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GIVE 'EM L: WHY LEQVIO 2026 Guidelines Information and how LEQVIO data aligns

With lower LDL-C targets, adherence is a metric that matters1

The 2026 Guideline on the Management of Dyslipidemia stresses early and aggressive treatment to get to LDL-C target and that adherence is a key to long-term LDL-C management1*
 

  • LDL-C target of <70 mg/dL for patients with ASCVD not at very high risk1†
  • LDL-C target of <55 mg/dL for patients at very high risk of ASCVD events1

The effect of LEQVIO on cardiovascular morbidity and mortality has not been determined.

LEQVIO was proven to get the majority of patients to guideline-recommended LDL-C targets2,3

In the ORION-10 (N=1561) study, on top of a maximally tolerated statin:

  • 52% LDL-C reduction in adults with hypercholesterolemia and ASCVD vs placebo at Month 17 (95% CI: -56%, -49%; P<0.0001)4

Results were similar in adult patients with ASCVD in ORION-11.5,6

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 percent change in LDL-C from baseline to Day 510.4,7

LEQVIO is the only LDL-C–lowering therapy specifically designed to guarantee 6 months of continuous treatment after HCP administration4‖

After 2 initial doses.4

The 2026 Guideline is clear: Adherence is equally as important as response to therapy1*

In a 1-year, real-world study of adherence, >40% of patients taking PCSK9 mAbs were unable to adhere to a self-administered, higher frequency dosing regimen.8-10#

More patients were fully adherent vs PCSK9 mAbs8
12-month real-world adherence and persistence study for LEQVIO

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.

LEQVIO is an HCP-administered PCSK9 siRNA.4 Therefore claims ensure patients received the injection. Evolocumab and alirocumab claims do not confirm self-administration, so PDC for PCSK9 mAbs may be overestimated.8-10

Study design: A retrospective, observational real-world study evaluated 1-year adherence and persistence for newly initiated adult patients on LEQVIO (N=852), evolocumab (N=27,171), and alirocumab (N=8878) using administrative claims databases.** Adherence was defined as the PDC††; fully adherent patients were defined as having a PDC of ≥0.8. Persistence was defined as patients on therapy for 1 year after index date with a ≤90-day gap for LEQVIO and ≤60-day gap for evolocumab and alirocumab between last day of supply and start of the next prescription.8

Limitations: The study was conducted using administrative claims data (collected for nonresearch purposes), with limited details on clinical variables and susceptibility to missing data and coding-related errors. Clinical characteristics and medications were captured during the 1 year prior to the initiation period; anything beyond the 1-year period was not observable.8

LEQVIO is the only twice-yearlyPCSK9 inhibitor therapy4

After 2 initial doses.4

Updated Guideline, updated expectations for treatment: 
Check adherence regularly1*

*The 2026 Multisociety Guideline recommends that patients receiving lipid lowering therapy (LLT) should receive a follow-up lipid profile 4 to 12 weeks after initiation or intensification, and states that inadequate response to treatment may lead to further intensification of lifestyle or statin regimen changes and/or initiation of a nonstatin LLT. Assessment of adherence to therapy is considered as equally important as response to therapy. Refinement of individualized communication with patients about treatment options may have major implications for long-term treatment adherence and patient outcomes by fostering trust, buy-in, and engagement.1,12
Very high risk includes a history of multiple major ASCVD events (ACS within past 12 months, history of MI [other than ACS above], history of ischemic stroke, symptomatic PAD) or 1 major ASCVD event and multiple high-risk conditions (age >65 years of age, coronary artery revascularization, current smoker, diabetes, history of heart failure, hypertension, LDL-C >100 mg/dL despite maximally tolerated statin + ezetimibe).1
LDL-C target was <70 mg/dL for patients with ASCVD and aligned with 2018 ACC/AHA Guideline.2,11
§Factors that increase risk of CVD include HeFH, T2DM, or 10-year risk of ≥20%.5
The allowable dosing window for all treatments was added as per prescribing information. For LEQVIO +90 days and for evolocumab and alirocumab +7 days.8
#LEQVIO dosing was initial and at 3 months, then twice yearly, while alirocumab or evolocumab dosing was every 2 weeks or once every month.4,9,10
**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 2023.8
††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.8

There’s more to know about LEQVIO

See how LEQVIO can help get patients to LDL-C target after a coronary event

ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA American Heart Association; ASCVD, atherosclerotic cardiovascular disease; CVD; cardiovascular disease; HCP, health care professional; HeFH, heterozygous familial hypercholesterolemia; LDL-C, low-density lipoprotein cholesterol; LLT, lipid-lowering therapy; mAb, monoclonal antibody; MI, myocardial infarction; PAD, peripheral artery disease; PCSK9, proprotein convertase subtilisin/kexin type 9; PDC, proportion of days covered; siRNA, small interfering ribonucleic acid; T2DM, type 2 diabetes mellitus.
References: 1. Blumenthal RS, Morris PB, Gaudino M, et al. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2026. doi:10.1161/CIR.0000000000001423 2. Data on file. ORION-10. Novartis Pharmaceuticals Corp; 2019. 3. Data on file. ORION-10. Novartis Pharmaceuticals Corp; 2025. 4. Leqvio. Prescribing information. Novartis Pharmaceuticals Corp. 5. Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020(supplement):1-31. 6. Data on file. ORION-11. Novartis Pharmaceuticals Corp; 2025. 7. Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519. doi:10.1056/NEJMoa1912387 8. Niu X, Popadic L, Xinshuo M, et al. Treatment patterns among early inclisiran vs anti-PCSK9 mAbs users: a retrospective analysis of US claims databases. Poster presented at: National Lipid Association Scientific Sessions 2024; May 30-June 2, 2024; Las Vegas, NV. 9. Repatha. Prescribing information. Amgen Inc. 10. Praluent. Prescribing information. Regeneron Pharmaceuticals, Inc. 11. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.0000000000000625. 12. Blumenthal RS, Morris PB, Gaudino M, et al. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2026;S0735-1097(25):10254-4. doi: 10.1016/j.jacc.2025.11.016