Randomized Comparison of Efficacy and Safety of Lipid Lowering With Statin Monotherapy Versus Statin-Ezetimibe Combination for High-Risk Cardiovascular Disease - RACING
Contribution To Literature:
The RACING trial showed that, among patients with ASCVD, moderate-intensity statin with ezetimibe combined therapy was noninferior to high-intensity monotherapy with respect to the primary endpoint of cardiovascular death, major cardiovascular events, or nonfatal stroke.
The goal of the trial was to compare the clinical efficacy and safety of moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients at very high risk for cardiovascular diseases.
The RACING trial was a multicenter, open-label trial among 26 centers in South Korea. Patients with documented atherosclerotic cardiovascular disease (ASCVD) were randomized in a 1:1 fashion to ezetimibe and moderate-intensity statin (rosuvastatin 10 mg with ezetimibe 10 mg once daily; n = 1,894) or high-intensity statin monotherapy (rosuvastatin 20 mg once daily; n = 1,886). Results were analyzed in an intention-to-treat fashion.
- Total randomized participants: 3,780
- Median duration of follow-up: 3 years
- Mean patient age: 64 years
- Percentage female: 25%
- Age 19-80 years
- Documented ASCVD (previous myocardial infarction [MI], acute coronary syndrome, coronary or arterial revascularization, ischemic stroke, peripheral artery disease) with goal low-density lipoprotein (LDL) cholesterol <70 mg/dL
- Acute liver disease or elevated AST/ALT greater than two-fold the normal upper limit
- Allergy or insensitivity to statin or ezetimibe
- Solid-organ transplant
- History of adverse reaction to a statin
- Pregnant women
- Life-expectancy <3 years
Other salient features/characteristics:
- Previous MI: 40%
- Prior percutaneous coronary intervention (PCI): 66%
- Diabetes: 37%
The primary outcome, occurrence of cardiovascular death, major cardiovascular events, or nonfatal stroke within 3 years, for moderate-intensity statin + ezetimibe vs. high-intensity statin, was 9.1% vs. 9.9% (p = 0.43).
The secondary efficacy endpoint, a composite of all-cause death, major cardiovascular event, or nonfatal stroke, was 9.8% vs. 10.4% (p = 0.94).
Secondary outcomes for moderate-intensity statin + ezetimibe vs. high-intensity statin:
- All-cause death: 1.4% vs. 1.2% (p = 0.56)
- Major cardiovascular events: 8.1% vs. 8.9% (p = 0.41)
- Cardiovascular death: 0.4% vs. 0.3% (p = 0.59)
Proportion of patients with LDL cholesterol <70 mg/dL at 3 years, for moderate-intensity statin + ezetimibe vs. high-intensity statin, was 72% vs. 58% (p < 0.001).
Discontinuation or dose reduction due to adverse effects, for moderate-intensity statin + ezetimibe vs. high-intensity statin, was 4.8% vs. 8.2% (p < 0.001).
The results of this trial show that, among patients with ASCVD, treatment with a moderate-intensity statin and ezetimibe was noninferior to treatment with high-intensity statin with respect to the composite of cardiovascular death, major cardiovascular events, or nonfatal stroke at 3 years. This study shows that a drug combination strategy can be utilized to achieve reductions in LDL cholesterol. Importantly, patients with moderate-intensity statin and ezetimibe had lower rates of drug discontinuation or dose reduction than patients receiving high-intensity statin. However, the study is limited by its open-labeled design, which may have impacted reporting of patient-adverse effects. It also included East Asian patients only. The long follow-up time (3 years), as compared to other trials of lower-intensity statin and ezetimibe versus a higher-intensity statin, and assessment of clinical outcomes provides evidence for possible adoption of this strategy to achieve LDL reductions among patients with ASCVD.
Kim BK, Hong SJ, Lee YJ, et al., on behalf of the RACING Investigators. 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 randomized, open-label, non-inferiority trial. Lancet 2022;400:380-90.
Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Diabetes and Cardiometabolic Disease, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Prevention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and Arrhythmias, Lipid Metabolism, Nonstatins, Novel Agents, Statins, Interventions and ACS, Interventions and Vascular Medicine
Keywords: Acute Coronary Syndrome, Atherosclerosis, Cardiovascular Diseases, Cholesterol, LDL, Drug Combinations, Dyslipidemias, Ezetimibe, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Ischemic Stroke, Lipids, Metabolic Syndrome, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Peripheral Arterial Disease, Primary Prevention, Rosuvastatin Calcium, Stroke, Vascular Diseases
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