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Low-dose aspirin and risk of upper/lower gastrointestinal bleeding by bleed severity: a cohort study with nested case-control analysis using primary care electronic health records from the United Kingdom.

ABSTRACT: Introduction: Risks of low-dose aspirin-associated upper and lower gastrointestinal bleeds (UGIB/LGIB) may vary by severity and presence of cardiovascular disease (CVD). No study has quantified these risks for UGIB and LGIB in the same real-world study population. Patients and methods: Using UK primary care data, 199,049 new users of low-dose aspirin (75-300?mg/day) and 1:1 matched non-users were followed to identify incident UGIB (N?=?1843)/LGIB (N?=?2763) cases. Nested case-control analyses compared current low-dose aspirin vs. non-use on UGIB/LGIB risk. Results: Adjusted incidence rate ratios (ORs; 95% CIs) were 1.62 (1.42-1.86) for non-fatal UGIB, 1.63 (1.47-1.81) for non-fatal LGIB, 0.77 (0.51-1.16) for fatal UGIB, 1.29 (0.50-3.36) for fatal LGIB. For hospitalizations, adjusted ORs (95% CIs) were 1.55 (1.32-1.81) for UGIB and 1.89 (1.58-2.27) for LGIB; for referred only cases, they were 1.52 (1.26-1.84) for UGIB and 1.54 (1.37-1.73) for LGIB. In primary CVD prevention, adjusted ORs (95% CI) were 1.62 (1.38-1.90) for UGIB and 1.60 (1.42-1.81) for LGIB; in secondary CVD prevention, they were 1.16 (0.89-1.50) for UGIB and 1.67 (1.34-2.09) for LGIB. Conclusion: Low-dose aspirin was associated with increased risks of non-fatal but not fatal UGIB/LGIB. Key message Low-dose aspirin is associated with an increased risks of non-fatal UGIB/LGIB but not fatal UGIB/LGIB.

SUBMITTER: Garcia Rodriguez LA

PROVIDER: S-EPMC7856917 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Low-dose aspirin and risk of upper/lower gastrointestinal bleeding by bleed severity: a cohort study with nested case-control analysis using primary care electronic health records from the United Kingdom.

García Rodríguez Luis A LA Lanas Angel A Soriano-Gabarró Montse M Cea Soriano Lucía L

Annals of medicine 20190301 2

Introduction: Risks of low-dose aspirin-associated upper and lower gastrointestinal bleeds (UGIB/LGIB) may vary by severity and presence of cardiovascular disease (CVD). No study has quantified these risks for UGIB and LGIB in the same real-world study population. Patients and methods: Using UK primary care data, 199,049 new users of low-dose aspirin (75-300 mg/day) and 1:1 matched non-users were followed to identify incident UGIB (N = 1843)/LGIB (N = 2763) cases. Nes ...[more]

PMID: 31025592

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Project description:BackgroundUpper gastrointestinal (GI) bleeding is one of the most common, high risk emergency disorders in the western world. Almost nothing has been reported on longer term prognosis following upper GI bleeding. The aim of this study was to establish mortality up to three years following hospital admission with upper GI bleeding and its relationship with aetiology, co-morbidities and socio-demographic factors.MethodsSystematic record linkage of hospital inpatient and mortality data for 14 212 people in Wales, UK, hospitalised with upper GI bleeding between 1999 and 2004 with three year follow-up to 2007. The main outcome measures were mortality rates, standardised mortality ratios (SMRs) and relative survival.ResultsMortality at three years was 36.7% overall, based on 5215 fatalities. It was highest for upper GI malignancy (95% died within three years) and varices (52%). Compared with the general population, mortality was increased 27-fold during the first month after admission. It fell to 4.3 by month four, but remained significantly elevated during every month throughout the three years following admission. The most important independent prognostic predictors of mortality at three years were older age (mortality increased 53 fold for people aged 85 years and over compared with those under 40 years); oesophageal and gastric/duodenal malignancy (48 and 32 respectively) and gastric varices aetiologies (2.8) when compared with other bleeds; non-upper GI malignancy, liver disease and renal failure co-morbidities (15, 7.9 and 3.9); social deprivation (29% increase for quintile V vs I); incident bleeds as an inpatient (31% vs admitted with bleeding) and male patients (25% vs female).ConclusionOur study shows a high late as well as early mortality for upper GI bleeding, with very poor longer term prognosis following bleeding due to malignancies and varices. Aetiologies with the worst prognosis were often associated with high levels of social deprivation.

Project description:ImportanceEpidemiological data on lower gastrointestinal bleeding (GIB) in the general population are sparse.ObjectiveTo describe the incidence, recurrence, mortality, and case fatality rates of major upper GIB and lower GIB in the general population of Finland between 1987 and 2016.Design, setting, and participantsThis prospective cohort study used data from the 1987 to the 2012 cycles of the National FINRISK Study, a health examination survey that was conducted every 5 years in Finland. Survey participants were adults aged 25 to 74 years who were recruited from a population register by random sampling; those with a history of hospitalization for GIB were excluded. Participants were followed up from survey enrollment to onset of GIB that led to hospitalization, death from any cause, or study end (December 31, 2016). Follow-up was performed through linkage with national electronic health registers. Data were analyzed from February 1, 2019, to January 31, 2020.Main outcomes and measuresIncidence, recurrence, mortality, and case fatality rates for all, upper, lower, and unspecified GIB. Outcome measures were stratified by sex and age group.ResultsAmong the 39 054 participants included in the study, 494 (1.3%) experienced upper GIB (321 men [65.0%]; mean [SD] age, 52.8 [12.1] years) and 645 (1.7%) had lower GIB (371 men [57.5%]; mean [SD] age, 54.0 [11.7] years). The age-standardized incidence rate was 0.94 per 1000 person-years (95% CI, 0.85-1.04) for upper GIB and 1.26 per 1000 person-years (95% CI, 1.15-1.38) for lower GIB; the incidence was higher in men than in women. Between 1987 and 2016 the incidence rate of upper GIB remained mostly stable, ranging from 0.40 to 0.66 per 1000 person-years, whereas constant increases occurred in the incidence of lower GIB until the rate stabilized. The proportion of recurrent GIB events showed an increasing trend from 1987 to 2016. The upper GIB-specific mortality was higher (0.07 per 1000 person-years; 95% CI, 0.04-0.09) than the lower GIB-specific mortality (0.01 per 1000 person-years; 95% CI, 0.001-0.03). Case fatality was high for those with upper GIB (7.0%; 95% CI, 4.7-10.1) compared with those with lower GIB (0.4%; 95% CI, 0.1-1.3). Case fatality remained stable over the years but was higher in men (between 5% and 10%) than women (<2%) with GIB.Conclusions and relevanceThis study found that the overall incidence rate of upper GIB was lower than the incidence of lower GIB, but the recurrence, mortality, and 28-day case fatality were higher in participants with upper GIB. These data can serve as a reference when putting into context the rates of drug-associated GIB and can inform efforts to improve GIB care and outcome and to prevent rebleeding or death for patients with major GIB.

Project description:BackgroundOral bisphosphonates are commonly used to prevent / treat osteoporosis. However, bisphosphonate treatment is not without risk and serious adverse effects, including upper gastrointestinal bleeding (UGIB) have been described. We sought to determine if new users of bisphosphonate drugs were more likely to suffer a serious UGIB within 120 days of drug initiation.MethodsThis was a population-based nested cohort study utilizing administrative healthcare data in British Columbia, Canada. Community based individuals ? 65 years with a new prescription for a bisphosphonate between 1991 and 2007 were included. A multivariate logistic regression model was used to examine the relationship between older age and the development of a serious UGIB within 120 days of new exposure to oral bisphosphonate drugs.ResultsWithin the exposure cohort (n = 26,223), 117 individuals had suffered a serious UGIB within 120 days of incident bisphosphonate use. Cases tended to be > 80 years old, and were significantly more likely to have had a past history of gastric ulcer disease, a remote history of serious UGIB, and had been dispensed proton pump inhibitor (PPI) medications (p < 0.001 for all comparisons). After adjustment for confounding covariates, those > 80 years were more than twice as likely to suffer a UGIB when compared to those ? 80 years (adjusted OR = 2.03; 95% CI 1.40-2.94). A past history of serious UGIB was the strongest predictor of UGIB within 120 days of incident bisphosphonate use (adjusted OR = 2.28; 95% CI = 1.29-4.03) followed by PPI use (adjusted OR = 2.04; 95% CI = 1.35-3.07). Males were 70% more likely to suffer an UGIB compared to females (adjusted OR = 1.69; 95% CI = 1.05-2.72).ConclusionsUpper GIB is a rare, but serious, side effect of bisphosphonate therapy more often afflicting older individuals. At the same time, concern about potential rare adverse events should not discourage clinicians from prescribing bisphosphonate drugs, particularly in older patients who have already sustained a fragility fracture. Clinicians must remain cognizant of potential adverse events associated with bisphosphonate use and should routinely ask about pre-existing GI disorders and concurrent medication history prior to prescribing these drugs.

Dataset Information

Low-dose aspirin and risk of upper/lower gastrointestinal bleeding by bleed severity: a cohort study with nested case-control analysis using primary care electronic health records from the United Kingdom.

Publications

Low-dose aspirin and risk of upper/lower gastrointestinal bleeding by bleed severity: a cohort study with nested case-control analysis using primary care electronic health records from the United Kingdom.

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