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21. Misoprostol for small bowel ulcers in patients with obscure bleeding taking aspirin and non-steroidal anti-inflammatory drugs (MASTERS): a randomised, double-blind, placebo-controlled, phase 3 trial. Full Text available with Trip Pro

Misoprostol for small bowel ulcers in patients with obscure bleeding taking aspirin and non-steroidal anti-inflammatory drugs (MASTERS): a randomised, double-blind, placebo-controlled, phase 3 trial. The incidence of obscure gastrointestinal bleeding, which originates from the small bowel and is mainly associated with the use of aspirin and non-steroidal anti-inflammatory drugs (NSAIDs), is rising. We assessed the efficacy and safety of misoprostol for the treatment of small bowel ulcers (...) and erosions in patients taking low-dose aspirin or NSAIDs with obscure gastrointestinal bleeding.In this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients (aged ≥18 years) with small bowel ulcers who were taking low-dose aspirin, NSAIDs, or both for a minimum of 4 weeks, at University Hospital Crosshouse (Kilmarnock, UK). Eligible patients had evidence of obscure gastrointestinal bleeding (iron deficiency anaemia, a decrease in haemoglobin concentration of ≥20 × 103 mg/L

2019 The lancet. Gastroenterology & hepatology Controlled trial quality: predicted high

22. Management of Patients With Acute Lower Gastrointestinal Bleeding

recommendation, very-low-quality evidence). 24. If a diagnostic test is desired for localization of the bleeding site before angiography, CT angiography should be considered (conditional recommenda- tion, very-low-quality evidence). Prevention of recurrent lower gastrointestinal bleeding 25. Non-aspirin NSAID use should be avoided in patients with a history of acute LGIB, particularly if secondary to diverticulosis or angioectasia (strong recommendation, low-quality evidence). 26. In patients (...) on multidisciplinary assessment of cardiovascular and GI risk and the adequacy of endoscopic therapy (as above, aspirin use should not be discontinued). However, dual antiplatelet therapy should not be discontinued in patients with an acute coronary syndrome within the past 90 days or coronary stenting within the past 30 days (strong recommendation, low-quality evidence). CT, computed tomographic; GI, gastrointestinal; INR, international normalized ratio; LGIB, lower gastrointestinal bleeding; NSAID, nonsteroidal

2016 American College of Gastroenterology

23. Clinical, clinicopathologic, and gastrointestinal changes from aspirin, prednisone, or combination treatment in healthy research dogs: A double-blind randomized trial. Full Text available with Trip Pro

-73.6) and 31.5 times (95% CI, 3.5-288.0) higher odds, respectively, of having endoscopic mucosal lesion scores ≥4 than dogs receiving placebo (P ≤ .01).Gastrointestinal bleeding occurs commonly in dogs administered aspirin, prednisone, or prednisone/aspirin treatment, with higher lesion scores for dogs receiving combination treatment. Even severe lesions are not accompanied by clinical signs.© 2019 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf (...) Clinical, clinicopathologic, and gastrointestinal changes from aspirin, prednisone, or combination treatment in healthy research dogs: A double-blind randomized trial. Dogs with immune-mediated disease are often coadministered glucocorticoids and aspirin, but ulcerogenic effects of current protocols are unknown.To compare gastrointestinal changes among dogs administered aspirin, prednisone, and combination treatment.Twenty-four healthy research dogs.Double-blinded, placebo-controlled randomized

2019 Journal of Veterinary Internal Medicine Controlled trial quality: predicted high

24. Upper Gastrointestinal Complications and Cardiovascular/Gastrointestinal Risk Calculator in Patients with Myocardial Infarction Treated with Aspirin Full Text available with Trip Pro

Upper Gastrointestinal Complications and Cardiovascular/Gastrointestinal Risk Calculator in Patients with Myocardial Infarction Treated with Aspirin Aspirin is widely used for the prevention of cardiovascular and cerebrovascular diseases for the past few years. However, much attention has been paid to the adverse effects associated with aspirin such as gastrointestinal bleeding. How to weigh the benefits and hazards? The current study aimed to assess the feasibility of a cardiovascular (...) diagnostic cutoff point of predicted gastrointestinal events was 68.0‰, yielding sensitivity and specificity of 60.6% and 93.1%, respectively, for predicting gastrointestinal events in Chinese patients with MI.AsaRiskCalculator had a predictive value for gastrointestinal events in Chinese patients with MI. HP infection seemed to be an independent risk factor for gastrointestinal events caused by long-term aspirin treatment in Chinese patients with MI, and it should be included in the risk calculator

2017 Chinese medical journal

25. Comparative outcomes in patients with ulcer- vs non-ulcer-related acute upper gastrointestinal bleeding in the United Kingdom: a nationwide cohort of 4478 patients. (Abstract)

Comparative outcomes in patients with ulcer- vs non-ulcer-related acute upper gastrointestinal bleeding in the United Kingdom: a nationwide cohort of 4478 patients. Outcomes after Nonvariceal upper gastrointestinal bleeding (NVUGIB) have historically focused on ulcer-related causes. Little is known regarding non-ulcer bleeding, the most common cause of NVUGIB.To compare outcomes between ulcer- and non-ulcer-related NVUGIB and explore whether these could be explained by differences in baseline (...) to have been taking aspirin (40% vs 27%, P < 0.001) and present with shock (43% vs 32%, P < 0.001). Furthermore, those with ulcer-related bleeding were more likely to receive blood transfusion (66% vs 39%, P < 0.001), PPI infusion (27% vs 5%, P < 0.001) and endoscopic therapy (37% vs 8%, P < 0.001). Overall, ulcer-related bleeding had higher odds of in-hospital mortality (OR: 1.54; 95% CI: 1.21-1.96, P < 0.0001), rebleeding (OR: 2.08; 95% CI: 1.73-2.51, P < 0.0001) and need for surgical/radiologic

2019 Alimentary Pharmacology & Therapeutics

26. Development of a standardized definition for clinically significant bleeding in the ASPirin in Reducing Events in the Elderly (ASPREE) trial Full Text available with Trip Pro

Development of a standardized definition for clinically significant bleeding in the ASPirin in Reducing Events in the Elderly (ASPREE) trial Bleeding is the major risk of aspirin treatment, especially in the elderly. A consensus definition for clinically significant bleeding (CSB) in aspirin primary prevention trials is lacking in the literature.This paper details the development, modification, application, and quality control of a definition for clinically significant bleeding in the ASPirin (...) in Reducing Events in the Elderly (ASPREE) trial, a primary prevention trial of aspirin in 19,114 community-dwelling elderly men and women. In ASPREE a confirmed bleeding event needed to meet criteria both for substantiated bleeding and clinical significance. Substantiated bleeding was defined as: 1) observed bleeding, 2) a reasonable report of symptoms of bleeding, 3) medical, nursing or paramedical report, or 4) imaging evidence. Bleeding was defined as clinically significant if it: 1) required

2018 Contemporary clinical trials communications

27. Randomised controlled trial: Addition of omeprazole to dual antiplatelet therapy with clopidogrel plus aspirin lowers the risk of upper gastrointestinal bleeding

Randomised controlled trial: Addition of omeprazole to dual antiplatelet therapy with clopidogrel plus aspirin lowers the risk of upper gastrointestinal bleeding Addition of omeprazole to dual antiplatelet therapy with clopidogrel plus aspirin lowers the risk of upper gastrointestinal bleeding | BMJ Evidence-Based Medicine We use cookies to improve our service and to tailor our content and advertising to you. You can manage your cookie settings via your browser at any time. To learn more about (...) the risk of upper gastrointestinal bleeding Article Text Therapeutics Randomised controlled trial Addition of omeprazole to dual antiplatelet therapy with clopidogrel plus aspirin lowers the risk of upper gastrointestinal bleeding Jolanta M Siller-Matula 1 , Georg Delle-Karth 1 Statistics from Altmetric.com Commentary on: Bhatt DL , Cryer BL , Contant CF , et al. ; COGENT Investigators . Clopidogrel with or without omeprazole in coronary artery disease. Context Antiplatelet therapy represents

2011 Evidence-Based Medicine

28. Effect of pharmacological therapies for stroke prevention on major gastrointestinal bleeding in patients with atrial fibrillation Full Text available with Trip Pro

-conducted review found that adjusted-dose vitamin K antagonists increased the risk of major gastrointestinal bleeding compared with placebo or aspirin when used for stroke prevention in atrial fibrillation patients; combining vitamin K antagonists with aspirin also increased this risk. The authors' findings are generally reliable but limited by the small number of trials and rarity of events. Authors' objectives To investigate the incidence of major gastrointestinal bleeding when using various (...) were eligible for inclusion. Eligible trials had to report the incidence of major gastrointestinal bleeding. Trials of patients with postoperative atrial fibrillation or valvular disease were excluded. The included trials evaluated the following agents: aspirin, clopidogrel, dabigatran, triflusal, vitamin K antagonists (adjusted-dose or low-intensity), warfarin (adjusted-dose or low-intensity) and ximelagatran. There were five placebo or control arms, nine aspirin (or triflusal or indoprofen) arms

2012 DARE.

29. Aspirin use for primary prophylaxis: Adverse outcomes in non-variceal upper gastrointestinal bleeding Full Text available with Trip Pro

Aspirin use for primary prophylaxis: Adverse outcomes in non-variceal upper gastrointestinal bleeding To compare outcomes of patients with non-variceal upper gastrointestinal bleeding (NVUGIB) taking aspirin for primary prophylaxis to those not taking it.Patients not known to have any vascular disease (coronary artery or cerebrovascular disease) who were admitted to the American University of Beirut Medical Center between 1993 and 2010 with NVUGIB were included. The frequencies of in-hospital (...) mortality, re-bleeding, severe bleeding, need for surgery or embolization, and of a composite outcome defined as the occurrence of any of the 4 bleeding related adverse outcomes were compared between patients receiving aspirin and those on no antithrombotics. We also compared frequency of in hospital complications and length of hospital stay between the two groups.Of 357 eligible patients, 94 were on aspirin and 263 patients were on no antithrombotics (control group). Patients in the aspirin group were

2016 World journal of gastrointestinal surgery

30. Systematic Review and Meta-Analysis of Randomised Trials to Ascertain Fatal Gastrointestinal Bleeding Events Attributable to Preventive Low-Dose Aspirin: No Evidence of Increased Risk. Full Text available with Trip Pro

Systematic Review and Meta-Analysis of Randomised Trials to Ascertain Fatal Gastrointestinal Bleeding Events Attributable to Preventive Low-Dose Aspirin: No Evidence of Increased Risk. Aspirin has been shown to lower the incidence and the mortality of vascular disease and cancer but its wider adoption appears to be seriously impeded by concerns about gastrointestinal (GI) bleeding. Unlike heart attacks, stroke and cancer, GI bleeding is an acute event, usually followed by complete recovery. We (...) in which fatal events had not been adequately described were contacted via email and asked for further details. A meta-analyses was then performed to estimate the risk of fatal gastrointestinal bleeding attributable to low-dose aspirin.Eleven randomised trials were identified in the literature search. In these the relative risk (RR) of 'major' incident GI bleeding in subjects who had been randomised to low-dose aspirin was 1.55 (95% CI 1.33, 1.83), and the risk of a bleed attributable to aspirin being

2016 PloS one

31. Similar Efficacy of Proton-Pump Inhibitors vs H2-Receptor Antagonists in Reducing Risk of Upper Gastrointestinal Bleeding or Ulcers in High-Risk Users of Low-Dose Aspirin. Full Text available with Trip Pro

Similar Efficacy of Proton-Pump Inhibitors vs H2-Receptor Antagonists in Reducing Risk of Upper Gastrointestinal Bleeding or Ulcers in High-Risk Users of Low-Dose Aspirin. It is not clear whether H2-receptor antagonists (H2RAs) reduce the risk of gastrointestinal (GI) bleeding in aspirin users at high risk. We performed a double-blind randomized trial to compare the effects of a proton pump inhibitor (PPI) vs a H2RA antagonist in preventing recurrent upper GI bleeding and ulcers in high-risk (...) aspirin users.We studied 270 users of low-dose aspirin (≤325 mg/day) with a history of endoscopically confirmed ulcer bleeding at 8 sites in Hong Kong and Japan. After healing of ulcers, subjects with negative results from tests for Helicobacter pylori resumed aspirin (80 mg) daily and were assigned randomly to groups given a once-daily PPI (rabeprazole, 20 mg; n = 138) or H2RA (famotidine, 40 mg; n = 132) for up to 12 months. Subjects were evaluated every 2 months; endoscopy was repeated

2016 Gastroenterology Controlled trial quality: predicted high

32. Peptic Ulcer Is the Most Common Cause of Non-Variceal Upper-Gastrointestinal Bleeding (NVUGIB) in China Full Text available with Trip Pro

Peptic Ulcer Is the Most Common Cause of Non-Variceal Upper-Gastrointestinal Bleeding (NVUGIB) in China BACKGROUND This study aimed to discover the common cause of non-variceal upper-gastrointestinal bleeding (NVUGIB) by conducting a multi-center retrospective study from 2008 to 2012. MATERIAL AND METHODS Hospitalized patients ages ≥18 years old, from 8 hospitals in China, diagnosed with NVUGIB by endoscopy from 1 January 2008 to 31 December 2012 were enrolled. Questionnaires were developed (...) after gastrointestinal bleeding was controlled. The median length of hospitalization was 8 days (IQR, 5-11) and the mortality rate was 1.71% (51/2977). CONCLUSIONS Peptic ulcer was still the most common cause of NVUGIB in China. The proportion of patients with high-risk peptic ulcer bleeding who received endoscopic therapy was 16.9%. Only 19.65% of NVUGIB patients underwent emergency endoscopy.

2018 Medical science monitor : international medical journal of experimental and clinical research

33. Impact of INR monitoring, reversal agent use, heparin bridging, and anticoagulant interruption on rebleeding and thromboembolism in acute gastrointestinal bleeding. Full Text available with Trip Pro

Impact of INR monitoring, reversal agent use, heparin bridging, and anticoagulant interruption on rebleeding and thromboembolism in acute gastrointestinal bleeding. Anticoagulant management of acute gastrointestinal bleeding (GIB) during the pre-endoscopic period has not been fully addressed in American, European, or Asian guidelines. This study sought to evaluate the risks of rebleeding and thromboembolism in anticoagulated patients with acute GIB.Baseline, endoscopy, and outcome data were (...) , low platelet count and albumin level, and low-dose aspirin use but not HAS-BLED score, any endoscopic results, heparin bridge, or international normalized ratio (INR) ≥ 2.5. Risks for thromboembolism were INR ≥ 2.5, difference in onset and pre-endoscopic INR, reversal agent use, and anticoagulant interruption but not CHA2DS2-VASc score, any endoscopic results, or heparin bridge. In patients without reversal agent use, heparin bridge, or anticoagulant interruption, there was only one rebleeding

2017 PLoS ONE

34. Gastrointestinal Bleeding With Edoxaban Versus Warfarin: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction). Full Text available with Trip Pro

with atrial fibrillation. The risk factors and clinical impact of gastrointestinal bleeding (GIB) in this trial have not been described in detail.This analysis was undertaken to identify risk factors for major GIB (MGIB) and compare the severity and outcomes of GIB with edoxaban and warfarin. During 2.8 years mean follow-up, there were 579 MGIB (1.22% per year), of which 63 were life-threatening or fatal (0.13% per year). Male sex, increased age, prior GIB, concomitant aspirin, lower baseline hemoglobin (...) Gastrointestinal Bleeding With Edoxaban Versus Warfarin: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction). The ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction) compared higher-dose edoxaban regimen (HD-ER) and lower-dose edoxaban regimen with well-managed warfarin in 21 105 patients

2018 Circulation. Cardiovascular quality and outcomes

35. Effect of low-dose proton pump inhibitor on preventing upper gastrointestinal bleeding in chronic kidney disease patients receiving aspirin. (Abstract)

Effect of low-dose proton pump inhibitor on preventing upper gastrointestinal bleeding in chronic kidney disease patients receiving aspirin. Upper gastrointestinal bleeding (UGIB) leads to significant morbidity and mortality in chronic kidney disease (CKD) patients. This study determined the efficacy of using a low-dose proton pump inhibitor (PPI) to reduce the risk of non-variceal UGIB in CKD patients receiving aspirin.We retrospectively reviewed the medical records of 500 CKD patients who (...) received aspirin between January 2008 and March 2013. Cumulative incidence analysis using the Kaplan-Meier method was performed to analyze the rate of non-variceal UGIB and association with the administration of low-dose PPI.Of the 500 patients, 191 received low-dose PPI. Over the follow-up period, which lasted 1067 person-years, three patients in the low-dose PPI group (8.9 per 1000 person-years) and 19 patients in the non-PPI group (25.9 per 1000 person-years) developed non-variceal UGIB

2015 Journal of gastroenterology and hepatology

36. Individualised prediction of alternate-day aspirin treatment effects on the combined risk of cancer, cardiovascular disease and gastrointestinal bleeding in healthy women. Full Text available with Trip Pro

Individualised prediction of alternate-day aspirin treatment effects on the combined risk of cancer, cardiovascular disease and gastrointestinal bleeding in healthy women. The value of aspirin in primary prevention of cancer and cardiovascular disease (CVD) remains unclear. The aim of this study was to identify women who benefit from alternate-day aspirin with regard to all relevant outcomes, including cancer, CVD and major gastrointestinal bleeding.Long term follow-up data of 27 939 healthy (...) women with baseline plasma samples in the Women's Health Study, a randomised trial of 100 mg alternate-day aspirin versus placebo, were used to develop competing risks models for individualised prediction of absolute risk reduction of the combination of CVD, cancer and major gastrointestinal bleeding by aspirin.Although aspirin was associated with a modestly decreased 15-year risk of colorectal cancer, CVD, and in some women non-colorectal cancer, aspirin treatment resulted in a negative treatment

2015 Heart Controlled trial quality: uncertain

37. Effect of proton-pump inhibitors on the risk of lower gastrointestinal bleeding associated with NSAIDs, aspirin, clopidogrel, and warfarin. (Abstract)

Effect of proton-pump inhibitors on the risk of lower gastrointestinal bleeding associated with NSAIDs, aspirin, clopidogrel, and warfarin. We investigated the effects of proton-pump inhibitors (PPIs) on lower gastrointestinal bleeding (LGIB) and of their interactions with nonsteroidal anti-inflammatory drugs (NSAIDs), low-dose aspirin, clopidogrel, and warfarin on LGIB risk.We prospectively studied 355 patients emergently hospitalized for LGIB and 8,221 nonbleeding patients. All patients (...) underwent colonoscopy. Smoking, alcohol drinking, drug exposure, and the Charlson comorbidity index score were assessed before colonoscopy. Adjusted odds ratios (AOR) of LGIB were estimated.LGIB was significantly associated with older age, higher comorbidity index, and NSAID, aspirin, clopidogrel, or warfarin use. PPI use was significantly associated with older age, male sex, being a current alcohol drinker, higher comorbidity index, and NSAID, aspirin, clopidogrel, warfarin, acetaminophen

2015 Journal of gastroenterology

38. Kaiser Permanente National Aspirin Clinician Guide

artery disease or peripheral artery disease, e.g., aortic atherosclerosis, or abnormal ankle brachial index (ABI) detected on screening. Exclusions for Aspirin Therapy ? Exclude adults with increased risk of bleeding. This includes those with a history of gastrointestinal (GI) bleeding, GI ulcers, intracranial bleed, bleeding disorders, renal failure, severe liver disease, thrombocytopenia, or using other medicine to prevent blood clots. Kaiser Permanente National CLINICAL PRACTICE GUIDELINES (...) National Clinical Practice Guidelines This Clinician Guide expires within two years of the posted month. 2 See National Clinical Library for current version (https://cl.kp.org). © 2018 Kaiser Permanente Care Management Institute Table 1: Lifetime Events in 10,000 taking aspirin. Green = start aspirin, Blue = consider aspirin ASCVD Risk Gender MIs Prevented Ischemic Strokes Prevented Colorectal Cancer Cases Prevented Serious GI Bleeding Caused Hemorrhagic Strokes Caused Net Life- Years Gained Quality

2019 Kaiser Permanente National Guideline Program

39. Aspirin Use to Prevent Cardiovascular Disease and Colorectal Cancer

daily. • There is no recommendation for or against aspirin therapy in adults aged < 50 or = 60 years. • Exclude adults with increased risk of bleeding. This includes those with a history of gastrointestinal (GI) bleeding, GI ulcers, intracranial bleed, bleeding disorders, renal failure, severe liver disease, thrombocytopenia, or using NSAIDS daily, or other medicine to prevent blood clots. The recommendations above reflect a change from initiate to consider in adults aged 50-59 years with 10-year (...) cardiovascular risk patients who were over 55 years of age (males) or 60 years of age (females) to 100 mg aspirin or placebo. The primary efficacy endpoint was a composite outcome consisting of time to first occurrence of confirmed myocardial infarction, stroke, cardiovascular death, unstable angina, or transient ischemic attack. There was no difference in CV events between groups. There were significantly higher rates of gastrointestinal bleeding among patients taking aspirin (0.97%) compared to the placebo

2019 Kaiser Permanente National Guideline Program

40. Risk of major bleeding and stroke associated with the use of vitamin K antagonists, nonvitamin K antagonist oral anticoagulants and aspirin in patients with atrial fibrillation: a cohort study Full Text available with Trip Pro

use with Cox regression analysis.A total of 31 497 patients were eligible for the study. The hazard ratio (HR) of major bleeding was 2.07 [95% confidence interval (CI) 1.27-3.38] for NOACs compared with VKAs, which was mainly attributed by the increased risk of gastrointestinal bleeding (HR 2.63, 95% CI 1.50-4.62). This increased bleeding risk was restricted to women (HR 3.14, 95% CI 1.76-5.60). Aspirin showed a similar bleeding risk as VKAs. NOACs showed equal effectiveness as VKA in preventing (...) ischaemic stroke (HR 1.22, 95% CI 0.67-2.19). VKAs were more effective than aspirin (HR 2.18, 95% CI 1.83-2.59).NOACs were associated with a higher risk on gastrointestinal bleeding, particularly in women. The use of NOACs in patients who are vulnerable for this type of bleeding should be carefully considered. NOACs and VKAs are equally effective in preventing stroke. Aspirin was not effective in the prevention of stroke in AF.© 2017 The British Pharmacological Society.

2017 British journal of clinical pharmacology

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