Extra-Cranial Bleeding and Other Symptoms due to Low Dose Aspirin and Low Intensity Oral Anticoagulation

T W Meade; P J Roderick; P J Brennan; H C Wilkes; C C Kelleher

doi:10.1055/s-0038-1656307

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1992; 68(01): 001-006
DOI: 10.1055/s-0038-1656307

Original Article

Schattauer GmbH Stuttgart

Extra-Cranial Bleeding and Other Symptoms due to Low Dose Aspirin and Low Intensity Oral Anticoagulation

T W Meade

The MRC Epidemiology and Medical Care Unit and British Heart Foundation Cardiovascular Epidemiology Research Group, Wolfson Institute of Preventive Medicine, The Medical College of St Bartholomew’s Hospital, London, United Kingdom

,

P J Roderick

The MRC Epidemiology and Medical Care Unit and British Heart Foundation Cardiovascular Epidemiology Research Group, Wolfson Institute of Preventive Medicine, The Medical College of St Bartholomew’s Hospital, London, United Kingdom

,

P J Brennan

The MRC Epidemiology and Medical Care Unit and British Heart Foundation Cardiovascular Epidemiology Research Group, Wolfson Institute of Preventive Medicine, The Medical College of St Bartholomew’s Hospital, London, United Kingdom

,

H C Wilkes

The MRC Epidemiology and Medical Care Unit and British Heart Foundation Cardiovascular Epidemiology Research Group, Wolfson Institute of Preventive Medicine, The Medical College of St Bartholomew’s Hospital, London, United Kingdom

,

C C Kelleher

The MRC Epidemiology and Medical Care Unit and British Heart Foundation Cardiovascular Epidemiology Research Group, Wolfson Institute of Preventive Medicine, The Medical College of St Bartholomew’s Hospital, London, United Kingdom

› Author Affiliations

Abstract

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Summary

Data from the early stages of the thrombosis prevention trial (TPT) have been used to establish and quantify the risk of extracranial bleeding due to low dose aspirin (75 mg) and low intensity oral anticoagulation with warfarin (international normalised ratio, INR, 1.5) singly or in combination, in men aged between 45 and 69 who are at high risk of ischaemic heart disease (IHD). The design of the trial is factorial, the four treatments being combined low dose aspirin and low intensity anticoagulation (WA), low intensity anticoagulation alone (W), low dose aspirin alone (A) and double placebo treatment (P). The trial is being carried out through the Medical Research Council’s General Practice Research Framework, with participating practices throughout the United Kingdom. Results are based on the first 3,667 men entered. The risk of major gastrointestinal bleeding due to active treatment is probably about 1 in 500 man-years of treatment, there currently being no difference between the three active regimes (WA, W, A). Intermediate and minor bleeding episodes occur more frequently with WA than with W or A on their own, the excess being mainly due to minor nose bleeds and bruises. In turn, both W and A on their own cause more such minor episodes than placebo treatment, P. There is no evidence that any of the three active regimes increases the risk of peptic ulceration, nor do they increase reports of indigestion. Aspirin increases reports of constipation and reduces reports of blurred vision. Minor bleeding occurs less frequently in smokers than in non-smokers but is not influenced by age. The antithrombotic regimes used are feasible and acceptable. So far, combined treatment and treatment with warfarin alone are not associated with more frequent serious hazards than low dose aspirin on its own, a regime that is increasingly used in clinical practice. The results provide a measure of reassurance for further trials of low intensity oral anticoagulation with warfarin alone or in combination with low dose aspirin.

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References

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