• Sayed Idrees Shah, Abdul Ghafoor, Shafiq Ur Rahman, AbidullahDepartment of Pharmacy, Shaheed Benazir Bhutto University, Sheringal, Pakistan., Nafees Ahmad, Ayman M Al-Qaaneh, and Faisal Younis.
• Department of Pharmacy, Shaheed Benazir Bhutto University, Sheringal, Pakistan.
• J Eval Clin Pract. 2024 Nov 4.

BackgroundPatients suffering from multidrug/rifampicin resistant tuberculosis (MDR/RR-TB) are treated for prolonged periods with a complex regimen comprised of relatively less effective and more toxic anti-TB drugs, consequently resulting in high incidence of adverse events (AEs).Study AimThe current study evaluates the incidence, types, management and predictors of AEs, and their impact on treatment outcomes in MDR/RR-TB patients receiving all oral treatment regimens.Study DesignA total of 242 eligible MDR/RR-TB patients treated at two different study sites from June 2019 to December 2021 were included in this study.Measures And OutcomesPatients' sociodemographic, microbiological, clinical characteristics, reported AEs and treatment outcomes were retrospectively abstracted from their medical records. Chi-square, and Fisher exact tests (wherever applicable) were used to find the association between the variable and the occurrence of AEs.ResultsMajority of the patients were suffered from MDR-TB (71.9%) and were treated with longer treatment regimen (77.7%). Overall 206/242 patients (85%) experienced at least one AE during their treatment. Gastrointestinal disturbance was the most common AE (49.6%), followed by arthralgia (49.2%), psychiatric disturbances (39.3%), dermatological reactions (27.7%), body/headache (24.8%) and hyperuricemia (19%). Due to AEs, treatment modification was noted in 55 (22.72%) patients. Level of modification in the treatment regimen was higher in optic neuritis (100%) followed by neuropathies (80%) and myelosuppression (59%). Similarly, hepatotoxicity was the most serious AE in which the whole treatment regimen was terminated in 27% of patients. Furthermore, the results revealed that only patients' education status had statistically significant association with the incidence of AEs (p = 0.02). The treatment success rate was 80.6% whereas the ratio of died and LTFU patients were 15.3% and 4.1% respectively. Although patients who experienced AEs were more likely to develop successful treatment outcomes (82%) than their counterparts (72.2%), though this difference was not statistically significant.ConclusionAlthough AEs were highly present in the current cohort, but they were successfully managed mostly by nonpharmacological interventions or symptomatic treatment. Besides, the incidence of AEs did not have a negative impact on treatment outcomes. High-risk patients for AEs must receive special attention and enhanced clinical management.© 2024 John Wiley & Sons Ltd.

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