IMPORTANCE Chronic subdural hematoma (CSDH) is a trauma-associated condition commonly found in elderly patients. Surgery is currently the treatment of choice, but it carries a significant risk of recurrence and death. Nonsurgical treatments remain limited and ineffective. Our recent studies suggest that atorvastatin reduces hematomas and improves the clinical outcomes of patients with CSDH.
OBJECTIVE To investigate the safety and therapeutic efficacy of atorvastatin to nonsurgically treat patients with CSDH.
DESIGN, SETTING, AND PARTICIPANTS The Effect of Atorvastatin on Chronic Subdural Hematoma (ATOCH) randomized, placebo-controlled, double-blind phase II clinical trial was conducted in multiple centers in China from February 2014 to November 2015. For this trial, we approached 254 patients with CSDH who received a diagnosis via a computed tomography scan; of these, 200 (78.7%) were enrolled because 23 patients (9.1%) refused to participate and 31(12.2%) were disqualified.
INTERVENTIONS Patients were randomly assigned to receive either 20 mg of atorvastatin or placebo daily for 8 weeks and were followed up for an additional 16 weeks.
MAIN OUTCOMES AND MEASURES The primary outcome was change in hematoma volume (HV) by computed tomography after 8 weeks of treatment. The secondary outcomes included HV measured at the 4th, 12th, and 24th weeks and neurological function that was evaluated using the Markwalder grading scale/Glasgow Coma Scale and the Barthel Index at the 8th week.
RESULTS One hundred ninety-six patients received treatment (169 men [86.2%); median [SD] age, 63.6 [14.2] years). The baseline HV and clinical presentations were similar between patients who were taking atorvastatin (98 [50%]) and the placebo (98 [50%]). After 8 weeks, the HV reduction in patients who were taking atorvastatin was 12.55 mL more than those taking the placebo (95% CI, 0.9-23.9 mL; P = .003). Forty-five patients (45.9%) who were taking atorvastatin significantly improved their 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). Eleven patients (11.2%) who were taking atorvastatin and 23 (23.5%) who were taking the placebo underwent 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). No significant adverse events were reported.
CONCLUSIONS AND RELEVANCE Atorvastatin may be a safe and efficacious nonsurgical alternative for treating patients with CSDH.
[1]Minist Educ China & Tianjin, Tianjin Neurol Inst, Key Lab Postneurotrauma Neurorepair & Regenerat C, Tianjin, Peoples R China;
[2]Harbin Med Univ, Affiliated Hosp 1, Dept Neurosurg, Harbin, Heilongjiang, Peoples R China;
[3]Peking Union Med Coll Hosp, Dept Neurosurg, Beijing, Peoples R China;
[4]Southwest Hosp, Dept Neurosurg, Chongqing, Peoples R China;
[5]Zhejiang Univ, Sch Med, Affiliated Hosp 2, Dept Neurosurg, Hangzhou, Zhejiang, Peoples R China;
[6]Shandong Univ, Qilu Hosp, Dept Neurosurg, Jinan, Shandong, Peoples R China;
[7]Fudan Univ, Huashan Hosp, Dept Neurosurg, Shanghai, Peoples R China;
[8]Cent S Univ, Xiangya Hosp, Dept Neurosurg, Changsha, Hunan, Peoples R China;
[9]Xijing Hosp, Dept Neurosurg, Xian, Shaanxi, Peoples R China;
[10]Capital Med Univ, Beijing TianTan Hosp, Dept Neurosurg, Beijing, Peoples R China;
[11]Chinese Peoples Liberat Army, Gen Hosp, Dept Neurosurg, Beijing, Peoples R China;
[12]Chinese Univ Hong Kong, Prince Wales Hosp, Dept Surg, Div Neurosurg, Shatin, Hong Kong, Peoples R China;
[13]Linyi Peoples Hosp, Dept Neurosurg, Linyi, Peoples R China;
[14]Nanjing Med Univ, Affiliated Hosp 1, Dept Neurosurg, Jiangsu Prov Hosp, Nanjing, Jiangsu, Peoples R China;
[15]Fujian Med Univ, Affiliated Hosp 1, Dept Neurosurg, Fuzhou, Fujian, Peoples R China;
[16]Ningxia Med Univ, Gen Hosp, Dept Neurosurg, Yinchuan, Peoples R China;
[17]Hebei Med Univ, Affiliated Hosp 2, Dept Neurosurg, Shijiazhuang, Hebei, Peoples R China;
[18]Zhengzhou Univ, Affiliated Hosp 1, Dept Neurosurg, Zhengzhou, Henan, Peoples R China;
[19]Xuzhou Med Coll, Affiliated Hosp, Dept Neurosurg, Xuzhou, Jiangsu, Peoples R China;
[20]Cent Hosp Erdos, Dept Neurosurg, Erdos, Peoples R China;
[21]Fourth Mil Med Univ, Dept Neurosurg, Xian Tangdu Hosp, Xian, Shaanxi, Peoples R China;
[22]Shanxi Med Univ, Affiliated Hosp 1, Dept Neurosurg, Taiyuan, Shanxi, Peoples R China;
[23]Prov Peoples Hosp Inner Mongolia, Dept Neurosurg, Hohhot, Peoples R China;
[24]Cangzhou Cent Hosp, Dept Neurosurg, Cangzhou, Peoples R China;
[25]Nanchang Univ, Affiliated Hosp 2, Dept Neurosurg, Nanchang, Jiangxi, Peoples R China;
[26]Shanghai Changzheng Hosp, Dept Neurosurg, Shanghai, Peoples R China;
[27]Chinese Peoples Liberat Army, Hosp 117, Dept Neurosurg, Hangzhou, Zhejiang, Peoples R China;
[28]Tianjin Med Univ, Gen Hosp, Tianjin Geriatr Inst, Lab Neurotrauma & Neurodegenerat Disorders, Tianjin, Peoples R China;
[29]Tianjin Med Univ, Gen Hosp, Dept Geriatr, Tianjin, Peoples R China;
[30]Univ Washington, Sch Med, Dept Med, Bloodworks Res Inst,Div Hematol, Seattle, WA 98195 USA
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