Risks of gastrointestinal bleeding during secondary prevention of vascular events with aspirin--analysis of gastrointestinal bleeding during the UK-TIA trial.

From 1979 to 1985 2435 patients having had transient ischaemic attacks (TIAs) or minor ischaemic strokes, were enrolled in the UK TIA trial and were randomised to receive either aspirin 300 mg, daily or aspirin 1200 mg or placebo. Analysis of reported upper gastrointestinal bleeding events (defined as haematemesis or melaena, or both) showed a risk of bleeding in a dose dependent manner, odds ratios (95% CI) for 300 mg of aspirin = 3.3 (1.2 to 9.0) and for 1200 mg = 6.4 (2.5 to 16.5) and, as would be expected, an increased risk of hospitalisation because of bleeding also in a dose dependent manner, odds ratio = 3.6 (0.7 to 17.2) for 300 mg and 8.7 (2.0 to 37.6) for 1200 mg. Further analysis suggested greater risks of bleeding from duodenal ulcers than gastric ulcers and that bleeding is more likely early in the course of treatment with aspirin used as secondary prevention. There was also an increased risk of lower gastrointestinal bleeding, defined as fresh blood per rectum for both doses of aspirin, odds ratio 1.8 (0.5 to 6.1) for 300 mg of aspirin, and 1.5 (0.4 to 5.3) for 1200 mg of aspirin.

[1]  M. Rawlins,et al.  Prophylactic aspirin and risk of peptic ulcer bleeding , 1995, BMJ.

[2]  M. Rawlins,et al.  Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs , 1994, The Lancet.

[3]  Walker,et al.  Collaborative overview of randomised trials of antiplatelet therapy Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients , 1994 .

[4]  C Warlow,et al.  The United Kingdom transient ischaemic attack (UK-TIA) aspirin trial: final results. , 1991, Journal of neurology, neurosurgery, and psychiatry.

[5]  I Russell,et al.  Statistics--with confidence? , 1991, The British journal of general practice : the journal of the Royal College of General Practitioners.

[6]  W. Ray,et al.  Nonsteroidal anti-inflammatory drug use and increased risk for peptic ulcer disease in elderly persons. , 1991, Annals of internal medicine.

[7]  C. Madden.  Risk of myocardial infarction and death during treatment with low dose aspirin and intravenous heparin in men with unstable coronary artery disease: The RISC Group Lancet 336: 827–830 Oct 1990 , 1991 .

[8]  The Risc Group.  Risk of myocardial infarction and death during treatment with low dose aspirin and intravenous heparin in men with unstable coronary artery disease , 1990, The Lancet.

[9]  R. Prescott,et al.  The effects of indomethacin on gastroduodenal morphology and mucosal pH gradient in the healthy human stomach. , 1990, Gastroenterology.

[10]  M. Langman,et al.  Epidemiologic evidence on the association between peptic ulceration and antiinflammatory drug use. , 1989, Gastroenterology.

[11]  L. Bolognese,et al.  RANDOMISED TRIAL OF INTRAVENOUS STREPTOKINASE, ORAL ASPIRIN, BOTH, OR NEITHER AMONG 17 187 CASES OF SUSPECTED ACUTE MYOCARDIAL INFARCTION: ISIS-2 , 1988, The Lancet.

[12]  Sarah Parish,et al.  Randomized trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2.ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. , 1988, Journal of the American College of Cardiology.

[13]  United Kingdom transient ischaemic attack (UK-TIA) aspirin trial: interim results , 1988, British medical journal.

[14]  D. Graham,et al.  Gastric adaptation. Studies in humans during continuous aspirin administration. , 1988, Gastroenterology.

[15]  M. Langman,et al.  Use of anti-inflammatory drugs by patients admitted with small or large bowel perforations and haemorrhage. , 1985, British medical journal.