Current Concepts in the Management of the Metabolic Syndrome:A Workbook for Clinicians (A CME Monograph)

**Sponsored by The Foundation for Better Health Care in collaboration with the American Medical Association**

Original release date: March 1, 2007
Date of update: November 1, 2007
Expiration date: November 1, 2008
Estimated time to complete: 3 hours

Grantor:

The Foundation for Better Health Care (FBHC) gratefully acknowledges AstraZeneca LP and Eli Lilly and Co. for its support of this program through educational grants to The Foundation for Better Health Care.

Sponsor

This activity is sponsored by The Foundation for Better Health Care.

Overview

The National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) has identified the metabolic syndrome, with its combination of dyslipidemia (high triglyceridemia, low high-density lipoprotein cholesterol), elevated blood pressure, central obesity, high fasting glucose (impaired glucose tolerance, insulin resistance, diabetes mellitus), and microalbuminuria, as a multifactorial risk factor for cardiovascular disease.1 Metabolic syndrome has reached epidemic proportions in the US; however, a knowledge gap among primary care physicians, nurse practitioners, and physician assistants has resulted in a failure to identify and manage affected patients appropriately. The FBHC has designed this monograph to shed light on potential clinical strategies for managing the composite of comorbid metabolic disturbances that comprise the syndrome.

Intended Audience

This educational activity is designed for physicians, physician assistants, nurse practitioners, and allied health professionals in primary care.

Needs Assessment

Through needs assessment surveys, literature searches, advisory board suggestions, and previous meeting evaluations, the FBHC has determined a need to address the current state of knowledge regarding the metabolic syndrome. Specifically, because there are no generally accepted guidelines for treatment of the syndrome as a singular aggregate of metabolic risk factors, the need exists to address each risk factor individually, including diagnosis, treatment strategies, and guideline recommendations for each factor.

Method of Clinician Participation

Read the monograph carefully and complete the online posttest at www.fbhc.org/cme/posttests. A minimum score of 80% must be obtained for credit to be awarded by the FBHC. There is no fee for this activity. Credit for the posttest is available until February 1, 2008.

Content Validation

The FBHC validates the content of its CME activities through a peer review process and by utilizing evidencebased medicine sources throughout the planning and implementation of its activities. Adopting the levels of evidence used by the American Academy of Family Physicians1 and the principles of evidence-based medicine outlined by Straus et al,2 the FBHC rates the level of evidence of the literature used to determine needs and learning objectives, as well as all therapeutic recommendations discussed.

All recommendations involving clinical medicine are based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. Further, all scientific research referred to, reported, or used in support or justification of a patient care recommendation conforms to the generally accepted standards of experimental design, data collection, and analysis.

Levels of Evidence1

  • Level A (randomized controlled trial [RCT]/meta-analysis)
  • Level B (other evidence): A well-designed, nonrandomized clinical trial. A nonquantitative systematic review with appropriate search strategies and well-substantiated conclusions. Includes lower-quality RCTs, clinical cohort studies, and case-controlled studies with nonbiased selection of study participants and consistent findings. High-quality, historical, uncontrolled studies, or well-designed epidemiologic studies with compelling findings, are also included
  • Level C (consensus/expert opinion)
    1. Siwek J, Gourlay ML, Slawson DC, Shaughnessy AF. How to write an evidence-based clinical review article. Am Fam Physician. 2002;65:251-258.
    2. Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-Based Medicine. 3rd ed. Edinburgh, Scotland: Churchill Livingstone; 2005.

Learning Objectives

The monograph is designed to help you in your professional development to:

  • Recognize the metabolic syndrome and list the diagnostic criteria to better identify and manage patients presenting with the syndrome or aspects of it
    • Grundy SM, Brewer B, Cleeman JI, Smith SC Jr, Lenfant C; American Heart Association; National Heart, Lung, and Blood Institute. Definition of metabolic syndrome: report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004;109:433-438. [Evidence Level C]
    • Grundy SM, Cleeman JI, Merz CN, et al; National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110:227-239. [Evidence Level C]
    • Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Bethesda, Md: US Department of Health and Human Services, Public Health Service, National Institutes of Health, National Heart, Lung and Blood Institute; 2001. [Evidence Level C]
    • The IDF consensus worldwide definition of the metabolic syndrome. International Diabetes Federation; Brussels, Belgium. [Evidence Level C]
    • Ford ES, Giles WH, Dietz WH. Prevalence of metabolic syndrome among US adults: findings from the Third National Health and Nutrition Examination Survey. JAMA. 2002;287:356-359. [Evidence Level B]

  • Identify the epidemiologic and clinical data supporting the benefits of weight loss, lipid control, hypertension management, and high glucose reduction, to better understand how prevention and aggressive treatment can reduce cardiovascular and other health risks in the metabolic syndrome
    • Lakka HM, Laaksonen DE, Lakka TA, et al. The metabolic syndrome and total and cardiovascular disease mortality in middle-aged men. JAMA. 2002;288:2709-2716. [Evidence Level B]
    • Ryan MJ Jr, Gibson J, Simmons P, Stanek E. Effectiveness of aggressive management of dyslipidemia in a collaborative-care practice model. Am J Cardiol. 2003;91:1427-1431. [Evidence Level B]
    • Davidson MH, Toth PP. Combination therapy in the management of complex dyslipidemias. Curr Opin Lipidol. 2004;15:423-431. [Evidence Level C]
    • Haffner SM; American Diabetes Association. Dyslipidemia management in adults with diabetes. Diabetes Care. 2004;27(suppl 1):S68- S71. [Evidence Level C]
    • Wang TJ, Parise H, Levy D, et al. Obesity and the risk of new-onset atrial fibrillation. JAMA. 2004;292:2471-2477. [Evidence Level B] US Preventive Services Task Force. Screening for obesity in adults: recommendations and rationale. Ann Intern Med. 2003;139:930- 932. [Evidence Level C]
    • Eckel RH, Krauss RM. American Heart Association call to action; obesity as a major risk factor for coronary heart disease. AHA Nutrition Committee. Circulation. 1998;97:2099-2100. [Evidence Level C]
    • UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837-853. [Evidence Level A]
    • UK Prospective Diabetes Study (UKPDS) Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes (UKPDS 38). BMJ. 1998;317:703-713. [Evidence level A]
    • Yusuf S, Hawken S, Ounpuu S, et al; INTERHEART study investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004;364:937-952. [Evidence Level B]
    • Isomaa B, Almgren P, Tuomi T, et al. Cardiovascular morbidity and mortality associated with the metabolic syndrome. Diabetes Care. 2001;24:683-689. [Evidence Level B]
    • North of England Hypertension Guideline Development Group. Essential hypertension: managing adult patients in primary care. Newcastle-upon-Tyne, UK: Centre for Health Services Research, University of Newcastle; 2004. [Evidence Level C]
  • Discuss the role of therapeutic lifestyle changes in the treatment of glucose intolerance or type 2 diabetes mellitus, hypercholesterolemia, hypertension, and obesity to help patients achieve the best health outcome
    • Johnston CS, Tjonn SL, Swan PD. High-protein, low-fat diets are effective for weight loss and favorably alter biomarkers in healthy adults. J Nutr. 2004;134:586-591. [Evidence Level B]
    • Layman DK, Boileau RA, Erickson DJ, et al. A reduced ratio of dietary carbohydrate to protein improves body composition and blood lipid profiles during weight loss in adult women. J Nutr. 2003;133:411-417. [Evidence Level B]
    • Flechtner-Mors M, Ditschuneit HH, Johnson TD, Suchard MA, Adler G. Metabolic and weight loss effects of long-term dietary intervention in obese patients: four year results. Obes Res. 2000;8:399-402. [Evidence Level A]
    • He K, Hu FB, Colditz GA, Manson JE, Willett WC, Liu S. Changes in intake of fruits and vegetables in relation to risk of obesity and weight gain among middle-aged women. Int J Obes Relat Metab Disord. 2004;28:1569-1574. [Evidence Level B]
    • Klein S, Sheard NF, Pi-Sunyer FX, et al; American Diabetes Association; North American Association for the Study of Obesity; American Society for Clinical Nutrition. Weight management through lifestyle modification for the prevention and management of type 2 diabetes: rationale and strategies. Am J Clin Nutr. 2004;80:257-263. [Evidence Level C]
    • Baster T, Baster-Brooks C. Exercise and hypertension. Aust Fam Physician. 2005;34:419-424. [Evidence Level C]
    • Nicolson DJ, Dickinson HO, Campbell F, Mason JM. Lifestyle interventions or drugs for patients with essential hypertension: a systematic review. J Hypertens. 2004;22:2043-2048. [Evidence Level A]
  • Describe established and emerging pharmacotherapeutic options in achieving recommended goals in patients with the metabolic syndrome
    • American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2005;28:S4-S36. [Evidence Level C] UK Prospective Diabetes Study Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet. 1998;352:854-865. [Evidence Level A]
    • Goudswaard AN, Furlong NJ, Rutten GE, Stolk RP, Valk GD. Insulin monotherapy versus combinations of insulin with oral hypoglycaemic agents in patients with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2004;(4):CD003418. [Evidence Level A]
    • Dailey, G. New strategies for basal insulin treatment in type 2 diabetes mellitus. Clin Ther. 2004;26:889-901. [Evidence Level C]
    • Williams ME, Tuttle KR. The next generation of diabetic nephropathy therapies: an update. Adv Chronic Kidney Dis. 2005;12:212-222. [Evidence Level C]
    • Studer M, Briel M, Leimenstoll B, Glass TR, Bucher HC. Effect of different antilipidemic agents and diets on mortality: a systematic review. Arch Intern Med. 2005;165;725-730. [Evidence Level A]
    • Third Report of the National Cholesterol Education Program (NCEP) Expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). Bethesda, Md: National Heart, Lung and Blood Institute, US Dept of Health and Human Services; 2001. [Evidence Level C]
    • Berkowitz RI, Wadden TA, Tershakovec AM, Cronquist JL. Behavior therapy and sibutramine for the treatment of adolescent obesity: a randomized controlled trial. JAMA. 2003;289:1805-1812. [Evidence Level A]
    • Chanoine JP, Hampl S, Jensen C, Boldrin M, Hauptman J. Effect of orlistat on weight and body composition in obese adolescents: a randomized controlled trial. JAMA. 2005;293:2873-2883. [Evidence Level A]
  • Define comorbid conditions that may afflict patients with the metabolic syndrome, and discuss strategies for managing these conditions to improve patients’ cardiovascular and quality-of-life outcomes
    • Apridonidze T, Essah PA, Iuorno MJ, Nestler JE. Prevalence and characteristics of the metabolic syndrome in women with polycystic ovary syndrome. Obstet Gynecol Surv. 2005;60:589-591. [Evidence Level B]
    • Mosca L, Appel LJ, Benjamin EJ, et al, and the American Heart Association. Evidence-based guidelines for cardiovascular disease prevention in women. Circulation. 2004;109:672-693. [Evidence Level C]
    • Gross JL, de Azevedo MJ, Silveiro SP, Canani LH, Caramori ML, Zelmanovitz T. Diabetic nephropathy: diagnosis, prevention, and treatment. Diabetes Care. 2005;28:164-176. [Evidence Level C]
    • Agarwal R, Acharya M, Tian J, et al. Antiproteinuric effect of oral paricalcitol in chronic kidney disease. Kidney Int. 2005;68:2823- 2828. [Evidence Level A]
    • Coyne D, Acharya M, Qiu P, et al. Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD. Am J Kidney Dis. 2006;47:263-276. [Evidence Level A]
    • American Heart Association. Women and cardiovascular diseases—statistics. Updated 2004. Available at: http://www.americanheart. org/downloadable/heart/1075705991817FS10WM04.pdf. Accessed: July 15, 2005. [Evidence Level B]
    • Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292:1724-1737. [Evidence Level A]
    • Nilsson M, Lagergren J. The relation between body mass and gastro-oesophageal reflux. Best Pract Res Clin Gastroenterol. 2004;18: 1117-1123. [Evidence Level B]
    • Asplund K. What MONICA told us about stroke. Lancet Neurol. 2005;4:64-68. [Evidence Level C]
    • Olsson SB; Executive Steering Committee on behalf of the SPORTIF III investigators. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation: randomised controlled trial. Lancet. 2003;362:1691-1698. [Evidence Level A]
    • Wassertheil-Smoller S, Hendrix SL, Limacher M, et al, and the WHI investigators. Effect of estrogen plus progestin on stroke in postmenopausal women: the Women’s Health Initiative: a randomized trial. JAMA. 2003;289:2673-2684. [Evidence Level A]
    • Angeli F, Verdecchia P, Reboldi GP, et al. Calcium channel blockade to prevent stroke in hypertension: a meta-analysis of 13 studies with 103,793 subjects. Am J Hypertens. 2004;17:817-822. [Evidence Level A]

Credit Designation

The FBHC designates this educational activity for a maximum of 3 AMA PRA Category 1 CreditTM. Physicians should only claim credit commensurate with the extent of their participation in each of these activities.

Identifying and Resolving Conflicts of Interest

The FBHC requires all planning committee members, faculty, teachers, authors, and staff of a CME activity to identify all relevant financial relationships that benefit the individual and his or her spouse or partner in any financial amount within the past 12 months. Such relationships may create the opportunity to affect the content of CME regarding the products or services of the commercial interest.

The FBHC has created the FBHC Committee to Identify and Resolve Conflicts of Interest which reviews Faculty and Staff Disclosure Statements, identifies and resolves conflicts of interest, and determines the level of participation of planning committee members, faculty members, teachers, and authors.

FBHC Disclosure Statement

The FBHC is an independent professional organization that does not endorse specific products of any pharmaceutical concern. This FBHC CME activity has been independently planned by the FBHC.

Independent Reviewer

John Russell, MD
Associate Director
Family Medicine Residency Program
Abington Memorial Hospital
Abington, PA
Clinical Associate Professor
Department of Family and Community Medicine
Temple University School of Medicine
Philadelphia, PA

Medical Writer and Reviewer Disclosures

It is the policy of the FBHC to ensure balance, independence, objectivity, and scientific rigor in all its sponsored educational activities. All faculty are expected to disclose to the activity audience any real or apparent conflict(s) of interest related to the content of their presentation(s). The following relationships have been disclosed:

John R. Ferguson
Medical Writer
Nothing to disclose

John Russell, MD
Reviewer
Nothing to disclose

Disclaimer

The views expressed are those of the author(s). It should not be assumed that this monograph activity expresses the views of AstraZeneca LP and King Pharmaceuticals, Inc or any manufacturer of pharmaceuticals. This FBHC CME activity has been independently planned by the FBHC.

All rights reserved, including translation into other languages. No part of this monograph may be reproduced or transmitted in any form or by any means—electronic or mechanical, including photocopying, recording, or storage in information storage and retrieval systems—without permission in writing from The Foundation for Better Health Care, 33 East 33rd Street, 8th Floor, New York, NY 10016. Copyright © 2007 The Foundation for Better Health Care.

FBHC Staff Disclosures

The FBHC, in keeping with the ACCME’s Essential Areas and their Elements and Standards for Commercial Support, has asked each FBHC staff member who has developed and/or reviewed content for this activity, to disclose to learners all financial relationships, including those of their spouse or partner, with the manufacturer(s) of any pharmaceutical product(s), device(s), or providers of commercial services in any financial amount within the past 12 months. The FBHC staff members have disclosed the following:

Eresso Aga, PhD, Scientific Director
Nothing to disclose

Susan Duff, Managing Editor
Nothing to disclose

Michael Hite, CEO
Nothing to disclose

Nancy Larsen, Consultant
Nothing to disclose

Nina Leeds, PhD, Scientific Codirector
Nothing to disclose

Andrew McCrea, PhD, Executive Director
Nothing to disclose

Sejal Patel, Account Manager
Nothing to disclose

Lauren Schachter, Project Coordinator
Nothing to disclose

Judy Seraphine, Consultant
Nothing to disclose

Diane Zuckerman, RPh, Consultant
Nothing to disclose

System Requirements

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OBTAINING CME CREDIT

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© 2008 The Foundation for Better Health Care