ArticleTherapeutics and clinical risk management2023
Magnitude and Impacts of Adverse Events of Injectable Containing Shorter Regimen in Programmatic Management of Multi-Drug Resistant Tuberculosis in Ethiopia: A Retrospective Cohort Study.
Article in Therapeutics and clinical risk management, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of treatment regimens for drug-resistant tuberculosis in different regions: a systematic review and meta-analysis.BMC infectious diseases · 2026Pooled it
- Effectiveness and safety of bedaquiline, pretomanid, linezolid and moxifloxacin in drug-resistant tuberculosis patients in selected public hospitals in Ethiopia: a multicenter retrospective cohort study.BMC infectious diseases · 2026Article
- Adverse drug reactions and contributing factors in patients with drug-resistant tuberculosis: A 7-year retrospective cohort study in Addis Ababa, Ethiopia.Journal of clinical tuberculosis and other mycobacterial diseases · 2025Article
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3 authors.
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Abstract
Background: Since its launch as a standardized treatment for multidrug-resistant tuberculosis (MDR-TB) in Ethiopia in April 2018, the safety profile of the shorter injectable regimen under a programmatic setting has not been well studied. Thus, this study aimed to assess the status of adverse events in patients treated with a shorter injectable regimen in Ethiopia. Methods: This is a retrospective cohort study. Data were collected using a structured data abstraction form and analyzed using SPSS, version 25, both descriptively and analytically. Logistic regression was conducted to assess predictors, and Kaplan-Meier analysis was used to examine the time to AEs and survival experiences. Results: Of 256 patients, 245 (95.7%) were eligible for the study. Of 245, 107 (43.7%) patients experienced at least one AE. In total, 276 AE cases were observed out of which the most common were nausea/vomiting (20.3%), dyspepsia (18.1%), and ototoxicity (11.6%). Of 276 AEs, approximately 49 (17.8%) were serious. AEs led to drug discontinuation, dose modification, and regimen change in 29 (27%), 15 (14%) and 10 (9.3%) patients, respectively. Only 19.2% of 276 the overall AEs and 22.6% of 62 AE of special interest (AESI) were reported to the National Pharmacovigilance Center. Conclusion: Although the observed extent of AEs associated with the shorter regimen (SR) seemed to be moderate, it significantly influenced the treatment schemes and patient conditions. Reporting of AEs was low, irrespective of their severity and AESI. Therefore, strengthening the implementation of active drug safety monitoring and management is required.
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