Asundexian reduced ischemic stroke risk by 26% after recent non-cardioembolic stroke or high-risk transient ischemic attack

1. Asundexian reduced ischemic stroke risk by 26% versus placebo in adults receiving antiplatelet therapy after recent non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).

2. Overall major bleeding was similar between groups, but gastrointestinal bleeding was more common with asundexian and risk increased in adults older than 75 years and during the first 90 days.

Evidence Rating Level: 2 (Good)

2MM Brief: The U.S. Food and Drug Administration (FDA) approved asundexian, marketed as Sunharbo, with antiplatelet therapy to reduce stroke risk in adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or high-risk TIA. FDA reported results from OCEANIC-STROKE, a multicenter, randomized, double-blind, placebo-controlled phase 3 study of 12,327 adults. Participants had a recent non-cardioembolic ischemic stroke with a National Institutes of Health (NIH) Stroke Scale score of 15 or less or a high-risk TIA and were assigned to asundexian 50 mg once daily or placebo within 72 hours of symptom onset; both groups received antiplatelet therapy. Over a median treatment period of 14.2 months, asundexian significantly reduced the risk of ischemic stroke by 26% compared with placebo. The overall rate of major bleeding was similar between groups, although bleeding was increased with asundexian among patients older than 75 years and during the first 90 days of treatment. Gastrointestinal bleeding occurred more often with asundexian, and diarrhea was the most frequently reported adverse reaction, occurring in 3% or greater of asundexian-treated patients. FDA said concomitant use with combined P-glycoprotein (P-gp) and strong cytochrome P450 3A4 (CYP3A4) inducers, such as carbamazepine, is not recommended; the drug is also not recommended for patients with moderate or severe hepatic impairment. The FDA announcement did not provide a confidence interval or P value for the primary result and did not identify a journal publication. The findings support asundexian as an FDA-approved option for secondary stroke prevention in the studied population, although the reported results come from a single trial and the announcement provides limited details on secondary outcomes.

Citation: U.S. Food and Drug Administration

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