한빛사논문
- 조회326
Ju Hwan Kim a, Hyesung Lee a,b, In-Sun Oh a,b, Han Eol Jeong a,b, Sungho Bea a, Seung Hun Jang c, Hyunjin Son d, Ju-Young Shin a,b,e
aSchool of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea
bDepartment of Biohealth Regulatory Science, School of Pharmacy, Sungkyunkwan University, South Korea
cDepartment of Pulmonary, Allergy and Critical Care Medicine, Hallym University Sacred Heart Hospital, Anyang, South Korea
dDepartment of Preventive Medicine, College of Medicine, Dong-A University, Busan, South Korea
eSamsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, South Korea
Corresponding author : Ju-Young Shin
Abstract
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 (2014-2020) 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, 0.42-1.27] and 0.89 [0.50-1.60], respectively). Bedaquiline-containing regimen increased risk of acute liver injury (1.76 [1.31-2.36]), while delamanid-containing regimen increased risk of long QT-related cardiac events (2.38 [1.05-3.57]) 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 risk-benefit assessment in patients with pre-existing cardiovascular disease.
논문정보
- Research article
- 2023년 05월 (BRIC 등록일 2023-06-12)
- 국내 연구진
- 의약학 > 약학
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