Indobufen versus aspirin in patients with indication for antiplatelet therapy: A systematic review and meta-analysis

Deivyd Vieira Silva Cavalcante; Mrinal Murali Krishna; Meghna Joseph; Ana Clara Felix de Farias Santos; Beatriz Ximenes Mendes; Nicole Asbeg; Wilton Francisco Gomes

doi:10.1016/j.vph.2025.107465

Indobufen versus aspirin in patients with indication for antiplatelet therapy: A systematic review and meta-analysis

Vascul Pharmacol. 2025 Jan 23:158:107465. doi: 10.1016/j.vph.2025.107465. Online ahead of print.

Authors

Deivyd Vieira Silva Cavalcante¹, Mrinal Murali Krishna², Meghna Joseph², Ana Clara Felix de Farias Santos³, Beatriz Ximenes Mendes⁴, Nicole Asbeg⁵, Wilton Francisco Gomes⁶

Affiliations

¹ Federal University of Maranhao, São Luís, Brazil. Electronic address: deivyd@phdfoc.us.
² Medical College Thiruvananthapuram, Kerala, India.
³ City University of São Paulo, Sao Paulo, Brazil.
⁴ Christus University Center, Fortaleza, Brazil.
⁵ Federal University of Bahia, Salvador, Brazil.
⁶ INC Hospital, Curitiba, Brazil; Faculdades Pequeno Príncipe, Curitiba, Brazil; Irmandade da Santa Casa de Misericórdia de Curitiba, Curitiba, Brazil. Electronic address: wiltonfg@cardiol.br.

PMID: 39862902
DOI: 10.1016/j.vph.2025.107465

Abstract

Introduction: Aspirin is commonly recommended for individuals who have experienced stroke or myocardial infarction (MI). Indobufen, a cyclooxygenase-1 inhibitor, has been studied as a potential alternative. We conducted a meta-analysis and trial sequential analysis (TSA) to compare indobufen with aspirin in patients requiring antiplatelet therapy.

Methods: We searched PubMed, Scopus, and Cochrane Central for studies that compared indobufen and aspirin antiplatelet therapies. We focused on efficacy outcomes, such as composite vascular events, MI, and ischemic stroke, and safety outcomes, such as major bleeding and any bleeding. Heterogeneity was assessed using I2 statistics, and our analysis followed the PRISMA guidelines.

Results: The review included 5 studies with 11,943 patients (indobufen n = 5952, 49.84 %), three involving post-MI and two involving post-stroke patients. No significant differences were found between the groups in composite vascular events at 90 days (RR 0.84; 95 % CI 0.46-1.53; p = 0.560; I2 = 53 %) and 1-year (RR 1.13; 95 % CI 0.99-1.29; p = 0.08; I2 = 0 %). MI (RR 0.73; 95 % CI 0.43-1.22; p = 0.22; I2 = 0 %), ischemic stroke (RR 1.16; 95 % CI 0.99-1.37; p = 0.06; I2 = 0 %), and cardiovascular death (RR 1.35; 95 % CI 0.80-2.26; p = 0.257; I2 = 0 %) at 1-year also showed no significant differences. Major bleeding at 1 year (RR 0.73; 95 % CI 0.41-1.31; p = 0.297; I2 = 64 %) was comparable, but any bleeding at 1 year showed a significant difference (RR 0.65; 95 % CI 0.43-0.98; p = 0.03; I2 = 87 %) favoring indobufen. Subgroup analysis of RCTs showed marginally significant increased risk regarding ischemic stroke with indobufen (RR 1.18; 95 % CI 1.00-1.39; p = 0.05).

Conclusion: The efficacy and safety of antiplatelet therapy with indobufen were comparable to those of aspirin alone. Therefore, indobufen can be considered as a suitable alternative for patients who are intolerant or hypersensitive to aspirin. Nevertheless, additional trials involving larger populations are required to establish their clinical applicability.

Keywords: Antiplatelet therapy; Aspirin; Composite vascular events; Indobufen; Ischemic stroke; Major bleeding; Myocardial infarction.

Publication types

Review