Allopurinol does not improve cardiovascular outcomes in patients with ischemic heart disease but no gout (ALL-HEART)

Reference

Mackenzie IS, Hawkey CJ, Ford I, et al, for the ALL-HEART Study Group. Allopurinol versus usual care in UK patients with ischaemic heart disease (ALL-HEART): a multicentre, prospective, randomised, open-label, blinded-endpoint trial. Lancet 2022;400(10359):1195-1205.

Synopsis

These investigators recruited adults 60 years and older with ischemic heart disease and no history of gout. The participants were recruited mostly from primary care practices in England and Scotland. The researchers randomized 5721 patients to receive allopurinol (titrated up to 600 mg daily; 300 mg in those with estimated glomerular filtration rates < 60 mL/min) or to usual care. The researchers used the national health systems’ databases to assess hospitalizations, deaths, and cancers. They used modified intention-to-treat analysis to evaluate the primary outcome, a composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. After randomization, the authors excluded 216 participants who retrospectively had either not met the inclusion criteria or met the exclusion criteria. Although this seems reasonable, the fact that it occurred after randomization raises concerns about sloppy procedures and the potential for excluding people they just didn’t like. After an average of 4.8 years of follow-up, 1.3% of the allopurinol-treated patients dropped out for adverse events or serious adverse events compared with only 0.2% of the control patients (number needed to treat to harm = 91; 95% CI 63 - 147), and there was no difference in the frequency of the composite outcome (11.0% vs 11.3%) nor any of its components. Additionally all-cause mortality was similar in both the allopurinol and control groups (10.1% vs 10.6%, respectively).