Adverse Drug Reactions and Associated Clinical Outcomes in Patients with Drug Resistant Tuberculosis: A Facility-Based Retrospective Cohort Study in Addis Ababa, Ethiopia
| dc.contributor.advisor | Manyazewal Tsegahun | |
| dc.contributor.advisor | Manyazewal Yimtubezinash | |
| dc.contributor.author | Solomon Bisrat | |
| dc.date.accessioned | 2025-08-13T06:17:53Z | |
| dc.date.available | 2025-08-13T06:17:53Z | |
| dc.date.issued | 2024-04-13 | |
| dc.description.abstract | Background; Drug-resistant Tuberculosis (DR-TB) poses a significant global public health threat, with adverse drug reactions (ADRs) during treatment complicating medication outcomes and leading to substantial mortality. In Ethiopia, despite a high prevalence of DR-TB, there have been limited studies on ADRs during treatment and their effects on patient outcomes. Objective; This study aimed to assess the incidence, clinical outcomes, and risk factors associated with ADRs in the treatment of patients with DR-TB in Addis Ababa, Ethiopia. Methods: A facility-based, retrospective cohort study was conducted on patients with DR-TB who were followed up in two major DR-TB treatment sites, the St. Peter’s Specialized Hospital and the ALERT Comprehensive Specialized Hospital, in the years 01 January 2017 to 31 December 2023. Records of the patients were monitored throughout their treatment time. Information on ADR diagnosis, laboratory findings, clinical observations, type of second-line anti-TB regimen, type and nature of the DR-TB, presence of co-morbidities such as HIV, hypertension, diabetes mellitus, chronic obstructive pulmonary diseases, and asthma, and sociodemographic characteristics were abstracted from patients' charts and registries. The World Health Organization - Uppsala Monitoring Center (WHO-UMC) system was employed for standardized causality assessment of ADRs. Multivariate Cox regression analysis was employed to identify factors associated with ADRs. Survival among predictor variables was assessed using Kaplan-Meier (KM) curves. Adjusted hazard ratios (AHR) with their corresponding 95% confidence intervals (CI) were estimated, and statistical significance was declared for a p-value < 0.05. Result: A total of 292 patients with DR-TB were included, with a median age of 30 years [interquartile range (IQR) = 29–32], 161 (55%) male, and 113 (38%) had comorbidities. Cases were mainly rifampicin-resistant [281(96%)], pulmonary TB [225 (77%)], and on long-term regimens with new drugs [173 (59%)]. Drugs identified during treatment were Levofloxacin, Moxifloxacin, Bedaquiline, Linezolid, Clofazamine, Cycloserine, Caperomycin, Proteonamid, pyrazinamide, Ethambutol, Isonaizid, Ethionamide, and Kanamycin. The overall incidence of ADRs was 8.10 per 100 person-month (PM) (95% CI: 7.02-9.36) during a total follow-up time of xiv 2294 months. The most frequently reported ADRs were gastrointestinal disturbance (31.9%), followed by peripheral neuropathy (21.9%), and arthralgia (17.5%). Temporary and permanent drug discontinuation were noted in 17.1% and 21.9% of patients, respectively. Predictors of ADRs were hospitalization (AHR = 1.53, 95% CI: 1.10-2.13), baseline anemia (AHR = 1.58, 95% CI: 1.16-2.17), the age group of 25-49 years (AHR =1.53, 95% CI: 1.05-2.21), and older age above 50 years (AHR = 1.87, 95% CI: 1.19-2.93). Good treatment outcome was observed in 76% of cases, with no significant association found between ADRs and treatment outcomes. Conclusion: In this study involving patients with DR-TB, over half of the participants encountered at least one ADR. Patient admission, baseline anemia, and older age were identified as predictors of ADRs during MDR-TB treatment. Particular emphasis should be placed on these susceptible groups to facilitate early prediction, prompt management, and the formulation of appropriate treatment regimens that address ADRs effectively. Keywords: Adverse drug reaction, drug-resistant tuberculosis, treatment outcome, Ethiopia | |
| dc.identifier.uri | https://etd.aau.edu.et/handle/123456789/6570 | |
| dc.language.iso | en_US | |
| dc.publisher | Addis Ababa University | |
| dc.subject | Adverse drug reaction drug-resistant tuberculosistreatment outcome Ethiopia | |
| dc.title | Adverse Drug Reactions and Associated Clinical Outcomes in Patients with Drug Resistant Tuberculosis: A Facility-Based Retrospective Cohort Study in Addis Ababa, Ethiopia | |
| dc.type | Thesis |