LOw-Dose RAbeprazole Therapy for Reducing Gastrointestinal Events in Patients with High Bleeding Risk (LORA-HBR): A...

Area of Science:

• Gastroenterology
• Cardiology
• Pharmacology

Background:

• Antithrombotic therapies increase bleeding risk, especially in high bleeding risk (HBR) patients.
• Proton pump inhibitors (PPIs) are recommended for preventing upper gastrointestinal (UGI) bleeding, but optimal agent and dosage are unclear.
• This study assessed low-dose rabeprazole (5 mg) for GI event reduction in HBR patients on antithrombotics.

Purpose of the Study:

• To evaluate the efficacy and safety of low-dose rabeprazole in preventing GI adverse events.
• To assess the incidence of significant GI events, including bleeding and peptic ulcer disease (PUD).
• To determine drug adherence and safety outcomes in a specific patient cohort.

Main Methods:

• Prospective, multicenter, interventional study involving 909 South Korean HBR patients.
• Patients received long-term antithrombotic therapy with HBR features (e.g., age ≥70, dual antiplatelet therapy).
• Primary endpoint: incidence of significant GI events; secondary endpoints: drug discontinuation, cardiovascular events, mortality.

Main Results:

• No significant UGI bleeding or symptomatic PUD observed.
• Median adherence rate was 92.0%; 3.52% discontinued due to GI symptoms.
• GI-related adverse events occurred in 3.96%; cardiovascular events and mortality were low (0.33% and 0.55%, respectively).

Conclusions:

• Low-dose rabeprazole significantly reduced GI complications in HBR patients on antithrombotic therapy.
• The agent exhibited a favorable safety profile and high patient adherence.
• Further large-scale studies are needed to confirm these findings in diverse populations.