1. The composite score for non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death was comparable between allopurinol (11.0%) and usual care (11.3%).
2. All-cause mortality was similar among both groups (10.1% allopurinol vs. 10.6% usual care).
Evidence Rating Level: 1 (Excellent)
Study Rundown: Allopurinol is often used for gout prophylaxis given its urate-lowering effect; however, treatment for asymptomatic hyperuricemia is not currently indicated. Studies show that allopurinol may have a positive impact on cardiovascular outcomes; however, current evidence is limited. This randomized trial aimed to assess the safety and efficacy of allopurinol on cardiovascular outcomes in patients with ischemic heart disease but with no history of gout. The primary outcome was a composite of non-fatal myocardial infarction (MI), non-fatal stroke, and cardiovascular death. According to study results, allopurinol was comparable to usual care for patients with cardiovascular disease. This study was strengthened by a large sample size with patients from over 400 primary care practices. However, the cohort largely favors male sex and White ethnicities which may limit its generalizability.
Relevant Reading: Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout
In-depth [randomized-controlled trial]: Between Feb 7, 2014, and Oct 2, 2017, 6134 patients were screened for eligibility across 18 regional centers in England and Scotland. Included were those ≥ 60 years or older with ischemic heart disease without gout. Altogether, 5721 patients (2853 to allopurinol and 2868 to usual care) were included in the intention-to-treat analysis. The mean age of patients was 72.0 years (standard deviation [SD] 6.8) and the majority were white (99.2%) males (75.5%). The primary endpoint composite of non-fatal MI, non-fatal stroke, and cardiovascular death was comparable between the allopurinol and usual care group (11.0% vs. 11.3%, 2.47 vs. 2.37 events per 100 patient-years, hazard ratio [HR] 1.04, 95% confidence interval [CI] 0.89-1.21, p=0.65). Moreover, all-cause mortality was similar for both groups (10.1% in allopurinol vs. 10.6% in usual care, HR 1.02, 95% CI 0.87-1.20, p=0.77). Findings from this study suggest that allopurinol does not decrease the risk of myocardial infarction, stroke, and cardiovascular demise among patients with ischemic heart disease.
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