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New England Journal of Medicine (12/31/21) doi: 10.1056/NEJMoa2020473

Hutchinson, Peter J.; Edlmann, Ellie; Bulters, Diederik; et al.

https://www.nejm.org/doi/full/10.1056/NEJMoa2020473

Patients with chronic subdural hematoma who were treated with dexamethasone had fewer favorable outcomes and more adverse events at six months compared with those who received placebo, according to new research. The multicenter, randomized trial — which was conducted in the United Kingdom from August 2015 through November 2019 — included 748 adults with symptomatic chronic subdural hematoma. The participants had a mean age of 74 years, and 94% had undergone surgery to remove their hematomas during the index admission. In each group, 60% of the patients had a score of 1 to 3 on the modified Rankin Scale at admission. A modified intention-to-treat analysis involving 680 patients showed a favorable outcome — a score of 0 to 3 on the modified Rankin Scale at six months after randomization — in 83.9% patients (286 of 341) in the dexamethasone group and in 90.3% (306 of 339) of the placebo group. In all, 1.7% (6) patients in the dexamethasone group and 7.1% (25) in the placebo group had repeat surgery for recurrence for the hematoma. Adverse events were more frequent in the dexamethasone group compared with the placebo group, with serious adverse events occurring in 16.0% and 6.4%, respectively. Adverse events of special interest — including hyperglycemia leading to treatment or discontinuation of the trial regimen, new-onset diabetes, hyperosmolar hyperglycemic state, new-onset psychosis, and upper gastrointestinal adverse effects — were reported in 10.9% and 3.2% in the two groups, respectively. The risk of any infection was 6.4% in the dexamethasone arm vs. 1.1% in the placebo arm.

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