Last edited 11/2022 and last reviewed 11/2022


  • randomized trial of pemafibrate for triglyceride reduction in the prevention of cardiovascular disease investigated the effect of pemafibrate on CV outcomes in patients with T2DM, TG 200-499 mg/dL and HDL <=40 mg/dL

  • total of 10,497 patients were randomized to pemafibrate 0.2 mg twice daily or placebo
    • primary endpoint was MI, ischemic stroke, coronary revascularization or CV death
    • median follow-up was 3.4 years

  • study results:
    • was no difference between groups for the primary endpoint of MI, ischemic stroke, coronary revascularization or CV death (HR 1.03, 95% CI 0.91-1.15, P=0.67). Total mortality was also similar in both groups (HR 1.04, 95% CI 0.91-1.20)

    • safety results showed an increased risk of venous thromboembolism (HR 2.05, 95% CI 1.35-3.17) and renal adverse events (HR 1.12, 95% CI 1.04-1.20) in the pemafibrate group

  • conclusion:
    • pemafibrate reduced TG, VLDL-c, remnant cholesterol and ApoCIII by 20 to 30% in patients with T2DM, mild-to-moderate hypertriglyceridemia and low HDL-c
    • pemafibrate did not reduce CV outcomes, compared with placebo in this population