Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa

Simple item page
dc.contributor.authorShean, Karenen_ZA
dc.contributor.authorStreicher, Elizabeth M.en_ZA
dc.contributor.authorPieterson, Elizeen_ZA
dc.contributor.authorSymons, Gregen_ZA
dc.contributor.authorVan Zyl Smit, Richarden_ZA
dc.contributor.authorTheron, Granten_ZA
dc.contributor.authorLehloenya, Rannakoeen_ZA
dc.contributor.authorPadanilam, Xavieren_ZA
dc.contributor.authorWilcox, Paulen_ZA
dc.contributor.authorVictor, Tommie C.en_ZA
dc.contributor.authorVan Helden, Paul D.en_ZA
dc.contributor.authorGroubusch, Martinen_ZA
dc.contributor.authorWarren, Robin M.en_ZA
dc.contributor.authorBadri, Motasimen_ZA
dc.contributor.authorDheda, Keertanen_ZA
dc.date.accessioned2014-07-07T12:18:30Z
dc.date.available2014-07-07T12:18:30Z
dc.date.issued2013-05-07
dc.descriptionCITATION: Shean, K. et al. 2013. Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa. PLoS ONE, 8(5): e63057, doi:10.1371/journal.pone.0063057.
dc.descriptionThe original publication is available at http://journals.plos.org/plosone
dc.description.abstractBackground: Treatment-related outcomes in patients with extensively drug-resistant tuberculosis (XDR-TB) are poor. However, data about the type, frequency and severity of presumed drug-associated adverse events (AEs) and their association with treatment-related outcomes in patients with XDR-TB are scarce. Methods: Case records of 115 South-African XDR-TB patients were retrospectively reviewed by a trained researcher. AEs were estimated and graded according to severity [grade 0 = none; grade 1–2 = mild to moderate; and grade 3–5 = severe (drug stopped, life-threatening or death)]. Findings: 161 AEs were experienced by 67/115(58%) patients: 23/67(34%) required modification of treatment, the offending drug was discontinued in 19/67(28%), reactions were life-threatening in 2/67(3.0%), and 6/67(9.0%) died. ∼50% of the patients were still on treatment at the time of data capture. Sputum culture-conversion was less likely in those with severe (grade 3–5) vs. grade 0–2 AEs [2/27(7%) vs. 24/88(27%); p = 0.02]. The type, frequency and severity of AEs was similar in HIV-infected and uninfected patients. Capreomycin, which was empirically administered in most cases, was withdrawn in 14/104(14%) patients, implicated in (14/34) 41% of the total drug withdrawals, and was associated with all 6 deaths in the severe AE group (renal failure in five patients and hypokalemia in one patient). Conclusion: Drug-associated AEs occur commonly with XDR-TB treatment, are often severe, frequently interrupt therapy, and negatively impact on culture conversion outcomes. These preliminary data inform on the need for standardised strategies (including pre-treatment counselling, early detection, monitoring, and follow-up) and less toxic drugs to optimally manage patients with XDR-TB.
dc.description.urihttp://journals.plos.org/plosone/article?id=10.1371/journal.pone.0063057
dc.description.versionPublisher's version
dc.format.extent10 pages
dc.identifier.citationShean, K. et al. 2013. Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa. PLoS ONE, 8(5): e63057, doi:10.1371/journal.pone.0063057.
dc.identifier.issn1932-6203 (online)
dc.identifier.otherdoi:10.1371/journal.pone.0063057
dc.identifier.urihttp://hdl.handle.net/10019.1/93368
dc.language.isoen
dc.publisherPublic Library of Science
dc.rights.holderAuthors retain copyright
dc.subjectTuberculosis -- South Africaen_ZA
dc.subjectTuberculosis -- Treatment -- South Africaen_ZA
dc.titleDrug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africaen_ZA
dc.typeArticle
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
shean_drug_2013.PDF
Size:
440.78 KB
Format:
Adobe Portable Document Format
Description:
Download article
Download
Collections
Research Articles (Molecular Biology and Human Genetics)