Incidences, temporal trends and risks of hospitalisation for gastrointestinal bleeding in new or chronic low-dose...

Area of Science:

• Gastroenterology
• Pharmacovigilance
• Infectious Disease Epidemiology

Background:

• The risk of gastrointestinal bleeding (GIB) in aspirin users following Helicobacter pylori (HP) eradication is not well-established.
• Understanding temporal trends of GIB hospitalizations is crucial for patient safety.

Purpose of the Study:

• To characterize the incidence and temporal patterns of GIB hospitalizations in aspirin users after HP eradication.
• To compare GIB risk among new, chronic, and non-aspirin users post-HP eradication.

Main Methods:

• Retrospective cohort study using a territory-wide health database.
• Inclusion of patients receiving clarithromycin-based triple therapy for HP eradication (2003-2012).
• Stratification into new, chronic, and non-aspirin user cohorts; primary outcome: GIB hospitalization risk.

Main Results:

• Incidence of GIB hospitalization was 10.4/1000 person-years for new users, 7.2 for chronic users, and 4.6 for non-users.
• New aspirin users exhibited a significantly higher risk of GIB (HR: 1.89) compared to chronic users.
• Increased GIB risk in new users was concentrated within the first 6 months, particularly for upper GIB.

Conclusions:

• New aspirin users have an elevated GIB risk post-HP eradication, especially within the initial 6 months.
• Lower GIB is more prevalent than upper GIB in this patient population.
• Risk stratification and monitoring are essential for aspirin users initiating therapy after HP eradication.