In the ORION-10 (N=1561) on top
of a maximally tolerated statin
difference from placebo at month 17 (95% CI: -56%, -49%; P<0.0001)1 (LEQVIO n=781 or placebo n=780)
LDL-C reduction on top of a maximally tolerated statin, LEQVIO vs placebo1
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84% of patients achieved guideline-recommended LDL-C target‡
compared with 18% of patients on placebo at month 173,10
Study Design: ORION-10 (N=1561) & ORION-11 (N=1617) were multicenter, double-blind, randomized, placebo-controlled, 18-month, Phase III 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 percent change in LDL-C from baseline to day 510.1,2
CONSISTENT EFFICACY BEYOND 6 YEARS1,8,9*
In ORION-8 (N=3274), an open-label extension study
~80% OF PATIENTS
achieved guideline-recommended LDL-C target3,8‡
(78%; 95% CI: 77, 80)8,9
~50% LDL-C REDUCTION
n=2731 (49% at end of study||; 95% CI: 48%, 50%)8,9
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 increased risk for CVD§ and elevated LDL-C, despite ongoing treatment with lipid-lowering therapy.8,9
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.
*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.30
†Greater LDL-C reduction was maintained during each 6-month dosing interval vs placebo as a complement to a maximally tolerated statin.1
‡ 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.3,8
§ Factors that increase risk of CVD include HeFH, T2DM, or 10-year risk of ≥20%.2
|| End of study was defined as day 1080 or ≥90 days after the last LEQVIO dose.8
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LEQVIO DEMONSTRATED CONSISTENT REDUCTION ACROSS PREDEFINED SUBGROUPS5,6
Percent change in LDL-C from baseline at month 17 in a pooled analysis of Phase III trials5,6
a Patients with a history of a statin intolerance.
b Factors that increase risk of CVD include HeFH, T2DM, or 10-year risk of ≥20%.
Study Description: ORION-1 was a Phase II, multicenter, double-blinded, randomized, placebo-controlled clinical trial of 345 subjects with established ASCVD who were taking a maximally tolerated statin and required additional LDL-C reduction. Of those, 91 patients received the 284-mg dose of LEQVIO. The primary efficacy end point was the percent reduction in LDL-C from baseline to day 180 and was calculated for multiple time points at days 14, 30, 60, 90, 120, 150, 180, 210, and 240.1,7
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ASCVD, atherosclerotic cardiovascular
disease; CI, confidence interval;
LDL-C, low-density lipoprotein cholesterol.