Moderate-Intensity Statin With Ezetimibe Combination Therapy vs High-Intensity Statin Monotherapy in Patients at Very High Risk of Atherosclerotic Cardiovascular Disease

doi:10.1001/jamacardio.2023.2222

Prevention & lipidsSecondary analysis

Moderate-Intensity Statin With Ezetimibe Combination Therapy vs High-Intensity Statin Monotherapy in Patients at Very High Risk of Atherosclerotic Cardiovascular Disease

JAMA CardiolPublished 1 Sep 2023

Secondary analysis of the RACING randomised trial
post hoc analysis
open-label
multicentre
26 centres in Korea

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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: Combination therapy vs High-intensity statin
Primary endpoint: CV death, coronary or peripheral revascularization, hospitalization for CV events, or nonfatal stroke
Follow-up: 3 years

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	Lower risk with VHR ←→ Higher risk with VHR	HR (95% CI)
VHR vs non-VHR, primary end point		1.42 (1.15–1.75)
	0.512Hazard ratio (log scale)

Median LDL-C, VHR · 1 year

Combination therapymedian 57 mg/dLIQR 47–71

High-intensity statinmedian 65 mg/dLIQR 53–78

Median LDL-C, non-VHR · 1 year

Combination therapymedian 58 mg/dL

High-intensity statinmedian 68 mg/dL

LDL-C <70 mg/dL · 1 year

VHR

Combination therapy73%

High-intensity statin58%

non-VHR

Combination therapy72%

High-intensity statin53%

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

Combination therapy4.6%

High-intensity statin7.7%

non-VHR

Combination therapy5.0%

High-intensity statin8.7%

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. JAMA Cardiol. Published 1 September 2023. doi:10.1001/jamacardio.2023.2222

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Summarised from the published abstract; every number is checked against it