Atorvastatin safe, effective for subdural hematoma treatment
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After 8 weeks, patients with chronic subdural hematoma who received atorvastatin had a greater difference in hematoma volume vs. patients who received placebo, according to phase 2 clinical trial data recently published in JAMA Neurology.
Chronic subdural hematoma occurs in 127.1 of every 100,000 patients aged older than 80 years, according to researchers.
“The current treatment for [chronic subdural hematoma] is surgery is to remove the hematoma, but the surgery carries a recurrence rate of approximately 25.6% in high-risk patients and a mortality rate of 24% to 32% in elderly patients. An overall mortality rate of 38.4% is reported for patients 90 years or older, independent of treatments,” Rongcai Jiang, MD, PhD, of the Tianjin Neurological Institute in China and colleagues wrote.
“Safer and more effective nonsurgical treatments are therefore highly desirable,” they added.
Researchers looked at hematoma volumes in 196 patients who had been diagnosed with chronic subdural hematoma by CT and were randomly assigned in a 1:1 ratio to receive either 20 mg of atorvastatin or placebo for 8 weeks. The patients’ hematoma volumes were nearly identical at baseline.
Jiang and colleagues found that after the 8-week period, hematoma volume dropped by 12.55 mL more in those receiving atorvastatin vs. those receiving placebo (95% CI, 0.9-23.9 mL). Atorvastatin’s effect on hematoma volume continued for 16 weeks of follow-up.
Researchers also noted that 45.9% of patients who received atorvastatin had significantly improved neurological function vs. 28.6% of those receiving placebo. Though no significant adverse events were reported, 11.2% of those receiving atorvastatin had surgery during the trial for an enlarging hematoma and/or a deteriorating clinical condition vs. 23.5% of those receiving placebo (HR = 0.47; 95% CI, 0.24-0.92).
“Our findings laid the foundation for a phase 3 trial to determine the efficacy of atorvastatin for treating patients with [chronic subdural hematoma]. The findings also call for the study of other statins for preventing and treating [chronic subdural hematoma],” Jiang and colleagues concluded. – by Janel Miller
Disclosure: The authors report no relevant financial disclosures.