Abstract | BACKGROUND: METHODS: Vietnamese adults and adolescents with tuberculous meningitis recruited to a randomised, double-blind, placebo-controlled trial of adjunctive dexamethasone were followed-up at five years, to determine the effect of dexamethasone on long-term survival and neurological disability. RESULTS: 545 patients were randomised to receive either dexamethasone (274 patients) or placebo (271 patients). 50 patients (9.2%) were lost to follow-up at five years. In all patients two-year survival, probabilities tended to be higher in the dexamethasone arm (0.63 versus 0.55; p = 0.07) but five-year survival rates were similar (0.54 versus 0.51, p = 0.51) in both groups. In patients with grade 1 TBM, but not with grade 2 or grade 3 TBM, the benefit of dexamethasone treatment tended to persist over time (five-year survival probabilities 0.69 versus 0.55, p = 0.07) but there was no conclusive evidence of treatment effect heterogeneity by TBM grade (p = 0.36). The dexamethasone group had a similar proportion of severely disabled patients among survivors at five years as the placebo group (17/128, 13.2% vs. 17/116, 14.7%) and there was no significant association between dexamethasone treatment and disability status at five years (p = 0.32). CONCLUSIONS: Adjunctive dexamethasone appears to improve the probability of survival in patients with TBM, until at least two years of follow-up. We could not demonstrate a five-year survival benefit of dexamethasone treatment which may be confined to patients with grade 1 TBM. TRIAL REGISTRATION: ClinicalTrials.gov NCT01317654.
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Authors | M Estée Török, Duc Bang Nguyen, Thi Hong Chau Tran, Thi Bich Yen Nguyen, Guy E Thwaites, Thi Quy Hoang, Huy Dung Nguyen, Tinh Hien Tran, Tran Chinh Nguyen, Hoang Thi Thanh Hoang, Marcel Wolbers, Jeremy J Farrar |
Journal | PloS one
(PLoS One)
Vol. 6
Issue 12
Pg. e27821
( 2011)
ISSN: 1932-6203 [Electronic] United States |
PMID | 22174748
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Dexamethasone
(therapeutic use)
- Female
- Follow-Up Studies
- Humans
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Proportional Hazards Models
- Time Factors
- Treatment Outcome
- Tuberculosis, Meningeal
(drug therapy)
- Vietnam
- Young Adult
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