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Research Article| Volume 16, ISSUE 1, P94-103, January 2022

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Real-world utilization of bempedoic acid in an academic preventive cardiology practice

  • Bruce A. Warden
    Correspondence
    Corresponding author at: BCPS-AQ Cardiology, CLS, FNLA, Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Mail code HRC5N, Portland, OR 97239
    Affiliations
    Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239
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  • BCPS-AQ Cardiology
    Affiliations
    Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239
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  • Jonathan Q Purnell
    Affiliations
    Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239

    Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health & Science University, Portland, OR, USA
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  • P. Barton Duell
    Affiliations
    Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239

    Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health & Science University, Portland, OR, USA
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  • Sergio Fazio
    Correspondence
    Dr. Fazio is currently Scientific Council Chair of Cardio-Metabolic Disease at Regeneron Pharmaceuticals, Inc., in Tarrytown, NY
    Affiliations
    Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239
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Published:December 03, 2021DOI:https://doi.org/10.1016/j.jacl.2021.11.013

      Highlights

      • Bempedoic acid required insurance approval or cost mitigation in 94.5% of cases
      • Bempedoic acid reduced LDL-C by 20.3%-36.7%, with wide inter-individual variability
      • Hyper- and hypo-responder phenotypes were present in 25% and 14% of patients
      • Drug discontinuations were common, occurring in 35.9% of patients
      • The most common TEAEs were musculoskeletal

      Background

      Lipid management for prevention and treatment of cardiovascular disease remains insufficient for many with currently available therapies.

      Objective

      Evaluate real-world use of bempedoic acid.

      Methods

      Retrospective study of patients in our Center for Preventive Cardiology who were prescribed bempedoic acid between February 2020 and July 2021. Patients were managed according to clinical standards of care, with lipid assessments at months ≤3, 6, and 12 post-bempedoic acid initiation.

      Results

      Seventy-three patients were prescribed bempedoic acid, with 64 initiating therapy. The majority had atherosclerosis (89%), familial hypercholesterolemia (64%), and statin intolerance (74%), with baseline low-density lipoprotein cholesterol (LDL-C) 120 mg/dL. Prior authorization requests and appeals of denials were required in 90% and 19% of cases, respectively. Cost-mitigating strategies reduced median monthly drug costs from $432 pre-insurance approval to $80 post-insurance approval, to $10 after financial assistance intervention. Bempedoic acid reduced LDL-C by -36.7%, -31%, and -20.3% at ≤3, 6, and 12, respectively, with >20% achieving LDL-C <70 mg/dL. There was substantial inter-individual heterogeneity in LDL-C lowering. We observed high rates of drug discontinuation (35.9%), mostly related to treatment-emergent adverse events (TEAEs) (32.8%), primarily musculoskeletal complaints. Use of reduced dose bempedoic acid (<180 mg) was associated similar LDL-C lowering but TEAE and drug discontinuation were still common.

      Conclusions

      Real-world use of bempedoic acid was limited by insurance and cost barriers requiring substantial post-prescription interventions. In patients at heightened risk for atherosclerotic events and statin intolerance, bempedoic acid was associated with clinically meaningful LDL-C lowering, but high rates of TEAEs and drug discontinuations.

      Keywords

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