Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy

AstraZeneca35,604 enrolled

Overview

This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained .The aims of the post hoc analyses are: To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use versus non-use, crude and adjusted by confounding. To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use stratified by age and sex. To evaluate other predictors of discontinuation of low-dose ASA during the first year of ASA therapy.

Assessment of low-dose ASA discontinuation risk associated with concomitant PPI use during the first year of ASA therapy for secondary prevention

Study Type

OBSERVATIONAL

Enrollment

35,604

Conditions

Cardiovascular Prevention

Interventions

Risk of low dose aspirin discontinuationDRUG

PPI continuous use; No PPI usePPI

Eligibility

Sex: ALLMin age: 50 YearsMax age: 84 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 50-84 years in 2000-2007. * Patients with first prescription of low dose ASA ( see study population description). * Patients were required to have been enrolled with their primary care practitioner (PCP) for at least 2 years and to have a computerized prescription history of at least 1 year before the start of the study. Exclusion Criteria: * Patients aged below age 50 and 85 years and above ( see study population description). * Patients with a diagnosis of cancer, alcohol abuse or alcohol-related disease. * Incomplete data recording in THIN.

Locations (1)

Research Site

Madrid, Spain

Outcomes

Primary Outcomes

Risk of low dose ASA discontinuation associated with continuous PPI use vs.non-use

Risk (hazard ratios) of low dose ASA discontinuation associated with continuous PPI use vs. non-use.

Time frame: Up to 1 year.

Risk of low dose ASA discontinuation associated with baseline gastrointestinal risk category ( high risk versus low risk)

Risk ( hazard ratios) of low dose ASA discontinuation associated with baseline gastrointestinal risk category( high risk versus low risk).

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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