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Praluent logo

In patients with a prior cv event, Praluent® (alirocumab) significantly reduced the risk of MACE (primary endpoint) in patients already on high intensity statins1,2

~90% of patients in ODYSSEY OUTCOMES were on high-intensity statins1

Study design: ODYSSEY OUTCOMES was a randomized, double-blind, placebo-controlled phase 3 study. Patients with a recent MI or unstable angina, and on high-intensity statin (40 or 80 mg atorvastatin or 20 or 40 mg rosuvastatin, or maximally tolerated dose of one of these agents) +/- other lipid-lowering therapy but not at predefined target LDL-C were enrolled.1

MACE

In patients with a prior CV event, Praluent® demonstrated a significant reduction in the risk of MACE for the overall trial population vs placebo, HR 0.85 [95% CI 0.78 - 0.93] p=0.0003).2

A greater absolute benefit was observed in patients with baseline ≥2.6 mmol/L LDL-C (non-prespecified analysis).2

See Kaplan-Meier curves for MACE

Overall efficacy in main CV outcomes

Praluent® provided consistent results across CV outcomes1
Among the main secondary endpoints, the risks of any CHD event (including CHD death, nonfatal MI, UA requiring hospitalisation, and an ischaemia-driven coronary revascularisation procedure), major CHD event (including death from CHD and nonfatal MI), CV event (including nonfatal MI and nonfatal ischaemic stroke), and a composite of death from any cause, nonfatal MI or nonfatal ischemic stroke were significantly lower among patients treated with Praluent® than those who received placebo.1

View table and forest plot of CV outcome results

All-cause mortality

Praluent® was associated with a reduction of all-cause mortality (nominal significance by hierarchical testing) for the overall trial population vs placebo, HR 0.85 [95% CI 0.73–0.98]2,3.

In a post-hoc analysis, a greater benefit was observed in patients with baseline 100 mg/dL LDL-C for the overall trial population vs placebo, HR 0.71 [95% CI 0.56–0.90].2,3**

**Post-hoc analysis.

ACS=acute coronary syndrome; ARR=absolute risk reduction; CHD=coronary heart disease; CI=confidence interval; CV=cardiovascular; HCL-C=high-density lipoprotein cholesterol; HR=hazard ratio; LDL-C=low-density lipoprotein cholesterol; MACE=major adverse cardiac events (primary composite endpoint of CHD death, nonfatal myocardial infarction, fatal and nonfatal ischaemic stroke, or unstable angina requiring hospitalization); MI=myocardial infarction; NNT=number needed to treat; PCSK9i=proprotein convertase subtilisin/kexin type 9 inhibitor; RRR=relative risk reduction.

View forest plot for all-cause mortality

Praluent®

Find more information on Indication, Administration and Mechanism of Action and watch videos about Praluent®.

Patient Website

Find resources and support for your patients on Praluent®. Find useful links about how patients can manage their cholesterol.

Get in touch with the Dyslipidaemia Team

References
  1. Schwartz G, et al. N Engl J Med 2018;379:2097–2107.
  2. Praluent Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/product/8093/smpc. Accessed October 2023.
  3. Schwartz G, et al. N Engl J Med 2018;379:2097–2107. Supplementary Appendix.

MAT-XU-2204592 (v3.0) Date of Preparation: October 2023