Cardiovascular outcome trial · N Engl J Med 2022
PROMINENT trial
Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk.
The bottom line
In patients with type 2 diabetes, mild-to-moderate hypertriglyceridemia, and low HDL/LDL cholesterol, pemafibrate lowered triglycerides and related lipid markers but did not reduce cardiovascular events compared with placebo and increased risks of renal events and venous thromboembolism.
No significant benefitUS status: Not US-approved
At a glance
- Medicine
- Pemafibrate (0.2-mg tablets twice daily)
- Compared with
- Matching placebo
- People
- 10,497
- Who took part
- Patients with type 2 diabetes, mild-to-moderate hypertriglyceridemia (triglyceride level, 200 to 499 mg per deciliter), and HDL cholesterol levels of 40 mg per deciliter or lower, receiving guideline-directed lipid-lowering therapy or unable to receive statins, with LDL cholesterol levels of 100 mg per deciliter or lower (66.9% with previous cardiovascular disease)
- Design
- multinational, double-blind, randomized, controlled trial
- Follow-up
- Median follow-up was 3.4 years
- Main question
- Composite of nonfatal myocardial infarction, ischemic stroke, coronary revascularization, or death from cardiovascular causes
Main result
A primary end-point event occurred in 572 patients in the pemafibrate group and in 560 of those in the placebo group (hazard ratio, 1.03; 95% confidence interval, 0.91 to 1.15)
Effect on LDL cholesterol
4.8% for apolipoprotein B (no direct LDL percent change reported; triglycerides -26.2%, VLDL cholesterol -25.8%, remnant cholesterol -25.6%, apolipoprotein C-III -27.6%)
Other results
No apparent effect modification in any prespecified subgroup
Safety
The overall incidence of serious adverse events did not differ significantly between the groups, but pemafibrate was associated with a higher incidence of adverse renal events and venous thromboembolism and a lower incidence of nonalcoholic fatty liver disease.
In the trial's own words
“A primary end-point event occurred in 572 patients in the pemafibrate group and in 560 of those in the placebo group (hazard ratio, 1.03; 95% confidence interval, 0.91 to 1.15), with no apparent effect modification in any prespecified subgroup.”
Quoted from the abstract of N Engl J Med 2022, checked word for word against PubMed. PubMed 36342113 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Fibrates (fenofibrate)
Common questions
What did the PROMINENT trial find?
In patients with type 2 diabetes, mild-to-moderate hypertriglyceridemia, and low HDL/LDL cholesterol, pemafibrate lowered triglycerides and related lipid markers but did not reduce cardiovascular events compared with placebo and increased risks of renal events and venous thromboembolism.
Who was in PROMINENT?
10,497 people. Patients with type 2 diabetes, mild-to-moderate hypertriglyceridemia (triglyceride level, 200 to 499 mg per deciliter), and HDL cholesterol levels of 40 mg per deciliter or lower, receiving guideline-directed lipid-lowering therapy or unable to receive statins, with LDL cholesterol levels of 100 mg per deciliter or lower (66.9% with previous cardiovascular disease).
What was PROMINENT's main result?
A primary end-point event occurred in 572 patients in the pemafibrate group and in 560 of those in the placebo group (hazard ratio, 1.03; 95% confidence interval, 0.91 to 1.15)
How much did LDL cholesterol change in PROMINENT?
4.8% for apolipoprotein B (no direct LDL percent change reported; triglycerides -26.2%, VLDL cholesterol -25.8%, remnant cholesterol -25.6%, apolipoprotein C-III -27.6%)
Related trials
- STRENGTH (2020)In statin-treated high-risk patients, adding high-dose omega-3 carboxylic acids to usual therapy did not reduce major adverse cardiovascular events compared with corn oil and caused more GI side effects.
- REDUCE-IT (2019)In statin-treated patients with elevated triglycerides, icosapent ethyl significantly reduced cardiovascular events including cardiovascular death, though at the cost of more atrial fibrillation hospitalizations and a trend toward more serious bleeding.
- VITAL (2019)Daily supplementation with 1 g marine omega-3 fatty acids did not reduce the incidence of major cardiovascular events or invasive cancer compared with placebo, though it was safe and reduced total myocardial infarction as a secondary finding.
- ASCEND (2018)In diabetic patients without known cardiovascular disease, daily 1-g omega-3 fatty acid supplementation did not reduce serious vascular events compared with placebo.
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