Moderate statin and ezetimibe combo non inferior to high-intensity statin monotherapy in ASCVD: RACING trial
South Korea: A moderate-intensity statin with ezetimibe combination therapy among patients with atherosclerotic cardiovascular disease (ASCVD) is non-inferior to high-intensity statin monotherapy, according to results from the RACING trial.
The non-inferiority in the study published in The Lancet was seen with regard to the 3-year composite outcomes with lower intolerance-related drug discontinuation or dose reduction and a higher proportion of patients with LDL cholesterol concentrations of less than 70 mg/dL.
Previous studies have suggested that drug combinations rather than increasing doses of one drug can achieve greater efficacy and lower risks. Thus, moderate-intensity statin with ezetimibe combination therapy as an alternative to high-intensity statin monotherapy can lower LDL cholesterol concentrations effectively while reducing adverse effects. However, there is a need for evidence from randomized trials to compare long-term clinical outcomes.
To fill the knowledge gap described above, a research team from South Korea led by Prof Byeong-Keuk Kim performed an open-label, non-inferiority trial that included patients with atherosclerotic cardiovascular disease at 26 clinical centers in South Korea. They were randomly assigned in a ratio of 1: 1 to receive either moderate-intensity statin with ezetimibe combination therapy (rosuvastatin 10 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg).
The primary endpoint was the 3-year composite of cardiovascular death, non-fatal stroke, or major cardiovascular events in the intention-to-treat population with a non-inferiority margin of 2·0%.
Key findings include:
· 3780 patients were enrolled between Feb 14, 2017, and Dec 18, 2018: 1894 patients in the combination therapy group and 1886 in the high-intensity statin monotherapy group.
· The primary endpoint occurred in 9·1% of patients in the combination therapy group and 9·9% of patients in the high-intensity statin monotherapy group.
· 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.
· Discontinuation or dose reduction of the study drug by intolerance was observed in 4·8% of patients and 8·2% of patients respectively.
"Moderate-intensity statin with ezetimibe combination therapy among patients with ASCVD was non-inferior to high-intensity statin monotherapy for the 3-year composite outcomes," wrote the authors. "with a higher proportion of patients with LDL cholesterol concentrations of less than 70 mg/dL and lower intolerance-related drug discontinuation or dose reduction."
Reference:
The study titled, "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," was published in The Lancet.
DOI: https://doi.org/10.1016/S0140-6736(22)00916-3
