PROMINENT
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
72.0% male
N = 10497
10497 patients (2891 female, 7606 male).
Inclusion criteria: patients with T2DM, mild-to-moderate hypertriglyceridemia, and HDL-C 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
Composite of nonfatal MI, ischemic stroke, coronary revascularization, or CV death
10.9%
10.6%
10.9 %
8.2 %
5.5 %
2.7 %
0.0 %
Pemafibrate
Placebo
No significant
difference ↔
No significant difference in nonfatal MI, ischemic stroke, coronary revascularization, or CV death (10.9% vs. 10.6%; HR 1.03, 95% CI 0.91 to 1.15).
Secondary outcomes
No significant difference in MI, ischemic stroke, unstable angina warranting hospitalization for urgent coronary revascularization, or CV death (8.2% vs. 7.9%; HR 1.04, 95% CI 0.91 to 1.19).
No significant difference in nonfatal MI, nonfatal ischemic stroke, or CV death (7.2% vs. 7.1%; HR 1.02, 95% CI 0.88 to 1.18).
Significantly greater 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%), MASLD (2.9% vs. 3.8%).
Conclusion
In patients with T2DM, mild-to-moderate hypertriglyceridemia, and HDL-C levels ≤ 40 mg/dL, pemafibrate was not superior to placebo with respect to the composite of nonfatal MI, ischemic stroke, coronary revascularization, or CV death.
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.
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