Cardiology ·
Initial Statin–Ezetimibe Therapy Shows Similar Outcomes to Statin Alone in Ez-PAVE
A prespecified secondary analysis of the randomized Ez-PAVE trial included 3,048 patients with atherosclerotic cardiovascular disease in South Korea. Over three years, cardiovascular event rates did not differ significantly between patients initially assigned statin–ezetimibe combination therapy and those assigned statin monotherapy within LDL-C target-based treatment strategies.
- Primary cardiovascular events were 8.5% versus 7.9%.
- The difference in outcomes was not statistically significant.
- Initial combination therapy achieved lower median LDL-C.
- Treatment could be adjusted to meet assigned LDL-C targets.
This prespecified secondary analysis of the randomized Ez-PAVE trial compared initial statin–ezetimibe combination therapy with statin monotherapy in 3,048 patients with atherosclerotic cardiovascular disease at 17 South Korean centers. Participants had first been assigned to an intensive LDL-C target (<55 mg/dL) or a conventional target (<70 mg/dL), then randomized to an initial treatment regimen. Therapy could be adjusted under a predefined protocol, and follow-up lasted three years. The primary outcome combined cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, any revascularization, or hospitalization for unstable angina.
The primary outcome occurred in 128 patients (8.5%) assigned combination therapy and 119 (7.9%) assigned monotherapy (hazard ratio 1.07; 95% CI 0.83–1.37; P=0.596). Median LDL-C during follow-up was lower with initial combination therapy in both target groups: 53 versus 62 mg/dL with the intensive target, and 63 versus 70 mg/dL with the conventional target. Safety outcomes were similar. Ezetimibe was subsequently added for some patients initially assigned statin alone.
These findings show no significant difference in cardiovascular outcomes by initial regimen within this protocolized, target-directed approach, although combination therapy achieved lower LDL-C levels. The results do not establish equivalence, and the analysis reflects treatment adjustments and a South Korean study population.
In practice
For patients with atherosclerotic cardiovascular disease treated to LDL-C targets, this analysis found no significant difference in three-year composite cardiovascular outcomes according to whether treatment began with statin–ezetimibe or statin alone. Initial combination therapy achieved lower median LDL-C, but treatment was adjusted during follow-up, including addition of ezetimibe for some patients initially on statin monotherapy. The findings do not establish equivalence or support a universal preferred starting regimen; applicability is also informed by the South Korean study population.
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Circulation: Statin–Ezetimibe Combination Therapy versus Statin Monotherapy in Atherosclerotic Cardiovascular Disease: A Prespecified Secondary Analysis of the Randomized Ez-PAVE Trial ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.