ALL-HEART
Trial question
What is the role of allopurinol in patients with ischemic heart disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
24.0% female
76.0% male
N = 5721
5721 patients (1398 female, 4321 male)
Inclusion criteria: patients aged ≥ 60 years with ischemic heart disease but no history of gout
Key exclusion criteria: history of gout; moderate-severe renal impairment; moderate-to-severe HF; significant hepatic disease; severe adverse skin reaction to any drug or significant malignancy within the past 5 years
Interventions
N=2853 allopurinol (up-titration to an oral dose of 600 mg/day, 300 mg/day in moderate renal impairment)
N=2868 standard care (continuation of usual care)
Primary outcome
Nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death
11
11.3
11.3 %
8.5 %
5.7 %
2.8 %
0.0 %
Allopurinol
Standard care
No significant difference ↔
No significant difference in nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death (11% vs. 11.3%; HR 0.96, 96% CI 0.82 to 1.12)
Secondary outcomes
No significant difference in death from any cause (10.1% vs. 10.6%; HR 0.98, 95% CI 0.83 to 1.15)
No significant difference in nonfatal myocardial infarction (5.5% vs. 6%; HR 0.97, 95% CI 0.78 to 1.21)
No significant difference in cardiovascular death (3.9% vs. 3.8%; HR 1.1, 95% CI 0.85 to 1.43)
Safety outcomes
No significant difference in serious adverse events.
Significant difference in new rash during the previous 12 months (13.1% vs. 9.1%).
Conclusion
In patients aged ≥ 60 years with ischemic heart disease but no history of gout, allopurinol was not superior to standard care with respect to nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death.
Reference
Isla S Mackenzie, Christopher J Hawkey, Ian Ford et al. Allopurinol versus usual care in UK patients with ischaemic heart disease (ALL-HEART): a multicentre, prospective, randomised, open-label, blinded-endpoint trial. Lancet. 2022 Oct 8;400(10359):1195-1205.
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