How To Measure Lipids In Bipolar Disorder

Transcription

1 SYLLABUS AND COURSE GUIDE TV Measuring Lipids in Patients with Bipolar Disorder: Why We Must A Free, One-Hour CME/CNE/CEP/NASW/CCMC/CPE Live and On Demand Activity Release Date: December 1, 2010 Credit Expiration Date: March 31, 2012 On the Web: FACULTY: David C. Henderson, MD, Roger S. McIntyre, MD, FRCPC MODERATOR: Paul E. Keck, Jr., MD Take advantage of our 24/7 dial-in archive! Call anytime before March 1, Questions? Call CME Outfitters at 877.CME.PROS. Co-sponsored by The recipient may make a request to the sender not to send any future faxes and failure to comply with the request within 30 days is unlawful. To opt out from future faxes go to enter PIN# 11105, or call , or fax back to

2 INFORMATION FOR PARTICIPANTS Statement of Need The STandards for BipoLar Excellence (STABLE) project outlined 15 evidence-based measures for quality assessment and improvement of care for patients with bipolar disorder (BPD). One of these relates to lipid measurement and assesses the percentage of patients diagnosed with bipolar disorder and treated with an atypical antipsychotic agent who receive at least one assessment for hyperlipidemia within the initial 16 weeks of treatment. This STABLE measure is based on joint recommendations from the American Psychiatric Association (APA) and the America Diabetes Association (ADA) and the fact that studies quantifying levels of clinician performance reveal that this assessment is underperformed. This educational intervention is designed to help you improve your practice by addressing clinician gaps in and health system barriers to implementation of consistent lipid measurement. This neurosciencecme Live and On Demand activity will provide the rationale for lipid measurement in bipolar disorder pharmacotherapy and strategies for increasing the frequency with which you perform it and respond appropriately to test results. Center for Quality Assessment and Improvement in Mental Health. The STAndards for BipoLar Excellence Project. Available at: Accessed October 28, Haupt DW, Rosenblatt LC, Kim E, Baker RA, Whitehead R, Newcomer JW. Prevalence and predictors of lipid and glucose monitoring in commercially insured patients treated with second-generation antipsychotic agents. Am J Psychiatry 2009;166: Activity Goal To increase clinician knowledge of and performance against the STABLE measure related to assessment of hyperlipidemia in patients with bipolar disorder who are being treated with an atypical antipsychotic agent. Learning Objectives At the end of this CE activity, participants should be able to: Identify strategies to overcome barriers that hinder lipid measurement. Increase the rate at which you perform at least one assessment for hyperlipidemia within the initial 16-week treatment period among patients with BPD who are being treated with an atypical antipsychotic agent, in accordance with the STABLE measure regarding lipid assessment. Select an appropriate clinical strategy for addressing an abnormal lipid test. The following learning objectives pertain only to those requesting CNE credit: Explain the rationale for measuring lipids in patients with BPD who take atypical antipsychotic agents in order to effectively handle patient queries. Describe a patient-centered strategy that will help patients with BPD obtain blood draws for needed laboratory tests. Target Audience Physicians, physician assistants, nurses, nurse practitioners, psychologists, pharmacists, social workers, certified case managers, and other healthcare professionals with an interest in bipolar disorder. CREDIT INFORMATION CME Credit (Physicians) USF Health is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. USF Health designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit. Physicians should only claim credit commensurate with the extent of their participation in the activity. Note to Physician Assistants: AAPA accepts Category I credit from AOACCME, Prescribed credit from AAFP, and AMA Category I CME credit for the PRA from organizations accredited by ACCME. CNE Credit (Nurses) Provider approved by the California Board of Registered Nursing, Provider Number CEP 15510, for 1.0 contact hour. 2

3 CEP Credit (Psychologists) CME Outfitters is approved by the American Psychological Association to sponsor continuing education for psychologists. CME Outfitters maintains responsibility for this program and its content. (1.0 CE credit) CPE Credit (Pharmacists) CME Outfitters, LLC, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 1.0 contact hour(s) (0.1 CEUs) Universal Program Number: H01-P Activity Type: knowledge-based All other clinicians will either receive a CME Attendance Certificate or may choose any of the types of CE credit being offered. Financial Support This activity is supported by an educational grant from Janssen, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., administered by Ortho-McNeil Janssen Scientific Affairs, LLC., and from Lilly USA, LLC. For further information concerning Lilly grant funding, visit CREDIT REQUIREMENTS Successful completion of this CE activity includes participating in the live or recorded activity, reviewing the course materials, and following the instructions below within 30 days of completion of the activity: To complete your credit request form, activity evaluation, and post-test online, and print your certificate or statement of credit immediately (70% pass rate required), please visit and click on the Testing/Certification link under the Activities tab (requires free account activation). There is no fee for participation in this activity. The estimated time for completion is 60 minutes. Questions? Please call 877.CME.PROS. FACULTY BIOS & DISCLOSURES Paul E. Keck, Jr., MD (Moderator) Dr. Keck is Craig and Frances Lindner Professor of Psychiatry and Neuroscience at the University of Cincinnati (UC) College of Medicine. He is also President-CEO of the Lindner Center of HOPE, a state-of-the-science, UC-affiliated comprehensive mental health center in Mason, Ohio. Dr. Keck has conducted extensive research in bipolar disorder and clinical psychopharmacology, supported by grants from the NIMH, NARSAD, the Stanley Foundation, and industry. Since 1996, he has been in the top 10 of the most cited scientists in the world publishing in the fields of psychology and psychiatry. A magna cum laude and Phi Beta Kappa graduate of Dartmouth College, Dr. Keck received his MD with honors from the Mount Sinai School of Medicine, New York, NY. He served his internship in Internal Medicine at the Beth Israel Medical Center in New York and completed his residency training in Psychiatry at Harvard Medical School and McLean Hospital, Belmont, MA. Dr. Keck remained on faculty at McLean and Harvard before joining the Department of Psychiatry at the University of Cincinnati in Dr. Keck is the author of over 350 scientific papers in leading medical journals. He has also contributed over 160 reviews and chapters to major psychiatric textbooks, and is the editor or author of 6 scientific books. Dr. Keck is the recipient of numerous honors, including the Gerald Klerman Young Investigator Award from the National Depressive and Manic-Depressive Association (NDMDA); the Gerald Klerman Senior Investigator Award from the Depression & Bipolar Support Alliance (DBSA); the Exemplary Psychiatrist Award from the National Alliance of the Mentally Ill (NAMI); the Philip Isenberg Teaching Award from Harvard Medical School; the Nancy C A Roeske Certificate for medical student education from the American Psychiatric Association; Distinguished Fellow of the American Psychiatric Association; the Wyeth-Ayerst AADPRT Mentorship Award; two Communicator Awards for Continuing Medical Education; the Outstanding Physician Partner Award of the Postgraduate Institute for Medicine; and two Golden Apple Teaching Awards from the University of Cincinnati College of 3

4 Medicine. He is listed as one of the Best Doctors in Cincinnati by Cincinnati Magazine; The Best Doctors in America, a directory of the top one percent of physicians in the United States as rated by their peers. David C. Henderson, MD Dr. Henderson is Associate Professor of Psychiatry at Harvard Medical School and Associate Psychiatrist at the Massachusetts General Hospital (MGH). He serves as the Director of the MGH Chester M. Pierce Division of Global Psychiatry at MGH, and the Medical Director for the Harvard Program in Refugee Trauma at MGH. He is also the Director of the MGH Schizophrenia, Diabetes, and Weight Reduction Research Program, Director of the Clozapine Program, and Associate Director of the MGH Schizophrenia Program. Dr. Henderson s main research interests focus on psychopharmacological and antipsychotic agents in the treatment of schizophrenia, impacts of antipsychotic agents on metabolic anomalies and glucose metabolism, and ethnic and cultural impacts on psychiatry. His first experience in global mental health was following the Rwanda genocide; Dr. Henderson conducted a field study and wrote his first mental health policy document. He followed this up by writing a weekly radio program on mental health for Rwandans. Dr. Henderson then went on to participate in training of primary care clinicians in post-conflict societies or disasters including Cambodia, Bosnia, East Timor, and Peru. While providing training, he also developed methodology to address the clinicians confidence in performing psychiatric diagnosis and treatments. Over the last 15 years, he has provided lectures, consultations, and capacity building efforts in nearly 40 countries to improve the quality of mental health care. He also has worked in areas of disasters including projects in New Orleans, New York City, and Haiti. Dr. Henderson has published in journals such as the Archives of General Psychiatry, American Journal of Psychiatry, British Journal of Psychiatry, and Biological Psychiatry. He is editor of the International Journal of Culture and Mental Health. He has lectured extensively throughout the United States and internationally on schizophrenia, treatment-resistant schizophrenia, metabolic disorders and schizophrenia, psychopharmacology, ethnopsychopharmacology, trauma, and cultural psychiatry. He has received numerous local, national, and international awards for his clinical care, teaching and research. Roger S. McIntyre, MD, FRCPC Dr. McIntyre is currently an Associate Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada. Dr. McIntyre is involved in multiple research endeavors that primarily aim to characterize the association between mood disorders and medical comorbidity. This research involves elucidating metabolic adverse events associated with the use of psychotropic medications, the impact of medical comorbidity on the course of mood disorders, and the effect of glucose homeostasis on neurocognition. Dr. McIntyre is extensively involved in medical education. He is a highly sought-after speaker at both national and international meetings. He has received several teaching awards from the University of Toronto, Department of Psychiatry and has been a recipient of the joint Canadian Psychiatric Association (CPA)/Council of Psychiatric Continuing Education Award for the Most Outstanding Continuing Education Activity in Psychiatry in Canada. Dr. McIntyre is a contributor to the CPA guidelines for the treatment of depressive disorders and the Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of bipolar disorder. Dr. McIntyre has published extensively in leading peer-reviewed journals and textbooks. Dr. McIntyre is also a reviewer for many journals including the American Journal of Psychiatry, Biological Psychiatry, Journal of Clinical Psychiatry and The New England Journal of Medicine. Dr. McIntyre completed his medical degree at Dalhousie University. He received his Psychiatry residency training and Fellowship in Psychiatric Pharmacology at the University of Toronto. Disclosure Declaration USF Health endorses the standards of the ACCME that requires everyone in a position to control the content of a CME activity to disclose all financial relationships with commercial interests that are related to the content of the CME activity. CME activities must be balanced, independent of commercial bias and promote improvements or quality in healthcare. All recommendations involving clinical medicine must be based on evidence accepted within the medical profession. A conflict of interest is created when individuals in a position to control the content of CME have a relevant financial relationship with a commercial interest which therefore may bias his/her opinion and teaching. This may include receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, stocks or other financial benefits. USF Health will identify, review, and resolve all conflicts of interest that speakers, authors or planners disclose prior to an educational activity being delivered to learners. Disclosure of a relationship is not intended to suggest or condone bias in any presentation but is made to provide participants with information that might be of potential importance to their evaluation of a 4

5 presentation. Relevant financial relationships exist between the following individuals and commercial interests: Dr. Keck is employed by the University of Cincinnati College of Medicine, University of Cincinnati Physicians, and the Lindner Center of HOPE. Dr. Keck has disclosed that he receives research/grants from Alkermes, Inc., AstraZeneca Pharmaceuticals LP, Cephalon, Inc., GlaxoSmithKline, Eli Lilly and Company, EPI-Q, Inc., Jazz Pharmaceuticals, Inc., The Marriott Foundation, National Institute of Mental Health (NIMH), Orexigen Therapeutics, Inc., Pfizer Inc., and Shire Pharmaceuticals. He serves as a consultant to Bristol-Myers Squibb Company, GlaxoSmithKline, Medco Health Solutions, Inc., Pfizer Inc., Quantia Communications, Inc., Schering-Plough Corporation, and Sepracor Inc. He is a co-inventor on United States Patent No. 6,387,956: Shapira NA, Goldsmith TD, Keck, PE Jr. (University of Cincinnati) Methods of treating obsessive-compulsive spectrum disorder comprises the step of administering an effective amount of tramadol to an individual. Filed March 25, 1999; approved May 14, Dr. Keck has received no financial gain from this patent. Dr. Henderson has disclosed that he receives grants/research support from Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., and Takeda Pharmaceuticals North America, Inc. He serves as a consultant to Johnson & Johnson Pharmaceutical Research & Development, L.L.C., and Pfizer Inc. Dr. McIntyre has disclosed that he receives grants/research support from Eli Lilly and Company, Janssen-Ortho, Inc., and Shire Pharmaceuticals, as well as Private Industries or Non-Profit Funds: National Alliance for Research on Schizophrenia and Depression (NARSAD), and Stanley Medical Research Institute. He serves on the advisory boards of AstraZeneca Pharmaceuticals LP, Biovail Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Eli Lilly and Company, France Foundation, GlaxoSmithKline, Janssen-Ortho, Inc., H. Lundbeck A/S, Organon, Pfizer Inc., Schering-Plough Corporation, Shire Pharmaceuticals, and Solvay/Wyeth. He serves on the speakers bureaus of AstraZeneca Pharmaceuticals LP, Biovail Pharmaceuticals, Inc., Eli Lilly and Company, Janssen-Ortho, Inc., H. Lundbeck A/S, and Wyeth Pharmaceuticals. Disclosures were obtained from the planning committee members and are on file in the USF Health Office of Continuing Professional Development (OCPD) for review. Disclosures were obtained from the USF Health OCPD staff: Nothing to Disclose. Howard Bliwise, MD (peer/content reviewer) has no disclosures to report. Ruth Cody, BSN, RN-BC (peer/content reviewer) has no disclosures to report. M. Anthony Graham, MD (peer/content reviewer) has no disclosures to report. Philip D. Harvey, PhD (peer/content reviewer) has disclosed that he receives grants/research support from AstraZeneca Pharmaceuticals LP. He serves as a consultant to Abbott Laboratories, Cypress Pharmaceutical, Inc., Merck & Co., Inc., Sunovion Pharmaceuticals Inc., and Shire Pharmaceuticals. Nancy Jennings, MSN, MBA, MHA (peer/content reviewer) has no disclosures to report. Louis D. Murden, LISW (peer/content reviewer) has no disclosures to report. Unlabeled Use Disclosure Faculty of this CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational uses (any uses not approved by the FDA) of products or devices. USF Health, CME Outfitters, LLC, the faculty, Ortho-McNeil Janssen Scientific Affairs, LLC, and Lilly USA, LLC, do not endorse the use of any product outside of the FDA labeled indications. Medical professionals should not utilize the procedures, products, or diagnosis techniques discussed during this activity without evaluation of their patient for contraindications or dangers of use. Activity Slides The slides that are presented in this activity are available for download and printout at the neurosciencecme website: Activity slides may also be obtained via fax or by calling 877.CME.PROS. 5

6 Abbreviation List ADA APA ARI BDNF BMI BPD CLO CMS CVD FDA HDL HTN IDF IGT IQ LDL LMR MGH NART NCEP ATP III NGT NHANES III OLZ QUE RIS SD SGA STABLE TLC WHO ZIP American Diabetes Association American Psychiatric Association Aripiprazole Brain-derived neurotrophic factor Body mass index Bipolar disorder Clozapine Cardiometabolic syndrome Cardiovascular disease Food and Drug Administration High-density lipoprotein Hypertension International Diabetes Foundation Impaired glucose tolerance Intelligence quotient Low-density lipoprotein Longitudinal medical record Massachusetts General Hospital National Adult Reading Test US National Cholesterol Education Program Adult Treatment Panel III Normal glucose tolerance Third National Health and Nutrition Examination Survey Olanzapine Quetiapine Risperidone Standard deviation Second-generation antipsychotic agent STAndards for BipoLar Excellence Project Therapeutic lifestyle changes World Health Organization Ziprasidone 6

7 This continuing education activity is co-sponsored by USF Health and by CME Outfitters, LLC. This CE activity is supported by educational grants from Janssen, a Division of Ortho-McNeil- Janssen Pharmaceuticals, Inc., administered by Ortho-McNeil Janssen Scientific Affairs, LLC, and from Lilly USA, LLC. For further information concerning Lilly grant funding, visit The course guide for this activity includes slides, disclosures of faculty financial relationships, and biographical profiles. For additional copies of these materials, please visit neurosciencecme.com or call 877.CME.PROS. To receive CME/CE credits for this activity, participants must complete the post-test and evaluation online at neurosciencecme.com/test 7

8 The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational uses (any use not approved by the FDA) of products or devices. Moderator: Paul E. Keck, Jr., MD President-CEO, Lindner Center of HOPE Professor of Psychiatry & Behavior Neuroscience University of Cincinnati College of Medicine Cincinnati, OH Paul E. Keck, Jr., MD Disclosures Research/Grants: Alkermes, Inc.; AstraZeneca Pharmaceuticals LP; Cephalon, Inc.; GlaxoSmithKline; Eli Lilly and Company; EPI-Q, Inc.; Jazz Pharmaceuticals, Inc.; The Marriott Foundation; National Institute of Mental Health (NIMH); Orexigen Therapeutics, Inc.; Pfizer Inc.; Shire Pharmaceuticals Speakers Bureau: None Consultant: Bristol-Myers Squibb Company; GlaxoSmithKline; Medco Health Solutions, Inc.; Pfizer Inc.; Quantia Communications, Inc.; Schering-Plough Corporation; Sepracor Inc. Stockholder: None Other Financial Interests: Employed by the University of Cincinnati College of Medicine, University of Cincinnati Physicians, and the Lindner Center of HOPE Advisory Board: None Dr. Keck is a co-inventor on United States Patent No. 6,387,956: Shapira NA, Goldsmith TD, Keck, PE Jr. (University of Cincinnati) Methods of treating obsessive-compulsive spectrum disorder comprises the step of administering an effective amount of tramadol to an individual. Filed March 25, 1999; approved May 14, Dr. Keck has received no financial gain from this patent. Faculty: David C. Henderson, MD Associate Professor of Psychiatry Harvard Medical School Director, Schizophrenia, Diabetes, and Weight Reduction Research Program Director, The Chester M. Pierce, MD, Division of Global Psychiatry Massachusetts General Hospital Boston, MA 8

9 David C. Henderson, MD Disclosures Research/Grants: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Ortho-McNeil, Division of Ortho-McNeil- Janssen Pharmaceuticals, Inc.; Takeda Pharmaceuticals North America, Inc. Speakers Bureau: None Consultant: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Pfizer Inc. Stockholder: None Other Financial Interests: None Advisory Board: None Faculty: Roger S. McIntyre, MD, FRCPC Associate Professor of Psychiatry and Pharmacology University of Toronto Head, Mood Disorders Psychopharmacology Unit University Health Network Toronto, ON Roger S. McIntyre, MD, FRCPC Disclosures Research/Grants: Eli Lilly and Company; Janssen-Ortho, Inc.; National Alliance for Research on Schizophrenia and Depression (NARSAD); Shire Pharmaceuticals; Stanley Medical Research Institute Speakers Bureau: AstraZeneca Pharmaceuticals LP; Biovail Pharmaceuticals, Inc.; Eli Lilly and Company; Janssen-Ortho, Inc.; H. Lundbeck A/S; Wyeth Pharmaceuticals Consultant: AstraZeneca Pharmaceuticals LP; Bristol-Myers Squibb Company; Biovail Corporation; H. Lundbeck A/S; Janssen, L.P.; litigation regarding medication effects; Obecure Ltd.; Otsuka America Pharmaceutical, Inc.; Pfizer Inc.; Sepracor, Inc.; Solvay Pharmaceuticals, Inc.; VANDA Pharmaceuticals; Wyeth Pharmaceuticals Stockholder: None Other Financial Interests: None Advisory Board: AstraZeneca Pharmaceuticals LP; Biovail Pharmaceuticals, Inc.; Bristol-Myers Squibb Company; Eli Lilly and Company; France Foundation; GlaxoSmithKline; Janssen-Ortho, Inc.; H. Lundbeck A/S; Organon; Pfizer Inc.; Schering-Plough Corporation; Shire Pharmaceuticals; Solvay/Wyeth Measuring Lipids in Patients with Bipolar Disorder: Why We Must December 1,

10 Learning Objective 1 Learning Objective 2 Identify strategies to overcome barriers that hinder lipid measurement Increase the rate at which you perform at least one assessment for hyperlipidemia within the initial 16-week treatment period among patients with BPD who are being treated with an atypical antipsychotic agent, in accordance with the STABLE measure regarding lipid assessment Learning Objective 3 Select an appropriate clinical strategy for addressing an abnormal lipid test Cardiometabolic Syndrome (CMS) and Cardiometabolic Risk 10

11 Clustering of Related Risk Factors for CVD and Diabetes CMS Definitions Definitions from 3 major groups NCEP ATP III 1 IDF 2 WHO 3 Wilson PWF, et al. Circulation 2005;112: WHO = World Health Organization; NCEP ATP III = US National Cholesterol Education Program Adult Treatment Panel III; IDF = International Diabetes Foundation See supplemental bibliography for full references. Criterion NCEP ATP III and IDF Definitions for CMS Abdominal obesity (waist circumference, inches) NCEP ATP III 1 (When 3 criteria are present) IDF 2 (Abdominal obesity plus 2 other criteria) Caucasian (EU) South Asian/ Chinese Men > Women > Fasting triglycerides (mg/dl) or treatment for this lipid abnormally HDL (mg/dl) Men < 40 < 40 Women < 50 < 50 or treatment for this lipid abnormally Blood pressure (mm Hg) 130/ / 85 or treatment for previously diagnosed hypertension Fasting glucose (mg/dl) or previously diagnosed type 2 diabetes See supplemental bibliography for full references. CMS Prevalence in the General U.S. Population From NHANES III data, using definition from NCEP ATP III % Current prevalence estimated to be higher now due to the unrelenting increase in the prevalence of obesity in the general population 2 1. Ford ES, et al. JAMA 2002;2873: Mokdad AH, et al. JAMA 2000;284:

12 Increased Cardiometabolic Risk in Patients with Major Mental Illness Epidemiology Increased prevalence of individual risk factors, compared to general population 1 Obesity Hyperglycemia Dyslipidemia Hypertension CMS prevalence in bipolar disorder (BPD) 20% - 66% 2 Increased Cardiometabolic Risk in Patients with Major Mental Illness Risk Factors Smoking Sedentary lifestyle Use of second-generation antipsychotic agents (SGAs) 1. Newcomer JW. Am J Manag Care 2007;13:S170-S McIntyre RS, et al. J Affect Disord 2010;126: Newcomer JW. Am J Manag Care 2007;13:S170-S177. SGAs Offer Important Benefits to Patients with BPD... SGAs and Cardiometabolic Risk FDA-Approved Oral SGAs for Adults with BPD Generic Name Manic Mixed Maint. Depression Aripiprazole X X X Asenapine X X Olanzapine X X X Quetiapine X X X* X Risperidone X X Ziprasidone X X X* Olanzapine/fluoxetine combination X * Augmentation only See supplemental bibliography for full references. 12

13 ...But Have Metabolic Side Effects FDA alerts and label warning FDA has asked manufacturers of all atypical antipsychotic drugs to add a new warning to the drugs' labels about the increased risk of hyperglycemia and diabetes FDA has labeled this as a class effect, although there are major differences in risk associated with the various medications Food and Drug Administration. FDA Patient Safety News: Show #28, June Differential Metabolic Side Effects Among SGAs 1-4 Antipsychotic Weight Gain Diabetes Risk Dyslipidemia Clozapine Olanzapine Risperidone Quetiapine Aripiprazole ± - - Ziprasidone ± = increased effect - = minimal effect 0 = discrepant results See supplemental bibliography for full references. Learning Objective 1 Identify strategies to overcome barriers that hinder lipid measurement Consensus Guidelines on Metabolic Monitoring All patients receiving an SGA should have fasting blood glucose and lipid levels determined at baseline and after 12 weeks of treatment ADA/APA Consensus on Antipsychotic Drugs and Metabolic Monitoring Start 4 wks 8 wks 12 wks Qtrly 12 mos 5 yrs Personal/family hx X X Weight (BMI) X X X X X Waist circumference X X Blood pressure X X X Fasting glucose X X X Fasting lipid profile X X X X American Diabetes Association and American Psychiatric Association. J Clin Psychiatry 2004;65:

14 Metabolic Monitoring Is Underperformed in Mental Illness PharMetrics database study 1 Percentage of Patients Prescribed Antipsychotics Who Received Adverse Effect Testing Test July 2000 to Oct 2003 Mar 2004 to Dec 2006 Baseline lipid level week lipid level Baseline glucose level week glucose level Medicaid cohort study (N = 109,451) 2 Initial testing rates (27% tested for glucose; 10% for lipids) remained unchanged during a period from January 2002 through December Haupt W, et al. Am J Psychiatry 2009;166: Morrato EH, et al. Arch Gen Psychiatry 2010;67: Barriers to Monitoring Lipid Levels Psychiatric care often conceptualized as most important form of medical care 1 Under awareness of medical burden and medical risk factor clustering in BPD 1,2 Lack of time and resources to address physical health issues 3,4 Offices/clinics not equipped to provide full medical care and have limited ability to coordinate off-site care 3,4 See supplemental bibliography for full references. Quality Improvement Project on Metabolic Screening Rates How can we overcome barriers to measuring lipids? MGH Outpatient Psychiatry Resident Clinic Education Session #1/ Supervisor Memo Focus Group LMR/ Labs BMI Table Education Session #2 Feedback Session Education Session #3 Oct 08 Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct 09 B Q1 Q2 Q3 Q4 Wiechers IR, et al. Poster Presented at 2010 Harvard Psychiatry Research Day Poster Session and Mysell Lecture. March 24, 2010; Boston, MA. 14

15 Quality Improvement Project on Metabolic Screening Rates Rates of Screening in Patients at Baseline and Quarter 4 (N = 90) Baseline Wiechers IR, et al. Poster Presented at 2010 Harvard Psychiatry Research Day Poster Session and Mysell Lecture. March 24, 2010; Boston, MA. Q4 Δ Baseline to Q4 p-value Ordered glucose 16.7% 45.6% 28.9 <.0001 Ordered lipid panel 13.3% 44.4% 31.1 <.0001 Documented BMI 6.7% 48.9% 42.2 <.0001 Documented glucose 16.7% 58.9% 42.2 <.0001 Documented BP 4.4% 43.4% 39.0 <.0001 Documented lipid panel 17.8% 62.2% 44.4 <.0001 Documented full bundle 1.1% 31.1% 30.0 <.0001 Learning Objective 2 Increase the rate at which you perform at least one assessment for hyperlipidemia within the initial 16-week treatment period among patients with BPD who are being treated with an atypical antipsychotic agent, in accordance with the STABLE measure regarding lipid assessment Bipolar Performance Measures STABLE* Project STAndards for BipoLar Excellence project Organized in 2005 Evidence-based measures related to identifying, assessing, managing, and coordinating care for BPD STABLE Measure on Hyperlipidemia Assessment Perform at least one assessment for hyperlipidemia within the initial 16-week treatment period among patients with BPD who are being treated with an atypical antipsychotic agent * AstraZeneca LLP, Wilmington, Delaware, provided financial sponsorship for the STABLE Project. They did not otherwise participate in the development of either the measures or toolkit. Center for Quality Assessment and Improvement in Mental Health. The STAndards for BipoLar Excellence Project. Available at: * AstraZeneca LLP, Wilmington, Delaware, provided financial sponsorship for the STABLE Project. They did not otherwise participate in the development of either the measures or toolkit. Center for Quality Assessment and Improvement in Mental Health. The STAndards for BipoLar Excellence Project. Available at: 15

16 Learning Objective 3 Select an appropriate clinical strategy for addressing an abnormal lipid test When Results Indicate Hyperlipidemia... Mental health clinicians can: Handle themselves Requires ongoing education on CMS and the chronic care needs of patients with mental illness Work closely with primary care clinician Such an alliance is useful for many other issues as well Requires vigilance in coordination of care skills Refer to specialty clinic, if available There are some Handling Yourself? Worsening dyslipidemia or glycemia Consider switching SGA Manage lipids as outlined in NCEP ATP III Refer patient to ADA self-management education program Development of diabetes Refer to clinician with experience in treating patients with diabetes Weight gain 5% of initial weight Consider switching SGA American Diabetes Association and American Psychiatric Association. J Clin Psychiatry 2004;65: NCEP ATP III Lipid Level Goals Lipid Target (mg/dl) LDL Cholesterol < 100 HDL Cholesterol 50 (F) 40 (M) Total Cholesterol < 200 Triglycerides < 150 Grundy SM, et al. Circulation 2004;110: National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Circulation 2002;106:

17 Positive Predictive Value of Screening Tests Screening Test Straker D, et al. Am J Psychiatry 2005;162: Positive Predictive Value Abdominal obesity for CMS 45.1% Digital rectal exam for PSA 21% Fecal occult testing for colon cancer Mammography in women aged w/ + family hx 14% 22% Clinical Connections Prevalence of CMS is high in the general population and higher in patients with major mental illness Some SGAs are associated with significant risk of adverse metabolic changes Monitoring for metabolic changes in patients taking SGAs is recommended, but underperformed The call to action is to increase metabolic monitoring in patients with BPD using practical strategies The Medical Health of Patients with Mental Health Conditions Because several data sets have shown that guidelines alone do not lead to an adequate level of monitoring of and interventions for cardiometabolic risk factors among patients with severe mental illness, mental health providers, patients, and families need to be educated and medical monitoring and management need to be an integral part of treating patients with severe mental illness. Additional Resources Visit neurosciencecme.com/bipolar for clinical information and certified educational activities on bipolar disorder Correll CU, et al. Psychiatr Serv 2010;61:

18 Bibliography Alberti KG, Zimmet P, Shaw J. The metabolic syndrome--a new worldwide definition. Lancet 2005;366: American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care 2004;27: American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. J Clin Psychiatry 2004;65: AstraZeneca. Highlights of prescribing information for SEROQUEL (quetiapine) tablets Drugs@FDA Web site. gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf. Accessed November 29, Bristol-Myers Squibb and Otsuka America Pharmaceuticals, Inc. Highlights of prescribing information for ABILIFY (aripiprazole) Drugs@ FDA Web site. Accessed November 29, Center for Quality Assessment and Improvement in Mental Health. The STAndards for BipoLar Excellence Project. Available at: cqaimh.org/stable.html. Accessed October 28, Correll CU, Druss BG, Lombardo I, et al. Findings of a U.S. national cardiometabolic screening program among 10,084 psychiatric outpatients. Psychiatr Serv 2010;61: Correll CU, Frederickson AM, Kane JM, Manu P. Equally increased risk for metabolic syndrome in patients with bipolar disorder and schizophrenia treated with second-generation antipsychotics. Bipolar Disord 2008;10: Eli Lilly & Co. Highlights of prescribing information for SYMBYAX (olanzapine and fluoxetine hydrochloride) Drugs@FDA Web site. Accessed November 29, Eli Lilly & Co. Highlights of prescribing information for ZYPREXA (olanzapine) tablets Drugs@FDA Web site. drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf. Accessed November 29, Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of the 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). JAMA 2001;285: Fiedorowicz JG, Palagummi NM, Forman-Hoffman VL, Miller DD, Haynes WG. Elevated prevalence of obesity, metabolic syndrome, and cardiovascular risk factors in bipolar disorder. Ann Clin Psychiatry 2008;20: Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA 2002;287: Friedman JI, Wallenstein S, Moshier E, et al. The effects of hypertension and body mass index on cognition in schizophrenia. Am J Psychiatry 2010;167: Haupt DW, Rosenblatt LC, Kim E, Baker RA, Whitehead R, Newcomer JW. Prevalence and predictors of lipid and glucose monitoring in commercially insured patients treated with second-generation antipsychotic agents. Am J Psychiatry 2009;166: Haupt DW. Differential metabolic effects of antipsychotic treatments. Eur Neuropsychopharmacol 2006;16 Suppl 3:S Krabbe KS, Nielsen AR, Krogh-Madsen R, et al. Brain-derived neurotrophic factor (BDNF) and type 2 diabetes. Diabetologia 2007;50: Kupfer DJ. The increasing medical burden in bipolar disorder. JAMA 2005;293: Lester H, Tritter JQ, Sorohan H. Patients and health professionals views on primary care for people with serious mental illness: focus group study. BMJ 2005;330:1122. McEvoy JP, Meyer JM, Goff DC, et al. Prevalence of the metabolic syndrome in patients with schizophrenia: baseline results from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res 2005;80: McIntyre RS, Danilewitz M, Liauw SS, et al. Bipolar disorder and metabolic syndrome: an international perspective. J Affect Disord 2010;126:

19 Bibliography, cont. Merck & Co. Highlights of prescribing information for SAPHIRIS (asenapine) Web site. drugsatfda_docs/label/2010/022117s003s004lbl.pdf. Accessed November 29, Meyer JM, Koro CE. The effects of antipsychotic therapy on serum lipids: a comprehensive review. Schizophr Res 2004;70:1-17. Mokdad AH, Serdula MK, Dietz WH, Bowman BA, Marks JS, Koplan JP. The continuing epidemic of obesity in the United States. JAMA 2000;284: Morrato EH, Druss B, Hartung DM, et al. Metabolic testing rates in 3 state Medicaid programs after FDA warnings and ADA/APA recommendations for second-generation antipsychotic drugs. Arch Gen Psychiatry 2010;67: Newcomer JW, Haupt DW. The metabolic effects of antipsychotic medications. Can J Psychiatry 2006;51: Newcomer JW, Nasrallah HA, Loebel AD. The Atypical Antipsychotic Therapy and Metabolic Issues National Survey: practice patterns and knowledge of psychiatrists. J Clin Psychopharmacol 2004;24:S1-6. Newcomer JW. Metabolic considerations in the use of antipsychotic medications: a review of recent evidence. J Clin Psychiatry 2007;68 Suppl 1: Newcomer JW. Metabolic risk during antipsychotic treatment. Clin Ther 2004;26: Newcomer JW. Metabolic syndrome and mental illness. Am J Manag Care 2007;13:S Newcomer JW. Second-generation (atypical) antipsychotics and metabolic effects: a comprehensive literature review. CNS Drugs 2005;19 Suppl 1:1-93. Ortho-McNeil-Janssen Pharmaceuticals. Highlights of prescribing information for RISPERDAL (risperidone) tablets Drugs@FDA Web site. Accessed November 29, Pajonk FG, Wobrock T, Gruber O, et al. Hippocampal plasticity in response to exercise in schizophrenia. Arch Gen Psychiatry 2010;67: Pfizer Inc. Highlights of prescribing information for GEODON (ziprasidone) capsules or injection for intramuscular use. November Drugs@ FDA Web site. Accessed November 29, Stroup TS, Lieberman JA, McEvoy JP, et al. Effectiveness of olanzapine, quetiapine, risperidone, and ziprasidone in patients with chronic schizophrenia following discontinuation of a previous atypical antipsychotic. Am J Psychiatry 2006;163: van Winkel R, De Hert M, Van Eyck D, et al. Prevalence of diabetes and the metabolic syndrome in a sample of patients with bipolar disorder. Bipolar Disord 2008;10: Wiechers IR, Viron M, Stoklosa J, Freudenreich O, Henderson D, Weiss AP. Impact of a Quality Improvement Project on Rates of Screening for Metabolic Syndrome in a Psychiatry Resident Outpatient Clinic. Poster presented at the 2010 Harvard Psychiatry Research Day Poster Session and Mysell Lecture; March 24, 2010; Boston, MA. Wilson PW, D Agostino RB, Parise H, Sullivan L, Meigs JB. Metabolic syndrome as a precursor of cardiovascular disease and type 2 diabetes mellitus. Circulation 2005;112:

20 Supplemental Bibliography Slide: CMS Definitions 1. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of the 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). JAMA 2001;285: Alberti KG, Zimmet P, Shaw J. The metabolic syndrome--a new worldwide definition. Lancet 2005;366: World Health Organization. Report of a WHO Consultation. Definition, Diagnosis and Classification of Diabetes Mellitus and Its Complications. Part 1: Diagnosis and Classification of Diabetes Mellitus. Available at: home/who_dmc.htm Accessed on June 15, Slide: NCEP ATP III and IDF Definitions for CMS 1. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of the 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). JAMA 2001;285: Alberti KG, Zimmet P, Shaw J. The metabolic syndrome a new worldwide definition. Lancet 2005;366: Slide: SGAs Offer Important Benefits to Patients with BPD Bristol-Myers Squibb and Otsuka America Pharmaceuticals, Inc. Highlights of prescribing information for ABILIFY (aripiprazole) Drugs@FDA Web site. Accessed November 29, Merck & Co. Highlights of prescribing information for SAPHIRIS (asenapine) Drugs@FDA Web site. accessdata.fda.gov/drugsatfda_docs/label/2010/022117s003s004lbl.pdf. Accessed November 29, Eli Lilly & Co. Highlights of prescribing information for ZYPREXA (olanzapine) tablets Drugs@FDA Web site. Accessed November 29, AstraZeneca. Highlights of prescribing information for SEROQUEL (quetiapine) tablets Drugs@FDA Web site. Accessed November 29, Ortho-McNeil-Janssen Pharmaceuticals. Highlights of prescribing information for RISPERDAL (risperidone) tablets Drugs@FDA Web site. Accessed November 29, Pfizer Inc. Highlights of prescribing information for GEODON (ziprasidone) capsules or injection for intramuscular use. November Drugs@FDA Web site. Accessed November 29, Eli Lilly & Co. Highlights of prescribing information for SYMBYAX (olanzapine and fluoxetine hydrochloride) Drugs@FDA Web site. Accessed November 29,

21 Supplemental Bibliography, cont. Slide: Differential Metabolic Side Effects Among SGAs American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. J Clin Psychiatry 2004;65: Kupfer DJ. The increasing medical burden in bipolar disorder. JAMA 2005;293: Lester H, Tritter JQ, Sorohan H. Patients and health professionals views on primary care for people with serious mental illness: focus group study. BMJ 2005;330: Newcomer JW, Nasrallah HA, Loebel AD. The Atypical Antipsychotic Therapy and Metabolic Issues National Survey: practice patterns and knowledge of psychiatrists. J Clin Psychopharmacol 2004;24:S1-6. Slide: Differential Metabolic Side Effects Among SGAs American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care 2004;27: Newcomer JW. Second-generation (atypical) antipsychotics and metabolic effects: a comprehensive literature review. CNS Drugs 2005;19(Suppl 1): Stroup TS, Lieberman JA, McEvoy JP, et al. Effectiveness of olanzapine, quetiapine, risperidone, and ziprasidone in patients with chronic schizophrenia following discontinuation of a previous atypical antipsychotic. Am J Psychiatry 2006;163: Newcomer JW. Metabolic considerations in the use of antipsychotic medications: a review of recent evidence. J Clin Psychiatry 2007;68(Suppl 1): Slide: Barriers to Monitoring Lipid Levels 1. Kupfer DJ. The increasing medical burden in bipolar disorder. JAMA 2005;293: American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. J Clin Psychiatry 2004;65: Newcomer JW, Nasrallah HA, Loebel AD. The Atypical Antipsychotic Therapy and Metabolic Issues National Survey: practice patterns and knowledge of psychiatrists. J Clin Psychopharmacol 2004;24(Suppl 1):S1-S6. 4. Lester H, Tritter JQ, Sorohan H. Patients and health professionals views on primary care for people with serious mental illness: focus group study. BMJ 2005;330:

22 Co-sponsored by TV Activity Title and Faculty: Measuring Lipids in Patients with Bipolar Disorder: Why We Must with David C. Henderson, MD, Roger S. McIntyre, MD, FRCPC, and Paul E. Keck, Jr., MD Attendance Form for Groups Please complete and FAX to Site/Institution Name: q Academic Center q Community Pharmacy Practice q Small Group Practice (less than 5) q Large Group Practice (5 or more) Practice Setting: q Hospital/Institution q Managed Care q Non-Direct Patient Care q Solo Practice Address: City: State: ZIP: Site Coordinator: Phone: Fax: q ARCHIVE webcast q ARCHIVE phone q Podcast Completion Date: We participated in a: Attendee Name (please print) Please Circle Discipline Please FAX completed form to and use additional sheets as necessary. Questions? Call 877.CME.PROS. Thank you for participating in this continuing education activity! The recipient may make a request to the sender not to send any future faxes and failure to comply with the request within 30 days is unlawful. To opt out from future faxes go to enter PIN# 11105, or call , or fax back to