Activity

Activity ID

8228

Expires

June 16, 2024

Format Type

Journal-based

CME Credit

1

Fee

$30

CME Provider: JAMA Ophthalmology

Description of CME Course

Importance  Systemic safety of intravitreal anti-vascular endothelial growth factor (anti-VEGF) is a matter of debate and regular updates are necessary.

Objective  To evaluate systemic adverse events (SAEs) associated with intravitreal anti-VEGF drugs compared with non–anti-VEGF treatments in patients with ocular diseases.

Data Sources  Electronic searches were conducted in MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases from inception to July 7, 2020.

Study Selection  Randomized clinical trials conducted in adults with retinal diseases who received intravitreal anti-VEGF drugs.

Data Extraction and Synthesis  Studies and treatment characteristics and outcome data were extracted and analyzed, and study quality was evaluated.

Main Outcomes and Measures  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.

Results  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.

Conclusions and Relevance  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.

Disclaimers

1. This activity is accredited by the American Medical Association.
2. This activity is free to AMA members.

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NOTE: If a Member Board has not deemed this activity for MOC approval as an accredited CME activity, this activity may count toward an ABMS Member Board’s general CME requirement. Please refer directly to your Member Board’s MOC Part II Lifelong Learning and Self-Assessment Program Requirements.

Educational Objectives

To evaluate systemic adverse events associated with intravitreal antivascular endothelial growth factor (anti-VEGF) drugs compared with nonanti-VEGF treatments in patients with ocular diseases.

Keywords

Adverse Drug Events, Diabetic Retinopathy, Ophthalmology, Retinal Disorders, Clinical Pharmacy and Pharmacology

Competencies

Medical Knowledge

CME Credit Type

AMA PRA Category 1 Credit

DOI

10.1001/jamaophthalmol.2021.0640

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