Jacobson TA. NLA Task Force on Statin Safety-2014 update. J Clin Lipidol. 2014;8:S1-S4.
Mach F, Ray KK, Wicklund O, et al. Adverse effects of statin therapy: perception vs. the evidence - focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract; European Heart Journal (2018) 0, 1-18.
Maddox TM, Borden WB, Tang F, et al. Implications of the 2013 ACC/AHA Cholesterol Guidelines for Adults in Contemporary Cardiovascular Practice: Insights From the NCDR PINNACLE Registry. JACC. 2014;64:2183-2192.
Virani SS, Woodard LD, Ramsey DJ, et al. Gender disparities in evidence-based statin therapy in patients with cardiovascular disease. Am J Cardiol. 2015;115:21-26.
Colantonio LD, Huang L, Monda KL, et al. Adherence to High-Intensity Statins Following a Myocardial Infarction Hospitalization Among Medicare Beneficiaries. JAMA Cardiol. 2017;2:890-895.
Serban MC, Colantonio LD, Manthripragada AD, et al. Statin Intolerance and Risk of Coronary Heart Events and All-Cause Mortality Following Myocardial Infarction. J Am Coll Cardiol. 2017;69:1386-1395.
Guyton JR, Bays HE, Grundy SM, et al. An assessment by the Statin Intolerance Panel: 2014 update. J Clin Lipidol. 2014;8:S72-S81.
Rosenson RS, Baker SK, Jacobson TA, et al. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol. 2014;8:S58-S71.
Brush JE, Jr, Handberg EM, Biga C, et al. 2015 ACC Health Policy Statement on Cardiovascular Team-Based Care and the Role of Advanced Practice Providers. J Am Coll Cardiol. 2015;65:2118-2136.
Ross, J, NLA Lipid University https://www.lipid.org/sites/default/files/4-_lipid_u-pharmacologic_therapies-_brown.pdf. Accessed 10/11/18.
Stone NJ, Robinson JG, Lichtenstein AH, et al. Treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk in adults: synopsis of the 2013 American College of Cardiology/American Heart Association cholesterol guideline. Ann Intern Med. 2014;160:339-343.
Toth PP, Journal of Fam Practice medicine June 2012 · Vol. 61, No. 06 Suppl: S34-S39.
Orringer CE, Jacobson TA, Saseen JJ, et al. Update on the use of PCSK9 inhibitors in adults: Recommendations from an Expert Panel of the National Lipid Association. J Clin Lipidol. 2017;11:880-890.
Rosenson RS, Baker SK, Jacobson TA, et al. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol. 2014;8:S58-S71.

CME / CE

Exploring Statin Intolerance: Real World Data

Authors: James A. Underberg, MD; Joseph J. Saseen, PharmD
CME / CE Released: 11/9/2018
THIS ACTIVITY HAS EXPIRED FOR CREDIT
Valid for credit through: 11/9/2019, 11:59 PM EST

Target Audience and Goal Statement

This activity is intended for cardiologists, diabetologists and endocrinologists, primary care physicians, nurses, nurse practitioners (NPs), pharmacists, and all clinicians interested in management of dyslipidemia.

The goal of this activity is to encourage and improve teamwork when managing patients with statin intolerance.

Upon completion of this activity, participants will:

Have greater competence related to
- effective team-based strategies to address statin intolerance in high-risk patients
- use of HCP-patient communication strategies to improve adherence to statin therapy

Disclosures

As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.

Faculty

James Underberg, MD

Clinical Assistant Professor of Medicine
NYU School of Medicine
NYU Center for CVD Prevention
Director
Bellevue Hospital Lipid Clinic
New York, New York

Disclosures

Disclosure: James A. Underberg, MD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Amarin Corporation plc; Amgen Inc.
Served as a speaker or a member of a speakers bureau for: Aegerion Pharmaceuticals, Inc.; Akcea Therapeutics; Alexion Pharmaceuticals, Inc.; Amarin Corporation plc; Amgen Inc.; Pfizer Inc.; Regeneron Pharmaceuticals, Inc.; Sanofi
Received grants for clinical research from: Amarin Corporation plc; Amgen Inc.
Other: Advisory Boards: Aegerion Pharmaceuticals, Inc.; Akcea Therapeutics; Alexion Pharmaceuticals, Inc.; Amarin Corporation plc; Ambry Genetics; Amgen Inc.; Regeneron Pharmaceuticals, Inc.; Sanofi

Dr Underberg does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Underberg does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Joseph Saseen, PharmD

Professor
Vice Chair
University of Colorado Skaggs School of Pharmacy
Aurora, Colorado

Disclosures

Disclosure: Joseph J. Saseen, PharmD, has disclosed no relevant financial relationships.

Dr Saseen does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by (Select as applicable…).

Dr Saseen does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Steering Committee

Alan S. Brown, MD

Director
Advocate Heart Institute
Advocate Lutheran General Hospital
Park Ridge, Illinois

Disclosures

Disclosure: Alan S. Brown, MD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Akcea Therapeutics; Amgen Inc.; Kastle Therapeutics; Merck & Co., Inc.; Regeneron Pharmaceuticals, Inc.; Sanofi
Served as a speaker or a member of a speakers bureau for: Amgen Inc.; Kowa Company Ltd.; Regeneron Pharmaceuticals, Inc.; Sanofi

Harold Edward Bays, MD

Medical Director
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky

Disclosures

Disclosure: Harold Edward Bays, MD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Akcea Therapeutics; Alnylam Pharmaceuticals, Inc.; Amgen Inc.; AstraZeneca Pharmaceuticals LP; Eisai Inc.; Esperion Therapeutics, Inc.; Ionis Pharmaceuticals, Inc.; Janssen Pharmaceuticals; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Kowa Company Ltd.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; ProSciento; Regeneron Pharmaceuticals, Inc.; Sanofi
Served as a speaker or a member of a speakers bureau for: Amarin Corporation plc; Amgen Inc.; Eisai Inc.; Kowa Company Ltd.; Orexigen Therapeutics, Inc.; Regeneron Pharmaceuticals, Inc.; Sanofi
Received grants for clinical research from: Alere; Allergan, Inc.; Amarin Corporation plc; Amgen Inc.; AstraZeneca Pharmaceuticals LP; Boehringer Ingelheim Pharmaceuticals, Inc.; Bristol-Myers Squibb Company; Catabasis Pharmaceuticals, Inc.; Chiltern; ChromaDex, Inc.; Dr. Reddy's Laboratories Ltd.; Eisai Inc.; Elcelyx Therapeutics, Inc.; Esperion Therapeutics, Inc.; Ferrer; Gemphire Therapeutics Inc.; Gilead Sciences, Inc.; GlaxoSmithKline; Home Access Health; Ionis Pharmaceuticals, Inc.; iSpecimen; Janssen Pharmaceuticals; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Lilly; Merck & Co., Inc.; Nektar Therapeutics; Nichi-Iko Pharmaceutical Co., Ltd.; Novartis Pharmaceuticals Corporation; Novo Nordisk; Omthera Pharmaceuticals, Inc.; Pfizer Inc; Regeneron Pharmaceuticals, Inc.; Sanofi; Selecta Biosciences, Inc.; Takeda Pharmaceuticals North America, Inc.

Joseph L. Lillo, DO

Assistant Professor
Family Medicine
Midwestern University College of Osteopathic Medicine
Glendale, Arizona, United States

Disclosures

Disclosure: Joseph L. Lillo, DO, has disclosed the following relevant financial relationships:
Served as a speaker or a member of a speakers bureau for: Amarin Corporation plc; Amgen Inc.; Kowa Company Ltd.; Sanofi

Kevin C. Maki, PhD

Chief Scientist
Midwest Biomedical Research
Wheaton, Illinois, United States

Disclosures

Disclosure: Kevin C. Maki, PhD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Akcea Therapeutics; Amgen Inc.; Kowa Company Ltd.; Regeneron Pharmaceuticals, Inc.; Sancilio & Company, Inc.

Kausik Ray, MBChB, MD, MPhil (Cantab), FRCP (Lon), FRCP (Ed)

Professor
Public Health
Imperial College London
London, United Kingdom

Disclosures

Disclosure: Kausik Ray, MBChB, MD, MPhil (Cantab), FRCP (Lon), FRCP (Ed), has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: AbbVie Inc.; Amgen Inc.; Cerenis Therapeutics; Ionis Pharmaceuticals, Inc.; Lilly; Medco Health Solutions, Inc.; Regeneron Pharmaceuticals, Inc.; Sanofi
Served as a speaker or a member of a speakers bureau for: Algorithme Pharma inc.; AstraZeneca Pharmaceuticals LP; Boehringer Ingelheim Pharmaceuticals, Inc.; Cipla Ltd.; Kowa Company Ltd.; Pfizer Inc; Takeda Pharmaceuticals North America, Inc.
Received grants for clinical research from: Amgen Inc.; Pfizer Inc; Regeneron Pharmaceuticals, Inc.; Sanofi

Joyce L. Ross, MSN, CRNP, CS

Diplomat
Accreditation Council for Clinical Lipidology
Immediate Past President
National Lipid Association
Past President
Preventive Cardiovascular Nurses Association
Philadelphia, Pennsylvania

Disclosures

Disclosure: Joyce L. Ross, MSN, CRNP, CS, has disclosed the following relevant financial relationships:
Served as a speaker or a member of a speakers bureau for: Amarin Corporation plc; Amgen Inc.; Kaneka Americas Holding, Inc.; Kowa Company Ltd.; Regeneron Pharmaceuticals, Inc.; Sanofi

Editor

Joy P. Marko, MS, APN-C, CCMEP

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Joy P. Marko, MS, APN-C, CCMEP, has disclosed no relevant financial relationships.

CME / CE Reviewer

Amy Bernard, MS, BSN, RN-BC, CHCP

Lead Nurse Planner, Medscape, LLC

Disclosures

Disclosure: Amy Bernard, MS, BSN, RN-BC, CHCP, has disclosed no relevant financial relationships.

Accreditation Statements

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From Medscape Education Cardiology

CME / CE

Exploring Statin Intolerance: Real World Data

Authors: James A. Underberg, MD; Joseph J. Saseen, PharmDFaculty and Disclosures

THIS ACTIVITY HAS EXPIRED FOR CREDIT

CME / CE Released: 11/9/2018

Valid for credit through: 11/9/2019, 11:59 PM EST

processing....

Exploring Statin Intolerance: Real World Data
[ CLOSE WINDOW ]

Slide 1.

Prevalence of Statin Intolerance ^[]
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Slide 2.

Statin AEs ^[2]
- The list of possible adverse events (AE)s include hemorrhagic stroke, cataract, diabetes, effects on the liver, proteinuria
- The main AEs affecting a patient's ability to take statins are that of muscle-related symptoms
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Slide 3.

High Risk Patients and Statin Intolerance^[3]
- Approximately 30% to 45% of patients, depending on the risk group, do not get put on statin therapy for a variety of reasons
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Slide 4.

Statins, ASCVD, VA Hospitals^[4]
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Slide 5.

Pattern of Statin Use After Discharge for MI^[5]
- After discharge from the hospital for myocardial infarction (MI), tracking statin use shows a dramatic drop-off in the number of patients who remain on or adhere to high-intensity statin, especially over the first 18-24 months
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Slide 6.

Statin Intolerance^[6]
- Patients who are already intolerant of statins, who also have preexisting atherosclerotic cardiovascular disease, are at greater risk for having subsequent events, as compared with patients who tolerate and take their statins
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Slide 7.

Key Points About SAMS for Clinicians^[2] {mach}
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Slide 8.

Who Is at Risk?^[2]
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Slide 9.

What Determines Management of SAMS?
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Slide 10.

AEs: Perception vs Evidence: Glucose homeostasis -- Clinical Update ESC 2018^[2]
- The FDA changed the labeling in 2012 to identify that there is a small increase in the risk of new-onset diabetes (NODM)
- NODM is prevalent in patients who are already at risk for diabetes
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Slide 11.

Benefits of Statins Far Outweigh Risks^[2] (mach)
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Slide 12.

NLA on Statin Intolerance^[7]
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Slide 13.

Spectrum of Statin-Associated Muscle Adverse Events^[8]
- For patients presenting with muscle symptoms, if creatine kinase (CK) is mildly above normal, that is usually not an issue
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Slide 14.

Ask About Change in Activity^[2]
- If patients cannot tolerate 2 statins, see whether their symptoms improve when statins are stopped and then re-challenged
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Slide 15.

Strategies to Address Intolerance
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Slide 16.

Cardiovascular Team-Based Care and the Role of Advanced Practice Providers^[9]
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Slide 17.

Statin Pharmacokinetics^[10]
- Lipophilic statins penetrate fat tissue and perhaps have a higher risk of statin-associated muscle symptoms
- Look at metabolism: explains to us that some statins have a higher risk for certain drug-drug related interactions
- More drug-drug interactions = More AEs
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Slide 18.

Statins: High/Medium/Low^[11]
- American College of Cardiology (ACC)/American Heart Association (AHA) clearly identifies what is considered high intensity, moderate intensity, and then low intensity
- Patients that are highest risk really are the best candidates for high intensity
- If patients cannot tolerate high-intensity statins, it is acceptable to step down to moderate intensity
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Slide 19.

Ethnic Differences in Statin Metabolism^[12]
- For multiple statins, dosage needs to be reduced in Asian populations
- Pitavastatin has been studied in Asian population, and a dose of 4mg or less is well tolerated
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Slide 20.

Strategies to Address Intolerance
- Address myths; misinformation from unreliable and anecdotal sources abounds
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Slide 21.

Exhaust the Statin Class Before Giving Up
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Slide 22.

NLA Recommendations: Consistent With Those Found in the ACC's Tool^[13]
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Slide 23.

The Takeaway
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Slide 24.

Keep Trying: Benefits Outweighs Risks!^[2]
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Slide 25.

Thank you
[ CLOSE WINDOW ]

Slide 26.

This content has been condensed for improved clarity.

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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

Faculty

James Underberg, MD

Joseph Saseen, PharmD

Steering Committee

Alan S. Brown, MD

Harold Edward Bays, MD

Joseph L. Lillo, DO

Kevin C. Maki, PhD

Kausik Ray, MBChB, MD, MPhil (Cantab), FRCP (Lon), FRCP (Ed)

Joyce L. Ross, MSN, CRNP, CS

Editor

Joy P. Marko, MS, APN-C, CCMEP

CME / CE Reviewer

Amy Bernard, MS, BSN, RN-BC, CHCP

CME / CE

Exploring Statin Intolerance: Real World Data

Target Audience and Goal Statement

Disclosures

Faculty

James Underberg, MD

Joseph Saseen, PharmD

Steering Committee

Alan S. Brown, MD

Harold Edward Bays, MD

Joseph L. Lillo, DO

Kevin C. Maki, PhD

Kausik Ray, MBChB, MD, MPhil (Cantab), FRCP (Lon), FRCP (Ed)

Joyce L. Ross, MSN, CRNP, CS

Editor

Joy P. Marko, MS, APN-C, CCMEP

CME / CE Reviewer

Amy Bernard, MS, BSN, RN-BC, CHCP

Accreditation Statements

For Physicians

For Nurses

For Pharmacists

Instructions for Participation and Credit

Exploring Statin Intolerance: Real World Data

Exploring Statin Intolerance: Real World Data

Slide 1.

Prevalence of Statin Intolerance []

Slide 2.

Statin AEs [2]

Slide 3.

High Risk Patients and Statin Intolerance[3]

Slide 4.

Statins, ASCVD, VA Hospitals[4]

Slide 5.

Pattern of Statin Use After Discharge for MI[5]

Slide 6.

Statin Intolerance[6]

Slide 7.

Key Points About SAMS for Clinicians[2] {mach}

Slide 8.

Who Is at Risk?[2]

Slide 9.

What Determines Management of SAMS?

Slide 10.

AEs: Perception vs Evidence: Glucose homeostasis -- Clinical Update ESC 2018[2]

Slide 11.

Benefits of Statins Far Outweigh Risks[2] (mach)

Slide 12.

NLA on Statin Intolerance[7]

Slide 13.

Spectrum of Statin-Associated Muscle Adverse Events[8]

Slide 14.

Ask About Change in Activity[2]

Slide 15.

Strategies to Address Intolerance

Slide 16.

Cardiovascular Team-Based Care and the Role of Advanced Practice Providers[9]

Slide 17.

Statin Pharmacokinetics[10]

Slide 18.

Statins: High/Medium/Low[11]

Slide 19.

Ethnic Differences in Statin Metabolism[12]

Slide 20.

Prevalence of Statin Intolerance ^[]

Statin AEs ^[2]

High Risk Patients and Statin Intolerance^[3]

Statins, ASCVD, VA Hospitals^[4]

Pattern of Statin Use After Discharge for MI^[5]

Statin Intolerance^[6]

Key Points About SAMS for Clinicians^[2] {mach}

Who Is at Risk?^[2]

AEs: Perception vs Evidence: Glucose homeostasis -- Clinical Update ESC 2018^[2]

Benefits of Statins Far Outweigh Risks^[2] (mach)

NLA on Statin Intolerance^[7]

Spectrum of Statin-Associated Muscle Adverse Events^[8]

Ask About Change in Activity^[2]

Cardiovascular Team-Based Care and the Role of Advanced Practice Providers^[9]

Statin Pharmacokinetics^[10]

Statins: High/Medium/Low^[11]

Ethnic Differences in Statin Metabolism^[12]

NLA Recommendations: Consistent With Those Found in the ACC's Tool^[13]

Keep Trying: Benefits Outweighs Risks!^[2]