The Italian General Practice Thrombosis Prevention Trial

Professor de Gaetano described the primary prevention of thrombosis trial of low dose aspirin and vitamin E in general practice in Italy, shortly to be published in the Lancet. Healthy patients with risk factors for thrombosis were randomly allocated to 100mg enteric-coated aspirin and/or 300mg vitamin E or placebo in a 2 x 2 factorial study by 315 GPs in all regions of Italy. In summer 1998 the good results of the British thrombosis prevention trial and the Hypertension Optimal Treatment (HOT) trial caused the Italian trial to be ended prematurely after 4,495 people had been enrolled. The follow up is complete for 92% of the subjects, there being data for 16,390 person years.

Risk factors were age >50 years, with at least one of the following risk factors: age >65, hypertension >160/95, hypercholesterolaemia TBC>6.4mmol/l, diabetes, obesity or family history of MI. Fifty seven per cent were female, 24% were ex smokers and 14.9% current smokers. aspirin reduced major cardiovascular events by around 30%. Total cardiovascular diseases or events were reduced by 23% and cardiovascular death by 44%, so that aspirin significantly reduced cardiovascular mortality and morbidity.

On the other hand vitamin E had no effect on any cardiovascular parameter. aspirin was linked to a slight increase in non-fatal bleeding episodes. There were five fatal cases of bleeding, but four patients had not taken aspirin. Haemorrhagic strokes were very few: three in the non-aspirin group and two on aspirin.

To avoid one cardiovascular event or death, 48 patients would need to take aspirin daily for 4 years. This is hugely cost-beneficial.

The British thrombosis prevention trial was effective in men at particularly high coronary risk: this trial showed it did so in females and males. Professor de Gaetano concluded that aspirin can transform the usual GP care for patients at cardiovascular risk into a simple and effective preventive strategy.

The Aspirin Age
Introduction
Migraine
Thrombosis Prevention Trial
Aspirin and Stroke
Aspirin against Cancer
Hughes Syndrome