Butylphthalide improved outcomes in more than half of patients with ischemic stroke

Butylphthalide improved 90-day clinical outcomes in those with acute ischemic stroke who also received IV recombinant tissue plasminogen activator and/or endovascular treatment, per research presented at International Stroke Conference.

“The medication was given to patients with acute ischemic stroke who were also receiving treatment to restore blood flow to the brain,” Baixue Jia, MD, co-author of the study and physician in interventional neuroradiology at Beijing Tiantan Hospital of Capital Medical University, stated in a related press release.

Jia and colleagues sought to evaluate the efficacy of butylphthalide for improving functional outcomes in those with acute ischemic stroke who previously received IV recombinant tissue plasminogen activator and/or endovascular treatment.

They conducted a double-blind, placebo-controlled trial and included 1,216 individuals (median age, 66 years; 68% men) across 59 centers who were randomized on a 1:1 basis to receive IV butylphthalide (n = 607) or placebo (n = 609) for 14 days, followed by 76 days of oral capsules.

The primary outcome of interest was adjusted favorable outcome at 90 days, defined by scores on three metrics: 0 on the modified Rankin Scale (mRS) in patients with a baseline score of 4 to 7 on the NIH Stroke Scale (NIHSS), an mRS score of 0 to 1 in patients with a baseline NIHSS score of 8 to 14 and an mRS score of 0 to 2 in patients with a baseline NIHSS score of 15 to 25. Secondary outcomes included symptomatic intracranial hemorrhage, stroke recurrence and death.

Analysis was performed in the intention-to-treat population and in subcategories based on age, sex, baseline NIHSS score, hypertension and method of reperfusion.

Researchers reported a favorable outcome on day 90 in 344 participants (56.7%) treated with butylphthalide and 268 individuals (44%) in the placebo group (OR = 1.7; 95% CI, 1.35-2.14), with similar secondary outcomes between cohorts.

“This is the first trial to show the benefit of using a medication that protects the brain from damage caused by a lack of oxygen to brain tissue,” Jia said in the release. “If the results are confirmed in other trials, this may lead to more options to treat strokes caused by clots.”

Reference:

• Novel celery seed-derived medicine given after clot treatment may improve stroke outcomes. https://newsroom.heart.org/news/novel-celery-seed-derived-medicine-given-after-clot-treatment-may-improve-stroke-outcomes?preview=5164. Published Feb. 2, 2023. Accessed Feb. 10, 2023.