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Adverse Drug Reactions during COVID-19 Treatment: A Comprehensive Analysis Focused on Hospitalized Patients, with the Use of a Survey in Cuba in 2020
AIMS: To evaluate the prevalence and type of adverse drug reactions (ADRs), together with associated risk factors, among Cuban COVID-19 patients treated with chloroquine (CQ), lopinavir/ritonavir (LPV/r), or interferon α2b (IFN α2b), according to the Cuban protocol. MATERIALS AND METHODS: A prospect...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Hindawi
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9908337/ https://www.ncbi.nlm.nih.gov/pubmed/36776283 http://dx.doi.org/10.1155/2023/1995642 |
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author | Gil-del-Valle, Lizette Gravier-Hernández, Rosario Baldoquin-Rodríguez, Waldemar Sierra-Vázquez, Beatriz Perez-Díaz, Ana Beatriz Sariol-Resik, Pablo Prieto-Dominguez, Tatiana Delgado-Guerra, Mario Manuel Sánchez- Márquez, Joniel Arnoldo López-Fernández, Olga Elena Fonseca-Betancourt, Faustina Valdés-Lanza, Liana Orraca-Castillo, Odalys Van Ostade, Xaveer Vanden Berghe, Wim Vanlerberghe, Veerle Guzmán-Tirado, M. Guadalupe |
author_facet | Gil-del-Valle, Lizette Gravier-Hernández, Rosario Baldoquin-Rodríguez, Waldemar Sierra-Vázquez, Beatriz Perez-Díaz, Ana Beatriz Sariol-Resik, Pablo Prieto-Dominguez, Tatiana Delgado-Guerra, Mario Manuel Sánchez- Márquez, Joniel Arnoldo López-Fernández, Olga Elena Fonseca-Betancourt, Faustina Valdés-Lanza, Liana Orraca-Castillo, Odalys Van Ostade, Xaveer Vanden Berghe, Wim Vanlerberghe, Veerle Guzmán-Tirado, M. Guadalupe |
author_sort | Gil-del-Valle, Lizette |
collection | PubMed |
description | AIMS: To evaluate the prevalence and type of adverse drug reactions (ADRs), together with associated risk factors, among Cuban COVID-19 patients treated with chloroquine (CQ), lopinavir/ritonavir (LPV/r), or interferon α2b (IFN α2b), according to the Cuban protocol. MATERIALS AND METHODS: A prospective descriptive analysis of ADRs was performed on 200 COVID-19 patients who were admitted consecutively to three hospitals in Havana and Pinar del Río from April to July 2020. Information on demographics, ADRs, outcomes, behavioral, and health-related factors was collected using a validated questionnaire and clinical records. Each potential ADR case was assessed for causality based on the WHO-UMC algorithm, concomitant drug influences, and the presence of any drug-drug interactions (DDI). RESULTS: The total frequency of ADRs was 55%, with predominantly gastrointestinal disorders and general symptoms (23% vs 20%). 95.1% of ADRs occurred within 10 days after treatment and 42 potential DDI in 55.5% of patients (61/110) were observed. The prevalence of ADRs was: 44%, 30.4%, and 26.4% for IFN α2b, LPV/r, and CQ, respectively. Sex (odds ratio (OR): 0.40 (95% confidence interval (CI): 0.211–0.742), age (OR: 2.36 (95% CI: 1.02–5.44)), and underlying diseases (OR: 0.12 (95% CI: 0.06–0.23)) were independently associated factors for ADRs (P < 0.05). CONCLUSIONS: The frequency of ADRs and potential DDI was high compared to their use during nonpandemic times (e.g., for malaria, HIV, or inflammatory diseases). The safety profile of these drugs when used for COVID-19 treatment showed similar characteristics. Comorbidities, age >37 years old, and female sex were associated with ADRs. |
format | Online Article Text |
id | pubmed-9908337 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Hindawi |
record_format | MEDLINE/PubMed |
spelling | pubmed-99083372023-02-09 Adverse Drug Reactions during COVID-19 Treatment: A Comprehensive Analysis Focused on Hospitalized Patients, with the Use of a Survey in Cuba in 2020 Gil-del-Valle, Lizette Gravier-Hernández, Rosario Baldoquin-Rodríguez, Waldemar Sierra-Vázquez, Beatriz Perez-Díaz, Ana Beatriz Sariol-Resik, Pablo Prieto-Dominguez, Tatiana Delgado-Guerra, Mario Manuel Sánchez- Márquez, Joniel Arnoldo López-Fernández, Olga Elena Fonseca-Betancourt, Faustina Valdés-Lanza, Liana Orraca-Castillo, Odalys Van Ostade, Xaveer Vanden Berghe, Wim Vanlerberghe, Veerle Guzmán-Tirado, M. Guadalupe Adv Pharmacol Pharm Sci Research Article AIMS: To evaluate the prevalence and type of adverse drug reactions (ADRs), together with associated risk factors, among Cuban COVID-19 patients treated with chloroquine (CQ), lopinavir/ritonavir (LPV/r), or interferon α2b (IFN α2b), according to the Cuban protocol. MATERIALS AND METHODS: A prospective descriptive analysis of ADRs was performed on 200 COVID-19 patients who were admitted consecutively to three hospitals in Havana and Pinar del Río from April to July 2020. Information on demographics, ADRs, outcomes, behavioral, and health-related factors was collected using a validated questionnaire and clinical records. Each potential ADR case was assessed for causality based on the WHO-UMC algorithm, concomitant drug influences, and the presence of any drug-drug interactions (DDI). RESULTS: The total frequency of ADRs was 55%, with predominantly gastrointestinal disorders and general symptoms (23% vs 20%). 95.1% of ADRs occurred within 10 days after treatment and 42 potential DDI in 55.5% of patients (61/110) were observed. The prevalence of ADRs was: 44%, 30.4%, and 26.4% for IFN α2b, LPV/r, and CQ, respectively. Sex (odds ratio (OR): 0.40 (95% confidence interval (CI): 0.211–0.742), age (OR: 2.36 (95% CI: 1.02–5.44)), and underlying diseases (OR: 0.12 (95% CI: 0.06–0.23)) were independently associated factors for ADRs (P < 0.05). CONCLUSIONS: The frequency of ADRs and potential DDI was high compared to their use during nonpandemic times (e.g., for malaria, HIV, or inflammatory diseases). The safety profile of these drugs when used for COVID-19 treatment showed similar characteristics. Comorbidities, age >37 years old, and female sex were associated with ADRs. Hindawi 2023-02-01 /pmc/articles/PMC9908337/ /pubmed/36776283 http://dx.doi.org/10.1155/2023/1995642 Text en Copyright © 2023 Lizette Gil-del-Valle et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Gil-del-Valle, Lizette Gravier-Hernández, Rosario Baldoquin-Rodríguez, Waldemar Sierra-Vázquez, Beatriz Perez-Díaz, Ana Beatriz Sariol-Resik, Pablo Prieto-Dominguez, Tatiana Delgado-Guerra, Mario Manuel Sánchez- Márquez, Joniel Arnoldo López-Fernández, Olga Elena Fonseca-Betancourt, Faustina Valdés-Lanza, Liana Orraca-Castillo, Odalys Van Ostade, Xaveer Vanden Berghe, Wim Vanlerberghe, Veerle Guzmán-Tirado, M. Guadalupe Adverse Drug Reactions during COVID-19 Treatment: A Comprehensive Analysis Focused on Hospitalized Patients, with the Use of a Survey in Cuba in 2020 |
title | Adverse Drug Reactions during COVID-19 Treatment: A Comprehensive Analysis Focused on Hospitalized Patients, with the Use of a Survey in Cuba in 2020 |
title_full | Adverse Drug Reactions during COVID-19 Treatment: A Comprehensive Analysis Focused on Hospitalized Patients, with the Use of a Survey in Cuba in 2020 |
title_fullStr | Adverse Drug Reactions during COVID-19 Treatment: A Comprehensive Analysis Focused on Hospitalized Patients, with the Use of a Survey in Cuba in 2020 |
title_full_unstemmed | Adverse Drug Reactions during COVID-19 Treatment: A Comprehensive Analysis Focused on Hospitalized Patients, with the Use of a Survey in Cuba in 2020 |
title_short | Adverse Drug Reactions during COVID-19 Treatment: A Comprehensive Analysis Focused on Hospitalized Patients, with the Use of a Survey in Cuba in 2020 |
title_sort | adverse drug reactions during covid-19 treatment: a comprehensive analysis focused on hospitalized patients, with the use of a survey in cuba in 2020 |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9908337/ https://www.ncbi.nlm.nih.gov/pubmed/36776283 http://dx.doi.org/10.1155/2023/1995642 |
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