Allopurinol, used to treat gout, has been shown to have several effects that may be beneficial in CVD,1 but can it reduce CV events in patients with ischaemic heart disease? That was the question investigated in the ALL-HEART study, as presented in a Hot Line session yesterday by Professor Isla Mackenzie (University of Dundee - Dundee, UK).
The open-label, blinded-endpoint ALL-HEART study included patients aged 60 years or older with ischaemic heart disease but no history of gout. Patients were randomised 1:1 to receive allopurinol up-titrated to 600 mg daily plus usual care or usual care alone. Participants were then followed up by record linkage and annual questionnaires for a mean of 4.8 years. The modified intention-to-treat analysis population included 5,721 randomised patients; the average age was 72 years and three-quarters (76%) were male.
There was no difference in the rate of the primary composite outcome of non-fatal myocardial infarction (MI), non-fatal stroke or CV death, which occurred in 11.0% of patients in the allopurinol arm and 11.3% in the usual care arm (hazard ratio [HR] 1.04; 95% CI 0.89 to 1.21; p=0.65).
There were also no differences between groups in any of the secondary time-to-event outcomes, which included non-fatal MI, non-fatal stroke, CV death, all-cause mortality, hospitalisation for acute coronary syndrome (ACS), coronary revascularisation, hospitalisation for ACS or coronary revascularisation, hospitalisation for heart failure and all CV hospitalisations. Regarding all-cause mortality, 10.1% of patients in the allopurinol arm died compared with 10.6% of patients in the usual care arm (HR 1.02; 95% CI 0.87 to 1.20; p=0.77).
Prof. Mackenzie summarises the findings by saying, “The ALL-HEART study has shown that allopurinol therapy does not improve major CV outcomes in patients with ischaemic heart disease. Allopurinol is already widely used in patients with gout to prevent acute flares, and many of these patients have co-existing ischaemic heart disease. The question of whether allopurinol might prevent CV events in people with heart disease but no clinical gout has been around for many years and we are pleased to have now definitively answered this question for patients and doctors in a robust study.”