Comparative safety profiles of intravitreal bevacizumab, ranibizumab and pegaptanib: the analysis of the WHO database of adverse drug reactions

التفاصيل البيبلوغرافية
العنوان: Comparative safety profiles of intravitreal bevacizumab, ranibizumab and pegaptanib: the analysis of the WHO database of adverse drug reactions
المؤلفون: Nicola Montanaro, Anna Covezzoli, Domenico Motola, Mauro Melis, Elena Buccellato, Monia Donati, Valentino Conti, Chiara Biagi, Mauro Venegoni, Rosario Amato, L Pazzi, Alberto Vaccheri
المساهمون: C. Biagi, V. Conti, N. Montanaro, M. Meli, E. Buccellato, M. Donati, A. Covezzoli, R. Amato, L. Pazzi, M. Venegoni, A. Vaccheri, D. Motola
المصدر: European Journal of Clinical Pharmacology. 70:1505-1512
بيانات النشر: Springer Science and Business Media LLC, 2014.
سنة النشر: 2014
مصطلحات موضوعية: 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
الوصف: 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
وصف الملف: STAMPA
تدمد: 1432-1041
0031-6970
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::07380bde29ce7150e951384f8597d977
https://doi.org/10.1007/s00228-014-1755-1
حقوق: CLOSED
رقم الأكسشن: edsair.doi.dedup.....07380bde29ce7150e951384f8597d977
قاعدة البيانات: OpenAIRE