Introduction: The intravitreal use of vascular endothelial growth factor (VEGF) antagonists, bevacizumab and ranibizumab, proved effectiveness in the treatment of age-related macular degeneration [1]. Intravitreal ranibizumab is approved for the treatment AMD while intravitreal bevacizumab is used off-label to treat this disease. Several studies have been published to evaluate both efficacy and safety of these two drugs. Aim: To compare the safety profile of intravitreal injections of bevacizumab and ranibizumab in the spontaneous reporting database in Italy. Methods: All the cases associated with bevacizumab or ranibizumab, used for intravitreal route, reported up to 28 February 2013 in the Italian database (RNF) were taken into account for this analysis. Adverse reaction were coded in RNF using the MedDRA terminology. Results: Up to 28 February 2013, 49 and 34 reports of ADRs associated to the intravitreal use of bevacizumab and ranibizumab were identified in the RNF respectively. In the database 1,123 further reports are present associated to bevacizumab used for other indications. Fifty-five per cent of the reports for bevacizumab and 65 % for ranibizumab were classified as serious. The distribution of adverse reactions according to the System Organ Classes shows an higher incidence of Eye disorder (38.2 % vs 26.5 %), Cardiovascular disorders (14.7 % vs 6.1 %) and Nervous system disorders (23.5 % vs 14.3 %) for ranibizumab compared to bevacizumab whereas an higher incidence of General conditions disorders (26.5 % vs 2.9 %) were reported for bevacizumab compared to ranibizumab. Considering the cardiovascular reactions, three reports of myocardial infarction are present for bevacizumab in RNF, while 1 report of coronary atherosclerosis, 1 fibrillation, 1 heart failure and 2 myocardial infarction for ranibizumab. Six cases of ocular haemorrhage and 4 cases of endophthalmitis for bevacizumab compared to 4 and 8 cases for ranibizumab respectively are identified in RNF. Conclusions: Data from literature, clinical trials, meta-analysis and observational studies with an overall high number of patients did not shown an higher toxicity linked to the intravitreal administration of bevacizumab

Safety Profile of Bevacizumab and Ranibizumab in the Intravitreal Use: Data from Spontaneous

Viola, Ermelinda;Coggiola Pittoni, Anna;LORA, Riccardo;LEONE, Roberto
2013-01-01

Abstract

Introduction: The intravitreal use of vascular endothelial growth factor (VEGF) antagonists, bevacizumab and ranibizumab, proved effectiveness in the treatment of age-related macular degeneration [1]. Intravitreal ranibizumab is approved for the treatment AMD while intravitreal bevacizumab is used off-label to treat this disease. Several studies have been published to evaluate both efficacy and safety of these two drugs. Aim: To compare the safety profile of intravitreal injections of bevacizumab and ranibizumab in the spontaneous reporting database in Italy. Methods: All the cases associated with bevacizumab or ranibizumab, used for intravitreal route, reported up to 28 February 2013 in the Italian database (RNF) were taken into account for this analysis. Adverse reaction were coded in RNF using the MedDRA terminology. Results: Up to 28 February 2013, 49 and 34 reports of ADRs associated to the intravitreal use of bevacizumab and ranibizumab were identified in the RNF respectively. In the database 1,123 further reports are present associated to bevacizumab used for other indications. Fifty-five per cent of the reports for bevacizumab and 65 % for ranibizumab were classified as serious. The distribution of adverse reactions according to the System Organ Classes shows an higher incidence of Eye disorder (38.2 % vs 26.5 %), Cardiovascular disorders (14.7 % vs 6.1 %) and Nervous system disorders (23.5 % vs 14.3 %) for ranibizumab compared to bevacizumab whereas an higher incidence of General conditions disorders (26.5 % vs 2.9 %) were reported for bevacizumab compared to ranibizumab. Considering the cardiovascular reactions, three reports of myocardial infarction are present for bevacizumab in RNF, while 1 report of coronary atherosclerosis, 1 fibrillation, 1 heart failure and 2 myocardial infarction for ranibizumab. Six cases of ocular haemorrhage and 4 cases of endophthalmitis for bevacizumab compared to 4 and 8 cases for ranibizumab respectively are identified in RNF. Conclusions: Data from literature, clinical trials, meta-analysis and observational studies with an overall high number of patients did not shown an higher toxicity linked to the intravitreal administration of bevacizumab
bevacizumab; pharmacovigilance database; drug safety
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11562/875212
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