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61. The best dose of aspirin for cardiovascular protection may depend on body weight

cardiovascular events. Aspirin is recommended as secondary prevention after a heart attack or ischaemic stroke, but its place in primary prevention of cardiovascular disease is less certain and recent large studies have questioned this role. Studies have shown that an antiplatelet effect may help reduce risk of a first cardiovascular event. However, the effect size is modest and varies in different groups (such as men and women). Aspirin also raises the risk of bleeding and gastrointestinal problems (...) disease is less certain and recent large studies have questioned this role. Studies have shown that an antiplatelet effect may help reduce risk of a first cardiovascular event. However, the effect size is modest and varies in different groups (such as men and women). Aspirin also raises the risk of bleeding and gastrointestinal problems. The researchers wanted to find out whether overall body weight (not body mass index) affected how much benefit people got from aspirin. What did this study do

2019 NIHR Dissemination Centre

62. A Prospective Study of Alcohol Consumption and Smoking and the Risk of Major Gastrointestinal Bleeding in Men. Full Text available with Trip Pro

A Prospective Study of Alcohol Consumption and Smoking and the Risk of Major Gastrointestinal Bleeding in Men. Data regarding smoking and alcohol consumption and risk of gastrointestinal bleeding (GIB) are sparse and conflicting. We assessed the risk of major GIB associated with smoking and alcohol consumption in a large, prospective cohort.We prospectively studied 48,000 men in the Health Professional follow-up Study (HPFS) who were aged 40-75 years at baseline in 1986. We identified men (...) -2.77; P for trend 0.02). Men who consumed ≥ 5 drinks/week vs. < 1 drink/month of liquor had a multivariable RR of 1.72 (95% CI, 1.26-2.35, P for trend <0.001). Wine and beer were not significantly associated with major GIB. The risk of GIB associated with NSAIDs/aspirin use increased with greater alcohol consumption (multivariable RR 1.37; 95% CI, 0.85-2.19 for 1-14g/day of alcohol, RR 1.75; 95% CI, 1.07-2.88 for ≥ 15g/day compared to nondrinkers). Smoking was not significantly associated

2016 PLoS ONE

63. Pantoprazole to Prevent Gastroduodenal Events in Patients Receiving Rivaroxaban and/or Aspirin in a Randomized, Double-Blind, Placebo-Controlled Trial Full Text available with Trip Pro

Pantoprazole to Prevent Gastroduodenal Events in Patients Receiving Rivaroxaban and/or Aspirin in a Randomized, Double-Blind, Placebo-Controlled Trial Antiplatelets and anticoagulants are associated with increased upper gastrointestinal bleeding. We evaluated whether proton pump inhibitor therapy could reduce this risk.We performed a 3 × 2 partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease. Participants were randomly (...) assigned to groups given pantoprazole 40 mg daily or placebo, as well as rivaroxaban 2.5 mg twice daily with aspirin 100 mg once daily, rivaroxaban 5 mg twice daily, or aspirin 100 mg alone. The primary outcome was time to first upper gastrointestinal event, defined as a composite of overt bleeding, upper gastrointestinal bleeding from a gastroduodenal lesion or of unknown origin, occult bleeding, symptomatic gastroduodenal ulcer or ≥5 erosions, upper gastrointestinal obstruction, or perforation.There

2019 EvidenceUpdates

64. Aspirin for Primary Prevention of Cardiovascular Events (Abstract)

of ≥1 year were included. Efficacy outcomes included all-cause death, cardiovascular (CV) death, myocardial infarction (MI), stroke, transient ischemic attack (TIA), and major adverse cardiovascular events. Safety outcomes included major bleeding, intracranial bleeding, fatal bleeding, and major gastrointestinal (GI) bleeding. Random effects DerSimonian-Laird risk ratios (RRs) for outcomes were calculated.A total of 15 randomized controlled trials including 165,502 participants (aspirin n = 83,529 (...) , control n = 81,973) were available for analysis. Compared with control, aspirin was associated with similar all-cause death (RR: 0.97; 95% confidence interval [CI]: 0.93 to 1.01), CV death (RR: 0.93; 95% CI: 0.86 to 1.00), and non-CV death (RR: 0.98; 95% CI: 0.92 to 1.05), but a lower risk of nonfatal MI (RR: 0.82; 95% CI: 0.72 to 0.94), TIA (RR: 0.79; 95% CI: 0.71 to 0.89), and ischemic stroke (RR: 0.87; 95% CI: 0.79 to 0.95). Aspirin was associated with a higher risk of major bleeding (RR: 1.5; 95

2019 EvidenceUpdates

65. Management of Bleeding in Patients on Oral Anticoagulants

If$1 of the following factors apply, the bleed is classi?ed as major. Bleeding in a Critical Site Criticalsitebleedsareconsideredbleedsthatcompromise the organ’s function. Intracranial hemorrhage and other central nervous system bleeds (e.g., intraocular, spinal) and thoracic, intra-abdominal, retroperitoneal, intra- articular, and intramuscular bleeds are considered critical as they may cause severe disability and require surgical procedures for hemostasis. Intraluminal gastrointestinal (GI (...) pressure and exacerbate bleeding (41). Patients with inherited bleeding disorders and other acquired hemostatic defects (e.g., use of dual antiplatelet therapy) may be at risk for more severe and prolonged bleeding. This writing committee recommends correction of any underlying hemostatic defects. At this time, there is limited evidence to support routine administration of platelets in the setting of antiplatelet agent use (e.g., aspirin, P2Y 12 inhibitors). Two systematic reviews of small studies

2017 American College of Cardiology

66. CRACKCast E30 – GI Bleeding

CRACKCast E30 – GI Bleeding CRACKCast E30 - GI Bleeding - CanadiEM CRACKCast E30 – GI Bleeding In , by Adam Thomas March 9, 2017 This episode of CRACKCast covers Rosen’s Chapter 30, GI Bleeding. This episode gives us a solid approach to the workup and management for GI bleeds. Showntoes – Rosen’s in perspective: Large burden of disease More than 1 million admissions in US per year. Risk factors: Medication use: Aspirin NSAIDs Steroids Anticoagulants (warfarin, heparin) Chemotherapeutic agents (...) History of PUD Known liver disease Cirrhosis Advanced age >60 Alcoholism Current Smoker Chronic medical comorbidities CHF Diabetes Renal Failure Malignancy CAD History of AAA or graft Anatomic classification : Upper versus Lower Above ligament of treitz (distal duodenum) is upper gastrointestinal bleed (UGIB) mortality 12-14% Below ligament of treitz is lower gastrointestinal bleed (LGIB) mortality 4% . UGIB – think hematemesis and melena and HIGH BUN LGIB – think hematochezia (BRPR versus maroon

2017 CandiEM

67. Non-steroidal anti-inflammatory drug (NSAID) therapy in patients with hypertension, cardiovascular, renal or gastrointestinal comorbidities: joint APAGE/APLAR/APSDE/APSH/APSN/PoA recommendations

: NSAIDs are a valuable armamentarium in clinical medicine, but appropriate recognition of high-risk cases, selection of a specific agent, choice of ulcer prophylaxis and monitoring after therapy are necessary to minimise the risk of adverse events. Keywords: aspirin; bleeding peptic ulcer; cardiovascular disease; non-steroidal anti-inflammatory drugs; portal hypertension. © Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ. Conflict of interest (...) Non-steroidal anti-inflammatory drug (NSAID) therapy in patients with hypertension, cardiovascular, renal or gastrointestinal comorbidities: joint APAGE/APLAR/APSDE/APSH/APSN/PoA recommendations Non-steroidal Anti-Inflammatory Drug (NSAID) Therapy in Patients With Hypertension, Cardiovascular, Renal or Gastrointestinal Comorbidities: Joint APAGE/APLAR/APSDE/APSH/APSN/PoA Recommendations - PubMed This site needs JavaScript to work properly. Please enable it to take advantage of the complete set

2020 EvidenceUpdates

68. Bleeding Risk with Long-Term Low-Dose Aspirin: A Systematic Review of Observational Studies. Full Text available with Trip Pro

conducted to identify observational studies published between 1946 and 4 March 2015 that reported the risks of gastrointestinal (GI) bleeding or intracranial hemorrhage (ICH) with long-term, low-dose aspirin (75-325 mg/day). Pooled estimates of the relative risk (RR) for bleeding events with aspirin versus non-use were calculated using random-effects models, based on reported estimates of RR (including odds ratios, hazard ratios, incidence rate ratios and standardized incidence ratios) in 39 (...) Bleeding Risk with Long-Term Low-Dose Aspirin: A Systematic Review of Observational Studies. Low-dose aspirin has proven effectiveness in secondary and primary prevention of cardiovascular events, but is also associated with an increased risk of major bleeding events. For primary prevention, this absolute risk must be carefully weighed against the benefits of aspirin; such assessments are currently limited by a lack of data from general populations.Systematic searches of Medline and Embase were

2016 PloS one

69. Bioequivalence of Single Dose Fast Release Aspirin (1000 mg) Tablet Versus Single Dose of Two 500 mg Fast Release Aspirin Tablets

History of gastrointestinal bleeding or perforation, including bleeding related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding). Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) seven days prior to dosing or during the Treatment Periods, other than study product Loss of blood in excess of 500 mL within 56 days of the first dose of trial treatment (e.g (...) Bioequivalence of Single Dose Fast Release Aspirin (1000 mg) Tablet Versus Single Dose of Two 500 mg Fast Release Aspirin Tablets Bioequivalence of Single Dose Fast Release Aspirin (1000 mg) Tablet Versus Single Dose of Two 500 mg Fast Release Aspirin Tablets - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have

2017 Clinical Trials

70. Gastroprotective [6]-Gingerol Aspirinate as a Novel Chemopreventive Prodrug of Aspirin for Colon Cancer Full Text available with Trip Pro

Gastroprotective [6]-Gingerol Aspirinate as a Novel Chemopreventive Prodrug of Aspirin for Colon Cancer A growing body of research suggests daily low-dose aspirin (ASA) reduces heart diseases and colorectal cancers. However, the major limitation to the use of aspirin is its side effect to cause ulceration and bleeding in the gastrointestinal tract. Preclinical studies have shown that ginger constituents ameliorate ASA-induced gastric ulceration. We here report the design and synthesis (...) of a novel prodrug of aspirin, [6]-gingerol aspirinate (GAS). Our data show that GAS exerts enhanced anti-cancer properties in vitro and superior gastroprotective effects in mice. GAS was also able to survive stomach acid and decomposed in intestinal linings or after absorption to simultaneously release ASA and [6]-gingerol. We further present that GAS inactivates both COX-1 and COX-2 equally. Our results demonstrate the enhanced anticancer properties along with gastroprotective effects of GAS

2017 Scientific reports

71. Gastrointestinal Safety of Aspirin for a High-Dose, Multiple-Day Treatment Regimen: A Meta-Analysis of Three Randomized Controlled Trials. Full Text available with Trip Pro

such as bleeding, perforation, or ulceration.The multiple-dose regimen of aspirin used for several days according to the OTC label is well-tolerated by otherwise healthy non-elderly subjects for short-term and symptomatic treatment of pain, fever, and the common cold. There were no reports of serious gastrointestinal complications in either of the groups. (...) Gastrointestinal Safety of Aspirin for a High-Dose, Multiple-Day Treatment Regimen: A Meta-Analysis of Three Randomized Controlled Trials. Aspirin is a commonly used over-the-counter (OTC) agent for the symptomatic treatment of acute pain, fever, or the common cold, but data regarding safety in this context are limited. In order to characterize the safety of aspirin beyond single-dose or long-term use data, we conducted a meta-analysis of multiple-dose, multiple-day studies of OTC aspirin

2016 Drugs in R&D

72. Determination of the adequate dosage of rebamipide, a gastric mucoprotective drug, to prevent low-dose aspirin-induced gastrointestinal mucosal injury Full Text available with Trip Pro

Determination of the adequate dosage of rebamipide, a gastric mucoprotective drug, to prevent low-dose aspirin-induced gastrointestinal mucosal injury Small intestinal mucosal injury caused by low-dose aspirin is a common cause of obscure gastrointestinal bleeding. We aimed to investigate the protective effects and optimal dose of rebamipide for low-dose aspirin-induced gastrointestinal mucosal injury. In this prospective randomized trial, 45 healthy volunteers (aged 20-65 years) were included (...) and divided into three groups. The groups received enteric-coated aspirin 100 mg (low-dose aspirin) plus omeprazole 10 mg (Group A: proton pump inhibitor group), low-dose aspirin plus rebamipide 300 mg (Group B: standard-dose group), or low-dose aspirin plus rebamipide 900 mg (Group C: high-dose group). Esophagogastroduodenoscopy and video capsule endoscopy were performed, and the fecal occult blood reaction and fecal calprotectin levels were measured before and two weeks after drug administration

2016 Journal of clinical biochemistry and nutrition Controlled trial quality: uncertain

73. Eicosapentaenoic acid and aspirin, alone and in combination, for the prevention of colorectal adenomas (seAFOod Polyp Prevention trial): a multicentre, randomised, double-blind, placebo-controlled, 2 × 2 factorial trial. Full Text available with Trip Pro

in the aspirin group, and 68 in the aspirin plus placebo group). Six upper-gastrointestinal bleeding events were reported across the treatment groups (two in the EPA group, three in the aspirin group, and one in the placebo group).Neither EPA nor aspirin treatment were associated with a reduction in the proportion of patients with at least one colorectal adenoma. Further research is needed regarding the effect on colorectal adenoma number according to adenoma type and location. Optimal use of EPA and aspirin (...) ·12; risk difference -0·9%, -8·8 to 6·9; p=0·81) or aspirin (RR 0·99 (0·87 to 1·12; risk difference -0·6%, -8·5 to 7·2; p=0·88). EPA and aspirin were well tolerated (78 [44%] of 176 had ≥1 adverse event in the placebo group compared with 82 [46%] in the EPA group, 68 [39%] in the aspirin group, and 76 [45%] in the EPA plus aspirin group), although the number of gastrointestinal adverse events was increased in the EPA alone group at 146 events (compared with 85 in the placebo group, 86

2018 Lancet Controlled trial quality: predicted high

74. Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus. Full Text available with Trip Pro

to 1.52; P=0.003), with most of the excess being gastrointestinal bleeding and other extracranial bleeding. There was no significant difference between the aspirin group and the placebo group in the incidence of gastrointestinal tract cancer (157 participants [2.0%] and 158 [2.0%], respectively) or all cancers (897 [11.6%] and 887 [11.5%]); long-term follow-up for these outcomes is planned.Aspirin use prevented serious vascular events in persons who had diabetes and no evident cardiovascular disease (...) Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus. Diabetes mellitus is associated with an increased risk of cardiovascular events. Aspirin use reduces the risk of occlusive vascular events but increases the risk of bleeding; the balance of benefits and hazards for the prevention of first cardiovascular events in patients with diabetes is unclear.We randomly assigned adults who had diabetes but no evident cardiovascular disease to receive aspirin at a dose of 100 mg

2018 NEJM Controlled trial quality: predicted high

75. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. (Abstract)

in seven countries. Eligible patients were aged 55 years (men) or 60 years (women) and older and had an average cardiovascular risk, deemed to be moderate on the basis of the number of specific risk factors. We excluded patients at high risk of gastrointestinal bleeding or other bleeding, or diabetes. Patients were randomly assigned (1:1) with a computer-generated randomisation code to receive enteric-coated aspirin tablets (100 mg) or placebo tablets, once daily. Patients, investigators, and others (...) , 12 546 patients were enrolled and randomly assigned to receive aspirin (n=6270) or placebo (n=6276) at 501 study sites. Median follow-up was 60 months. In the intention-to-treat analysis, the primary endpoint occurred in 269 (4·29%) patients in the aspirin group versus 281 (4·48%) patients in the placebo group (hazard ratio [HR] 0·96; 95% CI 0·81-1·13; p=0·6038). Gastrointestinal bleeding events (mostly mild) occurred in 61 (0·97%) patients in the aspirin group versus 29 (0·46%) in the placebo

2018 Lancet Controlled trial quality: predicted high

76. Aspirin for prophylactic use in the primary prevention of cardiovascular disease and cancer: a systematic review and overview of reviews

,TGurung, KFreeman,SJohnson, N-B Kandala, A Grove, B Gurung, S Morrow and A Clarke* Warwick Evidence, Warwick Medical School, University of Warwick, Coventry, UK *Corresponding author Background: Prophylactic aspirin has been considered to be bene?cial in reducing the risks of heart disease and cancer. However, potential bene?ts must be balanced against the possible harm from side effects, such as bleeding and gastrointestinal (GI) symptoms. It is particularly important to know the risk of side effects (...) -years) were as follows: 33–46 deaths (all-cause mortality), 60–84 MCEs, and 47–64 incidents of CHD. Retrospective analysis also indicated the possible avoidance of 34 deaths from colorectal cancer/100,000 person-years; however, in this analysis two large studies were excluded. Potential harms of aspirin use include bleeding at various sites. Reported increased RRs from aspirin use were 37% for gastrointestinal (GI) bleeding (RR 1.37, 95% CI 1.15 to 1.62), between 54% (RR 1.54, 95% CI 1.30 to 1.82

2013 NIHR HTA programme

77. Association of aspirin use with major bleeding in patients with and without diabetes. Full Text available with Trip Pro

Association of aspirin use with major bleeding in patients with and without diabetes. The benefit of aspirin for the primary prevention of cardiovascular events is relatively small for individuals with and without diabetes. This benefit could easily be offset by the risk of hemorrhage.To determine the incidence of major gastrointestinal and intracranial bleeding episodes in individuals with and without diabetes taking aspirin.A population-based cohort study, using administrative data from 4.1 (...) million citizens in 12 local health authorities in Puglia, Italy. Individuals with new prescriptions for low-dose aspirin (≤300 mg) were identified during the index period from January 1, 2003, to December 31, 2008, and were propensity-matched on a 1-to-1 basis with individuals who did not take aspirin during this period.Hospitalizations for major gastrointestinal bleeding or cerebral hemorrhage occurring after the initiation of antiplatelet therapy.There were 186,425 individuals being treated

2012 JAMA

78. Gastric mucosa and susceptibility to occult gastrointestinal bleeding caused by aspirin. Full Text available with Trip Pro

Gastric mucosa and susceptibility to occult gastrointestinal bleeding caused by aspirin. 5297151 1967 02 25 2018 11 13 0007-1447 1 5533 1967 Jan 21 British medical journal Br Med J Gastric mucosa and susceptibility to occult gastrointestinal bleeding caused by aspirin. 137-41 Croft D N DN Wood P H PH eng Clinical Trial Controlled Clinical Trial Journal Article England Br Med J 0372673 0007-1447 9007-49-2 DNA R16CO5Y76E Aspirin AIM IM Adult Aspirin adverse effects DNA analysis Female Gastrectomy (...) Gastric Lavage Gastric Mucosa drug effects Gastrointestinal Hemorrhage chemically induced Humans Male Middle Aged Stomach analysis 1967 1 21 1967 1 21 0 1 1967 1 21 0 0 ppublish 5297151 PMC1840577 Gut. 1966 Aug;7(4):333-43 5917419 Br Med J. 1953 Jul 11;2(4827):77-80 13051582 Br Med J. 1957 Feb 16;1(5015):372-7 13396263 Am J Med. 1961 Aug;31:259-65 13735596 Am J Med. 1961 Aug;31:266-78 13784037 Gastroenterology. 1961 Jan;40:56-63 13785825 Br Med J. 1962 Mar 10;1(5279):675-80 13917943 Br Med J. 1962 Mar

1967 British medical journal

79. Aspirin and gastrointestinal bleeding. An opinion. Full Text available with Trip Pro

Aspirin and gastrointestinal bleeding. An opinion. 5305637 1969 07 06 2018 11 13 0008-1264 110 5 1969 May California medicine Calif Med Aspirin and gastrointestinal bleeding. An opinion. 440-1 Babb R R RR Wilbur R S RS eng Journal Article United States Calif Med 0410260 0008-1264 R16CO5Y76E Aspirin IM Aspirin adverse effects Gastrointestinal Hemorrhage chemically induced Humans 1969 5 1 1969 5 1 0 1 1969 5 1 0 0 ppublish 5305637 PMC1503501 Am J Med. 1961 Aug;31:259-65 13735596 Lancet. 1958 Nov

1969 California Medicine

80. Alcohol, Aspirin, and Gastrointestinal Bleeding Full Text available with Trip Pro

Alcohol, Aspirin, and Gastrointestinal Bleeding In 20 healthy male subjects faecal blood loss was measured by means of a chromium-51-labelled red blood cell technique. Mean daily faecal blood loss associated with unbuffered aspirin ingestion was significantly increased by alcohol in the 13 subjects studied. In seven others alcohol alone did not cause gastrointestinal bleeding. These findings suggest that alcohol may accentuate gastrointestinal blood loss associated with unbuffered aspirin

1968 British medical journal

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