Key result
Statin with ezetimibe combination therapy showed no significant difference in the 3-year composite outcome of death, coronary artery disease, and ischemic stroke compared to statin monotherapy (HR 1.022).
Why the study?
Limited evidence exists regarding the use of statin with ezetimibe as a primary prevention strategy for middle-aged adults.
Does single pill combination therapy of statin with ezetimibe reduce the composite of death, coronary artery disease, and ischemic stroke in relatively healthy middle-aged adults for primary prevention compared to statin monotherapy?
Cohort (n=92,156)
Does single pill combination therapy of statin with ezetimibe reduce the composite of death, coronary artery disease, and ischemic stroke in relatively healthy middle-aged adults for primary prevention compared to statin monotherapy?
Hazard Ratio: 1.022 (95% CI 0.98–1.064)
Absolute Event Rate: 10.3% vs 10.1%
p-value: p=0.309
In middle-aged adults without prior cardiovascular disease, statin plus ezetimibe combination therapy did not reduce composite cardiovascular events compared to statin monotherapy, though it was associated with a lower risk of all-cause mortality.
BACKGROUND AND OBJECTIVES: Lipid lowering therapy is essential to reduce the risk of major cardiovascular events; however, limited evidence exists regarding the use of statin with ezetimibe as primary prevention strategy for middle-aged adults. We aimed to investigate the impact of single pill combination therapy on clinical outcomes in relatively healthy middle-aged patients when compared with statin monotherapy. METHODS: Using the Korean National Health Insurance Service database, a propensity score match analysis was performed for baseline characteristics of 92,156 patients categorized into combination therapy (n=46,078) and statin monotherapy (n=46,078) groups. Primary outcome was composite outcomes, including death, coronary artery disease, and ischemic stroke. And secondary outcome was all-cause death. The mean follow-up duration was 2.9±0.3 years. RESULTS: The 3-year composite outcomes of all-cause death, coronary artery disease, and ischemic stroke demonstrated no significant difference between the 2 groups (10.3% vs. 10.1%; hazard ratio [HR], 1.022; 95% confidence interval [CI], 0.980-1.064; p=0.309). Meanwhile, the 3-year all-cause death rate was lower in the combination therapy group than in the statin monotherapy group (0.2% vs. 0.4%; p<0.001), with a significant HR of 0.595 (95% CI, 0.460-0.769; p<0.001). Single pill combination therapy exhibited consistently lower mortality rates across various subgroups. CONCLUSIONS: Compared to the statin monotherapy, the combination therapy for primary prevention showed no difference in composite outcomes but may reduce mortality risk in relatively healthy middle-aged patients. However, since the study was observational, further randomized clinical trials are needed to confirm these findings.
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Cha et al. (2024) conducted a cohort in Primary prevention of cardiovascular disease (n=92,156). Statin with ezetimibe combination therapy vs. Statin monotherapy was evaluated on 3-year composite outcome of all-cause death, coronary artery disease, and ischemic stroke (HR 1.022, 95% CI 0.980-1.064, p=0.309). Statin with ezetimibe combination therapy showed no significant difference in the 3-year composite outcome of death, coronary artery disease, and ischemic stroke compared to statin monotherapy (HR 1.022).
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