Jiang R, et al. - The Effect of Atorvastatin on Chronic Subdural Hematoma (ATOCH) randomized, placebo-controlled, double-blind phase II clinical trial was carried out in multiple centers in China from February 2014 to November 2015 to examine the safety and therapeutic effectiveness of atorvastatin during nonsurgical treatment of patients with chronic subdural hematoma (CSDH). For treating patients with CSDH, atorvastatin could be a safe and effective nonsurgical alternative.

Methods

• For this investigation, 254 subjects with CSDH who received a diagnosis via a computed tomography scan were approached.
• Of these, 200 (78.7%) were enlisted; 23 patients (9.1%) declined to take an interest and 31 (12.2%) were disqualified.
• Patients were randomly assigned to get either 20 mg of atorvastatin or placebo daily for 8 weeks, and were followed up for an additional 16 weeks.
• Change in hematoma volume (HV) by computed tomography after 8 weeks of treatment was the primary outcome.
• The secondary outcomes involved HV measured at the 4th, 12th, and 24th weeks and neurological function that was assessed utilizing the Markwalder grading scale/Glasgow Coma Scale and the Barthel Index at the 8th week.

Results

• According to the findings, 196 subjects received treatment (169 men [86.2%]; median [SD] age, 63.6 [14.2] years).
• Baseline HV and clinical presentations were similar between subjects who were taking atorvastatin (98 [50%]) and placebo (98 [50%]).
• It was noted that the HV reduction in patients who were taking atorvastatin was 12.55 mL more than those taking placebo (95% CI, 0.9-23.9 mL; P=.003) after 8 weeks.
• Findings revealed that 45 patients (45.9%) who were taking atorvastatin had significant improvements in neurological function, but only 28 (28.6%) who were taking the placebo did, resulting in an adjusted odds ratio of 1.957 for clinical improvements (95% CI, 1.07-3.58; P=.03).
• Data revealed that 11 patients (11.2%) taking atorvastatin and 23 (23.5%) taking the placebo had surgery during the trial for an enlarging hematoma and/or a deteriorating clinical condition (hazard ratio, 0.47; 95% CI, 0.24-0.92; P=.03).
• The outcomes showed no significant adverse events were reported.