Analysis of the side effect of QTc interval prolongation in the bedaquiline regimen in drug resistant tuberculosis patients.

Abstract

Indonesia is one of the top 20 countries with the highest prevalence of drug resistant tuberculosis (DR-TB) worldwide with a percentage of new cases of 2.4% and retreatment of 13%. Bedaquiline (BDQ) is one of the drugs that used in the individual long regimen treating DR-TB. BDQ is also combined with levofloxacin (LFX) and/or clofazimine (CFZ) that can cause QTc interval prolongation. The aim was to study the differences in the use of BDQ regimens to the lengthening of the QTc interval and to study risk factors (diabetes, hypokalemia, sex, BMI, and age) in BDQ regimen. This study was an observational retrospective study with a total sampling method, which was conducted at Dr. Soetomo General Hospital Surabaya. Samples from this study were patients diagnosed with DR-TB at Dr. Soetomo General Hospital Surabaya in the period of January 2015-December 2019 who used BDQ regimen and met the inclusion criteria. The ECG data were analyzed from the mean of each group (BDQ regimen and risk factors), also analyzed using statistical analysis. Data obtained from total sample in this study were 73 patients. The most widely used different regimens in this study were the combination of BDQ+LFX by 36 patients (49.3%), BDQ+LFX+CFZ by 16 patients (21.9%), BDQ by 11 patients (15.1%) and BDQ+CFZ 10 patients (13.7%). Out of 73 patients, 52 patients (71.2%) experienced lengthening of the QT interval and grade 1 of QTc interval prolongation occurred in most patients and also the onset was mostly one month after using BDQ regimen. The side effects of QTc interval prolongation from groups of combination and risk factors were no difference in each month (p>0.05). This study can be concluded that there were no differences in the QTc prolongation between the groups of BDQ regimen (BDQ, BDQ+LFX, BDQ+CFZ and BDQ+LFX+CFZ) and the groups of risk factors.