Why the study?
European guidelines set LDL-C goals of <1.4 mmol/L after ACS and <1.0 mmol/L with recurrent events within 2 years, but many patients do not achieve them on statins alone.
Does alirocumab added to optimized statin therapy improve the achievement of ESC/EAS LDL-C treatment goals in patients with recent ACS compared to placebo?
Does alirocumab added to optimized statin therapy improve the achievement of ESC/EAS LDL-C treatment goals in patients with recent ACS compared to placebo?
In patients with recent ACS, adding alirocumab to optimized statin therapy enables the vast majority to achieve the stringent 2019 ESC/EAS LDL-C goals, whereas projected ezetimibe addition would be insufficient for most.
Alirocumab added to statin achieves ESC LDL-C goals in 95% of post-ACS patients; extends evidence supporting PCSK9 inhibition for guideline-directed therapy.
AIMS: European guidelines set low-density lipoprotein cholesterol (LDL-C) treatment goals <1.4 mmol/L after acute coronary syndrome (ACS), and <1.0 mmol/L for patients with recurrent cardiovascular events ≤2 years. Many ACS patients do not achieve these goals on statin alone. We examined actual goal achievement with alirocumab and projected achievement with ezetimibe, either added to optimized statin therapy. METHODS AND RESULTS: The ODYSSEY OUTCOMES trial (NCT01663402) compared alirocumab with placebo in 18 924 patients with recent ACS and hyperlipidaemia despite high-intensity or maximum-tolerated statin therapy. This subanalysis comprised 17 589 patients with LDL-C ≥1.4 mmol/L at baseline who did not receive ezetimibe treatment. High-intensity statin treatment was used in 88.8%. Median (interquartile range) baseline LDL-C was 2.3 (1.9-2.7) mmol/L. With alirocumab, 94.6% of patients achieved LDL-C <1.4 mmol/L at ≥1 post-baseline measurement vs. 17.3% with placebo. Among 2236 patients with a previous cardiovascular event within 2 years (before the qualifying ACS), 85.2% vs. 3.5%, respectively, achieved LDL-C <1.0 mmol/L. Among patients not treated with ezetimibe, we projected that its use would have achieved LDL-C <1.4 and <1.0 mmol/L in 10.6 and 0%, respectively, at baseline (assuming 18 ± 3% reduction of LDL-C). CONCLUSION: Among patients with recent ACS and LDL-C ≥1.4 mmol/L despite optimized statin therapy, the addition of alirocumab allowed 94.6% to achieve the 2019 European guideline LDL-C goal <1.4 mmol/L, and 85.2% of those with recurrent cardiovascular events to achieve <1.0 mmol/L. In contrast, the addition of ezetimibe to optimized statin therapy was projected to achieve LDL-C <1.4 mmol/L in only 10.6% of patients at baseline.
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Landmesser et al. (2022) studied this question.
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