| アブストラクト | 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. |
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| 投稿者 | Sultana, Janet; Giorgianni, Francesco; Scondotto, Giulia; Ientile, Valentina; Cananzi, Pasquale; Leoni, Olivia; Addario, Sebastiano Walter Pollina; De Sarro, Giovanbattista; De Francesco, Adele; Puzo, Maria Rosa; Renoux, Christel; Trifiro, Gianluca |
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| 組織名 | Department of Biomedical and Dental Sciences and of Morphological and Functional;Images, University of Messina, Messina, Italy. jsultana@unime.it.;U.O.S.D. Farmacologia Clinica, A.O.U. Policlinico "G. Martino", Messina, Italy.;Centre for Clinical Epidemiology, Jewish General Hospital-Lady Davis Institute,;Montreal, Canada.;Regional Pharmacovigilance Centre, Palermo, Italy.;Regional Pharmacovigilance Centre, Lombardy, Italy.;Department of Public Health and Epidemiology, Sicilian Regional Healthcare;Centre, Palermo, Italy.;Department of Healthcare Science, Catanzaro University, Catanzaro, Italy.;Mater Domini Hospital, Catanzaro, Italy.;Regional Pharmacovigilance Centre, Potenza, Italy.;Department of Epidemiology and Biostatistics, McGill University, Montreal,;Canada.;Department of Neurology and Neurosurgery, McGill University, Montreal, Canada.;Images, University of Messina, Messina, Italy. |
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