Overview
What Will It Take to Overcome Treatment Inertia in Reaching LDL-C Goals? Exploring Opportunities with Emerging PCSK9 Inhibitors to Reduce ASCVD Risk
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Atherosclerotic cardiovascular disease (ASCVD) is a common condition that is treated with lipid-lowering agents, and guidelines recommend individualized pharmacotherapy plans determined by the patient’s risk for ASCVD. While statins are recommended as the first-line treatment for lowering low-density lipoprotein cholesterol (LDL-C) levels, PCSK9 inhibitors are recommended in high- and very high-risk patients who are on maximally tolerated statin therapies. Yet despite this guidance, therapeutic inertia persists leading to poorly controlled LDL-C levels and greater cardiovascular risk.
While PCSK9 inhibitors have proven efficacy, safety, and tolerability, clinicians report concern about the expense of these medications and patients can be hesitant to consider due to the self-administration component. Emerging PCSK9s inhibitors look to overcome some of these barriers and clinicians must be ready to optimally adopt these therapies in patients with persistently high LDL-C levels per guideline recommendations.
This digital FAQ supports clinicians in mitigating these barriers by translating the latest evidence into easy-to-adopt strategies for routine clinical practice. Find answers to the questions of greatest relevance to you while bypassing areas of already established knowledge.
This educational activity is designed for cardiologists, PCPs, internists, family medicine physicians, NP/PAs, and other members of the multidisciplinary team managing cardiovascular issues
Dyslipidemia is a major risk factor for atherosclerotic CVD (ASCVD), with low-density lipoprotein cholesterol (LDL-C) most closely associated with ASCVD risk. Lipid lowering therapy is widely available and its use is associated with reductions in ASCVD as well as mortality. However, many patients are not meeting LDL-C goals for primary or secondary risk reduction despite the availability of evidence-based guidance for LDL-C target levels and treatment recommendations. Potential contributors to this widespread failure to meet LDL-C goals include intolerance to standard lipid-lowering therapy with statins, poor adherence to therapy, and gaps between LDL-C targets and what is achievable with standard lipid-lowering therapy. Current evidence-based recommendations include the addition of a PCSK9 inhibitor to statin therapy when LDL-C is not at goal in those with heterozygous familial hypercholesterolemia and primary severe hypercholesterolemia. Additionally, those with ASCVD at very high risk who have not met the LDL-C goal of less than 55 mg/dL on maximally tolerated statin therapy should receive a PCSK9 inhibitor or ezetimibe, with PCSK9-directed monoclonal antibodies preferred as initial therapy because of demonstrated safety, efficacy, and cardiovascular benefit. Yet, use of PCSK9 inhibitors is also suboptimal. To overcome barriers to use, new PCSK9 inhibitors, including injectable and oral therapy, are under evaluation in late-phase clinical trials and may soon become available for clinical use. Education is required to ensure that appropriate patients receive these therapies to reduce risks.
Upon completion of this activity, learners will be able to:
• Discuss safety and efficacy data for emerging PCSK9 inhibitors
• Identify patients who may be appropriate candidates for PCSK9 inhibitors based on expert consensus and evidence-based guidelines
• Employ protocols and patient education strategies to facilitate easier access, support therapy adherence, and improve patient satisfaction
• Discuss safety and efficacy data for emerging PCSK9 inhibitors
• Identify patients who may be appropriate candidates for PCSK9 inhibitors based on expert consensus and evidence-based guidelines
• Employ protocols and patient education strategies to facilitate easier access, support therapy adherence, and improve patient satisfaction
Provided by the Academy for Continued Healthcare Learning (ACHL).
Supported by an educational grant from Merck & Co., Inc.
Robert Giugliano, MD, SM, FACC, FAHA
Professor of Medicine
Harvard Medical School
Senior Investigator, TIMI Study Group
Cardiovascular Division
Brigham and Women’s Hospital
Boston, MA
Professor of Medicine
Harvard Medical School
Senior Investigator, TIMI Study Group
Cardiovascular Division
Brigham and Women’s Hospital
Boston, MA
The Academy for Continued Healthcare Learning (ACHL) requires that the faculty participating in an accredited continuing education activity disclose all affiliations or other financial relationships within 24 months (1) with the manufacturers of any commercial product(s) and/or provider(s) of commercial services discussed in an educational presentation and (2) with all ineligible companies. All relevant financial relationships have been mitigated prior to this activity.
The following financial relationships have been provided:
Robert Giugliano, MD
Grants/Research Support: Amgen, Anthos Therapeutics, Daiichi Sankyo, Ionis Pharmaceuticals
Consultant: Amgen, Astra Zeneca, Beckman Coulter, Daiichi Sankyo, Gilead, Inventiva, Medpace, Novartis, Perosphere, Samsung, Syneos Health
Honoraria : Amgen, CADECI, Centrix, Daiichi Sankyo, Dr. Reddy’s Laboratories, Menarini
ACHL staff members and others involved with the planning, development, and review of the content for this activity have no relevant affiliations or financial relationships to disclose.
The content for this activity was developed independently of any ineligible company. All materials are included with permission. The opinions expressed are those of the faculty and are not to be construed as those of the publisher or grantor(s).
This educational activity was planned and produced in accordance with the ACCME Standards for Integrity and Independence in Accredited Continuing Education. Recommendations involving clinical medicine in a continuing medical education (CME/CE) activity must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported, or used in CME/CE in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, and analysis.
This CME/CE activity might describe the off-label, investigational, or experimental use of medications and/or devices that may exceed their FDA-approved labeling. Physicians should consult the current manufacturers’ prescribing information for these products. ACHL requires the speaker to disclose that a product is not labeled for the use under discussion.
Discussion of scientific information on unapproved uses (SIUU), off-label, investigational, or experimental drug/device use: Investigational PCSK9 inhibitors, including lerodalcibep and enlicitide
To receive credit, learners are required to complete the pretest, view the online activity, and complete the posttest and evaluation. To receive credit, 66% must be achieved on the posttest. A certificate will be immediately available. There is no fee to participate in the activity or for the generation of the certificate.
The Academy for Continued Healthcare Learning designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Physician assistants, nurse practitioners, and nurses may participate in this educational activity and earn a certificate of completion as AAPA, AANP, and ANCC accept AMA PRA Category 1 Credits™ through their reciprocity agreements.