| Author | Araújo, Ana Carolina Galvão dos Santos de | |
| Author | Hacker, Mariana de Andrea Vilas-Boas | |
| Author | Pinheiro, Roberta Olmo | |
| Author | Illarramendi Rojas, Ximena | |
| Author | Durães, Sandra Maria Barbosa | |
| Author | Nobre, Maurício Lisboa | |
| Author | Moraes, Milton Ozório | |
| Author | Sales, Anna Maria | |
| Author | Silva, Gilberto Marcelo Sperandio da | |
| Access date | 2024-03-22T23:28:38Z | |
| Available date | 2024-03-22T23:28:38Z | |
| Document date | 2024 | |
| Citation | ARAÚJO, Ana Carolina Galvão dos Santos de et al. Development of a multivariate predictive model for dapsone adverse drug events in people with leprosy under standard WHO multidrug therapy. PLoS Neglected Tropical Diseases, v. 18, n. 1, p. 1-14, Jan. 2024. | |
| ISSN | 1935-2727 | |
| URI | https://www.arca.fiocruz.br/handle/icict/63180 | |
| Description | Produção científica do Laboratório de Hanseníase. | pt_BR |
| Description | Author summary: Adverse events (AE) produced by the drugs used to treat leprosy can hinder the successful completion of the therapeutic regimen. Well-known AE produced by dapsone (DDS) are related to liver problems, allergic reactions, or to the destruction of red and/or white blood cells, causing anemia. Helping the physician to recognize a patient that may develop these adverse reactions can be useful. Thus, we developed a model to predict AE in patients with leprosy receiving standard World Health Organization-recommended multidrug therapy (WHO/MDT). Our question was whether we could use sociodemographic and clinical variables to generate a predictive model for DDS-ADEs. The model developed in this study could be a useful tool to assist physicians in predicting DDS-ADEs when treating patients with standard WHO/MDT for leprosy, and thus, establish a safer therapeutic plan for patients with a greater ADE risk. | en_US |
| Description | Author Contributions: | en_US |
| Description | Conceptualization: Ana Carolina Galvão dos Santos de Araujo, Ximena Illarramendi, Sandra Maria Barbosa Durães, Maurício Lisboa Nobre, Milton Ozório Moraes, Anna Maria Sales, Gilberto Marcelo Sperandio da Silva. | en_US |
| Description | Data curation: Ana Carolina Galvão dos Santos de Araujo, Anna Maria Sales, Gilberto Marcelo Sperandio da Silva. | en_US |
| Description | Formal analysis: Ana Carolina Galvão dos Santos de Araújo, Mariana de Andrea Vilas-Boas Hacker, Anna Maria Sales, Gilberto Marcelo Sperandio da Silva. | en_US |
| Description | Investigation: Ana Carolina Galvão dos Santos de Araujo. | en_US |
| Description | Methodology: Ana Carolina Galvão dos Santos de Araújo, Mariana de Andrea Vilas-Boas Hacker, Anna Maria Sales, Gilberto Marcelo Sperandio da Silva. | en_US |
| Description | Supervision: Anna Maria Sales, Gilberto Marcelo Sperandio da Silva. | en_US |
| Description | Writing – original draft: Ana Carolina Galvão dos Santos de Araújo. | en_US |
| Description | Writing – review & editing: Roberta Olmo Pinheiro, Ximena Illarramendi, Sandra Maria Barbosa Durães, Maurício Lisboa Nobre, Anna Maria Sales, Gilberto Marcelo Sperandio da Silva. | en_US |
| Sponsorship | The work was financially supported by CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico (URL: https://www.gov.br/cnpq/pt-br, Grant number: 312802/2020-0 to Roberta Olmo Pinheiro). | |
| Sponsorship | FAPERJ - Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (URL: https://www.faperj.br/, Grant number: E-26/201.176/2021 (260734) to Roberta Olmo Pinheiro). | |
| Sponsorship | FIOCRUZ - Fundação Oswaldo Cruz. | |
| Language | eng | en_US |
| Publisher | Public Library of Science | en_US |
| Rights | open access | |
| Title | Development of a multivariate predictive model for dapsone adverse drug events in people with leprosy under standard WHO multidrug therapy | en_US |
| Type | Article | |
| DOI | 10.1371/journal.pntd.0011901 | |
| Abstract | Background: The occurrence of adverse drug events (ADEs) during dapsone (DDS) treatment in patients with leprosy can constitute a significant barrier to the successful completion of the standardized therapeutic regimen for this disease. Well-known DDS-ADEs are hemolytic anemia, methemoglobinemia, hepatotoxicity, agranulocytosis, and hypersensitivity reactions. Identifying risk factors for ADEs before starting World Health Organization recommended standard multidrug therapy (WHO/MDT) can guide therapeutic planning for the patient. The objective of this study was to develop a predictive model for DDS-ADEs in patients with leprosy receiving standard WHO/MDT. Methodology: This is a case-control study that involved the review of medical records of adult (≥18 years) patients registered at a Leprosy Reference Center in Rio de Janeiro, Brazil. The cohort included individuals that received standard WHO/MDT between January 2000 to December 2021. A prediction nomogram was developed by means of multivariable logistic regression (LR) using variables. The Hosmer–Lemeshow test was used to determine the model fit. Odds ratios (ORs) and their respective 95% confidence intervals (CIs) were estimated. The predictive ability of the LRM was assessed by the area under the receiver operating characteristic curve (AUC). Results: A total of 329 medical records were assessed, comprising 120 cases and 209 controls. Based on the final LRM analysis, female sex (OR = 3.61; 95% CI: 2.03–6.59), multibacillary classification (OR = 2.5; 95% CI: 1.39–4.66), and higher education level (completed primary education) (OR = 1.97; 95% CI: 1.14–3.47) were considered factors to predict ADEs that caused standard WHO/MDT discontinuation. The prediction model developed had an AUC of 0.7208, that is 72% capable of predicting DDS-ADEs. Conclusion: We propose a clinical model that could become a helpful tool for physicians in predicting ADEs in DDS-treated leprosy patients. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hanseníase. Rio de Janeiro, RJ, Brasil. | |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil. | |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hanseníase. Rio de Janeiro, RJ, Brasil. | |
| Affilliation | Fluminense Federal University. Dermatology Department. Niterói, RJ, Brasil. | |
| Affilliation | Rio Grande do Norte Federal State Public Health Department. Giselda Trigueiro Hospital. Natal, RN, Brasil. | |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hanseníase. Rio de Janeiro, RJ, Brasil. | |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hanseníase. Rio de Janeiro, RJ, Brasil. | |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | |
| Subject | Leprosy | en_US |
| Subject | Drug therapy | en_US |
| Subject | Forecasting | en_US |
| Subject | Medical risk factors | en_US |
| Subject | Skin diseases | en_US |
| Subject | Anemia | en_US |
| Subject | Hemolytic anemia | en_US |
| Subject | Outpatient clinics | en_US |
| e-ISSN | 1935-2735 | |
