Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa.
<h4>Background</h4>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 patient...
Guardado en:
| Autores principales: | , , , , , , , , , , , , , , |
|---|---|
| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
Public Library of Science (PLoS)
2013
|
| Materias: | |
| Acceso en línea: | https://doaj.org/article/8445b22ee32749ae8d66166770a7d2b1 |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:doaj.org-article:8445b22ee32749ae8d66166770a7d2b1 |
|---|---|
| record_format |
dspace |
| spelling |
oai:doaj.org-article:8445b22ee32749ae8d66166770a7d2b12021-11-18T07:46:36ZDrug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa.1932-620310.1371/journal.pone.0063057https://doaj.org/article/8445b22ee32749ae8d66166770a7d2b12013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23667572/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>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.<h4>Methods</h4>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)].<h4>Findings</h4>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).<h4>Conclusion</h4>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.Karen SheanElizabeth StreicherElize PietersonGreg SymonsRichard van Zyl SmitGrant TheronRannakoe LehloenyaXavier PadanilamPaul WilcoxTommie C VictorPaul van HeldenMartin P GrobuschRobin WarrenMotasim BadriKeertan DhedaPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 5, p e63057 (2013) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
Medicine R Science Q |
| spellingShingle |
Medicine R Science Q Karen Shean Elizabeth Streicher Elize Pieterson Greg Symons Richard van Zyl Smit Grant Theron Rannakoe Lehloenya Xavier Padanilam Paul Wilcox Tommie C Victor Paul van Helden Martin P Grobusch Robin Warren Motasim Badri Keertan Dheda Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa. |
| description |
<h4>Background</h4>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.<h4>Methods</h4>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)].<h4>Findings</h4>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).<h4>Conclusion</h4>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. |
| format |
article |
| author |
Karen Shean Elizabeth Streicher Elize Pieterson Greg Symons Richard van Zyl Smit Grant Theron Rannakoe Lehloenya Xavier Padanilam Paul Wilcox Tommie C Victor Paul van Helden Martin P Grobusch Robin Warren Motasim Badri Keertan Dheda |
| author_facet |
Karen Shean Elizabeth Streicher Elize Pieterson Greg Symons Richard van Zyl Smit Grant Theron Rannakoe Lehloenya Xavier Padanilam Paul Wilcox Tommie C Victor Paul van Helden Martin P Grobusch Robin Warren Motasim Badri Keertan Dheda |
| author_sort |
Karen Shean |
| title |
Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa. |
| title_short |
Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa. |
| title_full |
Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa. |
| title_fullStr |
Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa. |
| title_full_unstemmed |
Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa. |
| title_sort |
drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in south africa. |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2013 |
| url |
https://doaj.org/article/8445b22ee32749ae8d66166770a7d2b1 |
| work_keys_str_mv |
AT karenshean drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT elizabethstreicher drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT elizepieterson drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT gregsymons drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT richardvanzylsmit drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT granttheron drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT rannakoelehloenya drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT xavierpadanilam drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT paulwilcox drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT tommiecvictor drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT paulvanhelden drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT martinpgrobusch drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT robinwarren drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT motasimbadri drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica AT keertandheda drugassociatedadverseeventsandtheirrelationshipwithoutcomesinpatientsreceivingtreatmentforextensivelydrugresistanttuberculosisinsouthafrica |
| _version_ |
1718422984097529856 |