• Systemic Safety Profile of Anti-VEGF Therapy for DME

    By Lynda Seminara
    Selected By: Stephen D. McLeod, MD

    Journal Highlights

    Ophthalmology, July 2019

    Download PDF

    Although intravitreal anti-VEGF ther­apy is the standard of care for diabetic macular edema (DME), the systemic safety of this treatment has not been established. Maloney et al. used a large claims database to ascertain the risk of serious systemic events among patients with DME who received intravitreal injections of anti-VEGF drugs. Their analysis showed that, compared with patients treated by corticosteroids or macular laser, those who received intra­vitreal injections did not have a higher risk of cerebrovascular disease, myocar­dial infarction, or major bleeding.

    For this retrospective cohort study, the researchers included adults treated with intravitreal anti-VEGF therapy from 2006 to 2015. Patients were identified from a large U.S. insurance database. Eligible participants had private insurance or were members of a Medicare Advantage plan; all had medical coverage for at least one year before starting DME treatment. Using the same database, the authors also identified patients who were treated with macular laser or intravitreal corticosteroids; these patients served as controls.

    Main outcome measures were associations between the treatments and predefined systemic outcomes, using Cox proportional hazards re­gression, and they included the risk of cerebrovascular disease, myocardial in­farction (MI), major bleeding, and all-cause hospitalization occurring within six months of initial DME treatment.

    For the comparison between anti-VEGF and macular laser therapy, inverse propensity score weighting was used to account for treatment selection bias. Because relatively few patients received corticosteroids, the compari­son with anti-VEGF treatment required 2:1 propensity score matching for demographics, study year, and baseline comorbidities. Results were expressed as hazard ratios (HRs) and 95% confi­dence intervals (CIs).

    Altogether, 23,348 patients met the inclusion criteria. Of these, 13,365 were initially treated with macular laser, 9,219 with anti-VEGF therapy, and 764 with intravitreal corticosteroids. The analysis showed no link between anti-VEGF therapy and elevated risk of cerebrovascular disease (HR, 0.96; CI, 0.65-1.41; p = .83), major bleeding (HR, 1.23; CI, 0.76-1.99; p = .41), or MI (HR, 1.03; CI, 0.73-1.44; p = .88), as compared to macular laser treatment. Rates of primary systemic serious event were similar for anti-VEGF and corticosteroid treatment (all p > .05). The risk of all-cause hospital admission after treatment was higher with anti-VEGF therapy than with macular laser (HR, 1.17; CI, 1.05-1.30; p = .01). This find­ing may warrant further study.

    The original article can be found here.