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Prevention of nNon-Vitamin K Oral Anticoagulants-Related Gastrointestinal Bleeding With Acid Suppressants: A Systematic Review and Meta-Analysis.

ABSTRACT: Whether the use of acid suppressants can reduce non-vitamin K oral anticoagulants (NOACs)-related gastrointestinal bleeding (GIB) remains unclear. To systemically evaluate the effect of acid suppressants on the risk of GIB in patients treated with NOACs. All related studies were searched in four databases (Cochrane, Embase, PubMed, and Web of Science) from their establishment to August 10, 2021. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was used to identify studies and Stata 16.0 software was used for meta-analysis, including sensitivity and subgroup analysis. Six retrospective cohort studies were included in this study. The use of acid suppressants significantly reduced the GIB risk in patients taking NOACs, with an overall relative risk (RR) of 0.70 (95% confidence interval [CI]: 0.61-0.82; P < 0.001; I² = 56.3%). This trend of reduced risk for GIB in NOACs was more significant in upper GIB (UGIB; RR: 0.45; 95%CI: 0.22-0.90; P = 0.025; I² = 71.1%). The reduction was stronger for dabigatran than for rivaroxaban and apixaban. The least reduction in the risk of GIB with acid suppressant co-therapy was rivaroxaban (dabigatran: RR: 0.53; 95% CI: 0.45-0.62; P = <0.001; I² = 39.8%; apixaban: RR: 0.67; 95% CI: 0.54-0.84; P = <0.001; I² = 0; rivaroxaban: RR: 0.73; 95% CI: 0.66-0.81; P = <0.001; I² = 37.6%). The included studies revealed the protective effect of acid suppressants against NOACs-related GIB, especially in the upper gastrointestinal tract. The protective effect was even stronger in patients using dabigatran than in those using Xa inhibitors (rivaroxaban and apixaban).

SUBMITTER: Dong Y

PROVIDER: S-EPMC8777378 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesTo determine the real world safety of dabigatran or rivaroxaban compared with warfarin in terms of gastrointestinal bleeding.DesignRetrospective cohort study.SettingLarge administrative database of commercially insured people in United States from 1 October 2010 through 31 March 2012.ParticipantsEnrollees with a prescription of warfarin, dabigatran, or rivaroxaban between 1 October 2010 and 31 March 2012, who were aged 18 years or older, had continuous enrollment and no oral anticoagulant use during the six months before the entry date, with known age and sex, and with no gastrointestinal bleeding for at least six months before the cohort entry date. The final study sample of 46,163 patients included 4907 using dabigatran, 1649 using rivaroxaban, and 39,607 using warfarin.Main outcome measureTime to gastrointestinal bleeding. Hazard ratios were derived from Cox proportional hazard models with propensity score weighting and robust estimates of errors.ResultsDabigatran users tended to be older (dabigatran v rivaroxaban v warfarin: 62.0 v 57.6 v 57.4 years) and more likely to be male (69% v 49% v 53%). The rate of gastrointestinal bleeding was highest among dabigatran users and lowest among rivaroxaban users (dabigatran v rivaroxaban v warfarin: 9.01 v 3.41 v 7.02 cases per 100 person years). After adjustment for potentially confounding covariates, there was no evidence of a statistically significant difference in the risk of gastrointestinal bleeding between dabigatran and warfarin users (adjusted hazard ratio 1.21, 95% confidence interval 0.96 to 1.53) or between rivaroxaban and warfarin users (0.98, 0.36 to 2.69).ConclusionsAlthough rates of gastrointestinal bleeding seem to be similar in this commercially insured sample of adults in the United States, we cannot rule out as much as a 50% increase in the risk of gastrointestinal bleeding with dabigatran compared with warfarin or a more than twofold higher risk of bleeding with rivaroxaban compared with warfarin.

Project description:ImportanceMany patients with nonvalvular atrial fibrillation (NVAF) are at a high risk of gastrointestinal (GI) bleeding due to conditions including older age; stage III to V chronic kidney disease (CKD); HAS-BLED (hypertension, kidney or liver disease, stroke history, prior bleeding, unstable international normalized ratio, age >65, drug or alcohol use) score of 3 or greater; corticosteroid, antiplatelet or nonsteroidal anti-inflammatory drug (NSAID) use; or GI conditions.ObjectiveTo compare the risk of stroke and/or systemic embolism (SE) and major bleeding (MB) among patients with NVAF and high risk of GI bleeding who received non-vitamin K antagonist oral anticoagulants (NOACs) vs those who received warfarin.Design, setting, and participantsThis retrospective cohort study included patients with NVAF who were 75 years and older; had stage III to V CKD; had an HAS-BLED score of 3 or greater; used corticosteroids, antiplatelets, or NSAIDs; or had GI conditions. Data were collected from the Centers for Medicare & Medicaid Services and 4 commercial insurance databases between January 1, 2012, and September 30, 2015. Data analysis was conducted from January 2012 to September 2015.ExposuresNew prescription for apixaban, dabigatran, rivaroxaban, or warfarin between January 1, 2013, and September 30, 2015 (identification period).Main outcomes and measuresSix propensity score-matched cohorts were created to compare between study drugs. For the primary objective, Cox models were used to estimate stroke and/or SE and MB hazard ratios (HRs).ResultsA total of 381 054 patients (187 489 [49.2%] women) with NVAF and at least 1 high-risk GI bleeding factor were identified (HAS-BLED score ≥3: 284 527 [74.7%]; aged ≥75 years: 252 835 [66.4%]; corticosteroid, antiplatelet, or NSAID therapy: 107 675 [28.3%]; prior GI bleeding conditions: 74 818 [19.6%]; and stage III-V CKD: 56 892 [14.9%]). All NOACs were associated with a lower risk of stroke and/or SE vs warfarin (apixaban: HR, 0.60; 95% CI, 0.52-0.68; dabigatran: HR, 0.75; 95% CI, 0.64-0.88; rivaroxaban: HR, 0.79; 95% CI, 0.73-0.86). Compared with warfarin, apixaban and dabigatran were associated with a lower risk of MB (apixaban: HR, 0.59; 95% CI, 0.56-0.63; dabigatran: HR, 0.78; 95% CI, 0.70-0.86), while rivaroxaban was associated with a higher risk (HR, 1.11; 95% CI, 1.05-1.16).Conclusions and relevanceIn this study of patients with NVAF and high risk of GI bleed, NOACs were associated with lower rates of stroke and/or SE, but NOACs had varying risks of MB compared with warfarin. These results may help inform treatment options in this patient population.

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Prevention of nNon-Vitamin K Oral Anticoagulants-Related Gastrointestinal Bleeding With Acid Suppressants: A Systematic Review and Meta-Analysis.

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