A 600-mg daily dose of allopurinol did not improve cardiovascular outcomes compared with standard care in patients older than 60 years of age with ischemic heart disease but no history of gout, new trial results show. Isla Mackenzie, MBChB (Hons), PhD, of the University of Dundee, Scotland, reported these findings from the ALL-HEART study Saturday at the European Society of Cardiology (ESC) Congress 2022 in Barcelona, Spain. Allopurinol is a xanthine oxidase inhibitor commonly used to treat gout. The ALL-HEART study aimed to determine whether allopurinol therapy improves major cardiovascular outcomes in patients with ischemic heart disease, Mackenzie said. The prospective, randomized, open-label, blinded-endpoint, multicenter trial recruited patients from 424 primary-care practices in the U.K. beginning in February 2014, and follow-up ended in September 2021. Patients were randomized 1:1 to allopurinol or the usual care. Mackenzie noted that this was a decentralized trial with remote follow-up and record linkage to centralized National Health Service databases for hospitalizations and deaths. The analysis population included 5,721 participants. The primary outcome was a composite of non-fatal myocardial infarction (MI), non-fatal stroke or cardiovascular death. The protocol called for the study to end when 631 adjudicated primary outcomes had occurred. Allopurinol showed no effect on the composite number of primary-outcome events at an average follow-up of 4.8 years (hazard ratio [HR]: 1.04; 95% confidence interval [CI]: 0.89-1.21; p=0.65). The same was true for each of the components: non-fatal MI (HR: 0.97; 95% CI: 0.78-1.21; p=0.81), non-fatal stroke (HR: 1.20; 95% CI: 0.89-1.60; p=0.23), cardiovascular death (HR: 1.10; 95% CI: 0.85-1.43; p=0.48) and all-cause mortality (HR: 1.02; 95% CI: 0.87-1.20; p=0.77). Mackenzie noted that ALL-HEART is the first large, prospective randomized trial of the effect of allopurinol on major cardiovascular outcomes in patients with ischemic heart disease and provides robust evidence on the role of allopurinol in these patients. “Allopurinol remains an important medication in the management of gout, but other avenues for the treatment of ischemic heart disease should be explored in the future,” she said. “The ALL-HEART study suggests that allopurinol should not be recommended for the secondary prevention of cardiovascular events in patients aged over 60 years with ischemic heart disease but no gout.” The ALL-HEART study was funded by the U.K. National Institute for Health and Care Research’s Health Technology Assessment Program.