Moderate-Intensity Statin With Ezetimibe Combination Therapy vs High-Intensity Statin Monotherapy in Patients at Very High Risk of Atherosclerotic Cardiovascular Disease: A Post Hoc Analysis From the RACING Randomized Clinical Trial
An erratum to this article was published (JAMA Cardiol, 1 Sep 2023 ↗)
Authors' conclusion
Results suggest that the outcomes of ezetimibe combination observed in the RACING trial were consistent among patients at VHR of ASCVD.
Study context
- Population
- Patients with documented atherosclerotic cardiovascular disease (ASCVD), very high risk (VHR) and non-VHR (2018 AHA/ACC guidelines)1,511 VHR
- Participants
- 3,780 patients
- Comparison
- Moderate-intensity statin with ezetimibe vs high-intensity statin monotherapy, by VHR status
- Primary endpoint
- CV death, coronary or peripheral revascularization, hospitalization for CV events, or nonfatal stroke
- Follow-up
- 3 years
Methodological detailspost hoc analysis, open-label, multicentre, 26 centres in Korea
- Post hoc analysis
- Open-label
- Multicentre
- 26 centres in Korea
Primary result
As reported in the abstract
Primary end point by VHR status (subgroups)
Combination therapy vs High-intensity statinHazard ratio (95% CI)
VHR: 11.2% vs 11.7%
0.96(0.71–1.30)
non-VHR: 7.7% vs 8.7%
0.88(0.66–1.18)
Further findings
| Outcome | HR (95% CI) | |
|---|---|---|
| VHRvs non-VHR, primary end point | 1.42 (1.15–1.75) | |
| 0.512Hazard ratio (log scale) |
Median LDL-C, VHR · 1 year
Median LDL-C, non-VHR · 1 year
LDL-C <70 mg/dL · 1 year
VHR
non-VHR
| Outcome | Combination therapy | High-intensity statin |
|---|---|---|
| Mean change in LDL-C, VHR | ||
| 1 year | −19.1 | −10.1 |
| 2 years | −22.3 | −13.0 |
| 3 years | −18.8 | −9.7 |
| Mean change in LDL-C, non-VHR | ||
| 1 year | −23.7 | −12.5 |
| 2 years | −25.2 | −15.1 |
| 3 years | −23.5 | −12.6 |
- Median low-density lipoprotein cholesterol (LDL-C), VHR: P < .001
- Median LDL-C, non-VHR: P < .001
- Mean change in LDL-C, VHR: all P < .001
- Mean change in LDL-C, non-VHR: all P < .001
- LDL-C <70 mg/dL: P < .001
Safety
Discontinuation or dose reduction due to intolerance
VHR
non-VHR
- Discontinuation or dose reduction due to intolerance: VHR P = .02
- Discontinuation or dose reduction due to intolerance: non-VHR P = .001
Original publication
Moderate-Intensity Statin With Ezetimibe Combination Therapy vs High-Intensity Statin Monotherapy in Patients at Very High Risk of Atherosclerotic Cardiovascular Disease: A Post Hoc Analysis From the RACING Randomized Clinical Trial. JAMA Cardiol. Published 1 September 2023. doi:10.
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