Olezarsen in patients with hypertriglyceridemia at high cardiovascular risk: Rationale and design of the Essence–TIMI 73b trial
Study context
- Population
- Adults with either moderate hypertriglyceridemia (200–499 mg/dL) plus increased cardiovascular risk, or severe hypertriglyceridemia (≥500 mg/dL)randomized at 160 sites, 555 continued in the computed tomography angiography (CTA) substudy
- Participants
- 1,478 adults
- Planned comparison
- Difference between each olezarsen dose group and pooled placebo
- Primary endpoint
- percent change in triglyceride levels
- Follow-up
- From baseline to 6 months
Methodological detailsrationale and design, coronary computed tomography angiography (CTA) substudy, 160 sites in North America and Europe
- Rationale and design
- Coronary computed tomography angiography (CTA) substudy
- 160 sites in North America and Europe
No results yet. This paper sets out the design of a trial; its results are to come.
Baseline
Baseline characteristics · randomization
- Median age (IQR), years
- 63 (IQR 56-69)
- Women
- 39%
- non-Hispanic White
- 71%
- Diabetes
- 60%
- Atherosclerotic cardiovascular disease
- 42%
- Receiving lipid-lowering therapies
- 97%
- On a statin
- 82%
- Median baseline triglyceride level, mg/dL
- 249 (195-339)
- Triglycerides ≥500 mg/dL at enrollment
- 9%
Coronary CTA substudy enrollment · baseline
- Completed a baseline CTA
- ≈1000
- Of those with a baseline CTA, had measurable noncalcified coronary plaque and continued in the substudy
- 555 (55%)
Original publication
Olezarsen in patients with hypertriglyceridemia at high cardiovascular risk: Rationale and design of the Essence–TIMI 73b trial. Am Heart J. Published 11 March 2025. doi:10. 1016/ j. ahj. 2025. 02. 022
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