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CME: The Cholesterol Wars: Navigating a Shifting Battlefield: Identifying Patients Who Would Most Benefit from PCSK9 Inhibitors

Activity Description / Statement of Need:

***Please note that, in order to access these course materials, you must create a user profile if you do not already have one. Your profile one ScientiaCME's website is unrelated to your profile on North American Thrombosis Forum's (NATF's) website.***


The content of this internet enduring material activity was originally presented as part of a live event.

Statin therapy is the recommended treatment for lowering low-density lipoprotein cholesterol (LDL-C)and reducing atherosclerotic cardiovascular disease (ASCVD) risk. Unfortunately, many clinicians fail to help their patients achieve evidence-based and guidelinerecommended LDL-C targets and underutilize effective LDL-lowering therapies, including ezetimibe and PCSK9 inhibitors, even among the highest risk patients. As a result, a heavy, unmitigated burden of
cardiovascular risk persists. More education for healthcare providers and patients is urgently needed to address this problem.

PCSK9 inhibitor therapy has been shown to lower LDL- and ASCVD events in patients who cannot take statins. For individuals at high risk for ASCVD events, research shows that the goal should not just be lowering LDL-C, but helping patients achieve the lowest LDL-C possible. Several large trials have demonstrated the efficacy of PCSK9 inhibitors in addition to statin therapy for reduction of both LDL-C and ASCVD risk.

The GLAGOV trial demonstrated the efficacy of evolocumab, when added to statin therapy, in reducing the progression of atherosclerosis measured by serial intravascular ultrasound. This trial was followed by the FOURIER Cardiovascular Outcomes trial in more than 27,000 patients with stable ASCVD where evolocumab reduced the primary endpoint of atherosclerotic events by 15%, without significant safety differences between treatment groups. Subgroup analyses of FOURIER suggested greater benefits seen in those with longer exposure to evolocumab, including those with recent acute coronary syndrome (ACS), multiple myocardial infarctions, multivessel coronary artery disease, peripheral arterial disease, and the subgroup who achieved very low LDL-C levels of below 0.3 mmol/L (10 mg/dL). Finally, the ODYSSEY Cardiovascular Outcomes trial testing alirocumab in subjects with recent (within 1 year) ACS demonstrated a 15% relative risk reduction in the primary composite outcome, as well as a significant reduction in total mortality.

In statin-intolerant patients who have genetic cholesterol problems or aggressive cardiovascular disease, it is important to start them on a PCSK9 inhibitor as soon as possible. The GAUSS-34 randomized trial of patients with confirmed, lifestyle-limiting statin intolerance showed that PCSK9 inhibitor therapy yielded excellent LDL-C reduction with a low rate of muscle-related adverse effects and a good overall side effect profile.

The results of these trials show that the addition of PCSK9 inhibitors to traditional statin therapy in high-risk patients, or used alone in patients who are statin intolerant, is advantageous. Despite this evidence, many clinicians still struggle to prescribe appropriate treatment. This is a result of:

  • A lack of awareness around which patients would benefit from PCSK9 inhibitors
  • Limited education on outcomes data supporting the use of PCSK9 inhibitors to lower LDL-C in high-risk patients
  • Lengthy, burdensome, and sometimes, even conflicting guidelines
  • Difficulty getting insurance companies to pay for certain medications
  • Burdensome prior authorization processes

To address these important issues, NATF and ScientiaCME have developed a series of educational activities. This activity is focused on helping clinicians identify which patients would benefit from PCSK9 inhibitors.

Target Audience:

Physicians, nurse practitioners, physician assistants, pharmacists, and other clinicians specializing in:

  • Cardiology
  • Emergency Medicine
  • Endocrinology
  • Family Medicine
  • Hospital Medicine
  • Internal Medicine
  • Primary Care

This activity is supported by educational funding provided by Amgen.

The activity is available to learners free of charge.


Release Date: November 22, 2022 -- Expiration Date: November 22, 2023

Faculty: Multiple Faculty,

Agenda

  • Welcome and Introductions
  • Didactic Presentation
  • Case Presentation
  • Expert Panel Discussion
  • Audience Q&A

Learning Objectives

By the end of the session the participant will be able to:

  • Evaluate outcomes data supporting LDL-C reduction and proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) use in high cardiovascular (CV) risk patients
  • Assess indications for the PCSK9i use for CV risk reduction: not achieving LDL-C treatment goals and statin intolerance/side effects, and apply that information to a patient case
  • Identify patients most likely to benefit from adding PCSK9i therapy to their treatment regimen, and apply that information to a patient case
  • Discuss initiating PCSK9i therapy in CV risk patients, and apply that information to a patient case
  • Assess indications for use of PCSK9 inhibitors for CV risk reduction in a patient who has not achieved lipid goals

Accreditation

Learning objectives:

6. Recognize which patients are most likely to benefit from the addition of PCSK9i therapy to treatment regimen through the lens of both primary and secondary prevention

7. Discuss initiation of PCSK9i therapy in patients with CV risk who aren’t at LDL goal while taking patient values and preferences into consideration, and apply that information to a patient case

 

 

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of ScientiaCME and NATF. ScientiaCME is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation: ScientiaCME designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)™ toward the AMA Physician's Recognition Award. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Nurse Practitioners (NPs): The American Academy of Nurse Practitioners accepts AMA PRA Category 1 Credit(s)™ from organizations accredited by the ACCME.  ScientiaCME will provide NPs who successfully complete each activity with a certificate of participation indicating that the activity was designated for AMA PRA Category 1 Credit(s)™.

Physician Assistants: The American Academy of Physician Assistants accepts AMA PRA Category 1 Credit(s)™ from organizations accredited by the ACCME.

Pharmacists

ScientiaCME is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity is approved for 1 contact hour (0.1 CEUs) of continuing pharmacy education credit. Proof of participation will be posted to your NABP CPE profile within 4 to 6 weeks to participants who have successfully completed the post-test.   Participants must participate in the entire group of presentations and complete the course evaluation to receive continuing pharmacy education credit.  ACPE UAN: 0574-9999-22-045-H01-P.

This is an Application (A)-type activity.

Pharmacists: You must enter your NABP # and birth date correctly so that proof of participation can be posted to your NABP CPE profile. It is the learner's responsibility to provide this information completely and accurately at the completion of the activity. Without providing it, the learner will NOT receive CPE credit for this activity.

The CPE statements of credit contain information provided to NABP from the Accreditation Council for Pharmacy Education (ACPE) via CPE Monitor®. ACPE policy states paper and/or electronic statements of credit may no longer be distributed directly to learners as proof of ACPE credit. The official record of credit may be located in the learner’s e-profile in CPE Monitor®.

Faculty Disclosure and Resolution of COI

  • Jorge Plutzky, MD, Director, Preventive Cardiology, Brigham and Women’s Hospital, Boston, MA: Paid consultant -- Alnylam, Altimmune, Amgen, Esperion, Merck, MJ Health Lifesciences, Novo Nordisk; Grants: Boehringer Ingelheim, Novartis

  • Moderator: Allen Taylor, MD: Speaker – Amgen, Espirion

 

Individuals with no con´Čéicts of interest to disclose: 

  • Content reviewer: Charles J Turck, PharmD, BCPS, BCCCP, President, ScientiaCME
  • Anum Saeed, MD, Assistant Professor, University of Pittsburgh Medical Center

Instructions

  • Read the learning objectives above
  • Take the Pre-Test (optional). Completion of the pre-test will help us evaluate the knowedge gained by participating in this CME activity.
  • View the online activity. You may view this is in more than one session, and may pause or repeat any portion of the presentation if you need to.
  • Minimum participation threshold: Take the post-test. A score of 70% or higher is required to pass and proceed to the activity evaluation.
  • Complete the activity evaluation and CME registration. A CE certificate will be emailed to you immediately.

Cultural and Linguistic Competence

System Requirements

PC
Windows 7 or above
Internet Explorer 8
*Adobe Acrobat Reader
MAC
Mac OS 10.2.8
Safari or Chrome or Firefox
*Adobe Acrobat Reader
Internet Explorer is not supported on the Macintosh

*Required to view Printable PDF Version


Perform Pre-Test (optional)

Please take a few minutes to participate in the optional pre-test. It will help us measure the knowledge gained by participating in this activity.


Additional Courses That Are Related To This Activity

The Cholesterol Wars: Navigating a Shifting Battlefield: The Critical Importance of Lowering LDL-C in High-Risk Patients

The Cholesterol Wars: Navigating a Shifting Battlefield: Recent Cholesterol Guidelines and Integration into Clinical Practice

The Cholesterol Wars: Navigating a Shifting Battlefield: Current Treatments for LDL Lowering - and Why Patient Access Is Important