Add on N-butylphthalide improves functional outcomes in acute ischaemic stroke patients: JAMA

A new study by Anxin Wang and team showed that intravenous thrombolysis and/or endovascular therapy for acute ischemic stroke patients with DL-3-n-butylphthalide (NBP) resulted in a larger percentage of patients with favorable functional outcomes at 90 days. The findings of this study were published in the Journal of American Medical Association.

By acting on a number of active targets, the medication DL-3-n-butylphthalide, used to treat acute ischemic stroke, may also have neuroprotective effects. NBP has not been proven to be effective in acute ischemic stroke patients receiving reperfusion treatment. So, this study was carried out to evaluate the effectiveness and safety of NBP in patients with acute ischemic stroke undergoing intravenous thrombolysis and/or endovascular therapy for reperfusion.

The 59 centers in China that participated in this multicenter, double-blind, placebo-controlled, parallel randomized clinical study had a 90-day follow-up. After excluding 20 patients who refused treatment, 1216 patients with acute ischemic stroke who were 18 years of age or older, had a National Institutes of Health Stroke Scale score ranging from 4 to 25, could begin the trial medication within 6 hours of the onset of symptoms, and had either intravenous recombinant tissue plasminogen activator (rt-PA) or endovascular treatment or intravenous rt-PA bridging to endovascular treatment were enrolled. Between July 1, 2018, and May 22, 2022, data were gathered. Patients were randomly assigned to receive either NBP or a placebo within 6 hours of the beginning of symptoms.

The key findings of this study were:

1. The median (IQR) age of the 1216 recruited patients was 66 (56-72) years, and 827 (68.0%) of them were men.

2. The butylphthalide group received a total of 607 random assignments, whereas the placebo group received 609.

3. At 90 days, 344 butylphthalide-treated patients (56.7%) and 268 placebo-treated patients (44.0%) had positive functional outcomes.

4. 61 patients (10.1%) in the butylphthalide group and 73 patients (12.0%) in the placebo group experienced serious side events within 90 days.

Reference:

Wang, A., Jia, B., Zhang, X., Huo, X., Chen, J., Gui, L., Cai, Y., Guo, Z., Han, Y., Peng, Z., Jing, P., Chen, Y., Liu, Y., Yang, Y., Wang, F., Sun, Z., Li, T., Sun, H., … Yuan, H. (2023). Efficacy and Safety of Butylphthalide in Patients With Acute Ischemic Stroke. In JAMA Neurology. American Medical Association (AMA). https://doi.org/10.1001/jamaneurol.2023.1871