Cardiac Risk Factors in Drug-Resistant Tuberculosis Patients on Bedaquiline: A Retrospective Cohort Study

Area of Science:

• Cardiology
• Infectious Diseases
• Pharmacology

Background:

• Bedaquiline is crucial for treating drug-resistant tuberculosis (DR-TB).
• Bedaquiline use is associated with QT interval prolongation, requiring cardiac safety evaluation.
• Assessing cardiac safety and risk factors for bedaquiline regimens in DR-TB patients is essential.

Purpose of the Study:

• To evaluate the cardiac safety of bedaquiline-containing regimens in DR-TB patients.
• To identify risk factors associated with adverse cardiac events during bedaquiline treatment.
• To inform clinical application and risk mitigation strategies for bedaquiline therapy.

Main Methods:

• Retrospective cohort study of 202 DR-TB patients treated with bedaquiline-containing regimens.
• Cardiac safety assessment included ECG, cardiovascular symptoms, and electrolyte monitoring over 24 weeks.
• Statistical analysis identified risk factors for cardiac adverse events, including concomitant medications and electrolyte imbalances.

Main Results:

• QTcF prolongation (≥60 ms) occurred in 19.80% of patients; one patient had QTcF >500 ms.
• 139 patients (68.81%) had no cardiac events, while 44 (21.78%) experienced grade 3 events.
• Concomitant clofazimine use (OR=3.66) and hypokalemia (OR=24.77) significantly increased the risk of grade ≥3 cardiac events.

Conclusions:

• QT interval prolongation is frequent but rarely leads to bedaquiline discontinuation in DR-TB patients.
• Concomitant clofazimine and hypokalemia are significant risk factors for adverse cardiac events.
• Routine electrolyte monitoring, potassium supplementation, and cautious co-prescription are recommended for DR-TB patients on bedaquiline.