Real-world impact of the fixed-dose combination on improving treatment outcomes of drug-susceptible tuberculosis: a comparative study using multiyear national tuberculosis patient data

Background The fixed-dose combination (FDC) for first-line antituberculosis (TB) treatment has long been a standard practice worldwide; however, there is limited evidence on whether the use of FDC improves long-term treatment outcomes in the real-world setting.Methods We identified 32 239 newly diag...

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Main Authors: Hee-Yeon Kang, Young Ae Kang, Hojoon Sohn, Dawoon Jeong, Hongjo Choi, Min Seo Ki
Format: Article
Language:English
Published: BMJ Publishing Group 2023-12-01
Series:BMJ Open Respiratory Research
Online Access:https://bmjopenrespres.bmj.com/content/10/1/e001758.full
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author Hee-Yeon Kang
Young Ae Kang
Hojoon Sohn
Dawoon Jeong
Hongjo Choi
Min Seo Ki
author_facet Hee-Yeon Kang
Young Ae Kang
Hojoon Sohn
Dawoon Jeong
Hongjo Choi
Min Seo Ki
author_sort Hee-Yeon Kang
collection DOAJ
description Background The fixed-dose combination (FDC) for first-line antituberculosis (TB) treatment has long been a standard practice worldwide; however, there is limited evidence on whether the use of FDC improves long-term treatment outcomes in the real-world setting.Methods We identified 32 239 newly diagnosed patients with drug-susceptible (DS) TB in 2015 and 2016 who had been prescribed FDC or non-FDC TB treatment from a multiyear (2013–2018) national TB cohort database that linked the Korean National Tuberculosis Surveillance System, the National Health Insurance Database and the Health Insurance Review and Assessment Service database. Inverse probability of treatment weighting (IPTW) with a propensity score was used to control for differences in patient characteristics between 5926 patients with TB treated with FDC and 26 313 patients with non-FDC. Multivariable logistic regression analyses were performed to assess for the factors influencing treatment outcomes between the two groups.Results After IPTW, new patients with DS-TB treated with FDC had higher treatment completion rate (83.9% vs 78.9%, p<0.01) and lower death rates (8.2% vs 9.8%, p<0.01) with similar TB recurrence rate (2.3% vs 2.4%) compared with those treated with non-FDC. In multivariable analyses, FDC use had higher odds treatment completion (adjusted OR 1.45; 95% CI 1.34 to 1.56). Patients with TB with younger age (relative to 70+ age) and higher income level had higher odds for treatment completion. Use of FDC did not influence TB recurrence after treatment completion (adjusted HR 0.94; 95% CI 0.77 to 1.16). The acquired drug resistance rate was similar between the two groups (drug-resistant TB in FDC 4.7% vs non-FDC 5.3%; p=0.80).Conclusion In Korea, prescription of FDC to treat newly diagnosed patients with DS TB improved patient’s treatment completion. Use of FDC did not increase the risks of TB recurrence or development of drug resistance.
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spelling doaj.art-206389de80324f239d42169a96e336be2024-01-01T05:25:08ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392023-12-0110110.1136/bmjresp-2023-001758Real-world impact of the fixed-dose combination on improving treatment outcomes of drug-susceptible tuberculosis: a comparative study using multiyear national tuberculosis patient dataHee-Yeon Kang0Young Ae Kang1Hojoon Sohn2Dawoon Jeong3Hongjo Choi4Min Seo Ki5Department of Cancer Control and Population Health, National Cancer Center Graduate School of Cancer Science and Policy, Goyang, KoreaDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, KoreaDepartment of Preventive Medicine, Seoul National University College of Medicine, Seoul, KoreaDepartment of Preventive Medicine, Seoul National University College of Medicine, Seoul, KoreaDepartment of Preventive Medicine, Konyang University College of Medicine, Daejeon, KoreaDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, KoreaBackground The fixed-dose combination (FDC) for first-line antituberculosis (TB) treatment has long been a standard practice worldwide; however, there is limited evidence on whether the use of FDC improves long-term treatment outcomes in the real-world setting.Methods We identified 32 239 newly diagnosed patients with drug-susceptible (DS) TB in 2015 and 2016 who had been prescribed FDC or non-FDC TB treatment from a multiyear (2013–2018) national TB cohort database that linked the Korean National Tuberculosis Surveillance System, the National Health Insurance Database and the Health Insurance Review and Assessment Service database. Inverse probability of treatment weighting (IPTW) with a propensity score was used to control for differences in patient characteristics between 5926 patients with TB treated with FDC and 26 313 patients with non-FDC. Multivariable logistic regression analyses were performed to assess for the factors influencing treatment outcomes between the two groups.Results After IPTW, new patients with DS-TB treated with FDC had higher treatment completion rate (83.9% vs 78.9%, p<0.01) and lower death rates (8.2% vs 9.8%, p<0.01) with similar TB recurrence rate (2.3% vs 2.4%) compared with those treated with non-FDC. In multivariable analyses, FDC use had higher odds treatment completion (adjusted OR 1.45; 95% CI 1.34 to 1.56). Patients with TB with younger age (relative to 70+ age) and higher income level had higher odds for treatment completion. Use of FDC did not influence TB recurrence after treatment completion (adjusted HR 0.94; 95% CI 0.77 to 1.16). The acquired drug resistance rate was similar between the two groups (drug-resistant TB in FDC 4.7% vs non-FDC 5.3%; p=0.80).Conclusion In Korea, prescription of FDC to treat newly diagnosed patients with DS TB improved patient’s treatment completion. Use of FDC did not increase the risks of TB recurrence or development of drug resistance.https://bmjopenrespres.bmj.com/content/10/1/e001758.full
spellingShingle Hee-Yeon Kang
Young Ae Kang
Hojoon Sohn
Dawoon Jeong
Hongjo Choi
Min Seo Ki
Real-world impact of the fixed-dose combination on improving treatment outcomes of drug-susceptible tuberculosis: a comparative study using multiyear national tuberculosis patient data
BMJ Open Respiratory Research
title Real-world impact of the fixed-dose combination on improving treatment outcomes of drug-susceptible tuberculosis: a comparative study using multiyear national tuberculosis patient data
title_full Real-world impact of the fixed-dose combination on improving treatment outcomes of drug-susceptible tuberculosis: a comparative study using multiyear national tuberculosis patient data
title_fullStr Real-world impact of the fixed-dose combination on improving treatment outcomes of drug-susceptible tuberculosis: a comparative study using multiyear national tuberculosis patient data
title_full_unstemmed Real-world impact of the fixed-dose combination on improving treatment outcomes of drug-susceptible tuberculosis: a comparative study using multiyear national tuberculosis patient data
title_short Real-world impact of the fixed-dose combination on improving treatment outcomes of drug-susceptible tuberculosis: a comparative study using multiyear national tuberculosis patient data
title_sort real world impact of the fixed dose combination on improving treatment outcomes of drug susceptible tuberculosis a comparative study using multiyear national tuberculosis patient data
url https://bmjopenrespres.bmj.com/content/10/1/e001758.full
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