| Author | Ridolfi, Felipe | |
| Author | Amorim, Gustavo | |
| Author | Peetluk, Lauren S. | |
| Author | Haas, David W. | |
| Author | Staats, Cody | |
| Author | Araújo-Pereira, Mariana | |
| Author | Cordeiro-Santos, Marcelo | |
| Author | Kritski, Afrânio L. | |
| Author | Figueiredo, Marina C. | |
| Author | Andrade, Bruno B. | |
| Author | Rolla, Valeria Cavalcanti | |
| Author | Sterling, Timothy R. | |
| Access date | 2024-05-14T15:52:48Z | |
| Available date | 2024-05-14T15:52:48Z | |
| Document date | 2024 | |
| Citation | RIDOLFI, Felipe et al. Prediction models for adverse drug reactions during tuberculosis treatment in Brazil. The Journal of Infectious Diseases, v. 229, n. 3, p. 813-823, Mar. 2024. | en_US |
| ISSN | 0022-1899 | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/64060 | |
| Description | Collaborators: Regional Prospective Observational Research in Tuberculosis (RePORT)–Brazil Consortium: Aline Benjamin, Flavia M Sant'Anna, Jamile Garcia de Oliveira, João Marin, Adriana Rezende, Anna Cristina Carvalho, Michael Rocha, Betânia Nogueira, Alexandra Brito, Renata Spener, Megan Turner. | |
| Sponsorship | This work was funded by the Departamento de Ciência e Tecnologia (DECIT), Secretaria de Ciência e Tecnologia, Ministério da Saúde, Brazil (award number 25029.000507/2013-07 to V. C. R.); the National Institute of Allergy and Infectious Diseases, NIH (grant numbers U01 AI069923; U01 AI172064; R01 A1120790; F31
AI152614 to L. S. P.); and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES), Brazil (Finance Code 001, CAPES-PrInt 88887.694717/2022-00 to F. R.). L. K., M. C.-S., B. B. A., and V. C. R. are senior investigators and fellows from the Conselho Nacional de Desenvolvimento Científico e Tecnológico, Brazil. The National Institute of Allergy and Infectious Diseases, NIH grants support also included AI077505 (to D. W. H.), AI110527, and TR000445. | |
| Language | eng | en_US |
| Publisher | Oxford | en_US |
| Rights | restricted access | |
| Subject in Portuguese | Tratamento da tuberculose | en_US |
| Subject in Portuguese | Reações adversas a medicamentos | en_US |
| Subject in Portuguese | Modelo de previsão | en_US |
| Subject in Portuguese | Medicação concomitante | en_US |
| Title | Prediction models for adverse drug reactions during tuberculosis treatment in Brazil | en_US |
| Type | Article | |
| DOI | 10.1093/infdis/jiae025 | |
| Abstract | Background: Tuberculosis (TB) treatment–related adverse drug reactions (TB-ADRs) can negatively affect adherence and treatment success rates. Methods: We developed prediction models for TB-ADRs, considering participants with drug-susceptible pulmonary TB who initiated standard TB therapy. TB-ADRs were determined by the physician attending the participant, assessing causality to TB drugs, the affected organ system, and grade. Potential baseline predictors of TB-ADR included concomitant medication (CM) use, human immunodeficiency virus (HIV) status, glycated hemoglobin (HbA1c), age, body mass index (BMI), sex, substance use, and TB drug metabolism variables (NAT2 acetylator profiles). The models were developed through bootstrapped backward selection. Cox regression was used to evaluate TB-ADR risk. Results: There were 156 TB-ADRs among 102 of the 945 (11%) participants included. Most TB-ADRs were hepatic (n = 82 [53%]), of moderate severity (grade 2; n = 121 [78%]), and occurred in NAT2 slow acetylators (n = 62 [61%]). The main prediction model included CM use, HbA1c, alcohol use, HIV seropositivity, BMI, and age, with robust performance (c-statistic = 0.79 [95% confidence interval {CI}, .74–.83) and fit (optimism-corrected slope and intercept of −0.09 and 0.94, respectively). An alternative model replacing BMI with NAT2 had similar performance. HIV seropositivity (hazard ratio [HR], 2.68 [95% CI, 1.75–4.09]) and CM use (HR, 5.26 [95% CI, 2.63–10.52]) increased TB-ADR risk. Conclusions: The models, with clinical variables and with NAT2, were highly predictive of TB-ADRs. | en_US |
| Affilliation | Division of Infectious Diseases. Department of Medicine. Vanderbilt University Medical Center. Nashville, Tennessee, USA / Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Micobacterioses. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Department of Biostatistics. Vanderbilt University Medical Center. Nashville, Tennessee, USA. | en_US |
| Affilliation | Division of Epidemiology. Department of Medicine. Vanderbilt University Medical Center. Nashville, Tennessee, USA / Optum Epidemiology. Boston, Massachusetts, USA. | en_US |
| Affilliation | Division of Infectious Diseases. Department of Medicine. Vanderbilt University Medical Center. Nashville, Tennessee, USA. | en_US |
| Affilliation | Division of Infectious Diseases. Department of Medicine. Vanderbilt University Medical Center. Nashville, Tennessee, USA. | en_US |
| Affilliation | Multinational Organization Network Sponsoring Translational and Epidemiological Research Initiative. Salvador, BA, Brasil / Faculdade de Tecnologia e Ciências. Curso de Medicina. Salvador, BA, Brasil. | en_US |
| Affilliation | Fundação Medicina Tropical Dr Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil. | en_US |
| Affilliation | Universidade Federal do Rio de Janeiro. Faculdade de Medicina. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Division of Infectious Diseases. Department of Medicine. Vanderbilt University Medical Center. Nashville, Tennessee, USA. | en_US |
| Affilliation | Division of Infectious Diseases. Department of Medicine. Vanderbilt University Medical Center. Nashville, Tennessee, USA / Multinational Organization Network Sponsoring Translational and Epidemiological Research Initiative. Salvador, BA, Brasil / Faculdade de Tecnologia e Ciências. Curso de Medicina. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Pesquisa Clínica e Translacional. Salvador, BA, Brasil / Universidade Salvador. Curso de Medicina. Salvador, BA, Brasil / Escola Bahiana de Medicina e Saúde Pública. Curso de Medicina. Salvador, BA, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Division of Infectious Diseases. Department of Medicine. Vanderbilt University Medical Center. Nashville, Tennessee, USA. | en_US |
| Subject | Tuberculosis treatment | en_US |
| Subject | Adverse drug reactions | en_US |
| Subject | Prediction model | en_US |
| Subject | Concomitant medication | en_US |
| DeCS | Tuberculose | en_US |
| DeCS | Terapêutica | en_US |
| DeCS | Efeitos colaterais e reações adversas relacionados a medicamentos | en_US |
| e-ISSN | 1537-6613 | |
| Embargo date | 2030-12-31 | |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
