(HealthDay)—For patients with HIV-associated cryptococcal meningitis, dexamethasone does not reduce mortality compared with placebo, according to a study published in the Feb. 11 issue of the New England Journal of Medicine.
Justin Beardsley, M.B., Ch.B., from the Oxford University Clinical Research Unit in the United Kingdom, and colleagues recruited adult patients with HIV-associated cryptococcal meningitis in Vietnam, Thailand, Indonesia, Laos, Uganda, and Malawi. Participants were randomized to dexamethasone or placebo for six weeks, with combination antifungal therapy with amphotericin B and fluconazole.
After enrollment of 451 patients the trial was stopped for safety reasons. The researchers found that by 10 weeks, mortality was 47 and 41 percent in the dexamethasone and placebo groups, respectively (hazard ratio in the dexamethasone group, 1.11; 95 percent confidence interval, 0.84 to 1.47); by six months, mortality was 57 and 49 percent, respectively (hazard ratio, 1.18; 95 percent confidence interval, 0.91 to 1.53). At 10 weeks, the percentage of patients with disability was higher in the dexamethasone versus the placebo group (13 and 25 percent with a prespecified good outcome, respectively; odds ratio, 0.42; 95 percent confidence interval, 0.25 to 0.69). Compared with the placebo group, the dexamethasone group more frequently had clinical adverse events (667 versus 494 events; P = 0.01)
"Dexamethasone did not reduce mortality among patients with HIV-associated cryptococcal meningitis and was associated with more adverse events and disability than was placebo," the authors write.
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Journal information: New England Journal of Medicine
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