No survival benefit or benefit in any secondary end point seen for adjunctive dexamethasone versus placebo
By Elana Gotkine HealthDay Reporter
THURSDAY, Oct. 12, 2023 (HealthDay News) — For HIV-positive adults with tuberculous meningitis, adjunctive dexamethasone does not confer a benefit with respect to survival, according to a study published in the Oct. 12 issue of the New England Journal of Medicine.
Joseph Donovan, Ph.D., from the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam, and colleagues conducted a double-blind, randomized, placebo-controlled trial involving HIV-positive adults with tuberculous meningitis in Vietnam and Indonesia. In addition to 12 months of antituberculosis chemotherapy, participants were randomly assigned to receive a six- to eight-week tapering course of dexamethasone or placebo (263 and 257, respectively).
The researchers found that during 12 months of follow-up, death occurred in 44.1 and 49.0 percent of participants in the dexamethasone and placebo groups, respectively (hazard ratio, 0.85; 95 percent confidence interval, 0.66 to 1.10; P = 0.22). In prespecified analyses, no subgroup was found that clearly benefited from dexamethasone. The two trial groups had a similar incidence of secondary end points, including cases of immune reconstitution inflammatory syndrome during the first six months. The two groups had similar numbers of participants with at least one serious adverse event (73.0 and 75.5 percent, respectively).
“We did not find a benefit of adjunctive dexamethasone in HIV-positive adults with tuberculous meningitis with respect to survival or any secondary end point over a period of 12 months,” the authors write.
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