Risk of Uncomplicated Peptic Ulcer in the General Population

Study Overview
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Brief Summary
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The analyses are conducted in a previous population-based cohort study using The Health Improvement Network database in the UK (Cai et al 2009).The aims of the post hoc analyses are: To estimate the relative risk of uncomplicated symptomatic peptic ulcer (UPU) associated with use of low dose aspirin (ASA) and other anti-inflammatory drugs (NSAIDs, steroids) in the general population To estimate the dose-response and duration-response associated with use of these drugs To estimate the relative risk of UPU associated with naive/non-naive use of low dose ASA in the general population To evaluate the effect of proton pump inhibitors (PPI) (alone or in combination with anti-inflammatory drugs) on the occurrence of UPU in the general population To investigate the management of low dose ASA/oral antiplatelets after UPU

Detailed Description
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Risk of uncomplicated peptic ulcer in the general population

Official Title
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Risk of Uncomplicated Peptic Ulcer in the General Population

Conditions
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Peptic Ulcer [Iowa Type (107680.0010)]

Intervention / Treatment
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* Drug: Risk of symptomatic peptic ulcer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients aged 40-84 years in 1997-2005 ( see study population description) Exclusion Criteria: - Patients aged below age 40 and 85 years and above ( see study population description)

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- | --- |
| Cases<br>Patients with symptomatic peptic ulcer (UPU) | Drug: Risk of symptomatic peptic ulcer<br>* Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use<br>|
| Control group<br>Control group without symptomatic peptic ulcer (UPU). | Drug: Risk of symptomatic peptic ulcer<br>* Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative risk (ratio) of uncomplicated peptic ulcer (UPU) associated with low dose ASA, other antiinflammatory drugs and other common drugs for chronic diseases(paracetamol, SSRI, tricyclic antidepressants, anticoagulants, acid suppressing drugs) | Relative risk (ratio) of UPU associated with current use of the different types of drugs versus non-use. | From Januar 1 1997 till December 31 2005, an expected average of 4 years. | 
| Management of aspirin after uncomplicated peptic ulcer (UPU). |  | From January 1, 1997 till december 31, 2005, an average of 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncomplicated peptic ulcer, Low dose aspirin (ASA), Acid-suppressing drugs, Epidemiology