Vascular Safety of Ranibizumab in Patients With Diabetic Macular Edema: A Pooled Analysis of Patient-Level Data From Randomized Clinical Trials.

ABSTRACT:

Importance

Patients with diabetic macular edema (DME) are at high risk of vascular complications, including stroke and myocardial infarction (MI). Concerns have been raised that intravitreal dosing of vascular endothelial growth factor inhibitors in DME could be associated with an increase in cardiovascular and cerebrovascular adverse events.

Objective

To evaluate the cardiovascular and cerebrovascular safety of ranibizumab, 0.5 mg and 0.3 mg, compared with sham with and without laser in DME.

Data sources

Patient-level data from 6 randomized, double-masked, sham- and laser-controlled clinical trials.

Study selection

Company-sponsored (Genentech or Novartis) studies in DME completed as of December 31, 2013.

Data extraction and synthesis

Pairwise compariso

SUBMITTER: Zarbin MA 

PROVIDER: S-EPMC5847109 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature