In the ALL-HEART trial, the use of allopurinol or usual care produced similar outcomes in older adults with ischemic heart disease and no history of gout. The analysis was based on a composite cardiovascular endpoint of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in 5,937 patients at 18 regional centers in England and Scotland.
“Mean follow-up time in the study was 4.8 years (SD, 1.5),” the authors write. “There was no evidence of a difference between the randomised treatment groups in the rates of the primary endpoint. 314 (11.0%) participants in the allopurinol group (2.47 events per 100 patient-years) and 325 (11.3%) in the usual care group (2.37 events per 100 patient-years) had a primary endpoint (hazard ratio [HR] 1.04 [95% CI 0.89–1.21], P = 0.65). 288 (10.1%) participants in the allopurinol group and 303 (10.6%) participants in the usual care group died from any cause (HR 1.02 [95% CI 0.87–1.20], P = 0.77).”
“The generalisability of the ALL-HEART study findings to the population of patients with ischaemic heart disease is likely to be high,” the authors add.”Patients were recruited from, and treated within, their usual primary care setting. It was designed as a pragmatic study that could be delivered successfully within the UK National Health Service primary care setting. The final number of participants randomised (5,937) exceeded the target of 5,215 randomised participants due to a significant increase in the recruitment rate in the final weeks of recruitment. Follow-up was entirely remote after the first 6 weeks of the study, with a minimal effect on participants’ usual care environment. Better ethnic diversity in recruitment could have improved the generalisability to non-white populations. 99.2% of participants within the ALL-HEART study reported white ethnicity. No participants suffered severe Stevens-Johnson syndrome within the ALL-HEART study. If the study had been performed in a more diverse ethnic group, the potential risk of Stevens-Johnson syndrome would likely have been higher. Most of the participants had long-term ischaemic heart disease, with a median duration of ischaemic heart disease of 10.2 years at study entry, although patients with recent coronary events were not excluded. It is possible that different results might have been obtained if a more acute patient population had been recruited.”