Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 10/7/2025

Leqvio (Inclisiran) Therapy for Patients with Clinical ASCVD

Clinical Guideline Recommendations

  • The European Society of Cardiology recommends that patients with chronic coronary syndrome at very high cardiovascular risk should achieve LDL-C <55 mg/dL with ≥50% reduction from baseline 2
  • The American College of Cardiology supports inclisiran as an adjunct to maximally tolerated statin therapy for patients with clinical ASCVD requiring additional LDL-C lowering 1

Evidence for Inclisiran Efficacy

  • The ORION-10 and ORION-11 trials demonstrated that inclisiran reduces LDL-C by approximately 50% when added to statin therapy 4, 1
  • Inclisiran has demonstrated a favorable safety profile similar to placebo, with injection site reactions being the most common adverse event (5.0% vs 0.7%) 1

Patient Selection Criteria

  • The American College of Cardiology recommends inclisiran for patients with clinical ASCVD who require additional LDL-C lowering as an adjunct to diet and maximally tolerated statin therapy 1, 4
  • Patients with extensive ASCVD, severely reduced LVEF, prior MI, coronary stenosis, and ventricular arrhythmias are considered at extreme cardiovascular risk and may benefit from inclisiran therapy 2, 3

Standard of Care Assessment

  • Inclisiran is considered standard of care and is FDA-approved for adults with clinical ASCVD who require additional LDL-C lowering as an adjunct to diet and maximally tolerated statin therapy 1, 4, 2