Adverse Drug Reaction Monitoring in Multidrug-Resistant Tuberculosis Patients Receiving Bedaquiline and Delamanid-Based Regimen.

Abstract

Background and objectives Tuberculosis (TB) is an airborne contagious illness caused byMycobacterium tuberculosis.Ineffective anti-TB medication prolongs and exasperates illness, promotes disease spread,increases the probability of developing resistance to treatment, and increases death rate.Bedaquiline (BDQ) and Delamanid (DLM) were conditionally made available in the treatment of multidrug-resistant TB (MDR TB).In drug-resistantTB patients, adverse drug reactions (ADR) management is essential to improve medicationcompliance. In addition, we performed this study since there are very few studies published on the analysis ofADR monitoring of BDQ and DLM-based regimen. This study was performed tostudy the spectrum of ADR in drug-resistant TB patients receiving BDQ andDLM-based regimen. Methodology The study was conducted over a period of 26 months, in a hospital's departments of pharmacology and pulmonary medicine.Pre-extensively drug-resistant (Pre-XDR) and XDR TBwere established on the basis of cartridge-based nucleic acid amplification (CB-NAAT), line probe assay (LPA), drug susceptibility testing (DST), and bacteriological culture. Patients were prescribed with appropriate medicines at the initial visit and any adverse reactions to medication were assessed in the subsequent visit. The statistical analysis was done using frequency distribution procedure, chi-square test of independence. The significance level was set at p<0.05. Results It was revealed that there were as many as 24 types of ADRs manifested in different patients.The most frequent ADR was QTcF (corrected heart rate) prolongation. Conclusion The maximum number of patients had some form of ADR and the percentage was slightly higher in the BDQ group than in the DLM group.