Clinical trial NCT01814943: The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users
Official title: The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uncomplicated Peptic Ulcer
Keywords: Uncomplicated peptic ulcer
Acid-suppressing drugs
Epidemiology
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-03-20
Enrollment: 39000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 50-84 yrs who had a first prescription of low-dose ASA (75-300mg/day) for secondary cardiovascular or cerebrovascular prevention in 2000-2007 in The Health Improvement Network database in the UK. Patients had to be enrolled with their PCP (Primary Care Physician) for at least 2 years and have a health contact in the year prior. Patients with use of aspirin ever recorded in the database before start of follow-up as well as patient with cancer or alcohol abuse were excluded. Individuals were followed up until the earliest occurrence of one of the following endpoints; first recorded diagnosis of uncomplicated peptic ulcer, canser, alcohol abuse or alcohol related disease, reaching the age of 85 years old, date of last practice data collection, death or end of follow-up ( 30 September 2011).Patient records were manually reviewed to validate cases.

Brief summary: 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 incidence of uncomplicated peptic ulcer (UPU) in a cohort of low-dose ASA for secondary prevention of vascular disease and the relative risk of UPU associated with use and discontinuation of use of low dose ASA.

To estimate the effect of proton pump inhibitors (PPI) on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease To evaluate the effect of other risk factors on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease.

Detailed description: The risk of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users

Eligibility criteria: Inclusion Criteria:

- Patients aged 50-84 years in 2000-2007 with a first prescription of low dose ASA ( see study population description)

Exclusion Criteria:

- Patients aged below age 50 and 85 years and above ( see study population description)

Primary outcomes:
measure: Incidence rates of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users
timeFrame: From 1 January 2000 till 30 September 2011, an expected average of 6 years.
measure: Risk (hazard ratio) of developing uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users
timeFrame: From 1 Januart 2000 till 30 September 2011, an expected average of 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Research Site
Study officials:
affiliation: CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
name: Luis A Garcia Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cea Soriano L, Rodriguez LA. Risk of Upper Gastrointestinal Bleeding in a Cohort of New Users of Low-Dose ASA for Secondary Prevention of Cardiovascular Outcomes. Front Pharmacol. 2010 Oct 14;1:126. doi: 10.3389/fphar.2010.00126. eCollection 2010.
citation: Garcia Rodriguez LA, Cea Soriano L, Hill C, Johansson S. Increased risk of stroke after discontinuation of acetylsalicylic acid: a UK primary care study. Neurology. 2011 Feb 22;76(8):740-6. doi: 10.1212/WNL.0b013e31820d62b5. Epub 2011 Jan 26.