Abstract
Introduction: Bedaquiline should is administered under direct observation along with standard MDR-TB regimen. Recommended dose is 400 mg once daily for 2 weeks followed by 200 mg thrice weekly for 22 weeks. After 24 weeks of Bedaquiline therapy, MDR-TB regimen should be continued as per national TB treatment guidelines. The observed prolongation of the QT interval and potentially fatal cardiac arrhythmia may or may not be related to interference with membrane associated cation transports.
 Aims and objective: To analyze QTc Prolongation in patients who received Bedaquiline in District tuberculosis center at Rajkot.
 Material and method: All the patient who received and actively followed and developed QTc prolongation as Adverse Drug Reaction were included in the study. Demographic parameter and detailed information about ECG changes due to QTc Prolongation was noted from patient treatment sheet. Interim analysis was done in this study. Adverse drug reactions data was collected in Adverse Drug Reaction(ADR) form (version 1.3) by Indian Pharmacopoeia Commission. The ADR related data can be accessed through - https://vigiflow-in.who-umc.org.
 Result: Total 30 patient who received Tablet Bedaquiline were included in the study. Out of which 18 (60%) were males and 12 (40%) were females, Mean age of patient was 28.3 (years) ± 11.6 SD, Mean weight of patient was 48.2 (kg) ± 5.6 SD and 2 patient died due to cardiac arrest.
 Statistical analysis: Descriptive analysis like mean, standard deviation and percentage was done using excel office version 2016.
 Conclusion: Long QTc prolongation was noted more among male patients weighing 41 to 50 kg. Among all the participant, majority were having QTc prolongation and two death were observed during treatment of Bedaquiline. The patients will be further followed up for outcome analysis.
 Keywords: Bedaquiline, QTc interval, adverse effect.
Highlights
Bedaquiline should be administered under direct observation along with standard MDR-TB regimen
Previous studies have shown that women have a reduced repolarization reserve and greater susceptibility to the QTc prolongation to some drugs .[4]The observed prolongation of QT Interval and potentially fatal cardiac arrhythmia may or may not be related to interference with membrane associated cation transport, Potassium transport in cardiomyocytes secondary to cationic amphiphilic properties, an issue that requires investigation.[4 QT intervals and heart rate at all sites and heart rate measured by ECG machine
Our result showed that mean age of the patient was 28.3 years which was almost similar to study done by Singla N et al and Udwadia JF et at receptively. 12,13 Our finding observed that more males (60%) affected as compared to females (40%) which was similar to study done by Singla et al 12 but opposite to study done by Udwadia et al in which more females were effected
Summary
Bedaquiline should be administered under direct observation along with standard MDR-TB regimen. Previous studies have shown that women have a reduced repolarization reserve and greater susceptibility to the QTc prolongation to some drugs .[4]The observed prolongation of QT Interval and potentially fatal cardiac arrhythmia may or may not be related to interference with membrane associated cation transport, Potassium transport in cardiomyocytes secondary to cationic amphiphilic properties, an issue that requires investigation.[4 QT intervals and heart rate at all sites and heart rate measured by ECG machine. [6] The present study was planned to observe QTc interval at various time points of drug administration and analyse any prolongation in patients who have received bedaquiline in District Tuberculosis Center (DTC) at Rajkot Bazett's formula continues to be the most commonly used formula for QT rate correction in spite of the fact that it severely overcorrects at high heart rates. [6] The present study was planned to observe QTc interval at various time points of drug administration and analyse any prolongation in patients who have received bedaquiline in District Tuberculosis Center (DTC) at Rajkot
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