </bold>A total of 74 randomized clinical trials were analyzed: 32 trials (43%) included 14 190 patients with age-related macular degeneration (AMD), 24 (32%) included 5424 patients with diabetic retinopathy (diabetic macular edema or proliferative diabetic retinopathy), 17 trials (23%) included 3757 patients with retinal vein occlusion, and 1 trial (1%) included 122 patients with myopic choroidal neovascularization. Anti-VEGF drug administration did not increase MACEs compared with control agents (odds ratio [OR], 1.16; 95% CI, 0.85-1.58) or total mortality (OR, 1.27; 95% CI, 0.82-1.96). There was an interaction (subgroup difference, P = .04) in mortality risk depending on the underlying disease with an increase (OR, 1.80; 95% CI, 1.03-3.16; P = .04) in the risk of death in patients with diabetic retinopathy; however, no increase was observed in patients with AMD or retinal vein occlusion. Administration of anti-VEGF drugs increased the risk of nonocular hemorrhage (OR, 1.46; 95% CI, 1.01-2.10), mainly in patients with AMD.<bold>Conclusions and Relevance: </bold>Intravitreal anti-VEGF was not associated with an increase in MACEs in the trials examined herein. Increased mortality in patients with diabetes and nonocular hemorrhages, especially in those with AMD, could represent a safety signal, but the evidence was not strong. However, continued surveillance of SAEs remains warranted.
- Publication
JAMA Ophthalmology, 2021, Vol 139, Issue 6, p610
- ISSN
2168-6165
- Publication type
journal article
- DOI
10.1001/jamaophthalmol.2021.0640