REDUCE-IT
Trial question
What is the role of icosapent ethyl in patients with elevated triglyceride levels despite statins?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 8179
8179 patients (2357 female, 5822 male).
Inclusion criteria: patients with elevated triglyceride levels despite the use of statins.
Key exclusion criteria: severe HF, active severe liver disease, history of acute or chronic pancreatitis, a planned coronary intervention or surgery, a glycated hemoglobin level > 10.0%.
Interventions
N=4089 icosapent ethyl (2 g BID with food).
N=4090 placebo (mineral oil BID).
Primary outcome
Major adverse CV events
17.2%
22%
22.0 %
16.5 %
11.0 %
5.5 %
0.0 %
Icosapent
ethyl
Placebo
Significant
decrease ▼
NNT = 20
Significant decrease in major adverse CV events (17.2% vs. 22%; HR 0.75, 95% CI 0.68 to 0.83).
Secondary outcomes
Significant decrease in CV death, nonfatal MI or nonfatal CVA (11.2% vs. 14.8%; HR 0.74, 95% CI 0.65 to 0.83).
Significant decrease in CV death (4.3% vs. 5.2%; HR 0.8, 95% CI 0.66 to 0.98).
No significant difference in death from any cause (6.7% vs. 7.6%; HR 0.87, 95% CI 0.74 to 1.02).
Safety outcomes
No significant differences in serious adverse bleeding events (2.7% vs. 2.1%, p=0.06) and serious adverse event, pneumonia (2.6% vs. 2.9%, p=0.42).
Significant differences in a larger proportion of patients in the icosapent ethyl group than in the placebo group were hospitalized for AF or flutter (3.1% vs. 2.1%, p = 0.004).
Conclusion
In patients with elevated triglyceride levels despite the use of statins, icosapent ethyl was superior to placebo with respect to major adverse CV events.
Reference
Bhatt DL, Steg PG, Miller M et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22.
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