Pharmacological safety and real-world efficacy of the potassium-competitive acid blocker fexuprazan in cardiovascular patients receiving antithrombotic therapy: a prospective cohort study (FEXGARD)
Abstract
BACKGROUND AND AIMS: Gastroesophageal reflux disease (GERD) is common in patients with CVD receiving long-term antithrombotic therapy, increasing gastrointestinal (GI) bleeding risk. Potassium-competitive acid blockers, such as fexuprazan, provide rapid and potent acid suppression; however, relevant evidence in this high-risk population is limited. This study evaluated the effects of fexuprazan on fasting serum gastrin levels, GERD symptoms, and bleeding outcomes in patients with CVD receiving antithrombotic agents.
METHODS: In this prospective observational study conducted at a tertiary hospital, 400 patients receiving antiplatelet or anticoagulant therapy were administered fexuprazan. Fasting venous blood samples were collected at baseline and 6 months, and total serum gastrin levels were measured. GERD symptoms were assessed using the Frequency Scale for the Symptoms of GERD (FSSG). Secondary outcomes, including GI bleeding, other-site bleeding, and mortality, were recorded over 12 months. Subgroup analyses were performed according to antithrombotic regimen and age.
RESULTS: Fexuprazan significantly increased fasting serum gastrin (152.1 ± 215.9 vs. 249.1 ± 210.3 pg/mL; p < 0.001) and improved FSSG total scores (16.3 ± 5.0 vs. 15.0 ± 6.0; p < 0.001). During the 12 months, two GI bleeding events (0.5%), 11 other-site bleeding events (2.8%), and no deaths occurred. Subgroup analyses revealed no significant differences between users of antiplatelet agents, warfarin, and…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 400 participants or records.
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