Abstract
This article aims to evaluate the real world risk of gastrointestinal bleeding among users naïve to dabigatran. We adopted a self-controlled case series design. We sampled 1215 eligible adult participants who were continuous insured users between July 1, 2010 and March 31, 2012 with use of dabigatran and at least one gastrointestinal bleeding episode. We used a conditional Poisson regression to estimate incidence rate ratios. The population consisted of 64.69% of male and 60.25% patients equal to or greater than age 65 at start of observation. After adjustment for time-variant confounders, the incidence rate of gastrointestinal bleeding was similar during dabigatran risk period and non-exposed period (incidence rate ratio [IRR] = 1.01, 95% confidence interval [CI] 0.90, 1.15). There was no significant difference in GI incidence rate between periods of dabigatran and warfarin (IRR = 0.99, 95% CI 0.75–1.31). Among this database of young and healthy participants, dabigatran was not associated with increased incidence rate of GI bleeding compared with non-exposed period among naïve dabigatran users. We did not detect an increased risk of GI bleeding over dabigatran vs warfarin risk period. Along with other studies on safety and effectiveness, this study should help clinicians choose the appropriate anticoagulant for their patients.
Highlights
Despite the various potential adverse effects of anticoagulant, GI bleeding is of particular concern due to its mortality and morbidity
We considered the following variables as potential time-dependent confounders: age groups, co-medication use [proton pump inhibitors (PPIs), steroids, P-glycoprotein (PGP) inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs)], development of specific chronic conditions and the HAS-BLED bleeding score to concomitantly account for bleeding-related risk factors including Hypertension, Abnormal renal/ liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly and Drugs/alcohol[27,28,29]
By including prevalent warfarin users into our study population, we found that after adjusting for time-dependent covariates, dabigatran risk period was associated with 12% significantly higher risk of GI bleeding compared with the non-exposed period
Summary
Despite the various potential adverse effects of anticoagulant, GI bleeding is of particular concern due to its mortality and morbidity. In the United Kingdom (UK), 103 out of 100,000 adults experience upper GI bleeding per year; the rate is even higher among the elderly[16]. Those hospitalized in UK for acute upper GI bleeding had a mortality rate of 10% in 200717. We used a self-controlled case series design to compare the relative safety of dabigatran regarding the risk of GI bleeding among users naïve to dabigatran using claims data. The design has four implications: first, each subject can have multiple exposures and experience multiple events; second, the risk period with drug exposure can be compared against another drug exposure or the non-exposed period; third, the observation period can serve as a period to determine study population eligibility (e.g. the study population is restricted to individuals who experienced at least one outcome event); fourth, the intra-person comparison implicitly controls for all time-invariant confounders[23]
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