Doing no harm? Adverse events in a nation-wide cohort of patients with multidrug-resistant tuberculosis in Nigeria.
This was a observational study, using data collected at all multidrug-resistant-TB treatment centres in Nigeria
Abstract
Background
Adverse events (AEs) of second line anti-tuberculosis drugs (SLDs) are relatively well documented. However, the actual burden has rarely been described in detail in programmatic settings. We investigated the occurrence of these events in the national cohort of multidrug-resistant tuberculosis (MDR-TB) patients in Nigeria.
Method
This was a retrospective, observational cohort study, using pharmacovigilance data systematically collected at all MDR-TB treatment centers in Nigeria. Characteristics of AEs during the intensive phase treatment were documented, and risk factors for development of AEs were assessed.
Results
460 patients were included in the analysis: 62% were male; median age was 33 years and median weight was 51 kg. 203 (44%) patients experienced AEs; 4 died of conditions associated with SLD AEs. Gastro-intestinal, neurological, ototoxic and psychiatric AEs were the most commonly reported, whereas ototoxic and psychiatric AEs were the most debilitating. Majority of AEs developed after 1–2 months of therapy, and resolved in less than a month after treatment. Some treatment centers were twice as likely to report AEs compared with others, highlighting significant inconsistencies in reporting at different treatment centers. Patients with a higher body weight had an increased risk of experiencing AEs. No differences were observed in risk of AEs between HIV-infected and uninfected patients. Similarly, age was not significantly associated with AEs.
This research was supported by the UK Department for International Development’s Operational Research Capacity Building Programme led by the International Union Against TB and Lung Disease (The Union)
Citation
Avong YK, Isaakidis P, Hinderaker SG, Van den Bergh R, Ali E, Obembe BO, et al. (2015) Doing No Harm? Adverse Events in a Nation-Wide Cohort of Patients with Multidrug-Resistant Tuberculosis in Nigeria. PLoS ONE 10(3): doi:10.1371/journal.pone.0120161