• Rongcai Jiang, Shiguang Zhao, Renzhi Wang, Hua Feng, Jianmin Zhang, Xingang Li, Ying Mao, Xianrui Yuan, Zhou Fei, Yuanli Zhao, Xinguang Yu, Wai Sang Poon, Xide Zhu, Ning Liu, Dezhi Kang, Tao Sun, Baohua Jiao, Xianzhi Liu, Rutong Yu, Junyi Zhang, Guodong Gao, Jiehe Hao, Ning Su, Gangfeng Yin, Xingen Zhu, Yicheng Lu, Junji Wei, Jin Hu, Rong Hu, Jianrong Li, Dong Wang, Huijie Wei, Ye Tian, Ping Lei, Jing-Fei Dong, and Jianning Zhang.
• Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China.
• JAMA Neurol. 2018 Nov 1; 75 (11): 1338-1346.

ImportanceChronic 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.ObjectiveTo investigate the safety and therapeutic efficacy of atorvastatin to nonsurgically treat patients with CSDH.Design, Setting, And ParticipantsThe 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.InterventionsPatients 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 MeasuresThe 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.ResultsOne 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 RelevanceAtorvastatin may be a safe and efficacious nonsurgical alternative for treating patients with CSDH.Trial RegistrationClinicalTrials.gov Identifier: NCT02024373.

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