Indobufen showed no significant difference compared with aspirin in poor functional outcome at 90 days (OR 1.01; 95% CI 0.87-1.18) but increased early stroke recurrence (OR 1.59; p<0.0001).
Meta-Analysis (n=5,870)
Does indobufen improve functional outcomes and reduce stroke recurrence compared to aspirin in patients with acute ischemic stroke?
In patients with acute ischemic stroke, indobufen provides comparable functional outcomes to aspirin but is associated with a significantly higher risk of early stroke recurrence.
Effect estimate: OR 1.01 (95% CI 0.87-1.18)
p-value: p=0.90
Abstract Background and aims Aspirin is widely used in acute ischemic stroke (AIS) to reduce recurrent stroke and other secondary ischemic events. Indobufen is a newer antiplatelet agent with a similar mechanism of action and a potentially improved safety profile; however, comparative evidence with aspirin remains limited. We assess the efficacy and safety of indobufen versus aspirin in patients with AIS. Methods A systematic search of PubMed, Embase, Scopus, and the Cochrane Library from inception to December 2025 identified randomized controlled trials comparing indobufen with aspirin in acute ischemic stroke patients. Efficacy outcomes included poor functional outcome (mRS 3–6) at 90 days, NIHSS change from admission to 90 days, and stroke recurrence. Safety outcomes were occurrence of any moderate or severe bleeding and intracranial hemorrhage at 3 and 12 months. Results Four randomized controlled trials(RCTs) involving 5,870 patients were included. Indobufen showed no significant difference compared with aspirin in poor functional outcome (mRS 3–6; OR 1.01, 95% CI 0.87–1.18; p=0.90) or NIHSS change at 3 months (MD −0.03, 95% CI −0.11 to 0.05; p=0.42). However, indobufen was associated with a significantly higher risk of stroke recurrence within 3 months (OR 1.59, 95% CI 1.30–1.93; p0.0001). Rates of severe bleeding and ICH at 3 and 12 months were numerically lower with indobufen, although these differences were not statistically significant. Conclusions Indobufen provides comparable functional and neurological outcomes to aspirin in AIS with similar bleeding risk but may increase early stroke recurrence. Larger RCTs are needed to support findings. Conflict of interest Rashad G. Mohamed.nothing to disclose Amir Hegazi.nothing to disclose Khalid sarhan.nothing to disclose Mostafa Meshref.nothing to disclose
Mohamed et al. (2026) conducted a meta-analysis in Acute ischemic stroke (n=5,870). Indobufen vs. Aspirin was evaluated on Poor functional outcome (mRS 3–6) at 90 days (OR 1.01, 95% CI 0.87-1.18, p=0.90). Indobufen showed no significant difference compared with aspirin in poor functional outcome at 90 days (OR 1.01; 95% CI 0.87-1.18) but increased early stroke recurrence (OR 1.59; p<0.0001).
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