Prevalence and Predictors of Adverse Drug Effects with second Line Anti-tB drugs Under Programmatic Management of Drug Resistant tuberculosis (PMDt) services in Amritsar District

Nagpal, Manisha; Kaur, Harpreet; Devgun, Priyanka; Chawla, Naresh

doi:10.5958/0976-5506.2018.00032.3

Cited by 2 publications

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“…Pruritis, rash, or acne was reported in 35 (12.9%) patients. Similar findings have been reported with varying frequencies ranging from 45% to 2.64% ( Bezu et al, 2014 ; Akshata et al, 2015b ; Rathod et al, 2015 ; Nagpal et al, 2018 ). Pyrazinamide and amikacin were suspected as the causative agents.…”

Section: Discussionsupporting

confidence: 89%

Frequency and Management of Adverse Drug Reactions Among Drug-Resistant Tuberculosis Patients: Analysis From a Prospective Study

et al. 2022

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Drug-resistant tuberculosis (DR-TB) management is often linked with a higher rate of adverse drug reactions (ADRs) needing effective and timely management of these ADRs, which, if left untreated, may result in a higher rate of loss to follow-up of drug-resistant patients.Study objective: The study was aimed at prospectively identifying the nature, frequency, suspected drugs, and management approaches for ADRs along with risk factors of ADRs occurrence among DR-TB patients at Nishtar Medical University, Hospital, Multan, Pakistan.Materials and Methods: The prospective study included all the DR-TB patients enrolled for treatment from January 2016 to May 2017 at the study site. Patients were evaluated for the treatment-induced ADRs as per standard criteria of the National Tuberculosis Program, Pakistan. Multivariate logistic regression was used to assess the independent variables associated with the occurrence of ADRs.Results: Out of 271 DR-TB patients included in the final analysis, it was observed that 55 patients (20.3%) experienced at least three ADRs. A total of 50 (18.5%) patients experienced zero adverse effects, while 15 (5.5%), 33 (12.2%), and 53 (19.6%) patients experienced one, two, and four ADRs, respectively. Gastrointestinal disturbances (66.7%), nervous system disorders (59.4%), and electrolyte disturbances (55.7%) remained the highest reported ADRs during therapy, followed by arthralgia (49.1%), ototoxicity (24%), pruritic reactions/rash (12.9%), dyspnoea (12.5%), and tinnitus (8.8%). Pulmonary cavitation at the baseline visit (p-value 0.001, OR 3.419; 95% CI (1.694–6.902) was significantly associated with the occurrence of ADRs among DR-TB patients.Conclusion: The frequency of ADRs was high among the study cohort; however, these were managed effectively. Patients with recognized risk factors for ADRs occurrence need continuous clinical management efforts.

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Section: Discussionsupporting

confidence: 89%

Frequency and Management of Adverse Drug Reactions Among Drug-Resistant Tuberculosis Patients: Analysis From a Prospective Study

et al. 2022

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Incidence, types and predictors of adverse events and their impact on treatment outcomes in multidrug/rifampicin resistant tuberculosis patients receiving all oral treatment regimens

Shah,

Ghafoor,

Rahman

et al. 2024

Evaluation Clinical Practice

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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.

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Prevalence and Predictors of Adverse Drug Effects with second Line Anti-tB drugs Under Programmatic Management of Drug Resistant tuberculosis (PMDt) services in Amritsar District

Cited by 2 publications

References 0 publications

Frequency and Management of Adverse Drug Reactions Among Drug-Resistant Tuberculosis Patients: Analysis From a Prospective Study

Frequency and Management of Adverse Drug Reactions Among Drug-Resistant Tuberculosis Patients: Analysis From a Prospective Study

Incidence, types and predictors of adverse events and their impact on treatment outcomes in multidrug/rifampicin resistant tuberculosis patients receiving all oral treatment regimens

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