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Ulf Landmesser1, Jennifer McGinniss2, Ph. Gabriel Steg3,4, Deepak L. Bhatt5, Vera A. Bittner6, Rafael Diaz7, Mirza Dilic8, Shaun G. Goodman9,10, J. Wouter Jukema11,12, Megan Loy13, Ivan Pećin14, Robert Pordy15, Steen H. Poulsen16, Michael Szarek17,18, Harvey D. White19, Gregory G. Schwartz20, for the ODYSSEY OUTCOMES Investigators.

Background and Objectives

  • The 2019 ESC/EAS dyslipidemia guidelines lowered LDL-C treatment goals:
    • In patients considered at very high risk (including those with ACS), LDL-C goal of <1.4 mmol/L is recommended together with >50% LDL-C reduction and a lower goal of <1.0 mmol/L may be considered for those with recurrent CV events within 2 years
  • This analysis, using the data of ODYSSEY OUTCOMES trial:
    • Examined how many patients not at goal with high-intensity or MTD statin treatment achieved new LDL-C treatment goals with alirocumab, according to baseline LDL-C values
    • Projected how many would have achieved the new treatment goals with the use of ezetimibe when added to MTD statin therapy

Methods

  • This sub analysis of the ODYSSEY OUTCOMES trial (multicentre, double-blind, randomized placebo-controlled trial in 18,924 patients of ≥40 years of age, hospitalized with an ACS 1–12 months before randomization) comprised of 17,589 patients with LDL-C ≥1.4 mmol/L at baseline who did not receive ezetimibe treatment

Key Findings

  • 94.6% of patients receiving alirocumab achieved LDL-C goal <1.4 mmol/L at ≥1 post-baseline measurement vs. 17.3% patients receiving placebo
  • 85.2% of patients with recurrent CV events vs 3.5% receiving placebo, can achieve the lower goal (<1.0 mmol/L)
  • In contrast, 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
  • Although the statin/ezetimibe combination is more cost effective than the statin/PCSK9i combination, a substantial number of patients will not achieve the LDL-C goal with this combination

Conclusion

In post ACS patients with residual dyslipidemia despite intensive or MTD statin, adding alirocumab treatment which has been shown to further reduce the risk of MACE and is associated with a reduction in all-cause mortality after ACS, enabled majority of the patients to reach the 2019 ESC guideline targets for LDL-C <1.4 mmol/L (<55 mg/dL) and <1.0 mmol/L (<40 mg/dL) compared to placebo or ezetimibe

MAT-KW-2200376/V1/DEC2022