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aspirin and gastrointestinal bleeding

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7541. Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome

medications for less than 3 months, or who plan to take them for the first time during the next 3 months: ACE-inhibitors, angiotensin receptor blockers, calcium channel blockers, or statins. Patients who are currently cigarette smokers. Women patients who are pregnant, planning to become pregnant, nursing a child, or taking hormone replacement therapy. Patients with any coagulation, bleeding or blood disorders. Patients who are sensitive or allergic to aspirin. Patients with documented history of any (...) gastrointestinal disorders, including bleeding ulcers. Patients with any evidence of cancer or history of significant cardiovascular disease (including heart attack, stroke or drop attacks termed transient ischemic attacks (TIAs), or blockages of the arteries in the legs termed peripheral arterial disease (PAD)), kidney, liver, lung, blood, or brain disorders. Patients with asthma, rhinitis, or nasal polyps. Patients with any abnormal laboratory value or physical finding that, in the view of the responsible

2006 Clinical Trials

7542. Aspirin for the Prevention of Recurrent Venous Thromboembolism

or heterozygous factor V Leiden plus heterozygous prothrombin G21210A or antithrombin III deficiency; patients with active malignancy temporary risk factors for venous thromboembolism any recurrence of venous thromboembolism or bleeding episode during the established 6-month period of oral anticoagulant treatment allergy or intolerance of aspirin clear indication for aspirin or other anti-platelet therapy (e.g. clopidogrel, ticlopidine) clear indication for long-term anticoagulant therapy (e.g. recurrent (...) idiopathic venous thromboembolism, prosthetic heart valve) treatment with non-selective COX-1/2 non-steroidal anti-inflammatory drugs life expectancy less than 6 months active bleeding or at high risk of bleeding (gastrointestinal bleeding within the past 12 months; endoscopic diagnosis of peptic ulcer disease or ulcerative esophagitis within the past 6 months unless there is documented endoscopic evidence of healing; intracranial bleeding within the past year; known bleeding diathesis) anticipated non

2005 Clinical Trials

7543. To Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA Versus Enteric-Coated Aspirin

: omeprazole Phase 1 Detailed Description: PA 325 is proposed for the reduction in the risk of aspirin-associated gastrointestinal (GI) adverse events in patients requiring daily aspirin. This study is designed as a Proof of Concept study to evaluate the gastroprotective effects, pharmacokinetic profile, and safety of PA 325 in healthy volunteers. To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet combining 325 mg pH-sensitive aspirin and 20 mg immediate release (...) Effects and Pharmacokinetic Profile of PA 325 Versus Enteric-Coated Aspirin. Study Start Date : November 2006 Study Completion Date : January 2007 Resource links provided by the National Library of Medicine available for: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : To compare the gastroprotective effects of a once-daily dose of PA 325 Secondary Outcome Measures : To evaluate the safety and GI tolerability including ulcerogenic potential, the pharmacokinetic profile

2007 Clinical Trials

7544. A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension

: Simvastatin 40 mg, taken orally, once a day for 6 months Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months Drug: Simvastatin Simvastatin 40 mg, taken orally, once a day for 6 months Other Name: Zocor Drug: Aspirin Aspirin 81 mg, taken orally, once a day for 6 months Other Name: acetylsalicylic acid Active Comparator: Aspirin 81 mg + Placebo Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months Placebo taken orally, once a day for 6 months Drug: Aspirin Aspirin 81 mg, taken orally, once (...) or planned treatment with one of the following: amiodarone, cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, cimetidine, danazol, large quantities of grapefruit juice (more than 1 quart daily), verapamil, fibrates, or niacin Peptic or duodenal ulcer diagnosed within 1 year of study entry Gastrointestinal bleeding within 6 months prior of study entry Bleeding diathesis History of intracranial bleeding Anemia (hematocrit less than 30

2006 Clinical Trials

7545. Aspirin for everyone older than 50?: AGAINST (Full text)

Aspirin administration & dosage adverse effects Fibrinolytic Agents administration & dosage Gastrointestinal Hemorrhage chemically induced Humans Middle Aged Myocardial Infarction pathology Risk Factors 11 2005 6 18 9 0 2005 7 12 9 0 2005 6 18 9 0 ppublish 15961819 330/7505/1442 10.1136/bmj.330.7505.1442 PMC558386 Drugs Aging. 2003;20(12):897-903 14565783 Lancet. 2001 Jan 13;357(9250):89-95 11197445 Heart. 2001 Mar;85(3):265-71 11179262 BMJ. 2002 Jan 12;324(7329):71-86 11786451 J Clin Epidemiol. 2002 (...) Aspirin for everyone older than 50?: AGAINST 15961819 2005 07 11 2018 11 13 1756-1833 330 7505 2005 Jun 18 BMJ (Clinical research ed.) BMJ Aspirin for everyone older than 50? Against. 1442-3 Baigent Colin C Clinical Trial Service Unit and Epidemiological Studies Unit, Radcliffe Infirmary, Oxford OX2 6HE. colin.baigent@ctsu.ox.ac.uk eng Comment Journal Article Review England BMJ 8900488 0959-8138 0 Fibrinolytic Agents R16CO5Y76E Aspirin AIM IM BMJ. 2005 Jun 18;330(7505):1440-1 15961818 Aged

2005 BMJ : British Medical Journal PubMed abstract

7546. Aspirin prescription and outcomes in hemodialysis patients: the Dialysis Outcomes and Practice Patterns Study (DOPPS). (Abstract)

with increased odds of prescription included coronary artery disease, cerebrovascular disease, diabetes, male sex, nonblack race, peripheral vascular disease, age, hypertension, and absence of gastrointestinal bleeding. Aspirin was associated with decreased risk of stroke in all patients (relative risk [RR], 0.82; P < 0.01) and increased risk of myocardial infarction (RR, 1.21; P = 0.01) and cardiac event (RR, 1.08; P < 0.01) in all patients, with similar results for patients with coronary artery disease (...) -cause mortality, all-cause hospitalization, cardiac event, myocardial infarction, cerebrovascular (CVA), gastrointestinal bleed, transient ischemic attack, and subdural hematoma were examined. Cox regression examined the risk of mortality and hospitalization. All models accounted for facility clustering and demographics and comorbid conditions.Wide variation was found in aspirin prescription, from 8% in Japan to 41% in Australia and New Zealand. Characteristics significantly associated

2007 American journal of kidney diseases : the official journal of the National Kidney Foundation Controlled trial quality: uncertain

7547. Systematic review and meta-analysis of adverse events of low-dose aspirin and clopidogrel in randomized controlled trials. (Abstract)

of 22 trials for aspirin versus placebo and from single studies for aspirin versus clopidogrel, aspirin versus aspirin/clopidogrel, and clopidogrel versus aspirin/clopidogrel. Absolute risk increase was calculated by multiplying RR increase by the pooled weighted incidence of the control.Aspirin increased the risk of major bleeding (RR=1.71; 95% confidence interval [CI], 1.41-2.08), major gastrointestinal (GI) bleeding (RR=2.07; 95% CI, 1.61-2.66), and intracranial bleeding (RR=1.65; 95% CI, 1.06 (...) -5.99) versus placebo. No difference between 75-162.5 mg/day and >162.5-325 mg/day aspirin versus placebo was seen. The absolute annual increases attributable to aspirin were major bleeding: 0.13% (95% CI, 0.08-0.20); major GI bleeding: 0.12% (95% CI, 0.07-0.19), intracranial bleeding: 0.03% (95% CI, 0.01-0.08). No study compared clopidogrel with placebo. One study showed increased major GI bleeding (but not non-GI bleeding endpoints) with aspirin versus clopidogrel (RR=1.45; 95% CI, 1.00-2.10

2006 The American journal of medicine

7548. Ulcer recurrence in high-risk patients receiving nonsteroidalanti-inflammatory drugs plus low-dose aspirin: results of a post HOC subanalysis. (Abstract)

Ulcer recurrence in high-risk patients receiving nonsteroidalanti-inflammatory drugs plus low-dose aspirin: results of a post HOC subanalysis. Concomitant aspirin use is a risk factor for nonsteroidal anti-inflammatory drug (NSAID)-associated upper gastrointestinal toxicity. In high-risk individuals, such as those with a history of NSAID-related gastric ulcer bleeding, gastroprotective therapy with a proton pump inhibitor has been reported to reduce the risk of recurrent aspirin-associated (...) on baseline endoscopy. The study treatments were misoprostol 200 microg QID or lansoprazole 15 or 30 mg OD. The subanalysis included data from patients in the intent-to-treat cohort who took aspirin at an amount

2004 Clinical therapeutics Controlled trial quality: predicted high

7549. Aspirin Prophylaxis in Sickle Cell Disease

. Informed consent signed by the parent or legal guardian. Exclusion Criteria: 1. Prior history of overt stroke or cerebral hemorrhage. 2. Known history of allergic reaction to aspirin. 3. History of Reye's syndrome 4. Diagnosis of G-6-PD deficiency or von Willebrand's disease 5. Prolongation of the bleeding time or abnormal closure time, prothrombin time (PT), or partial thromboplastin time (PTT). 6. Active gastrointestinal (GI) bleeding or a history of GI bleeding. 7. Hepatic disease (AST or ALT >2x (...) topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Aspirin One-arm study Drug: aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months. Other Names: Acetylsalicyclic Acid ASA Outcome Measures Go to Primary Outcome Measures

2005 Clinical Trials

7550. A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin

Measures : Gastroduodenal ulcers at final visit [ Time Frame: Week 12 ] Secondary Outcome Measures : Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction) [ Time Frame: Week 12 ] Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores. [ Time Frame: Weeks 4,8, and 12 ] Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline. [ Time (...) Numbers: LAN-0003-0041 U1111-1114-2275 ( Registry Identifier: WHO ) First Posted: September 15, 2005 Last Update Posted: July 22, 2010 Last Verified: July 2010 Keywords provided by Takeda: Low dose aspirin Peptic Ulcer gastric ulcer duodenal ulcer NSAIDs Additional relevant MeSH terms: Layout table for MeSH terms Osteoarthritis Ulcer Peptic Ulcer Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Pathologic Processes Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases

2005 Clinical Trials

7551. Primary care physician perceptions of non-steroidal anti-inflammatory drug and aspirin-associated toxicity: results of a national survey. (Full text)

. Almost one-third of primary care physicians recommended 325 mg rather than 81 mg of aspirin/day for cardioprotection. Fifty-nine percent thought enteric-coated or buffered aspirin reduced the risk of upper gastrointestinal (GI) bleeding. Seventy-six percent believed that Helicobacter pylori infection increased the risk of NSAID ulcers but fewer than 25% tested NSAID users for this infection. More than two-thirds were aware that aspirin co-therapy decreased the GI safety benefits of the cyclo (...) Primary care physician perceptions of non-steroidal anti-inflammatory drug and aspirin-associated toxicity: results of a national survey. To assess primary care physician perceptions of non-steroidal anti-inflammatory drug (NSAID) and aspirin-associated toxicity.A group of gastroenterologists and internal medicine physicians created a survey, which was administered via the Internet to a large number of primary care physicians from across the US.One thousand primary care physicians participated

2006 Alimentary Pharmacology & Therapeutics PubMed abstract

7552. Review article: should NSAID/low-dose aspirin takers be tested routinely for H. pylori infection and treated if positive? Implications for primary risk of ulcer and ulcer relapse after initial healing. (Abstract)

suggest, and guidelines recommend, the careful selection of anti-inflammatory drugs - NSAIDs or selective COX-2 inhibitors (coxibs) based upon patients gastrointestinal history and use of aspirin therapy. Testing for, and cure of, H. pylori infection is recommended in patients prior to the initiation of NSAID therapy and in those who are currently receiving NSAIDs and have a history of dyspepsia, peptic ulcer or ulcer complications. For patients who present with peptic ulcer bleeding but require (...) NSAIDs long-term, H. pylori eradication therapy should be considered, followed by continuous proton pump inhibitor prophylaxis to prevent re-bleeding, regardless of which kind of NSAID (nonselective NSAID /coxib) is being prescribed. Routine testing for, and eradication of, H. pylori infection has not been recommended for current takers of NSAIDs with no or low risk of complications. The management of patients taking low-dose aspirin is complex, but eradication of H. pylori infection alone in those

2004 Alimentary Pharmacology & Therapeutics

7553. [Primary prevention of coronary heart disease with aspirin]. (Abstract)

[Primary prevention of coronary heart disease with aspirin]. According to meta-analysis and the results of the two studies with the highest power, aspirin is effective in primary prevention of coronary heart disease. These beneficial effects, however, are at least partially out-weight by unwanted effects-such as intense gastrointestinal bleeding and hemorrhagic stroke. These side effects remain constant with increasing risk of coronary heart disease, whereas the protective effects increase (...) . If an annual risk of coronary heart disease of < or =0.6% exists, aspirin is normally not indicated; for a risk of 0.7-1.4% the facts should be discussed with the patient. If a risk of > or =1.5% exists, aspirin should be given. Problems of aspirin therapy--such as "aspirin paradox" and "aspirin resistance"--have been documented for secondary prevention; they might, however, have likewise clinical implications in primary prevention.

2005 Zeitschrift für Kardiologie

7554. Aspirin for the primary prevention of adverse cardiovascular events. (Full text)

potential complications of low-dose aspirin therapy, including gastrointestinal bleeding and stroke. (...) Aspirin for the primary prevention of adverse cardiovascular events. There is consideration controversy regarding the use of aspirin for the prophylaxis of certain cardiovascular conditions, such as coronary thrombosis and stroke. An exploration of current literature suggests that the decision to adopt a routine aspirin regimen must follow a careful analysis of potential risks as well as benefits. Nurses share a vital role in patient education related to aspirin regimens, to guard against

2008 Critical care nursing quarterly PubMed abstract

7555. Application of U.S. guidelines in other countries: aspirin for the primary prevention of cardiovascular events in Japan. (Abstract)

derived for rates of coronary heart disease, hemorrhagic stroke, and major gastrointestinal bleeding for the Japanese population and for subgroups with different risk factors. Odds ratios derived from meta-analyses were used to assess the potential benefits and risks of aspirin use.The estimated incidence of coronary heart disease in middle-aged men in Japan is lower than in the United States (1.57 vs. 6.0 per 1000 person-years), while that of hemorrhagic stroke is higher (1.14 vs. 0.37 per 1000 (...) person-years). Because of higher baseline rates of hemorrhagic diseases, the expected reduction in cardiovascular events with aspirin use would be offset by a greater increase in hemorrhagic complications for women and most men in Japan, except for those with both hypertension and diabetes. To achieve the same 2:1 ratio of coronary heart disease events avoided to hemorrhagic events caused that is implied by the 3% threshold for 5-year coronary disease risk in U.S. guidelines, a 6% to 14% risk

2004 The American journal of medicine

7556. Aspirin use for the primary prevention of coronary heart disease: a population-based study in Switzerland. (Abstract)

perspective, a more appropriate aspirin use would reduce up to 2,348/24,310 CHD deaths expected over 10 years in Switzerland, and avoid about 700 gastrointestinal bleedings and hemorrhagic strokes among those not eligible.Individuals at intermediate CHD risk and diabetics are more likely to take aspirin, but there are significant opportunities for improvement. The underuse of aspirin for those at risk coexists with an overuse among those at low risk. (...) Aspirin use for the primary prevention of coronary heart disease: a population-based study in Switzerland. To determine the patterns of aspirin use for the primary prevention of coronary heart disease (CHD). Aspirin for primary prevention has a more favorable risk/benefit profile among adults with high CHD risk than among low-risk adults.We studied 5725 adults aged 35-75 without cardiovascular disease in a population-based study in Switzerland in 2003-2006. We examined regular aspirin use

2008 Preventive Medicine

7557. Consistent aspirin use associated with improved arteriovenous fistula survival among incident hemodialysis patients in the dialysis outcomes and practice patterns study. (Full text)

Patterns Study between 1996 and 2004 were analyzed. Cox regression was used to examine the association between aspirin use and the risk of final AVF failure, first AVF failure, and a gastrointestinal bleeding event. Aspirin use was determined at baseline and one year later. Patients using aspirin at baseline and one year later were considered consistent aspirin users. All models accounted for facility clustering effects and were adjusted for age, race, gender, body mass index, prior permanent access (...) failure, prior placement of a catheter, 10 comorbid conditions, laboratory data, and other medications, and stratified by regions.Consistent aspirin use was significantly related to a lower risk of final AVF failure. Facility-level analysis, which may reduce confounding by indication, also showed a nearly significant trend of reduced risk of final AVF failure with greater prevalence of consistent aspirin use within dialysis facilities (P for trend = 0.07). The occurrence of a new gastrointestinal

2008 Clinical Journal of the American Society of Nephrology PubMed abstract

7558. Cost-effectiveness of proton pump inhibitor cotherapy in patients taking long-term, low-dose aspirin for secondary cardiovascular prevention. (Full text)

Cost-effectiveness of proton pump inhibitor cotherapy in patients taking long-term, low-dose aspirin for secondary cardiovascular prevention. Patients with coronary heart disease (CHD) require long-term therapy with low-dose aspirin (ASA). Although these patients are at increased risk for upper gastrointestinal bleeding (UGIB) and proton pump inhibitor (PPI) cotherapy may reduce such risk, it is not known whether lifelong PPI cotherapy is cost-effective.A Markov model was developed to compare (...) lifelong therapy with ASA alone vs therapy with ASA plus PPI in patients with CHD who are at least 50 years old. Base-case assumptions were (1) starting age, 65 years (range, 50-80 years); (2) UGIB risk category, average risk (range, average to 8-fold increased risk); (3) PPI effectiveness (66% (range, 25%-75%); and (4) annual PPI cost, $250 (range, $250-$1400).In the base-case analysis, ASA plus PPI resulted in fewer lifetime UGIB events (3.1% vs 9.5%) and UGIB-related deaths (0.4% vs 1.4%). At over

2008 Archives of Internal Medicine PubMed abstract

7559. Cost-effectiveness of aspirin chemoprevention for Barrett's esophagus. (Abstract)

Cost-effectiveness of aspirin chemoprevention for Barrett's esophagus. Recent data suggest that nonsteroidal anti-inflammatory drugs, including aspirin, may prevent the progression of Barrett's esophagus to adenocarcinoma. However, use of aspirin is associated with numerous potential complications, including gastrointestinal bleeding and hemorrhagic strokes. We used a modeling approach to determine and compare the effectiveness and cost-effectiveness of aspirin with and without endoscopic (...) surveillance to prevent esophageal adenocarcinoma.A Markov Monte Carlo decision model was constructed to compare four strategies for management of Barrett's esophagus: aspirin therapy, endoscopic surveillance with biopsies, both, or neither. Patients who took a daily enteric-coated aspirin were modeled to have a 50% reduction in the incidence of esophageal adenocarcinoma but could have complications related to therapy, at which point the aspirin was discontinued. Potential cardiac benefits of aspirin

2004 Journal of the National Cancer Institute

7560. Guidelines for the Management of Inflammatory Bowel Disease (IBD) in Children in the United Kingdom

in central Israel. Scand J Gastroenterol. 1989; 24: 346-50. [160] Ekbom A, Helmick C, Zack M, Adami HO. Increased risk of large-bowel cancer in Crohn's disease with colonic involvement. Lancet. 1990; 336: 357-9. [161] Jess T, Loftus EV Jr, Velayos FS, Harmsen WS, Zinsmeister AR, Smyrk TC, Schleck CD, Tremaine WJ, Melton LJ 3rd, Munkholm P, Sandborn WJ. Risk of intestinal cancer in inflammatory bowel disease: a population-based study from Olmsted County, Minnesota. Gastroenterology 2006; 130: 1039-46 (...) , CI 1.54 to 1.96). This is largely dependent on age and distribution of disease. = Adult data have shown UC and to a much lesser extent, Crohn’s colitis is associated with an increased risk of colonic carcinoma.Guidelines for the Management of Inflammatory Bowel Disease (IBD) in Children in the United Kingdom 21 6.1 Impact of IBD on patients and society = 25% of IBD cases present before the age of 18 years and diagnosis is commonly made in the second and third decades. = IBD in children can result

2008 British Society of Paediatric Gastroenterology Hepatology and Nutrition

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