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Improved Completion Rates and Characterization of Drug Reactions with an Intensive Chagas Disease Treatment Program in Rural Bolivia

BACKGROUND: Chagas disease treatment is limited by drug availability, adverse side effect profiles of available medications, and poor adherence. METHODS: Adult Chagas disease patients initiating 60-days of benznidazole were randomized to weekly or twice-weekly evaluations of medication adherence and...

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Autores principales: Tornheim, Jeffrey A., Lozano Beltran, Daniel F., Gilman, Robert H., Castellon, Mario, Solano Mercado, Marco A., Sullca, Walter, Torrico, Faustino, Bern, Caryn
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3777865/
https://www.ncbi.nlm.nih.gov/pubmed/24069472
http://dx.doi.org/10.1371/journal.pntd.0002407
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author Tornheim, Jeffrey A.
Lozano Beltran, Daniel F.
Gilman, Robert H.
Castellon, Mario
Solano Mercado, Marco A.
Sullca, Walter
Torrico, Faustino
Bern, Caryn
author_facet Tornheim, Jeffrey A.
Lozano Beltran, Daniel F.
Gilman, Robert H.
Castellon, Mario
Solano Mercado, Marco A.
Sullca, Walter
Torrico, Faustino
Bern, Caryn
author_sort Tornheim, Jeffrey A.
collection PubMed
description BACKGROUND: Chagas disease treatment is limited by drug availability, adverse side effect profiles of available medications, and poor adherence. METHODS: Adult Chagas disease patients initiating 60-days of benznidazole were randomized to weekly or twice-weekly evaluations of medication adherence and screening for adverse drug events (ADEs). Mid-week evaluations employed phone-based evaluations. Adherence was measured by self-report, pill counts with intentional over-distribution, and Medication Event Monitoring Systems (MEMS). Prospective data were compared to historical controls treated with benznidazole at the same hospital. RESULTS: 162 prospective patients were compared to 172 historical patients. Pill counts correlated well with MEMS data (R = 0.498 for 7-day intervals, R = 0.872 for intervals >7 days). Treatment completion rates were higher among prospective than historical patients (82.1% vs. 65.1%), primarily due to lower abandonment rates. Rates of ADEs were lower among prospective than historical patients (56.8% vs. 66.9%). Twice-weekly evaluations increased identification of mild ADEs, prompting higher suspension rates than weekly evaluations. While twice-weekly evaluations identified ADEs earlier, they did not reduce incidence of moderate or severe ADEs. Many dermatologic ADEs were moderately severe upon presentation (35.6%), were not reduced by use of antihistamines, occurred among adult patients of all ages, and occurred throughout treatment, rather than the first few weeks alone. CONCLUSIONS: Intensive management improved completion and identified more ADEs, but did not reduce moderate or severe ADEs. Risk of dermatologic ADEs cannot be reduced by selecting younger adults or monitoring only during the first few weeks of treatment. Pill counts and phone-based encounters are reliable tools for treatment programming in rural Bolivia.
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spelling pubmed-37778652013-09-25 Improved Completion Rates and Characterization of Drug Reactions with an Intensive Chagas Disease Treatment Program in Rural Bolivia Tornheim, Jeffrey A. Lozano Beltran, Daniel F. Gilman, Robert H. Castellon, Mario Solano Mercado, Marco A. Sullca, Walter Torrico, Faustino Bern, Caryn PLoS Negl Trop Dis Research Article BACKGROUND: Chagas disease treatment is limited by drug availability, adverse side effect profiles of available medications, and poor adherence. METHODS: Adult Chagas disease patients initiating 60-days of benznidazole were randomized to weekly or twice-weekly evaluations of medication adherence and screening for adverse drug events (ADEs). Mid-week evaluations employed phone-based evaluations. Adherence was measured by self-report, pill counts with intentional over-distribution, and Medication Event Monitoring Systems (MEMS). Prospective data were compared to historical controls treated with benznidazole at the same hospital. RESULTS: 162 prospective patients were compared to 172 historical patients. Pill counts correlated well with MEMS data (R = 0.498 for 7-day intervals, R = 0.872 for intervals >7 days). Treatment completion rates were higher among prospective than historical patients (82.1% vs. 65.1%), primarily due to lower abandonment rates. Rates of ADEs were lower among prospective than historical patients (56.8% vs. 66.9%). Twice-weekly evaluations increased identification of mild ADEs, prompting higher suspension rates than weekly evaluations. While twice-weekly evaluations identified ADEs earlier, they did not reduce incidence of moderate or severe ADEs. Many dermatologic ADEs were moderately severe upon presentation (35.6%), were not reduced by use of antihistamines, occurred among adult patients of all ages, and occurred throughout treatment, rather than the first few weeks alone. CONCLUSIONS: Intensive management improved completion and identified more ADEs, but did not reduce moderate or severe ADEs. Risk of dermatologic ADEs cannot be reduced by selecting younger adults or monitoring only during the first few weeks of treatment. Pill counts and phone-based encounters are reliable tools for treatment programming in rural Bolivia. Public Library of Science 2013-09-19 /pmc/articles/PMC3777865/ /pubmed/24069472 http://dx.doi.org/10.1371/journal.pntd.0002407 Text en © 2013 Tornheim et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Tornheim, Jeffrey A.
Lozano Beltran, Daniel F.
Gilman, Robert H.
Castellon, Mario
Solano Mercado, Marco A.
Sullca, Walter
Torrico, Faustino
Bern, Caryn
Improved Completion Rates and Characterization of Drug Reactions with an Intensive Chagas Disease Treatment Program in Rural Bolivia
title Improved Completion Rates and Characterization of Drug Reactions with an Intensive Chagas Disease Treatment Program in Rural Bolivia
title_full Improved Completion Rates and Characterization of Drug Reactions with an Intensive Chagas Disease Treatment Program in Rural Bolivia
title_fullStr Improved Completion Rates and Characterization of Drug Reactions with an Intensive Chagas Disease Treatment Program in Rural Bolivia
title_full_unstemmed Improved Completion Rates and Characterization of Drug Reactions with an Intensive Chagas Disease Treatment Program in Rural Bolivia
title_short Improved Completion Rates and Characterization of Drug Reactions with an Intensive Chagas Disease Treatment Program in Rural Bolivia
title_sort improved completion rates and characterization of drug reactions with an intensive chagas disease treatment program in rural bolivia
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3777865/
https://www.ncbi.nlm.nih.gov/pubmed/24069472
http://dx.doi.org/10.1371/journal.pntd.0002407
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