New clinical trial could help make aspirin safer for patients
(25 March 2012)
Researchers have launched a major clinical trial to investigate whether eliminating a common stomach bug could help to make taking aspirin safer in some patients.
The Helicobacter Eradication Aspirin Trial (HEAT) will look at whether wiping out the bacterium Helicobacter pylori in the gut of patients taking up to 325mg of aspirin a day could reduce their chances of developing a stomach ulcer and dangerous associated bleeding - a complication which kills thousands of people every year.
One of the largest of its kind, it's estimated that the study, involving academics from Durham University in collaboration with researchers from the universities of Nottingham, Southampton, Oxford and Birmingham, will recruit in the region of 10,000 aspirin patients found to be infected with H. pylori.
Professor Greg Rubin, from Durham University's School of Medicine and Health, said: "Aspirin is a valuable and widely used drug, but it can have serious side-effects. In fact, aspirin is so widely used that it has become the most common cause of ulcer bleeding.
"This study will answer an important question about how we can make it a safer drug to take. It will be one of the largest trials that has been attempted in the UK and Yorkshire and the North East will be part of it because of the region's great support for our research.
"We hope the trial will allow us to more accurately establish whether eliminating H. pylori in patients taking aspirin reduces the risk of serious medical complications due to stomach ulcers and bleeds. This would not only be great news for patients but also reduce the multi-million pound burden on the NHS through treating them."
More than three million people aged 60 and over in England who are at high risk of heart attack and stroke take a dose of aspirin between 75mg and 300mg every day as an anti-clotting agent to reduce this risk.
Around 10 years ago, aspirin use was identified as the commonest cause of gastric duodenal or peptic ulcer bleeding. Since then, its use has risen by 75 per cent in the UK, accompanied by an increase in the incidence of ulcer bleeding.
In 2007, peptic ulcers killed almost 3,000 people in England and Wales, principally through bleeding, and in the same year, stomach ulcers saw almost 13,000 people admitted to hospital in England, at an estimated cost to the NHS of more than £10,000 per patient.
Previous studies have suggested that low dose aspirin is more likely to cause ulcer bleeding in patients infected with H. pylori. An endoscopy study revealed that patients with the bug were five-times more at risk of developing a stomach ulcer than their H. pylori-free counterparts.
The new HEAT trial will cover a geographical area covering almost half the population of England, with the hope that GPs will identify in the region of 120,000 people who could potentially take part and invite them to participate in the study.
The research team expect to hear back from around 40,000 patients, around one-quarter of whom are likely to already be infected by the H. pylori bacterium, diagnosed through a simple breath test.
Infected patients will either be given a course of medication aimed at eradicating the infection or a placebo, while continuing to take their aspirin, and will be followed up by the research team over a period of two to three years to establish whether the patient has gone on to develop a stomach ulcer after receiving the treatment.
At the end of the trial, the team will compare the results to establish whether those who received the medication developed fewer stomach ulcers and gastric bleeds than those who received the placebo.