Association Between Intravitreal Aflibercept and Serious Non-ocular Haemorrhage Compared with Intravitreal Ranibizumab:
- PDF / 721,707 Bytes
- 10 Pages / 595.276 x 790.866 pts Page_size
- 114 Downloads / 205 Views
ORIGINAL RESEARCH ARTICLE
Association Between Intravitreal Aflibercept and Serious Non‑ocular Haemorrhage Compared with Intravitreal Ranibizumab: A Multicentre Observational Cohort Study Janet Sultana1 · Francesco Giorgianni2,3 · Giulia Scondotto2 · Valentina Ientile2 · Pasquale Cananzi4 · Olivia Leoni5 · Sebastiano Walter Pollina Addario6 · Giovanbattista De Sarro7 · Adele De Francesco8 · Maria Rosa Puzo9 · Christel Renoux3,10,11 · Gianluca Trifirò1,2
© Springer Nature Switzerland AG 2020
Abstract Introduction Intravitreal anti-vascular endothelial growth factor (VEGF) drugs aflibercept and ranibizumab are used in neovascular retinal diseases but may be associated with non-ocular haemorrhage. Aims Our objective was to compare the risk of non-ocular haemorrhage with intravitreal aflibercept versus intravitreal ranibizumab and with individual intravitreal anti-VEGFs versus intravitreal dexamethasone. Methods A retrospective cohort study was conducted using four Italian claims databases, covering 18 million inhabitants from 2011 to 2016. Incident aflibercept users were matched 1:4 to incident ranibizumab users. The outcome was incident non-ocular haemorrhage requiring hospitalisation. Incidence per 1000 person-years (PYs) was estimated. Patients were followed for 180 days using an intention-to-treat (ITT) approach. An as-treated (AT) approach was also employed, using grace periods of 60 or 90 days. Analyses were repeated for aflibercept versus dexamethasone and ranibizumab versus dexamethasone. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Cox proportional hazards models. Results We identified incident users of intravitreal ranibizumab (n = 21,766), aflibercept (n = 3150) and dexamethasone (n = 3900). The incidence of haemorrhage was four events per 1000 PYs for each drug. Aflibercept was not associated with increased risk versus ranibizumab at 180 days (HR 0.97 [95% CI 0.37–2.56]). Results were consistent in the AT analysis (HR 1.19 [95% CI 0.52–2.75]). No increased risk was found for aflibercept and ranibizumab at 180 days versus dexamethasone (HR 0.70 [95% CI 0.30–2.60] and HR 0.67 [95% CI 0.33–1.38], respectively). Conclusion No association was identified between intravitreal aflibercept and non-ocular haemorrhage versus ranibizumab. A comparable risk for these intravitreal anti-VEGFs and intravitreal dexamethasone was observed.
1 Introduction Neovascular retinal diseases such as age-related macular degeneration (AMD) and diabetes mellitus-associated macular oedema (DME) are the two main causes of vision impairment worldwide [1–4]. Although these diseases differ in their pathological process, both diseases involve the upregulation of the vascular endothelial growth factor Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40264-020-00956-x) contains supplementary material, which is available to authorized users. * Janet Sultana [email protected] Extended author information available on the last page of the article
(VEGF), a c
Data Loading...
