In ORION-10 (N=1561), on top of a maximally tolerated statin, LEQVIO^® demonstrated:

52% LDL-C reduction in patients with hypercholesterolemia and ASCVD vs placebo at Month 17 (95% CI: -56%, -49%; P<0.0001).¹

84% of patients receiving LEQVIO achieved LDL-C target* <70 mg/dL vs 18% with placebo at Month 17.²

75% of patients receiving LEQVIO achieved an LDL-C <55 mg/dL vs 4% of patients on placebo at Month 17.^3,4

Results were similar in patients with ASCVD in ORION-11.^4,5

Study Design: ORION-10 (N=1561) and ORION-11 (N=1617) were multicenter, double-blind, randomized, placebo-controlled, 18-month, phase 3 trials in adults with established ASCVD (ORION-10 and ORION-11) or increased risk for CVD^† (ORION-11). Patients were taking a maximally tolerated statin with or without other lipid-modifying therapy and required additional LDL-C reduction. The primary efficacy measure was the percentage change in LDL-C from baseline to day 510.^1,6

*LDL-C target was <70 mg/dL for patients with ASCVD.^1
†Factors that increase risk of CVD include HeFH, T2DM, or 10-year risk of ≥20%.⁶

Consistent efficacy beyond 6 years^1,2,7‡

In ORION-8 (N=3274), an open-label extension study

Study Design: ORION-8, an open-label extension trial that included 3274 adults from ORION-9, ORION-10, ORION-11, and ORION-3, was designed to assess the long-term safety, efficacy, and tolerability of LEQVIO in patients with ASCVD or at increased risk for CVD^† and elevated LDL-C, despite ongoing treatment with lipid-lowering therapy.^5,7

Limitations: Study was not blinded nor controlled and includes inherent self-selection bias for continuing onto the extension trial. The open-label design and absence of a control group may present difficulties in the interpretation of results, allowing comparisons only to baseline values.^7§

^‡209 (6.4%) patients had exposure to LEQVIO for 6+ years, 213 (6.5%) patients had exposure to LEQVIO for 5+ years, 1553 (47.4%) patients had exposure for 4+ years, and 2095 (64%) patients had exposure for 3+ years.^8 
§LDL-C target was <70 mg/dL for patients with ASCVD and <100 mg/dL for patients at increased risk for CVD^† and aligns with the 2018 AHA/ACC Guideline.^5,9
‖End of study was defined as day 1080 or ≥90 days after the last LEQVIO dose.⁷

LEQVIO clinical insights: Understanding pivotal phase 3 and long-term trial data

Watch cardiologists Dr Dean Karalis and Dr Merle Myerson share clinical perspectives on LEQVIO efficacy and safety data—including long-term results—for managing LDL-C in patients with ASCVD or increased risk of CVD.