LOw-dose RAbeprazole therapy for reducing gastrointestinal events in patients with High Bleeding Risk (LORA-HBR): a prospective, multicenter, interventional study

초록

Background: The widespread use of antithrombotic therapies increases bleeding risk, particularly in patients with a high bleeding risk (HBR). Although proton pump inhibitors are recommended for lowering the risk of upper gastrointestinal (UGI) bleeding, the optimal agent and dosage remain uncertain. Purpose: This study evaluated the efficacy and safety of low-dose rabeprazole (LORA, 5 mg) for preventing GI-related adverse events in HBR patients receiving chronic antithrombotic therapy. Methods: This was a prospective, multicenter, interventional study that included 909 South Korean patients (mean age 72.9 ± 8.3 years; male 71.3% [n=648]) receiving long-term antithrombotic therapy with HBR features including age ≥70 years, dual antiplatelet therapy, combined antithrombotic regimens, and prior GI bleeding. The primary endpoint was the incidence of significant GI events, including overt/occult bleeding and symptomatic peptic ulcer disease (PUD). Secondary endpoints included study drug discontinuation owing to GI adverse events, composite cardiovascular events, and all-cause mortality. Results: The median follow-up period was 364 days (IQR, 350–385 days). Most patients presented with one (74.4%, n=676) or two (24.6%, n=224) HBR characteristics. No patients had significant UGI bleeding or symptomatic PUD during low-dose rabeprazole administration. The median adherence rate was 92.0% (interquartile range [IQR], 87.0–95.0). Drug discontinuation owing to GI symptoms occurred in 32 patients (3.52%) at a median of 81 days (IQR, 36–119 days). GI-related adverse events were reported in 3.96%, with diarrhea, epigastric discomfort, and constipation being the most common. Non-GI bleeding and cardiovascular composite events occurred in 0.33% (n=3) each, with all-cause mortality at 0.55% (n=5). Conclusions: Low-dose rabeprazole effectively prevented GI complications in patients receiving chronic antithrombotic therapy, demonstrating a favorable safety profile and high adherence. Further studies with larger and broader populations are required to confirm these findings.