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

Real-world adherence for LEQVIO vs PCSK9 mAbs^7‡

Adherence matters: 12-month real-world adherence and persistence study for LEQVIO^7‡§ 

• LEQVIO is an HCP-administered PCSK9 siRNA. Therefore, claims ensure patients received the injection¹
• Evolocumab and alirocumab claims do not confirm self-administration, so PDC for PCSK9 mAbs may be overestimated^7-9‖

^‡The comparison pertains only to differences in adherence or persistence as defined by this analysis and should not be considered a comparison of efficacy or safety. 

Study Design: A retrospective, observational real-world study evaluating 12-month adherence and persistence for newly-initiated patients on LEQVIO (N=852), evolocumab (N=27171), and alirocumab (N=8878) using administrative claims databases.^¶  Adherence was defined as the proportion of days covered (PDC)^‖; fully adherent patients were defined as having a PDC of ≥0.8. Persistence was defined as patients on therapy for 12 months after index date with ≤90 days gap for LEQVIO and ≤60 days gap for evolocumab and alirocumab between last day of supply and start of the next prescription.⁷

Limitations: The study was conducted using administrative claims data (collected for non-research purposes), with limited details on clinical variables and susceptibility to missing data and coding-related errors. Clinical characteristics and medications were captured during the 12 months prior to the initiation period; anything beyond the 12-month period was not observable. LEQVIO is HCP-administered; therefore, claims ensure patients received the injection, whereas evolocumab and alirocumab claims do not confirm self-administration, thus PDC for PCSK9 mAbs may be over-estimated.^7‖

^§The allowable dosing window for all treatments was added as per prescribing information. For LEQVIO +90 days and for evolocumab and alirocumab +7 days.^7
‖PDC calculates the proportion of days a patient has access to their prescribed medication over a defined period of interest, which was 12 months for this study.^7 
¶Komodo Health, a nationally representative longitudinal database that captures 330 million patients in the US, from open and closed administrative databases, was utilized from January 2021 to October 2023.⁷