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Safety and Efficacy of Atorvastatin for Chronic Subdural Hematoma in Chinese Patients: A Randomized ClinicalTrial
Rongcai Jiang1, Shiguang Zhao2, Renzhi Wang3
1Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China.
Insights
Atorvastatin significantly reduced hematoma volume and improved neurological function in patients with chronic subdural hematoma (CSDH) compared to placebo. This suggests atorvastatin is a safe and effective nonsurgical treatment option for CSDH.
Area of Science:
- Neurology
- Pharmacology
- Clinical Medicine
Background:
- Chronic subdural hematoma (CSDH) is a common condition in the elderly, often requiring surgery with significant risks.
- Current nonsurgical treatments for CSDH are limited and often ineffective.
- Atorvastatin has shown potential in preliminary studies to reduce hematomas and improve outcomes in CSDH patients.
Purpose of the Study:
- To evaluate the safety and efficacy of atorvastatin as a nonsurgical treatment for CSDH.
- To compare the effects of atorvastatin versus placebo on hematoma volume and neurological function in CSDH patients.
Main Methods:
- A randomized, placebo-controlled, double-blind phase II clinical trial (ATOCH) was conducted with 200 CSDH patients.
- Participants received either 20 mg of atorvastatin or placebo daily for 8 weeks, with a 16-week follow-up.
- Primary outcome: change in hematoma volume; secondary outcomes: neurological function and need for surgery.
Main Results:
- Atorvastatin treatment resulted in a significantly greater reduction in hematoma volume (12.55 mL more than placebo, P=.003).
- Neurological function improved significantly in 45.9% of atorvastatin patients versus 28.6% of placebo patients (OR=1.957, P=.03).
- Fewer patients in the atorvastatin group required surgery (11.2% vs. 23.5%, HR=0.47, P=.03), with no significant adverse events reported.
Conclusions:
- Atorvastatin demonstrated safety and efficacy as a nonsurgical treatment for CSDH.
- The findings suggest atorvastatin as a viable alternative to surgery for select CSDH patients.
- Further research may establish atorvastatin as a standard nonsurgical therapeutic option for CSDH.
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.
Trial Registration:
ClinicalTrials.gov Identifier: NCT02024373.
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