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Real-world evidence of safety profile of intravitreal bevacizumab (Avastin) in an Indian scenario

PURPOSE: The purpose of this study was to evaluate the safety profile of intravitreal bevacizumab (Avastin) as an off-label pharmacotherapeutic agent for various ocular conditions. METHODS: Retrospective analysis was carried out on 3806 injections of 1761 patients that were administered with intravi...

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Autores principales: Jain, Prashant, Sheth, Jay, Anantharaman, Giridhar, Gopalakrishnan, Mahesh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5549412/
https://www.ncbi.nlm.nih.gov/pubmed/28724817
http://dx.doi.org/10.4103/ijo.IJO_992_16
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author Jain, Prashant
Sheth, Jay
Anantharaman, Giridhar
Gopalakrishnan, Mahesh
author_facet Jain, Prashant
Sheth, Jay
Anantharaman, Giridhar
Gopalakrishnan, Mahesh
author_sort Jain, Prashant
collection PubMed
description PURPOSE: The purpose of this study was to evaluate the safety profile of intravitreal bevacizumab (Avastin) as an off-label pharmacotherapeutic agent for various ocular conditions. METHODS: Retrospective analysis was carried out on 3806 injections of 1761 patients that were administered with intravitreal bevacizumab injection at a tertiary eye care center in India. The injections were administered on a pro re nata basis for various indications such as age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). RESULTS: The mean age of the patients was 61.8 ± 11.59 years. A total of 59.2% of the patients were men and 40.8% women. The most common indications for which the injection was administered were DME (27.5%), AMD (26%), and branch RVO (12.3%). Among the ocular side effects, endophthalmitis was seen in three eyes (0.08%), retinal breaks in none of the eyes whereas 35 eyes had a rise in intraocular pressure (IOP) >21 mmHg (0.9%). Preexisting glaucoma was present in four eyes while remaining 31 eyes did not have any history of glaucoma. IOP rise was significantly more in eyes with preexisting glaucoma as compared to nonglaucomatous eyes (P = 0.04). No systemic adverse events were noted in our study population. CONCLUSION: Our study provides real-world evidence regarding the safety profile of intravitreal bevacizumab (Avastin). These data suggest that bevacizumab is a safe and economical pharmacotherapeutic agent that can be administered for a variety of ocular disorders. Analyzing the safety of bevacizumab is necessary for a developing country like India as the majority of the population cannot afford the costly ranibizumab as compared to bevacizumab for ocular healthcare.
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spelling pubmed-55494122017-08-21 Real-world evidence of safety profile of intravitreal bevacizumab (Avastin) in an Indian scenario Jain, Prashant Sheth, Jay Anantharaman, Giridhar Gopalakrishnan, Mahesh Indian J Ophthalmol Original Article PURPOSE: The purpose of this study was to evaluate the safety profile of intravitreal bevacizumab (Avastin) as an off-label pharmacotherapeutic agent for various ocular conditions. METHODS: Retrospective analysis was carried out on 3806 injections of 1761 patients that were administered with intravitreal bevacizumab injection at a tertiary eye care center in India. The injections were administered on a pro re nata basis for various indications such as age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). RESULTS: The mean age of the patients was 61.8 ± 11.59 years. A total of 59.2% of the patients were men and 40.8% women. The most common indications for which the injection was administered were DME (27.5%), AMD (26%), and branch RVO (12.3%). Among the ocular side effects, endophthalmitis was seen in three eyes (0.08%), retinal breaks in none of the eyes whereas 35 eyes had a rise in intraocular pressure (IOP) >21 mmHg (0.9%). Preexisting glaucoma was present in four eyes while remaining 31 eyes did not have any history of glaucoma. IOP rise was significantly more in eyes with preexisting glaucoma as compared to nonglaucomatous eyes (P = 0.04). No systemic adverse events were noted in our study population. CONCLUSION: Our study provides real-world evidence regarding the safety profile of intravitreal bevacizumab (Avastin). These data suggest that bevacizumab is a safe and economical pharmacotherapeutic agent that can be administered for a variety of ocular disorders. Analyzing the safety of bevacizumab is necessary for a developing country like India as the majority of the population cannot afford the costly ranibizumab as compared to bevacizumab for ocular healthcare. Medknow Publications & Media Pvt Ltd 2017-07 /pmc/articles/PMC5549412/ /pubmed/28724817 http://dx.doi.org/10.4103/ijo.IJO_992_16 Text en Copyright: © 2017 Indian Journal of Ophthalmology http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
spellingShingle Original Article
Jain, Prashant
Sheth, Jay
Anantharaman, Giridhar
Gopalakrishnan, Mahesh
Real-world evidence of safety profile of intravitreal bevacizumab (Avastin) in an Indian scenario
title Real-world evidence of safety profile of intravitreal bevacizumab (Avastin) in an Indian scenario
title_full Real-world evidence of safety profile of intravitreal bevacizumab (Avastin) in an Indian scenario
title_fullStr Real-world evidence of safety profile of intravitreal bevacizumab (Avastin) in an Indian scenario
title_full_unstemmed Real-world evidence of safety profile of intravitreal bevacizumab (Avastin) in an Indian scenario
title_short Real-world evidence of safety profile of intravitreal bevacizumab (Avastin) in an Indian scenario
title_sort real-world evidence of safety profile of intravitreal bevacizumab (avastin) in an indian scenario
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5549412/
https://www.ncbi.nlm.nih.gov/pubmed/28724817
http://dx.doi.org/10.4103/ijo.IJO_992_16
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