Abstract Body (Do not enter title and authors here): Introduction

Antiplatelet therapy with aspirin has been recommended for patients with stroke and myocardial infarction (MI). Clinicians face challenges when they come across aspirin hypersensitivity in their clinical practice. Therefore, potential alternative drugs can help avoid the omission of anti-thrombotic therapy. Indobufen is a cyclooxygenase-1 inhibitor studied as an alternative to aspirin.

Hypothesis

Compared to aspirin, indobufen will be equally effective in preventing cardiovascular events in patients needing antiplatelet therapy but will cause fewer bleeding complications.

Methods

We systematically searched PubMed, Scopus, and Cochrane Central databases for studies comparing antiplatelet therapy with indobufen vs. aspirin. The efficacy outcomes of interest were composite vascular events, MI, and ischemic stroke. The safety outcomes of interest were major bleeding and any bleeding. Heterogeneity was assessed using I² statistics. Analysis followed the PRISMA guideline and was registered in the PROSPERO database (CRD42024540911).

Results

The systematic review identified 4 studies, including 11,495 patients (indobufen n=5,728, 49.83%), with two studies in patients post-MI and two post-stroke patients. Composite vascular events at 90 days (RR 1.03; 95%CI 0.58-1.86; p=0.911; I²=46%) and 1 year (RR 1.10; 95%CI 0.96-1.27; p=0.184; I²=0%) did not show any difference between the groups. MI (RR 0.67; 95%CI 0.36-1.23; p=0.197; I²=0%) and ischemic stroke (RR 1.17; 95%CI 0.99-1.38; p=0.064; I²=0%) at 1 year did not show any significant difference between the groups. Major (RR 0.68; 95%CI 0.36-1.27; p=0.225; I²=74%) and any bleeding (RR 0.62; 95%CI 0.36-1.06; p=0.079; I²=91%) at 1 year were also comparable between the groups.

Conclusion

Antiplatelet therapy with indobufen was comparable with aspirin in efficacy and safety. Indobufen can be considered an alternative to aspirin in patients with intolerance or hypersensitivity. However, more trials with a larger population are needed to confirm the clinical applicability.