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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:
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.
Physicians, nurse practitioners, physician assistants, pharmacists, and other clinicians specializing in:
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,
By the end of the session the participant will be able to:
ACCME Activity #202402925
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.
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®.
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
Individuals with no conﬂicts of interest to disclose:
Anum Saeed, MD, Assistant Professor, University of Pittsburgh Medical Center
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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