Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination

Homero Contreras-Salinas,1 Mariana Barajas-Hernández,1 Leopoldo Martín Baiza-Durán,1 Alan Omar Vázquez-Álvarez,2 Manuel Alejandro Bautista-Castro,1 Lourdes Yolotzin Rodríguez-Herrera1 1Pharmacovigilance Department, Laboratorios Sophia...

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Autores principales:	Contreras-Salinas H, Barajas-Hernández M, Baiza-Durán LM, Vázquez-Álvarez AO, Bautista-Castro MA, Rodríguez-Herrera LY
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	adverse drug reactions active pharmacovigilance surveillance glaucoma timolol/brimonidine/dorzolamide. Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/0461246abb8d42d18a83b40487dc3999
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spelling	oai:doaj.org-article:0461246abb8d42d18a83b40487dc39992021-12-02T10:52:03ZActive Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination1177-5483https://doaj.org/article/0461246abb8d42d18a83b40487dc39992021-02-01T00:00:00Zhttps://www.dovepress.com/active-pharmacovigilance-in-peruvian-population-surveillance-of-a-timo-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Homero Contreras-Salinas,1 Mariana Barajas-Hernández,1 Leopoldo Martín Baiza-Durán,1 Alan Omar Vázquez-Álvarez,2 Manuel Alejandro Bautista-Castro,1 Lourdes Yolotzin Rodríguez-Herrera1 1Pharmacovigilance Department, Laboratorios Sophia, S.A. de C.V, Zapopan, Jalisco, México; 2School of Medicine and Health Science, Tecnológico de Monterrey, Guadalajara, Jalisco, MéxicoCorrespondence: Lourdes Yolotzin Rodríguez-Herrera Tel +52 3001 4200 ext 1188Email lourdes.rodriguez@sophia.com.mxPurpose: In this study active pharmacovigilance was used in an uncontrolled population to enrich the safety profile and canvass the Adverse Drug Reactions (ADRs) associated with the use of a fixed combination of 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide (TBD).Methods: Active pharmacovigilance consisting of 3 follow-up calls within 60 days was used to monitor the product’s safety and identify new risks by searching for unexpected ADRs and increased incidence, tolerability, drug interactions and special population-related ADRs.Results: Ninety-four ADRs were reported by a total of 246 patients (0.38 ADRs/patient); all of them were classified as “mild”. We found an increased risk of ADRs with a Relative Risk (RR) for simultaneous use of TBD + ophthalmic ciprofloxacin and TBD + oral atorvastatin; 2.0309 (95% CI, 1.2467– 3.3083) and 1.8864 (95% CI, 1.0543– 3.3754), respectively. Two unexpected ADRs were discovered, both of which presented belonged to the System Organ Class (SOC) of “infections and infestations” and the preferred term (PT) of “nasopharyngitis.”.Conclusion: Three safety signals were identified, two of them corresponded to an increase in the incidence of ADRs and the last one is associated with 2 unexpected ADR. Nevertheless, we found a good tolerability profile for TBD in the study population.Keywords: adverse drug reactions, active pharmacovigilance, surveillance, glaucoma, timolol/brimonidine/dorzolamideContreras-Salinas HBarajas-Hernández MBaiza-Durán LMVázquez-Álvarez AOBautista-Castro MARodríguez-Herrera LYDove Medical Pressarticleadverse drug reactionsactive pharmacovigilancesurveillanceglaucomatimolol/brimonidine/dorzolamide.OphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 583-590 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	adverse drug reactions active pharmacovigilance surveillance glaucoma timolol/brimonidine/dorzolamide. Ophthalmology RE1-994
spellingShingle	adverse drug reactions active pharmacovigilance surveillance glaucoma timolol/brimonidine/dorzolamide. Ophthalmology RE1-994 Contreras-Salinas H Barajas-Hernández M Baiza-Durán LM Vázquez-Álvarez AO Bautista-Castro MA Rodríguez-Herrera LY Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination
description	Homero Contreras-Salinas,1 Mariana Barajas-Hernández,1 Leopoldo Martín Baiza-Durán,1 Alan Omar Vázquez-Álvarez,2 Manuel Alejandro Bautista-Castro,1 Lourdes Yolotzin Rodríguez-Herrera1 1Pharmacovigilance Department, Laboratorios Sophia, S.A. de C.V, Zapopan, Jalisco, México; 2School of Medicine and Health Science, Tecnológico de Monterrey, Guadalajara, Jalisco, MéxicoCorrespondence: Lourdes Yolotzin Rodríguez-Herrera Tel +52 3001 4200 ext 1188Email lourdes.rodriguez@sophia.com.mxPurpose: In this study active pharmacovigilance was used in an uncontrolled population to enrich the safety profile and canvass the Adverse Drug Reactions (ADRs) associated with the use of a fixed combination of 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide (TBD).Methods: Active pharmacovigilance consisting of 3 follow-up calls within 60 days was used to monitor the product’s safety and identify new risks by searching for unexpected ADRs and increased incidence, tolerability, drug interactions and special population-related ADRs.Results: Ninety-four ADRs were reported by a total of 246 patients (0.38 ADRs/patient); all of them were classified as “mild”. We found an increased risk of ADRs with a Relative Risk (RR) for simultaneous use of TBD + ophthalmic ciprofloxacin and TBD + oral atorvastatin; 2.0309 (95% CI, 1.2467– 3.3083) and 1.8864 (95% CI, 1.0543– 3.3754), respectively. Two unexpected ADRs were discovered, both of which presented belonged to the System Organ Class (SOC) of “infections and infestations” and the preferred term (PT) of “nasopharyngitis.”.Conclusion: Three safety signals were identified, two of them corresponded to an increase in the incidence of ADRs and the last one is associated with 2 unexpected ADR. Nevertheless, we found a good tolerability profile for TBD in the study population.Keywords: adverse drug reactions, active pharmacovigilance, surveillance, glaucoma, timolol/brimonidine/dorzolamide
format	article
author	Contreras-Salinas H Barajas-Hernández M Baiza-Durán LM Vázquez-Álvarez AO Bautista-Castro MA Rodríguez-Herrera LY
author_facet	Contreras-Salinas H Barajas-Hernández M Baiza-Durán LM Vázquez-Álvarez AO Bautista-Castro MA Rodríguez-Herrera LY
author_sort	Contreras-Salinas H
title	Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination
title_short	Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination
title_full	Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination
title_fullStr	Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination
title_full_unstemmed	Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination
title_sort	active pharmacovigilance in peruvian population: surveillance of a timolol/brimonidine/dorzolamide ophthalmic fixed combination
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/0461246abb8d42d18a83b40487dc3999
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Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination

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