Treatment of chronic subdural hematoma with atorvastatin combined with low-dose dexamethasone: phase II randomized proof-of-concept clinical trial.

OBJECTIVE

The authors sought to test the hypothesis that adding dexamethasone (DXM) to atorvastatin (ATO) potentiates the effects of ATO on chronic subdural hematoma (CSDH).

METHODS

Sixty patients with CSDH underwent 5 weeks of treatment with an additional 7-week follow-up. Patients were randomized to receive a 5-week regimen of ATO 20 mg daily or ATO 20 mg daily plus a DXM regimen (ATO+DXM). The 5-week DXM regimen was 2.25 mg daily for 2 consecutive weeks, followed by 0.75 mg twice daily for 2 weeks and 0.75 mg once daily for 1 week. The primary endpoint was hematoma reduction assessed by neuroimaging at baseline and at 5 weeks of follow-up. Secondary outcomes included neurological improvement assessed by using the Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS).

RESULTS

The mean patient age was 66.6 years, and 25% of patients were women. The patients who were treated with ATO+DXM had more obvious hematoma reduction at the 5th week (between-groups difference 18.37 ml; 95% CI 8.17-28.57; p = 0.0005). This reduction started from the 2nd week (14.51 ml; 95% CI 4.31-24.71; p = 0.0056) of treatment and persisted until the 12th week (17.50 ml; 95% CI 7.30-27.70; p = 0.0009). Complete recovery of neurological function (MGS-GCS grade 0) at 5 weeks was achieved in 83.33% and 32.14% of patients in the ATO+DXM and ATO groups, respectively. At the 5th week, patients receiving ATO+DXM had significantly lower levels of T cells and higher levels of regulatory T cells and endothelial progenitor cells in their peripheral blood.

CONCLUSIONS

ATO+DXM was more effective than ATO alone in reducing hematoma and improving neurological function in patients with CSDH. These results require further confirmation in a randomized placebo-controlled trial.Clinical trial registration no.: ChiCTR-IPR-14005573 (http://www.chictr.org.cn/index.aspx).