Chinese trial shows atorvastatin decreased volume, improved neurologic function
Atorvastatin (Lipitor) may be an effective, non-surgical treatment for chronic subdural hematoma, a randomized controlled phase II trial suggests.
Patients with chronic subdural hematoma taking atorvastatin for 8 weeks had a larger decrease in hematoma volume and were twice as likely to show improved neurologic function compared with patients taking placebo, reported Jianning Zhang, MD, PhD, of Tianjin Medical University General Hospital in China, and colleagues in JAMA Neurology.
"Atorvastatin is effective in the treatment of chronic subdural hematoma in Chinese patients," Zhang told MedPage Today. "This treatment has been used in multiple neurosurgery hospitals in China and may also benefit patients in the U.S."
Chronic subdural hematoma, a collection of "old" blood on the brain's surface that sometimes follows a head injury, is prevalent mostly in elderly people. By 2030, it is expected to be the most common adult brain condition requiring neurosurgical intervention in the U.S.
"I haven't seen statin medications used this way before, but in the few last years there've been some interesting treatments for chronic subdural collections," commented Howard Riina, MD, of New York University Langone Health, who was not involved in the study.
Historically, chronic subdural hematomas have been treated surgically, "but the problem with surgery is that collections can re-accumulate," Riina said in an interview with MedPage Today. "If you go back many, many years, there was a whole group of neurologists who treated patients with steroids. Some patients got better; that indicated there might be an inflammatory component to the perpetuating natures of these collections."
More recently, tranexamic acid has been used with good results, but it can promote clots. Embolization of the middle meningeal artery to shut down the blood supply to the covering of the brain is a newer treatment with "a very, very high response, but it requires a procedure," Riina noted.
In this placebo-controlled, double-blind clinical trial,the researchers studied 196 patients with chronic subdural hematoma in multiple centers in China from February 2014 to November 2015. The team assigned patients randomly to receive either 20 mg of atorvastatin or placebo daily for 8 weeks and followed them for an additional 16 weeks.
The median age of patients in the study was 63.6, and 86.2% were men. Baseline hematoma volumes and clinical presentations were similar between the atorvastatin group (n=98) and the placebo group (n=98).
After 8 weeks, the reduction in hematoma volume was 29.40 mL for patients in the atorvastatin group, compared with 16.85 mL for patients in the placebo group, a difference of 12.55 mL (95% CI, 0.9-23.9 mL, P=0.003). In a post hoc subgroup analysis, patients age 65 or older appeared to have a greater reduction in hematoma volume than younger patients did.
Of patients taking atorvastatin, 45.9% had significantly improved neurologic function, compared with 28.6% using placebo (adjusted OR 1.957, 95% CI 1.07-3.58, P=0.03).
During the trial, 11.2% of the atorvastatin group had surgery for an enlarging hematoma or a deteriorating clinical condition, compared with 23.5% of the placebo group (HR 0.47, 95% CI 0.24-0.92, P=0.03).
The researchers reported no significant adverse events with treatment. Two patients died during the trial, including one in the atorvastatin group - - a 61-year-old man with pulmonary embolism caused by multiple limb fractures on day 172 after randomization. The monitoring board determined that both deaths were unrelated to the trial treatment.
This trial supports early observations in animal models that atorvastatin reduces hematomas, primarily by suppressing local inflammation, Zhang and colleagues observed.
"But to prove it really works, we need a randomized multi-center trial with a lot of patients," Riina said. "It's certainly an interesting idea. It shows some promise, but we need more data."
The findings raise the question of whether statins can prevent chronic subdural hematomas, he added: "There are a lot of people on statins. Should we be seeing a decrease in the number of chronic subdural patients as a result?"
The study has several limitations, the investigators noted: Since it was conducted exclusively among Chinese patients in China, whether the findings can be reproduced in other ethnicities or countries needs to be investigated. In addition, within the cohort, there may be regional biases, because the numbers of patients recruited from participating Chinese centers varied considerably. The post hoc subgroup analysis also may not be sufficiently powered.
The study was supported by the Chinese Society of Neurosurgery, Chinese Medical Association, National Natural Science Foundation of China, Tianjin Research Program of Advanced Technology, and the National Institutes of Health.
The authors reported no conflicts of interest.
Source Reference: Jaiang R, et al "Safety and efficacy of atorvastatin for chronic subdural hematoma in Chinese patients: A randomized clinical trial" JAMA Neurol 2018; DOI:10.1001/jamaneurol.2018.2030.
Read the original article on Medpage Today: Can a Statin Treat Chronic Subdural Hematoma?