Key result
Bedaquiline regimens caused QTc interval prolongation in 71.2% of drug-resistant tuberculosis patients, with no significant differences in prolongation between different regimen combinations (p>0.05).
Why the study?
Bedaquiline is used for drug-resistant tuberculosis and often combined with levofloxacin or clofazimine, which can prolong the QTc interval, but differences across regimens and clinical risk factors required evaluation.
Does the choice of bedaquiline combination regimen affect the risk of QTc interval prolongation in patients with drug-resistant tuberculosis?
Observational (n=73)
No
Does the choice of bedaquiline combination regimen affect the risk of QTc interval prolongation in patients with drug-resistant tuberculosis?
p-value: p=>0.05
In patients with drug-resistant tuberculosis, bedaquiline-based regimens frequently cause mild QTc prolongation, but the risk does not significantly differ when combined with levofloxacin and/or clofazimine.
Supports QTc monitoring with any bedaquiline regimen in drug-resistant TB; leaves open optimal combination to minimize cardiac risk.
OBJECTIVES: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
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Ardhianto et al. (2021) conducted an observational in drug resistant tuberculosis (DR-TB) (n=73). Bedaquiline regimens vs. Different bedaquiline combinations and risk factors was evaluated on QTc interval prolongation (p=>0.05). Bedaquiline regimens caused QTc interval prolongation in 71.2% of drug-resistant tuberculosis patients, with no significant differences in prolongation between different regimen combinations (p>0.05).
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