Early LDL-C Lowering Efficacy of High-intensity Atorvastatin and Ezetimibe Combination Compared with High-intensity Atorvastatin Alone in Acute Coronary Syndrome: The LAI EARLY ACS Study.

BACKGROUND

High-intensity statins are recommended in patients experiencing acute coronary syndrome (ACS) to lower low-density lipoprotein cholesterol (LDL-C) levels, but evidence-based recommended LDL-C goals often remain unmet. We assessed the therapeutic benefit of early LDL-C lowering and the safety of high-intensity atorvastatin and ezetimibe combination versus high-intensity atorvastatin alone in ACS.

METHODS

In this investigator-initiated trial, 254 patients admitted with ACS were randomized 1:1 to either atorvastatin 80 mg once daily (group A) or a combination of atorvastatin 80 mg and ezetimibe 10 mg once daily (group B). The first dose was administered orally immediately after diagnosis and then continued daily. The primary and secondary endpoints were percentage reductions in direct LDL-C measurements over the initial 4-week period and at 12 weeks, respectively.

RESULTS

The mean percentage reduction in LDL-C was 8.12% in group A vs 14.43% in group B (p < 0.001) at week 1, 16.62% in group A vs 28.34% in group B at 2 weeks (p < 0.001), 29.43% in group A vs 45.15% in group B at 4 weeks (p < 0.001), and 41.88% in group A vs 60.76% in group B (p < 0.001) at 12 weeks. Adverse events were similar in both groups.

CONCLUSION

Ezetimibe added to high-intensity statin therapy was well tolerated and resulted in an immediate and robust additional decrease in circulating LDL-C concentrations, with a markedly higher proportion of participants achieving LDL-C goals at 4 and 12 weeks. These promising results show that dual therapy started immediately at the diagnosis of ACS has the potential to improve cardiovascular outcomes in ACS.