Occurrence, Management, and Risk Factors for Adverse Drug Reactions in Multidrug Resistant Tuberculosis Patients

Abstract

Although Pakistan has a high burden of multidrug-resistant tuberculosis (MDR-TB), little is known about prevalence, management, and risk factors for adverse drug reactions (ADRs) in MDR-TB patients in Pakistan. To evaluate occurrence, management, and risk factors for ADRs in MDR-TB patients, and its impact on treatment outcomes, this observational cohort study was conducted at programmatic management unit for drug resistant TB of Lady Reading Hospital Peshawar, Pakistan. A total of 181 MDR-TB patients enrolled at the study site from January 1, 2012 to February 28, 2013 were included. Patients with drug resistant TB other than MDR-TB, transferred out patients and those who were still on treatment at the end of study duration (January 31, 2015) were excluded. Patients were followed until treatment outcomes were reported. ADRs were determined by laboratory data and/or clinical criteria. SPSS 16 was used for data analysis. A total of 131 patients (72.4%) experienced at least 1 ADR. Gastrointestinal disturbance was the most commonly observed adverse event (42%), followed by psychiatric disturbance (29.3%), arthralgia (24.3%), and ototoxicity (21%). Potentially life-threatening ADRs, such as nephrotoxicity (2.7%) and hypokalemia (2.8%) were relatively less prevalent. Owing to ADRs, treatment regimen was modified in 20 (11%) patients. On multivariate analysis, the only risk factor for ADRs was baseline body weight ≥ 40 kg (OR = 2.321, P-value = 0.013). ADRs neither led to permanent discontinuation of treatment nor adversely affected treatment outcomes. Adverse effects were prevalent in current cohort, but caused minimal modification of treatment regimen, and did not negatively impact treatment outcomes. Patient with baseline body weight ≥ 40 kg should be closely monitored.

Active surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in Viet Nam

“…Gastrointestinal disorders and arthralgia were the most common AEs, with 38.5% and 34.7%, respectively, in this study. These results were consistent with the previous study (35.8%) in Viet Nam in 2015 [ 4 ] however, higher than reported in other studies (18–24%) [ 6 , 18 ]. Nearly all patients in this study were treated with Pto in their regimens.…”

“…The frequency of AEs reported for patients on MDR-TB treatment varies between studies [ 6 , 18 , 19 ]. A systematic review and meta-analysis reported 57.3% of MDR-TB patients having at least one AE compared with 71.3% in our study [ 20 ].…”

Nephrotoxicity and ototoxic symptoms of injectable second-line anti-tubercular drugs among patients treated for MDR-TB in Ethiopia: a retrospective cohort study

“…This observations are comparable to other studies in the setting which reported prevalence of 8.8% renal insufficiency and 6.0% hearing impairment [21, 38] which reported comparable findings in small cohort of patients. However, ototoxic symptom finding in our study was several times lower than a study from Iran [39] which reported 14.5% auditory toxicity and Pakistan study [40] which reported 21% ototoxicity and a UK study [35] which reported 55% of ototoxicity. The differences might be due to lack of audiometric follow up at current study setting which underestimated our finding while stated studies indicated availability of audiometric assessments.…”

Effectiveness and Safety of a Shorter Treatment Regimen in a Setting with a High Burden of Multidrug-Resistant Tuberculosis

“…Although patients of older age, those under-nourished and those with co-morbid conditions had an increased hazard of DAE, these associations did not reach statistical significance in our study population, most likely to due to small sample sizes. This is in contrast to other studies conducted among RR/MDR-TB patients on the longer treatment regimen [ 36 , 37 ].…”