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

Study Overview
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Brief Summary
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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.

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

Official Title
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Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy for Secondary Prevention

Conditions
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Cardiovascular Prevention

Intervention / Treatment
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* Drug: Risk of low dose aspirin discontinuation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aspirin discontinuers; Aspirin non-discontinuers<br>Patients on low dose ASA for secondary prevention that discontinue aspirin and those not discontinuing aspirin | Drug: Risk of low dose aspirin discontinuation<br>* PPI continuous use; No PPI usePPI<br>|
| Drug<br>PPI continuous use; No PPI use | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Discontinuation of low dose ASA,, Secondary cardiovascular prevention,, Acid-suppressing drugs,, Gastrointestinal risk,, Epidemiology