Cardiovascular outcome trial · Lancet 2022
RACING trial
Long-term efficacy and safety of moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease (RACING): a randomised, open-label, non-inferiority trial.
The bottom line
In patients with atherosclerotic cardiovascular disease, moderate-intensity rosuvastatin plus ezetimibe was non-inferior to high-intensity rosuvastatin alone for 3-year cardiovascular outcomes, achieved more patients with LDL under 70 mg/dL, and caused less drug intolerance-related discontinuation or dose reduction.
No significant benefitUS status: US-approved
At a glance
- Medicine
- Moderate-intensity statin with ezetimibe combination therapy (rosuvastatin 10 mg with ezetimibe 10 mg)
- Compared with
- High-intensity statin monotherapy (rosuvastatin 20 mg)
- People
- 3,780
- Who took part
- Patients with atherosclerotic cardiovascular disease (ASCVD) at 26 clinical centres in South Korea
- Design
- randomised, open-label, non-inferiority trial
- Follow-up
- 3 years
- Main question
- 3-year composite of cardiovascular death, major cardiovascular events, or non-fatal stroke, in the intention-to-treat population with a non-inferiority margin of 2·0%
Main result
The primary endpoint occurred in 172 patients (9·1%) in the combination therapy group and 186 patients (9·9%) in the high-intensity statin monotherapy group (absolute difference -0·78%; 90% CI -2·39 to 0·83).
Effect on LDL cholesterol
LDL cholesterol concentrations of less than 70 mg/dL at 1, 2, and 3 years were observed in 73%, 75%, and 72% of patients in the combination therapy group, and 55%, 60%, and 58% of patients in the high-intensity statin monotherapy group (all p<0·0001).
Safety
Discontinuation or dose reduction of the study drug by intolerance was observed in 88 patients (4·8%) and 150 patients (8·2%), respectively (p<0·0001).
In the trial's own words
“The primary endpoint occurred in 172 patients (9·1%) in the combination therapy group and 186 patients (9·9%) in the high-intensity statin monotherapy group (absolute difference -0·78%; 90% CI -2·39 to 0·83).”
Quoted from the abstract of Lancet 2022, checked word for word against PubMed. PubMed 35863366 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Ezetimibe (Zetia)
Common questions
What did the RACING trial find?
In patients with atherosclerotic cardiovascular disease, moderate-intensity rosuvastatin plus ezetimibe was non-inferior to high-intensity rosuvastatin alone for 3-year cardiovascular outcomes, achieved more patients with LDL under 70 mg/dL, and caused less drug intolerance-related discontinuation or dose reduction.
Who was in RACING?
3,780 people. Patients with atherosclerotic cardiovascular disease (ASCVD) at 26 clinical centres in South Korea.
What was RACING's main result?
The primary endpoint occurred in 172 patients (9·1%) in the combination therapy group and 186 patients (9·9%) in the high-intensity statin monotherapy group (absolute difference -0·78%; 90% CI -2·39 to 0·83).
How much did LDL cholesterol change in RACING?
LDL cholesterol concentrations of less than 70 mg/dL at 1, 2, and 3 years were observed in 73%, 75%, and 72% of patients in the combination therapy group, and 55%, 60%, and 58% of patients in the high-intensity statin monotherapy group (all p<0·0001).
Related trials
- EWTOPIA 75 (2019)In patients aged 75 or older with elevated LDL-C and no history of coronary disease, adding ezetimibe to usual care reduced cardiovascular events, though open-label design, early termination, and follow-up issues warrant cautious interpretation of the benefit's magnitude.
- IMPROVE-IT (2015)Adding ezetimibe to statin therapy after acute coronary syndrome modestly reduces cardiovascular events beyond statin alone, with similar safety.
- SHARP (2011)In patients with moderate-to-severe chronic kidney disease, lowering LDL cholesterol with simvastatin plus ezetimibe safely reduced major atherosclerotic events compared with placebo.
- SEAS (2008)In patients with mild-to-moderate asymptomatic aortic stenosis, simvastatin plus ezetimibe did not reduce the composite of aortic-valve and ischemic cardiovascular events, though it reduced ischemic events alone and was associated with more cancer cases.
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