Bruckert E, Hayem G, Dejager S, Yau C, Bégaud B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients -- the PRIMO study. Cardiovasc Drugs Ther. 2005;19:403-414. Abstract
Cohen JC, Boerwinkle E, Mosley TH Jr, Hobbs HH. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. N Engl J Med. 2006;354:1264-1272. Abstract
McKenney JM, Koren MJ, Kereiakes DJ, Hanotin C, Ferrand AC, Stein EA. Safety and efficacy of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 serine protease, SAR236553/REGN727, in patients with primary hypercholesterolemia receiving ongoing stable atorvastatin therapy. J Am Coll Cardiol. 2012;59: 2344-2353. Abstract
Roth EM, McKenney JM, Hanotin C, Asset G, Stein EA. Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia. N Engl J Med. 2012;367:1891-1900. Abstract
Giugliano RP, Desai NR, Kohli P, et al; LAPLACE-TIMI 57 Investigators. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study. Lancet. 2012; 380: 2007-2017. Abstract
Cholesterol Treatment Trialists’ (CTT) Collaboration, Baigent C, Blackwell L, Emberson J, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010; 376: 1670-1681. Abstract
Hsia J, MacFadyen JG, Monyak J, Ridker PM. Cardiovascular event reduction and adverse events among subjects attaining low-density lipoprotein cholesterol <50 mg/dl with rosuvastatin. The JUPITER trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin). J Am Coll Cardiol. 2011;57:1666-1675. Abstract
Hochholzer W, Giugliano RP. Lipid lowering goals: back to nature? Ther Adv Cardiovasc Dis. 2010;4:185-191. Abstract
Nicholls SJ, Tuzcu EM, Sipahi I, et al. Statins, high-density lipoprotein cholesterol and regression of coronary atherosclerosis. JAMA. 2007;297:499-508. Abstract
ClinicalTrials.gov. GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV). NCT01813422. http://clinicaltrials.gov/ct2/show/NCT01813422. Accessed May 4, 2013.

Disclaimer
The information in this educational activity is provided for general medical education purposes only and is not meant to substitute for the independent medical judgment of a physician relative to diagnostic and treatment options for a specific patient's medical condition. The viewpoints expressed in this CME activity are those of the authors/faculty. They do not represent an endorsement by The Cleveland Clinic Foundation. In no event will The Cleveland Clinic Foundation be liable for any decision made or action taken in reliance upon the information provided through this CME activity.

In accordance with the Standards for Commercial Support issued by the Accreditation Council for Continuing Medical Education (ACCME), The Cleveland Clinic Foundation Center for Continuing Education requires resolution of all faculty conflicts of interest to ensure CME activities are free of commercial bias.

Author(s)

Steven E. Nissen, MD

Co-Activity Director; Professor of Medicine, Cleveland Clinic Lerner College of Medicine; Chairman, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio

Disclosures

Disclosure: Steven E. Nissen, MD, has disclosed no relevant financial relationships.

Christie M. Ballantyne, MD

Professor of Medicine, Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart & Vascular Center, Baylor College of Medicine, Houston, Texas

Disclosures

Disclosure: Christie M. Ballantyne, MD, has disclosed the following relevant financial relationships:
Consultant: Abbott Laboratories; Aegerion Pharmaceuticals, Inc.; Amarin Corporation plc; Amgen Inc.; Arena Pharmaceticals, Inc.; Cerenis Therapeutics; Esperion Therapeutics, Inc.; Genentech, Inc.; Genzyme Corporation; Kowa Company Ltd.; Merck & Co., Inc.; Novartis Pharmaceuticals, Inc.; Omthera Pharmaceuticals, Inc.; , Pfizer Inc; Resverlogix Corp; Regeneron Pharmaceuticals, Inc.; Roche; Sanofi-Synthelabo
Speakers Bureau: Abbott Laboratories; GlaxoSmithKline
Grant/Research Support (All paid to institution, not individual): Abbott Laboratories; Amarin Corporation plc; Amgen Inc.; Lilly USA, LLC; GlaxoSmithKline; Genentech, Inc.; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc; Regeneron Pharmaceuticals, Inc.; Roche; Sanofi-Synthelabo; Takeda Pharmaceuticals North America, Inc.; NIH; AHA

Stephen J. Nicholls, MBBS, PhD, FRACP

Professor of Cardiology, SAHMRI Heart Foundation Heart Disease Theme Leader, South Australian Health & Medical Research Institute, Adelaide, Australia

Disclosures

Disclosure: Stephen J. Nicholls, MBBS, PhD, FRACP, has disclosed the following relevant financial relationships:
Independent Contractor (including contracted research): Amgen Inc.; Takeda Pharmaceuticals North America, Inc.; AstraZeneca Pharmaceuticals LP; Roche, Eli Lilly and Company; Resverlogix Corp.
Served as an advisor or consultant for: Amgen Inc.; Takeda Pharmaceuticals North America, Inc.; AstraZeneca Pharmaceuticals LP; Roche, Eli Lilly and Company; Resverlogix Corp, Merck

Editor(s)

Ronald K. Miller, PhD

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Ronald K. Miller, PhD, has disclosed no relevant financial relationships.

Javier F. Negrón, PhD

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Javier F. Negrón, PhD, has disclosed no relevant financial relationships.

Activity Co-Director

Katherine J. Hoercher, RN

Co-Activity Director; Senior Director, Heart and Vascular Institute, Kaufman Center for Heart Failure, Cleveland Clinic, Cleveland, Ohio

Disclosures

Disclosure: Katherine J. Hoercher, RN, has disclosed no relevant financial relationships.

CME Reviewer(s)

Nafeez Zawahir, MD

CME Clinical Director, Medscape, LLC

Disclosures

Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

Content reviewers have no relevant financial relationships to disclose.

CME

Modulating PCSK9 and the LDL Receptor: Tipping the Balance of Power

Authors: Steven E. Nissen, MD; Christie M. Ballantyne, MD; Stephen J. Nicholls, MBBS, PhD, FRACP
CME Released: 6/6/2013
THIS ACTIVITY HAS EXPIRED FOR CREDIT
Valid for credit through: 6/6/2014

Start Activity

Target Audience and Goal Statement

This activity is intended for cardiologists, lipid specialists, endocrinologists, primary care physicians, and other physicians involved in the care of patients with hypercholesterolemia.

The goal of this activity is to provide focused education and practical guidance on the evidence-based use of intensive low-density lipoprotein cholesterol (LDL-C) reduction to manage residual cardiovascular risk within the limitations of current lipid-modifying therapy.

Upon completion of this activity, participants will be able to:

Summarize the need for additional LDL-C reduction in patients with residual cardiovascular risk despite current lipid-modifying therapy
Describe the mechanism of action of proprotein convertase subtilisin/kexin 9 (PCSK9) in regulation of cholesterol homeostasis
Review efficacy and safety data for the various PCSK9 inhibitors

Disclosures

Author(s)

Steven E. Nissen, MD

Co-Activity Director; Professor of Medicine, Cleveland Clinic Lerner College of Medicine; Chairman, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio

Disclosures

Disclosure: Steven E. Nissen, MD, has disclosed no relevant financial relationships.

Christie M. Ballantyne, MD

Professor of Medicine, Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart & Vascular Center, Baylor College of Medicine, Houston, Texas

Disclosures

Disclosure: Christie M. Ballantyne, MD, has disclosed the following relevant financial relationships:
Consultant: Abbott Laboratories; Aegerion Pharmaceuticals, Inc.; Amarin Corporation plc; Amgen Inc.; Arena Pharmaceticals, Inc.; Cerenis Therapeutics; Esperion Therapeutics, Inc.; Genentech, Inc.; Genzyme Corporation; Kowa Company Ltd.; Merck & Co., Inc.; Novartis Pharmaceuticals, Inc.; Omthera Pharmaceuticals, Inc.; , Pfizer Inc; Resverlogix Corp; Regeneron Pharmaceuticals, Inc.; Roche; Sanofi-Synthelabo
Speakers Bureau: Abbott Laboratories; GlaxoSmithKline
Grant/Research Support (All paid to institution, not individual): Abbott Laboratories; Amarin Corporation plc; Amgen Inc.; Lilly USA, LLC; GlaxoSmithKline; Genentech, Inc.; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc; Regeneron Pharmaceuticals, Inc.; Roche; Sanofi-Synthelabo; Takeda Pharmaceuticals North America, Inc.; NIH; AHA

Stephen J. Nicholls, MBBS, PhD, FRACP

Professor of Cardiology, SAHMRI Heart Foundation Heart Disease Theme Leader, South Australian Health & Medical Research Institute, Adelaide, Australia

Disclosures

Disclosure: Stephen J. Nicholls, MBBS, PhD, FRACP, has disclosed the following relevant financial relationships:
Independent Contractor (including contracted research): Amgen Inc.; Takeda Pharmaceuticals North America, Inc.; AstraZeneca Pharmaceuticals LP; Roche, Eli Lilly and Company; Resverlogix Corp.
Served as an advisor or consultant for: Amgen Inc.; Takeda Pharmaceuticals North America, Inc.; AstraZeneca Pharmaceuticals LP; Roche, Eli Lilly and Company; Resverlogix Corp, Merck

Editor(s)

Ronald K. Miller, PhD

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Ronald K. Miller, PhD, has disclosed no relevant financial relationships.

Javier F. Negrón, PhD

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Javier F. Negrón, PhD, has disclosed no relevant financial relationships.

Activity Co-Director

Katherine J. Hoercher, RN

Co-Activity Director; Senior Director, Heart and Vascular Institute, Kaufman Center for Heart Failure, Cleveland Clinic, Cleveland, Ohio

Disclosures

Disclosure: Katherine J. Hoercher, RN, has disclosed no relevant financial relationships.

CME Reviewer(s)

Nafeez Zawahir, MD

CME Clinical Director, Medscape, LLC

Disclosures

Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

Content reviewers have no relevant financial relationships to disclose.

Accreditation Statements

For Physicians

The Cleveland Clinic Foundation Center for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Cleveland Clinic Foundation Center for Continuing Education designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]

Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 70% on the post-test.

Follow these steps to earn CME/CE credit*:

Read the target audience, learning objectives, and author disclosures.
Study the educational content online or printed out.
Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. We encourage you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.

*The credit that you receive is based on your user profile.

From Medscape Education Cardiology

CME

Modulating PCSK9 and the LDL Receptor: Tipping the Balance of Power

Authors: Steven E. Nissen, MD; Christie M. Ballantyne, MD; Stephen J. Nicholls, MBBS, PhD, FRACPFaculty and Disclosures

THIS ACTIVITY HAS EXPIRED FOR CREDIT

CME Released: 6/6/2013

Valid for credit through: 6/6/2014

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Disclaimer

The educational activity presented above may involve simulated case-based scenarios. The patients depicted in these scenarios are fictitious and no association with any actual patient is intended or should be inferred.

The material presented here does not necessarily reflect the views of Medscape, LLC, or companies that support educational programming on medscape.org. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity.

References

Faculty and Disclosures

Author(s)

Steven E. Nissen, MD

Christie M. Ballantyne, MD

Stephen J. Nicholls, MBBS, PhD, FRACP

Editor(s)

Ronald K. Miller, PhD

Javier F. Negrón, PhD

Activity Co-Director

Katherine J. Hoercher, RN

CME Reviewer(s)

Nafeez Zawahir, MD

CME

Modulating PCSK9 and the LDL Receptor: Tipping the Balance of Power

Target Audience and Goal Statement

Disclosures

Author(s)

Steven E. Nissen, MD

Christie M. Ballantyne, MD

Stephen J. Nicholls, MBBS, PhD, FRACP

Editor(s)

Ronald K. Miller, PhD

Javier F. Negrón, PhD

Activity Co-Director

Katherine J. Hoercher, RN

CME Reviewer(s)

Nafeez Zawahir, MD

Accreditation Statements

For Physicians

Instructions for Participation and Credit

Modulating PCSK9 and the LDL Receptor: Tipping the Balance of Power