measuring lipids in bipolar disorder

8/6/2019 Measuring Lipids in Bipolar Disorder

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This continuing education

activity is co-sponsoredby USF Health and byCME Outfitters, LLC.


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This CE activity is supported byeducational grants from Janssen,

a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.,

administered by Ortho-McNeilJanssen Scientific Affairs, LLC,

and from Lilly USA, LLC.

For further informationconcerning Lilly grant funding,visit www.lillygrantoffice.com.


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The course guide for this

activity includes slides,disclosures of facultyfinancial relationships,

and biographical profiles.

For additional copies of

these materials, pleasevisit neuroscienceCME.com

or call 877.CME.PROS.


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To receive CME/CE creditsfor this activity,

participants must completethe post-test andevaluation online at

neuroscienceCME.com/test


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Please be sure to indicate

the media format utilized(live satellite broadcast,live webcast, live phone,

on demand webcast,or on demand phone)

and the date ofparticipationon the forms provided.


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The faculty have been

informed of theirresponsibility to disclose

to the audience if they willbe discussing off-labelor investigational uses

(any use not approvedby the FDA) of productsor devices.


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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


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Paul E. Keck, Jr., MDDisclosures

Research/Grants: Alkermes, Inc.; AstraZeneca Pharmaceuticals LP;Cephalon, Inc.; GlaxoSmithKline; Eli Lilly and Company; EPI-Q, Inc.;Jazz Pharmaceuticals, Inc.; The Marriott Foundation; National Instituteof Mental Health (NIMH); Orexigen Therapeutics, Inc.; Pfizer Inc.;Shire Pharmaceuticals

Speakers Bureau: None

Consultant: Bristol-Myers Squibb Company; GlaxoSmithKline; MedcoHealth Solutions, Inc.; Pfizer Inc.; Quantia Communications, Inc.;Schering-Plough Corporation; Sepracor Inc.

Stockholder: None

Other Financial Interests: Employed by the University of CincinnatiCollege of Medicine, University of Cincinnati Physicians, and theLindner Center of HOPE

Advisory Board: NoneDr. 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 comprisesthe step of administering an effective amount of tramadol to anindividual. Filed March 25, 1999; approved May 14, 2002.Dr. Keck has received no financial gain from this patent.


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Faculty:David C. Henderson, MD

Associate Professor of Psychiatry

Harvard Medical SchoolDirector, Schizophrenia, Diabetes, and Weight

Reduction Research Program

Director, The Chester M. Pierce, MD,

Division of Global PsychiatryMassachusetts General Hospital

Boston, MA


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David C. Henderson, MDDisclosures

Research/Grants: Johnson & JohnsonPharmaceutical Research & Development,L.L.C.; Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Takeda

Pharmaceuticals North America, Inc.Speakers Bureau: None

Consultant: Johnson & JohnsonPharmaceutical Research & Development,L.L.C.; Pfizer Inc.

Stockholder: None

Other Financial Interests: None

Advisory Board: None


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Faculty:Roger S. McIntyre, MD, FRCPC

Associate Professor of

Psychiatry and PharmacologyUniversity of Toronto

Head, Mood Disorders Psychopharmacology Unit

University Health Network

Toronto, ON


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Roger S. McIntyre, MD, FRCPCDisclosures

Research/Grants: Eli Lilly and Company; Janssen-Ortho, Inc.;National Alliance for Research on Schizophrenia and Depression(NARSAD); Shire Pharmaceuticals; Stanley Medical ResearchInstitute

Speakers Bureau: AstraZeneca Pharmaceuticals LP; BiovailPharmaceuticals, Inc.; Eli Lilly and Company; Janssen-Ortho, Inc.;H. Lundbeck A/S; Wyeth Pharmaceuticals

Consultant: AstraZeneca Pharmaceuticals LP; Bristol-MyersSquibb Company; Biovail Corporation; H. Lundbeck A/S; Janssen,L.P.; litigation regarding medication effects; Obecure Ltd.; OtsukaAmerica Pharmaceutical, Inc.; Pfizer Inc.; Sepracor, Inc.;Solvay Pharmaceuticals, Inc.; VANDA Pharmaceuticals;Wyeth Pharmaceuticals

Stockholder: None

Other Financial Interests: None

Advisory Board: AstraZeneca Pharmaceuticals LP; BiovailPharmaceuticals, Inc.; Bristol-Myers Squibb Company; Eli Lilly andCompany; France Foundation; GlaxoSmithKline; Janssen-Ortho,Inc.; H. Lundbeck A/S; Organon; Pfizer Inc.; Schering-PloughCorporation; Shire Pharmaceuticals; Solvay/Wyeth


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Measuring Lipids in Patientswith Bipolar Disorder:

Why We Must

December 1, 2010


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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


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1LearningObjectiveIdentify strategies to

overcome barriers thathinder lipid measurement


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2LearningObjectiveIncrease the rate at which youperform at least one assessment forhyperlipidemia within the initial16-week treatment period among

patients with BPD who are beingtreated with an atypical antipsychoticagent, in accordance with the STABLEmeasure regarding lipid assessment


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3LearningObjectiveSelect an appropriateclinical strategy for

addressing an abnormallipid test


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Faculty:David C. Henderson, MD

Associate Professor of Psychiatry

Harvard Medical SchoolDirector, Schizophrenia, Diabetes, and Weight

Reduction Research Program

Director, The Chester M. Pierce, MD,Division of Global Psychiatry

Massachusetts General Hospital

Boston, MA


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Cardiometabolic

Syndrome(CMS) andCardiometabolic Risk


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Clustering of Related RiskFactors for CVD and Diabetes

Wilson PWF, et al. Circulation 2005;112:3066-3072.


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See supplemental bibliography for full references.

NCEP ATP III and IDFDefinitions for CMS

CriterionNCEP ATP III1(When 3 criteria

are present)

IDF2(Abdominal obesity plus

2 other criteria)

Abdominal obesity(waist circumference, inches)

Caucasian (EU)South

Asian/Chinese

Men > 40 37 35

Women > 35 31 31Fasting triglycerides(mg/dL)

150 150or treatment for this lipid abnormally

HDL (mg/dL)

Men < 40 < 40

Women < 50 < 50or treatment for this lipid abnormally

Blood pressure (mm Hg) 130/85 130 / 85or treatment for previously diagnosed

hypertension

Fasting glucose (mg/dL) 100 100or previously diagnosed type 2 diabetes


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CMS Prevalence in theGeneral U.S. Population

From NHANES III data, usingdefinition from NCEP ATP III1

23.7%

Current prevalence estimated to behigher now due to the unrelentingincrease in the prevalence ofobesity in the general population2

1. Ford ES, et al.JAMA 2002;2873:356-359.2. Mokdad AH, et al.JAMA 2000;284:1650-1651.


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Increased CardiometabolicRisk in Patients with Major

Mental IllnessEpidemiology

Increased prevalence of individual risk

factors, compared to general population1

ObesityHyperglycemiaDyslipidemiaHypertension

CMS prevalence in bipolar disorder (BPD)20% - 66%2

1. Newcomer JW.Am J Manag Care 2007;13:S170-S177.2. McIntyre RS, et al.J Affect Disord2010;126:366-387.


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Increased CardiometabolicRisk in Patients with Major

Mental Illness

Risk Factors

SmokingSedentary lifestyle

Use of second-generationantipsychotic agents (SGAs)

Newcomer JW.Am J Manag Care 2007;13:S170-S177.


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SGAs andCardiometabolic Risk


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SGAs Offer Important Benefitsto Patients with BPD...

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/fluoxetinecombination

X

* Augmentation only



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...But Have Metabolic Side Effects

FDA alerts and label warning2004 - FDA has asked manufacturersof all atypical antipsychotic drugs toadd a new warning to the drugs'

labels about the increased risk ofhyperglycemia and diabetes

FDA has labeled this as a class effect,although there are major differences

in risk associated with the variousmedications

Food and Drug Administration. FDA Patient Safety News: Show #28,June 2004. http://www.accessdata.fda.gov/psn/printer-full.cfm?id=32.


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Differential Metabolic SideEffects Among SGAs1-4

Antipsychotic Weight Gain Diabetes Risk Dyslipidemia

Clozapine +++ + +

Olanzapine +++ + +

Risperidone ++ 0 0

Quetiapine ++ 0 0

Aripiprazole - -

Ziprasidone - -

+ = increased effect- = minimal effect0 = discrepant results



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1LearningObjectiveIdentify strategies to

overcome barriers thathinder lipid measurement


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Consensus Guidelineson Metabolic Monitoring

All patients receiving an SGA shouldhave fasting blood glucose and lipidlevels determined at baseline and after12 weeks of treatment

American Diabetes Association and American Psychiatric Association.J Clin Psychiatry2004;65:267-272.

ADA/APA Consensus on Antipsychotic Drugs and Metabolic Monitoring

Start4

wks8

wks12wks

Qtrly12

mos5

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


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Metabolic Monitoring IsUnderperformed in Mental Illness

PharMetrics database study1

Medicaid cohort study (N = 109,451)2Initial testing rates (27% tested for glucose;10% for lipids) remained unchanged during a periodfrom January 2002 through December 2005

1. Haupt W, et al.Am J Psychiatry2009;166:345-353.2. Morrato EH, et al.Arch Gen Psychiatry2010;67:17-24.

Percentage of Patients Prescribed Antipsychotics Who ReceivedAdverse Effect Testing

TestJuly 2000 to

Oct 2003Mar 2004 toDec 2006

Baseline lipid level 8.4 10.5

12-week lipid level 6.8 9.0

Baseline glucose level 17.3 21.8

12-week glucose level 14.1 17.9


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Barriers to MonitoringLipid Levels

Psychiatric care often conceptualized asmost important form of medical care1

Under awareness of medical burden and

medical risk factor clustering in BPD1,2

Lack of time and resources to addressphysical health issues3,4

Offices/clinics not equipped to providefull medical care and have limited abilityto coordinate off-site care3,4



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How can we overcomebarriers to measuring lipids?


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Quality Improvement Projecton Metabolic Screening Rates

MGH Outpatient PsychiatryResident Clinic

Wiechers IR, et al. Poster Presented at 2010 Harvard Psychiatry ResearchDay Poster Session and Mysell Lecture. March 24, 2010; Boston, MA.

Oct 08 Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct 09

B Q1 Q2 Q3 Q4

FocusGroup

LMR/Labs

BMITable

FeedbackSession

EducationSession

#1/SupervisorMemo

EducationSession #2

EducationSession #3


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Quality Improvement Projecton Metabolic Screening Rates

Wiechers IR, et al. Poster Presented at 2010 Harvard Psychiatry ResearchDay Poster Session and Mysell Lecture. March 24, 2010; Boston, MA.

Rates of Screening in Patients at Baseline and Quarter 4 (N = 90)

Baseline Q4 Baseline

to Q4p-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


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2LearningObjectiveIncrease the rate at which youperform at least one assessment forhyperlipidemia within the initial16-week treatment period among

patients with BPD who are beingtreated with an atypical antipsychoticagent, in accordance with the STABLEmeasure regarding lipid assessment


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Bipolar Performance MeasuresSTABLE* Project

STAndards for BipoLar Excellenceproject

Organized in 2005

Evidence-based measures related toidentifying, assessing, managing,and coordinating care for BPD

* AstraZeneca LLP, Wilmington, Delaware, provided financial sponsorshipfor the STABLE Project. They did not otherwise participate in thedevelopment of either the measures or toolkit.

Center for Quality Assessment and Improvement in Mental Health.The STAndards for BipoLar Excellence Project. Available at:http://www.cqaimh.org/stable.html.


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STABLEMeasureon Hyperlipidemia Assessment

Perform at least one assessmentfor hyperlipidemia within the initial16-week treatment period among

patients with BPD who are beingtreated with an atypicalantipsychotic agent

* AstraZeneca LLP, Wilmington, Delaware, provided financial sponsorshipfor the STABLE Project. They did not otherwise participate in thedevelopment of either the measures or toolkit.

Center for Quality Assessment and Improvement in Mental Health.The STAndards for BipoLar Excellence Project. Available at:http://www.cqaimh.org/stable.html.


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3LearningObjectiveSelect an appropriateclinical strategy for

addressing an abnormallipid test


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When Results IndicateHyperlipidemia...

Mental health clinicians can:

Handle themselvesRequires ongoing education on CMS and the

chronic care needs of patients with mentalillness

Work closely with primary care clinicianSuch an alliance is useful for many otherissues as well

Requires vigilance in coordination of careskills

Refer to specialty clinic, if availableThere are some


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Handling Yourself?

Worsening dyslipidemia or glycemiaConsider switching SGA

Manage lipids as outlined in NCEP ATP III

Refer patient to ADA self-managementeducation program

Development of diabetesRefer to clinician with experience in treatingpatients with diabetes

Weight gain 5% of initial weightConsider switching SGA

American Diabetes Association and American Psychiatric Association.J Clin Psychiatry2004;65:267-272.


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NCEP ATP IIILipid Level Goals

Grundy SM, et al. Circulation 2004;110:227-239.National Cholesterol Education Program (NCEP) Expert Panel onDetection, Evaluation and Treatment of High Blood Cholesterol inAdults (Adult Treatment Panel III). Circulation 2002;106:3143-3421.

LipidTarget

(mg/dL)

LDL Cholesterol < 100

HDL Cholesterol 50 (F) 40 (M)

Total Cholesterol < 200

Triglycerides < 150


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Positive Predictive Valueof Screening Tests

Straker D, et al.Am J Psychiatry2005;162:127-1221.

Screening TestPositive Predictive

Value

Abdominal obesity for CMS 45.1%

Digital rectal exam for PSA 21%

Fecal occult testing for colon

cancer14%

Mammography in women

aged 50-59 w/ + family hx22%


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Clinical Connections

Prevalence of CMS is high in the generalpopulation and higher in patients withmajor mental illness

Some SGAs are associated withsignificant risk of adverse metabolicchanges


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Clinical Connections

Prevalence of CMS is high in the generalpopulation and higher in patients withmajor mental illness

Some SGAs are associated withsignificant risk of adverse metabolicchanges

Monitoring for metabolic changes inpatients taking SGAs is recommended,but underperformed

The call to action is to increasemetabolic monitoring in patients withBPD using practical strategies


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The Medical Health ofPatients with Mental Health

ConditionsBecause several data sets have shownthat guidelines alone do not lead to anadequate level of monitoring of and

interventions for cardiometabolic riskfactors among patients with severemental illness, mental health providers,patients, and families need to be educated

and medical monitoring and managementneed to be an integral part of treatingpatients with severe mental illness.

Correll CU, et al. Psychiatr Serv2010;61:892-898.


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certified educational activitieson bipolar disorder


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