Comparative safety profiles of intravitreal bevacizumab, ranibizumab and pegaptanib: the analysis of the WHO database of adverse drug reactions
| Autor: | Nicola Montanaro, Anna Covezzoli, Domenico Motola, Mauro Melis, Elena Buccellato, Monia Donati, Valentino Conti, Chiara Biagi, Mauro Venegoni, Rosario Amato, L Pazzi, Alberto Vaccheri |
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| Přispěvatelé: | C. Biagi, V. Conti, N. Montanaro, M. Meli, E. Buccellato, M. Donati, A. Covezzoli, R. Amato, L. Pazzi, M. Venegoni, A. Vaccheri, D. Motola |
| Rok vydání: | 2014 |
| Předmět: |
Male
genetic structures Bevacizumab MedDRA Pegaptanib BEVACIZUMAB Angiogenesis Inhibitors Antibodies Monoclonal Humanized World Health Organization computer.software_genre Macular Degeneration Endophthalmitis Ranibizumab medicine Adverse Drug Reaction Reporting Systems Humans Pharmacology (medical) SAFETY PROFILE Pharmacology Database business.industry General Medicine Aptamers Nucleotide Macular degeneration medicine.disease Confidence interval Clinical trial Intravitreal Injections Female SPONTANEOUS REPORTING DATABASE Intravitreal use business computer medicine.drug |
| Zdroj: | European Journal of Clinical Pharmacology. 70:1505-1512 |
| ISSN: | 1432-1041 0031-6970 |
| DOI: | 10.1007/s00228-014-1755-1 |
| Popis: | Purpose The purpose of this study is to conduct a comparative analysis of the suspected adverse drug reactions (ADRs) associated with intravitreal bevacizumab, ranibizumab and pegaptanib in the WHO database in order to have a real-life information on these drugs, which now is only based on data coming from clinical trials. Methods ADR reports for intravitreal use of bevacizumab, ranibizumab and pegaptanib from January 2002 to December 2012 were selected from the WHO-VigiBase. Reporting odds ratio (ROR) with confidence interval of 95 % and p value was calculated. The analysis was performed for drug-reaction pairs. The Medical Dictionary for Regulatory Activities (MedDRA) terminology for ADRs was used. Results The analysis was performed on 3180 reports corresponding to 7753 drug-reaction pairs. Significant RORs for endophthalmitis and uveitis (1.90, 95 % confidence interval (CI) 1.48–2.43, and 10.62, 6.62–17.05, respectively) were retrieved for bevacizumab, and cerebrovascular accident and myocardial infarction produced significant ROR (1.54, 1.14– 2.10 and 1.73, 1.18–2.53, respectively) for ranibizumab. Pegaptanib was significantly associated with visual impairment (1.98, 1.12–3.5, p=0.02), nausea (3.29, 1.57– 6.86, p |
| Databáze: | OpenAIRE |
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