Very high-intensity statin with ezetimibe lowers LDL-C more than high-intensity regimen after AMI

This single-center randomized controlled trial enrolled 220 patients with ST- or non-ST-elevation acute myocardial infarction (AMI) during their hospitalization. Patients were randomized to receive either a very high-intensity statin (atorvastatin 80 mg or rosuvastatin 40 mg) combined with ezetimibe 10 mg daily (Group A) or a high-intensity statin (atorvastatin 40 mg or rosuvastatin 20 mg) combined with ezetimibe 10 mg daily (Group B). The primary outcome was achieving both an LDL-C level < 55 mg/dL and a ≥ 50% reduction in LDL-C at 30 days post-discharge.

The primary composite endpoint was not met, with 63% of patients in Group A achieving it versus 52% in Group B (p = 0.13). However, the component outcome of achieving LDL-C < 55 mg/dL was significantly higher in the very high-intensity group (86% vs. 73%, p = 0.02). Mean LDL-C at 30 days was also significantly lower in Group A (43 ± 16 mg/dL) compared to Group B (48 ± 14 mg/dL, p = 0.046). There was no significant difference between groups in achieving a ≥ 50% LDL-C reduction.

Regarding safety and tolerability, statin dose reduction due to intolerance occurred more often in the very high-intensity group (8% vs. 2%, p = 0.03). Other adverse events, serious adverse events, and discontinuation rates were not reported. Key limitations include the single-center design, a short 30-day follow-up focused solely on lipid outcomes, and the lack of data on clinical cardiovascular events or long-term safety. Funding and conflicts of interest were not reported.

For practice, this evidence suggests that initiating a very high-intensity statin plus ezetimibe regimen during AMI hospitalization can lead to lower LDL-C levels at 30 days compared to a high-intensity regimen, but with a higher observed rate of intolerance requiring dose reduction. The clinical significance of these short-term lipid differences is uncertain, and the findings should be interpreted cautiously given the non-significant primary endpoint and lack of long-term or clinical outcome data.