POWERFUL LDL-C REDUCTION AND CONSISTENT EFFICACY BEYOND 6 YEARS1-5*†
†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.5
Pivotal Trials
In ORION-10 (N=1561) on top of a maximally tolerated statin, LEQVIO demonstrated:
52% LDL-C reduction in patients with 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 176
75% of patients receiving LEQVIO achieved an LDL-C <55 mg/dL vs 4% of patients on placebo at month 176
Results were similar in patients with ASCVD in ORION-11.7,8
Study Design: ORION-10 (N=1561) & ORION-11 (N=1617) were multicenter, double-blind, randomized, placebo-controlled, 18-month, phase 3 trials in patients 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 510.1,8
‡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%.8
Long-Term Efficacy
Consistent efficacy beyond 6 years1,2,8
In ORION-8 (N=3274), an open-label extension study
~80% of patients
achieved guideline-recommended LDL-C target at end of study¶# (78%; 95% CI: 77%, 80%)3,4
~50% LDL-C reduction at EOS
n=2731 (mean percentage change in LDL-C was -49% at EOS#; 95% CI: -50%, -48%)4
Study Design: ORION-8, an open-label extension trial that included 3274 patients 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.4
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.8¶
‖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.5
¶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 AHA/ACC guidelines.3,4
#End of study was defined as day 1080 or ≥90 days after the last LEQVIO dose.4
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.
