6/29/23, 1:45 AM PROMINENT Pathway Feedback Search Clinical Topics Home Studies PROMINENT PROMINENT Disease Disease Disease Diabetes mellitus type 2 Dyslipidemia Hypertrig Trial question What is the role of pemafibrate in patients with T2DM and mild-to-moderate hypertriglyceridemia? Study design Multi-center Double blinded RCT Population Characteristics of study participants 28.0% female N = 10497 72.0% male 10497 patients (2891 female, 7606 male) Inclusion criteria: patients with T2DM, mild-to-moderate hypertriglyceridemia, and high-density lipoprotein cholesterol levels 40 mg/dL Key exclusion criteria: T1DM; uncontrolled diabetes; untreated or inadequately treated hypothyroidism or hyperthyroidism; severe HF; severe kidney disease; clinically significant liver disease Interventions N=5240 pemafibrate (at a dose of 0.2 mg tablets BID) N=5257 placebo (matching placebo) Primary outcome https://web.pathway.md/studies/recOii51pFmFUuKwI 1/2 6/29/23, 1:45 AM PROMINENT Pathway Composite of nonfatal myocardial infarction, ischemic stroke, coronary revascularization, or death from cardiovascular causes 10.9 % 10.9 10.6 8.2 % 5.5 % 2.7 % No significant difference 0.0 % Pemafibrate Placebo No significant difference in composite of nonfatal myocardial infarction, ischemic stroke, coronary revascularization, or death from cardiovascular causes (10.9% vs. 10.6%; HR 1.03, 95% CI 0.91 to 1.15) Secondary outcomes No significant difference in composite of myocardial infarction, ischemic stroke, unstable angina warranting hospitalization for urgent coronary revascularization, or death from cardiovascular causes (8.2% vs. 7.9%; HR 1.04, 95% CI 0.91 to 1.19) No significant difference in composite of nonfatal myocardial infarction, nonfatal ischemic stroke, or death from cardiovascular causes (7.2% vs. 7.1%; HR 1.02, 95% CI 0.88 to 1.18) Significant increase in reduction in triglyceride levels at 4 months (31.1 vs. 6.9; AD 26.2, 95% CI 24.1 to 28.4) Safety outcomes No significant difference in serious adverse events. Significant differences in renal adverse event (27.9% vs. 25.6%), VTE (1.3% vs. 0.7%), nonalcoholic fatty liver disease (2.9% vs. 3.8%). Conclusion In patients with T2DM, mild-to-moderate hypertriglyceridemia, and high-density lipoprotein cholesterol levels 40 mg/dL, pemafibrate was not superior to placebo with respect to the composite of nonfatal myocardial infarction, ischemic stroke, coronary revascularization, or death from cardiovascular causes. Reference Aruna Das Pradhan, Robert J Glynn, Jean-Charles Fruchart et al. Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk. N Engl J Med. 2022 Nov 24;387(21):1923-1934. Open reference URL https://web.pathway.md/studies/recOii51pFmFUuKwI 2/2