Clinical trial NCT01888575: Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy
Official title: 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
Overall status: COMPLETED
Conditions: Cardiovascular Prevention
Keywords: Discontinuation of low dose ASA,
Secondary cardiovascular prevention,
Acid-suppressing drugs,
Gastrointestinal risk,
Epidemiology
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-06-28
Enrollment: 35604
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: This is a pharmacoepidemiology study using data from The Health Improvement Network (THIN) primary care database in the UK. Patients aged 50-84 years with evidence of ischemic heart disease or cerebrovascular disease, who were new users of low-dose ASA (75-300 mg/day) and who had received at least two low-dose ASA prescriptions for the secondary prevention of cardiovascular disease or cerebrovascular disease between 2000 and 2007 were identified from THIN. .

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

Eligibility criteria: 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.

Primary outcomes:
measure: Risk of low dose ASA discontinuation associated with continuous PPI use vs.non-use
timeFrame: Up to 1 year.
measure: Risk of low dose ASA discontinuation associated with baseline gastrointestinal risk category ( high risk versus low risk)
timeFrame: Up to 1 year
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.