Abstract
The Health Improvement Network UK primary care database was used to identify a cohort of 38 077 individuals aged 50–84 years with a first prescription of low-dose acetylsalicylic acid (ASA; 75–300 mg/day) for secondary prevention of cardiovascular or cerebrovascular events during 2000–2007. From this cohort, 169 incident cases of upper gastrointestinal bleeding (UGIB) were identified. Controls with no UGIB (n = 2000) were frequency-matched to the cases by age, sex, and follow-up time. A nested case–control analysis was performed to determine risk factors associated with UGIB. The incidence of UGIB was 1.1 per 1000 person-years (95% CI, 1.0–1.3). Low-dose ASA users with a history of peptic ulcer disease had an increased risk of UGIB compared with those without (Relative Risk [RR], 4.59; 95% CI, 2.87–7.33). Concomitant use of ASA and clopidogrel (RR, 1.61; 95% CI, 0.85–3.05) or non-steroidal anti-inflammatory drugs (NSAIDs; RR, 2.92; 95% CI, 1.77–4.82) conferred an increased risk of UGIB compared with ASA monotherapy. Discontinuation of ASA therapy (RR: 0.71, 95% CI, 0.42–1.20) and PPI co-treatment given since the start of ASA therapy (RR, 0.56; 95% CI, 0.33–0.96) were associated with a reduced risk of UGIB. In conclusion, in a cohort of individuals receiving low-dose ASA for secondary prevention of cardiovascular or cerebrovascular events, patients with a history of peptic ulcer disease, or who were receiving clopidogrel or NSAIDs had an increased risk of UGIB. The prescription of PPI therapy at the initiation of low-dose ASA reduced the risk of UGIB by almost half.
Highlights
Evidence-based guidelines recommend long-term use of low-dose acetylsalicylic acid (ASA; 75–150 mg/day) for all patients with ischemic cardiovascular disease, unless contraindicated (Sacco et al, 2006; Smith et al, 2006; King et al, 2008)
The aims of this study were to estimate the incidence of upper gastrointestinal bleeding (UGIB) in a UK primary care setting and, through a nested case– control analysis, establish the principal risk factors associated with an increased risk of UGIB among a cohort of individuals starting low-dose ASA therapy for secondary prevention of cardiovascular events
There was no significant association between UGIB and sex, but older age was associated with UGIB (>70 years vs ≤70 years; log rank test p value = 0.0003)
Summary
Evidence-based guidelines recommend long-term use of low-dose acetylsalicylic acid (ASA; 75–150 mg/day) for all patients with ischemic cardiovascular disease, unless contraindicated (Sacco et al, 2006; Smith et al, 2006; King et al, 2008). Low-dose ASA is known to increase the risk of upper gastrointestinal bleeding (UGIB) (Lanas et al, 2007). Numerous observational studies have shown that the risk of upper gastrointestinal complications in patients receiving low-dose ASA is around twofold that in the general population (Weil et al, 1995; de Abajo and García Rodríguez, 2001; García Rodríguez et al, 2001). The cardiovascular benefits of low-dose ASA therapy should be weighed against the risk of any major bleeding, including UGIB. A dose of ASA not greater than 81 mg per day together with a gastroprotective medication is recommended for patients at high risk of bleeding (Bhatt et al, 2008)
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