Byun Ji-Hye, Park Jae-A, Kang Hye-Rim, Shin Ju-Young, Lee Eui-Kyung
Pharmaceutical Policy and Outcomes Research, Department of Pharmaceutical Industrial Science, School of Pharmacy, Sungkyunkwan University (SKKU), 300 Cheonchoen-dong, Jangan-gu, Suwon, Gyeonggi-do, 440-746, South Korea.
Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada.
Clin Drug Investig. 2016 Nov;36(11):957-968. doi: 10.1007/s40261-016-0443-6.
No clear evidence on the comparative effectiveness of delamanid (DLM) and bedaquiline (BDQ) has been published.
This study aims to estimate the incremental effectiveness of DLM versus BDQ in patients with multidrug-resistant tuberculosis (MDR-TB).
We developed a Markov model based on a cohort with MDR-TB, which consisted of success, failure, loss to follow-up, and death. The cohort simulation was conducted assuming each patient was 36 years old and, lived until age 82, and that the cycle length was 1 year. Patients with an inadequate response to DLM, the background regimen, or BDQ for 2 years were transitioned through the next treatment sequence. We evaluated the incremental effectiveness of the drugs using the quality-adjusted life-year (QALY) resulting from this Markov model over a lifetime.
The incremental effectiveness of DLM (13.96 QALYs) was greater by 2.44 QALYs per patient than the background regimen (11.52 QALY), while the incremental effectiveness of BDQ (10.40 QALY) was higher by 1.14 QALY per patient than the background regimen (9.26 QALY). Consequently, the incremental effectiveness of DLM was relatively more positive by 1.30 QALY than those of BDQ per patient over a lifetime.
This study is a simulation study. Therefore, the treatment sequence for patients may be different in the real world.
Our lifetime simulated data found that DLM was relatively more favorable than BDQ. A Markov model can be considered an alternative approach when there is an absence of head-to-head clinical data.
关于地拉米定（DLM）和贝达喹啉（BDQ）的比较有效性尚无明确证据发表。
本研究旨在评估DLM对比BDQ治疗耐多药结核病（MDR-TB）患者的增量有效性。
我们基于一组MDR-TB患者开发了一个马尔可夫模型，该模型包括成功、失败、失访和死亡状态。队列模拟假设每位患者36岁，活到82岁，周期长度为1年。对DLM、背景治疗方案或BDQ治疗2年反应不佳的患者进入下一治疗序列。我们使用该马尔可夫模型得出的质量调整生命年（QALY）评估了这些药物在患者一生中的增量有效性。
DLM的增量有效性（13.96 QALY）比背景治疗方案（11.52 QALY）每位患者高2.44 QALY，而BDQ的增量有效性（10.40 QALY）比背景治疗方案（9.26 QALY）每位患者高1.14 QALY。因此，在患者一生中，DLM的增量有效性相对于BDQ每位患者相对更积极，高出1.30 QALY。
本研究是一项模拟研究。因此，现实世界中患者的治疗序列可能不同。
我们的终生模拟数据发现，DLM比BDQ相对更具优势。当缺乏直接对比的临床数据时，马尔可夫模型可被视为一种替代方法。
