Please use this identifier to cite or link to this item: http://localhost:8080/xmlui/handle/123456789/9398
Full metadata record
DC FieldValueLanguage
dc.contributor.authorKim, Ju Hwan-
dc.contributor.authorLee, Hyesung-
dc.contributor.authorOh, In-Sun-
dc.contributor.authorJeong, Han Eol-
dc.contributor.authorBea, Sungho-
dc.contributor.authorJang, Seung Hun-
dc.date.accessioned2024-12-20T01:48:06Z-
dc.date.available2024-12-20T01:48:06Z-
dc.date.issued2023-08-
dc.identifier.citationOriginal Articleen_US
dc.identifier.urihttp://localhost:8080/xmlui/handle/123456789/9398-
dc.description.abstractAbstract Background/Purpose(s): Bedaquiline and delamanid were recently approved for multidrug resistant tuberculosis (MDR-TB). Bedaquiline carries a black box warning of increased risk of death compared to the placebo arm, and there is a need to establish the risks of QT prolongation and hepatotoxicity for bedaquiline and delamanid. Methods: We retrospectively analyzed data of MDR-TB patients retrieved from the South Korea national health insurance system database (2014e2020) to assess the risks of all-cause death, long QT-related cardiac event, and acute liver injury associated with bedaquiline or delamanid, compared with conventional regimen. Cox proportional hazards models were used to estimate hazard ratios (HR) with 95% confidence intervals (CI). Stabilized inverse probability of treatment weighting based on propensity score was used to balance characteristics between the treatment groups. Results: Of 1998 patients, 315 (15.8%) and 292 (14.6%) received bedaquiline and delamanid, respectively. Compared with conventional regimen, bedaquiline and delamanid did not increase risk of all-cause death at 24-month (HR 0.73 [95% CI, 0.42e1.27] and 0.89 [0.50e1.60], respectively). Bedaquiline-containing regimen increased risk of acute liver injury (1.76 [1.31e2.36]), while delamanid-containing regimen increased risk of long QT-related cardiac events (2.38 [1.05e3.57]) within 6 months of treatment. Conclusion: This study adds to the emerging evidence refuting the higher mortality rate observed in the bedaquiline trial population. Association between bedaquiline and acute liver injury needs careful interpretation considering for other background hepatotoxic anti-TB drugs. Our finding on delamanid and long QT-related cardiac events suggest careful riskbenefit assessment in patients with pre-existing cardiovascular disease.en_US
dc.language.isoen_USen_US
dc.publisherElsevier Taiwan LLCen_US
dc.subjectDrug-resistant tuberculosisen_US
dc.subjectBedaquilineen_US
dc.subjectDelamaniden_US
dc.subjectPharmacoepi demiologyen_US
dc.titleComparative safety of bedaquiline and delamanid in patients with multidrug resistant tuberculosis: A nationwide retrospective cohort studyen_US
dc.typeArticleen_US
Appears in Collections:VOL 56 NO 4 2023

Files in This Item:
File Description SizeFormat 
842-852.pdf1.13 MBAdobe PDFView/Open


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.