Surveillance of adverse events in the treatment of drug-resistant tuberculosis: First global report
European Respiratory Journal Oct 21, 2019
Borisov S, Danila E, Maryandyshev A, et al. - In a cohort of consecutive tuberculosis (TB) patients who received new (ie, bedaquiline, delamanid) and repurposed (ie, clofazimine, linezolid) drugs, researchers looked at the frequency and severity of adverse events (AEs) to anti-TB drugs, based on the WHO aDSM (active drug safety monitoring and management of adverse events-AEs) project, in this prospective analysis. Overall 658 patients (68.7% males, 4.4% HIV co-infected) who received bedaquiline (87.7%), delamanid (18.4%), linezolid (81.5%), and clofazimine (32.4%) at 45 centres from 26 countries/regions were analyzed. A total of 447 (447/504, 88.7%) minor (grade 1–2) AE episodes and 57 (57/504, 11.3%) serious (grade 3–5) AE episodes were reported. Among patients treated with amikacin, ethionamide/prothionamide, linezolid, and cycloserine/terizidone, 6.9% (9/131), 0.4% (1/221), 2.8% (15/536), and 1.8% (8/498), respectively, suffered serious AEs. Important information is offered by the aDSM study, but implementation requires scaling-up to support patient-centred care.
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