Comprehensive Cardiometabolic Risk-Reduction Program

1
Comprehensive Cardiometabolic Risk-Reduction
Program
Phase 2 2009
Sponsored by National Lipid Association
2

Case Study
Mixed Dyslipidemia in the Patient With
Cardiometabolic Risk
3
Overview
Case Study

• 57-year-old white female presents for new patient
  examination
• History of hypertension and borderline high
  cholesterol
• Family history of heart disease (mother, age
  57-years) and diabetes
• Does not smoke and is not on hormone-replacement
  therapy
• Current medications none
• On examination
• Blood pressure 139/84 mm Hg, BMI 29.6, height
  65 inches, weight 178 lbs, waist 37 inches
• No peripheral bruits, normal heart exam, and
  normal peripheral pulses

BMIbody mass index
4
Laboratory Results
Case Study

• TC 219 mg/dL
• TG 330 mg/dL
• HDL-C 44 mg/dL
• LDL-C 109 mg/dL
• NonHDL-C 175 mg/dL
• FPG 108 mg/dL
• TSH within normal limits
• ALT 68 U/L
• AST 46 U/L

TCtotal cholesterol, TGtriglycerides,
HDL-Chigh-density lipoprotein cholesterol, LDL-C
low-density lipoprotein cholesterol, FPGfasting
plasma glucose, TSHthryoid-stimulating hormone,
ALTalanine aminotranferase, ASTaspartate
aminotransferase
5
ARS Question
What is her Framingham risk for future coronary
heart disease events in the next 10 years?

1. Low
2. Intermediate
3. High

6
Framingham Risk Score
Case Study
Points
Age 57-years 8
TC 4
Nonsmoker 0
HDL-C 1
SBP 2
Total points 15
10-year risk3 10-year risk3
TCtotal cholesterol, HDL-Chigh-density
lipoprotein cholesterol, SBPsystolic blood
pressure
Expert Panel on Detection, Evaluation, and
Treatment of High Blood Cholesterol in
Adults. JAMA. 20012852486-2497.
7
Patient Characteristics Meeting Metabolic
Syndrome Criteria
Case Study

• Waist 37 inches
• TG 330 mg/dL
• HDL-C 44 mg/dL
• Blood pressure 139/84 mm Hg
• Glucose 108 mg/dL

TGtriglycerides, HDL-Chigh-density lipoprotein
cholesterol
8
ARS Question
What is her risk for developing diabetes in the
next 10 years?

1. 5
2. 10
3. 20
4. 30
5. 50

9
Prediction of Diabetes in ARIC9-Year Follow-Up
Percent of Total Incident Cases of Diabetes Per
Decile
Percent of People in Each Decile Who Developed
Diabetes
60 50 40 30 20 10 0
60 50 40 30 20 10 0
Decile of Estimated Risk
Schmidt MI, et al. Diabetes Care.
2005282013-2018.
10
ARS Question

• In your opinion, which of the following is the
  most useful motivator to get this patient to
  embark on a weight-reduction program?
• A. Reduce blood pressure
• B. Improve lipids
• C. Prevent diabetes
• D. Prevent heart attack

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Diabetes Prevention Program Modest Weight-Loss
Reduces the Incidence of New-Onset Diabetes in an
At-Risk Population
40
Weight loss Decrease in risk
0.1 kg
2.1 kg 31
5.6 kg 58
Placebo
30
Metformin
Cumulative Incidence of Diabetes ()
20
Lifestyle
10
0
0
1
2
3
4
Years
Plt0.001 for each comparison Decrease in risk of
developing diabetes compared to placebo
group Knowler WC, et al. N Engl J Med.
2002346393-403.
12
Diabetes Prevention Program Greater Weight-Loss
Further Reduces the Incidence of New-Onset
Diabetes
20 15 10 5 0
Overall risk at the mean weight-loss
Incidence Rate per 100 Person-Years
-15
-10
5
0
5
Change in Weight from Baseline (kg)
In the lifestyle intervention group over an
average 3.2 years of follow-up Hamman RF, et
al. Diabetes Care. 2006292102-2107.
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Clinical Pearl

• Weight loss of 918 lbs (510) would markedly
  reduce the risk of diabetes in a patient with
  these characteristics

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Case Study

• What is her lipid phenotype?
• What would be the impact of losing 15 lbs with
  lifestyle modification?

15
Look AHEAD (Action for Health in Diabetes) Lipid
Results
Weight Loss
LDL-C
TG
HDL-C
10



5
0
Change from Baseline ()
-5
-10
-15
-20
Plt0.001
Look AHEAD Research Group. Diabetes Care.
2007301374-1383.
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Which additional laboratory test would be helpful
for cardiovascular risk assessment?
ARS Question

• A. hs-CRP
• B. Lp(a)
• C. Lp-PLA2
• D. apo B
• E. Lipoprotein particle size/number

hs-CRPhigh-sensitivity C-reactive protein,
Lp(a)lipoprotein a, Lp-PLA2lipoprotein-associat
ed phospholipase A2, apo Bapolipoprotein B
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Treatment of Metabolic Syndrome or
Cardiometabolic Risk

• According to guidelines from
• Adult Treatment Panel III (ATP III)
• The Seventh Report of the Joint National
  Committee on Prevention, Detection, Evaluation,
  and Treatment of High Blood Pressure (JNC VII)
• American Diabetes Association (ADA)

First-line therapyweight reduction with
lifestyle modification
Expert Panel on Detection, Evaluation, and
Treatment of High Blood Cholesterol in Adults.
JAMA. 20012852486-2497. Chobanian AV, et al.
JAMA. 20032892560-2572. American Diabetes
Association. Diabetes Care. 200427S36-S46.
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Dietary Approaches to Cardiometabolic Health
Metabolic Target Diets or Dietary Components
LDL-C Diet portfolio fats, fiber, stanols
High TG, low HDL Weight loss, low glycemic index (GI)
Blood pressure Weight loss, DASH diet
Diabetes, prediabetes Weight loss, ? refined carbohydrates, ? fiber
Metabolic syndrome Weight loss, Mediterranean, DASH diet, low GI, therapeutic lifestyle change (TLC)
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Comparison of Popular Diets
Attrition and Mean Changes in Weight and LDL-C at
12 Months
Intent-to-Treat Population
Weight, kg
LDL-Cholesterol, mg/dL
0
-2
-2.1
-3.0
-3.2
-4
-3.3
-6
Mean Change
-7.1
-8
-10
-9.3
-12
-11.8
-12.6
-14
Dansinger, et al. JAMA. 200529343-53.
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Adherence and Weight Loss Are Paramount
Comparison of Popular Diets

• Short-term metabolic studies support that
  metabolic risk factors are affected by
  carbohydrate restriction, but longer-term
  effectiveness trials suggest the degree of
  dietary adherence and associated weight losses,
  rather than diet type, are the key predictors of
  metabolic cardiac risk factor reduction.

Dansinger ML. Curr Diabetes Reports.
20066(1)55-63.
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Clinical Pearl

• The most effective dietis the one that the
  patient has thebest chance of following

22
Additional Laboratory Tests
Case Study

• hs-CRP 6.5 mg/L (high risk gt3 mg/L)
• Lp-PLA2 180 ng/mL (high risk gt200 ng/mL)
• Lp(a) 130 nmol/L (ULN 75 mmol/L)
• apo B 122 mg/dL

hs-CRPhigh-sensitivity C-reactive protein,
Lp-PLA2lipoprotein-associated phospholipase A2,
Lp(a)lipoprotein a, apo Bapolipoprotein B
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Reynolds Risk Score
Case Study

• 10-year risk of having a heart attack, stroke, or
  other heart disease event

6
Includes high-sensitivity C-reactive protein and
family history
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What are her ADA/ACC lipid goals?
ARS Question

• A. LDL-C lt100 mg/dL
• B. NonHDL-C lt130 mg/dL
• C. TG lt150 mg/dL
• D. HDL-C gt50 mg/dL
• All of the above
• A and C

LDL-Clow-density lipoprotein cholesterol,
HDL-Chigh-density lipoprotein cholesterol,
TGtriglycerides
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ADA/ACC Consensus Conference Report Suggested
Treatment Goals in Patients With Cardiometabolic
Risk and Lipoprotein Abnormalities
Risk Category Goals, mg/dL Goals, mg/dL Goals, mg/dL Goals, mg/dL
Risk Category LDL-C NonHDL-C NonHDL-C apo B
Highest-risk patients, including those with Known CVD or Diabetes ?1 other major CVD risk-factor lt70 lt100 lt80 lt80
High-risk patients, including those with No diabetes or known clinical CVD, but ?2 other major CVD risk factors or Diabetes, but no other major CVD risk-factors lt100 lt130 lt90 lt90
Other major risk factors (beyond
dyslipoproteinemia) include smoking,
hypertension, and family history of premature CAD
ADAAmerican Diabetes Association, ACCAmerican
College of Cardiology, CVDcardiovascular
disease, CADcoronary artery disease
Brunzell JD, et al. J Am Coll Cardiol.
2008511512-1524.
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Intervention
Case Study

• The doctor explains that she has metabolic
  syndrome and high levels of
• NonHDL-C
• apo B
• hs-CRP
• Lp(a)
• She was told
• She has high-risk for diabetes and
  intermediate-risk for heart disease
• With improvements in lifestyle and weight loss
  she could probably avoid both

HDL-Chigh-density lipoprotein cholesterol, apo
Bapolipoprotein B, hs-CRPhigh-sensitivity
C-reactive protein, Lp(a)lipoprotein a
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Retirement Plan for Your Health
Clinical Pearl

• A small investment in lifestyle on a daily basis
  will result in a large return in health dividends

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Questions to Ask Before Prescribing Diet and
Lifestyle Modification

• Are they ready/able to change their lifestyle?
• If no, do not prescribe focus on increasing
  awareness of their risk
• This patient tried to lose weight in the past
  but nothing worked. Closer questioning reveals
  patient used magazine or fad diets
• Is cost an issue?
• Low cost options include Weight Watchers and the
  Cardiometabolic Support Network
• This patient Yes
• Do they eat for emotional reasons?
• If yes, Overeaters Anonymous or working with
  therapist or registered dietitian will be more
  effective
• This patient Often, especially in the last year
• Do they prefer working in groups or individually?
  
• Group Weight Watchers. Individually registered
  dietitian
• This patient Not sure

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Questions to Ask Before Prescribing Diet and
Lifestyle Modification (cont.)

• Do they have access to a track or a gym?
• Need for a safe, accessible, and affordable place
  to be active
• This patient Theres a mall where she can walk
• Do they have Internet capability and do they feel
  comfortable on the Internet?
• Internet weight-loss support programs like
  LivestrongTM.com, chat rooms, Weight Watchers
  online, CMSNonline, eDiets
• This patient Limited not comfortable on the
  Internet
• Do they have time to plan and prepare food?
• If yes, any option is viable. If no, meal
  replacements, Jenny Craig, use of lean frozen
  entrees
• This patient Yes, she is organized and likes to
  cook for her family

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Clinical Pearl

• Patients may lack confidence if theyve been
  unsuccessful at weight loss in the past, even if
  theyve only followed fad diets that had little
  chance of working
• Reassure them that the prescribed changes will be
  a medically sound, comprehensive approach to
  managing their health

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Intervention
Case Study

• Goals were set for weight loss of 10 lbs (6
  body weight) with a program of diet and exercise
• She was referred to a commercial weight-loss
  program
• Advised to walk 30-minutes daily
• Prescribed a statin

Per Diabetes Prevention Program
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What are the benefits of starting statin therapy
in a person of her age, with metabolic syndrome,
elevated hs-CRP, and LDL-c less than 130 mg/dL?
ARS Question

1. Decreases the rate of myocardial infarction
2. Decreases the rate of stroke
3. Decreases the rate of hospitalization for
   unstable angina
4. All of the above

hs-CRPhigh-sensitivity C-reactive protein,
LDL-Clow-density lipoprotein cholesterol
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JUPITER Primary Endpoint (MI, Stroke,
UA/Revascularization, CV Death)
Placebo 251/8901
0.08
Hazard Ratio (HR) 0.56, 95 Confidence Interval
(CI) 0.46-0.69 Plt0.00001
-44
0.06
Cumulative Incidence
0.04
Rosuvastatin 142/8901
0.02
0.00
0
1
2
3
4
Follow-Up (years)
Although a little younger than the JUPITER
population, this patient would most likely see
similar benefits
MImyocardial infarction, UAunstable
angina, CVcardiovascular
Ridker PM ,et al. N Engl J Med.
20083592195-2207.
34
Intervention Follow-Up
Case Study

• Patient calls the office
• After 3 weeks, the patient leaves a commercial
  weight-program
• She felt uncomfortable working in a group setting
• She called her insurance company, they will cover
  4 visits with a registered dietitian

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Update on Reimbursement for Medical Nutrition
Therapy (MNT) With Registered Dietitian

• Most insurances cover MNT for diabetes and renal
  disease
• Medicare bill HR-6331 expands use of MNT by a
  registered dietitian to Medicare beneficiaries
  with risk factors for developing diabetes
• January 1, 2009 bill being reviewed by CMS
• Medicare can cover preventive services that are
  USPSTF grade-A or grade-B recommendations
• American Dietetic Association is preparing an
  evidence-based report of the effectiveness/cost-ef
  fectiveness of MNT for dyslipidemia and
  hypertension with hopes of future coverage

USPSTFUnited States Preventive Service Task
Force, CMSCenters for Medicare Medicaid
Services
36
Initial Meeting With Dietitian
Case Study

• Diet
• Eats 3 meals, 2 snacks/day (2100 calories/day)
• Snacks on salty, crunchy foods (pretzels,
  crackers, chips) during periods of stress
• 30 of calories come from snacks and
  calorie-containing beverages
• Wants to change diet, but not sure she has the
  willpower
• Activity
• Began walking after MD told her to walk 30
  minutes, 5 days/week
• Currently walking 20 minutes, 3 days/week
• Psychosocially
• Experiences stress often
• Has supportive husband

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Lifestyle Plan of Action
Case Study

• To build patients self-efficacy, dietitian will
  focus on small, consistent changes
• Goals should be set by both dietitian and patient
• Diet
• 500/day caloric reduction from usual intake
• Focus on reducing snack foods replace with
  crunchy, lower-calorie snacks and water
• Emotional eating
• Over next 2-weeks, complete food-records with
  hunger scales to increase awareness of hunger,
  satiety, and reasons for eating
• Physical activity
• Gradually increase walking to 30 minutes, 6
  days/week

Self-efficacy is the belief that one can make
and sustain lifestyle changes
38
6Week Interim Laboratory Data
Case Study

• TC 133 mg/dL
• TG 185 mg/dL
• HDL-C 41 mg/dL
• LDL-C 55 mg/dL
• NonHDL-C 92 mg/dL
• ALT 46 U/L
• AST 37 U/L
• Glucose 104 mg/dL

TCtotal cholesterol, TGtriglycerides,
HDL-Chigh-density lipoprotein cholesterol, LDL-C
low-density lipoprotein cholesterol, ALTalanine
aminotranferase, ASTaspartate aminotransferase
39
3 Months MD Follow-Up Visit
Case Study

• The patient continues statin therapy
• Lost 9 pounds and feels much better
• Has decreased her snack-food intake, which has
  decreased her fat intake now consumes more
  fruits/vegetables and water
• Feels more confident about maintaining these
  changes
• Has realized and addressed some negative eating
  patterns
• Walks 30 minutes, 5 days/week and usually
  1x/weekend
• Physical examination
• Blood pressure 128/82 mm Hg, pulse 72 bpm
• Height 65 inches, weight 169 lbs
• Waist 34 inches, body mass index 28.1

40
3 Months MD Follow-Up Visit (cont.)
Case Study

• Action plan
• Encourage patient to continue statin and advise
  her that ? HDL-C is related to caloric
  restriction/weight loss
• Instruct her to increase her exercise
• Aim for 30-minutes/day on weekdays, more on
  weekends goal of 180 minutes/week
• Encourage her to continue dietitian visits

HDL-Chigh-density lipoprotein cholesterol
41
6 Months MD Follow-Up Visit
Case Study

• The patient is continuing her statin therapy
• She seems a little embarrassed that she lost only
  3 lbs in the last 3 months, but overall she feels
  well
• She has lost 3 inches from her waist
• She is consistently eating a lower-fat diet with
  greater intake of fiber, fruits, and vegetables
• She walks 30 minutes, 5 days/week and for 1 hour,
  1 day/weekend
• Physical examination
• Blood pressure 128/82 mm Hg, pulse 72 bpm
• Height 65 inches, weight 166 lbs
• Waist 34 inches, body mass index 27.6

42
6-Month Laboratory Data
Case Study

• TC 135 mg/dL
• TG 170 mg/dL
• HDL-C 46 mg/dL
• LDL-C 55 mg/dL
• NonHDL-C 89 mg/dL
• ALT 43 mg/dL
• AST 36 mg/dL
• Glucose 101 mg/dL

TCtotal cholesterol, TGtriglycerides,
HDL-Chigh-density lipoprotein cholesterol, LDL-C
low-density lipoprotein cholesterol, ALTalanine
aminotranferase, ASTaspartate aminotransferase
43
6 Months MD Follow-Up Visit
Case Study

• The patient is praised for her sustained weight
  loss and the improvements in lipids, glucose, and
  weight, as well as for her exercise and diet
• Action plan
• Continue statin
• Maintain or increase exercise
• Key to maintaining weight loss and metabolic
  benefits
• Discuss use of meal replacements for weight
  maintenance, self monitoring
• Encourage her to follow-up with dietitian as
  needed
• Schedule follow-up appointment in 3 months

44
Case Study

• Redefine success
• Patients image of success may be unrealistic and
  wanting to please MD
• Weight loss and stabilization (12 lbs, 3 inches
  off waist), improved diet quality, and increased
  physical activity are successes that need
  reinforcement
• Tools to use if patients believe they are
  slipping
• Monitor weight regularly
• Complete diet records
• Use meal replacements for 1 meal/day
• Get support (friends, family, commercial or
  medical programs)

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Key Learnings Medical

• The Framingham score may underestimate risk in
  women, especially those with the metabolic
  syndrome
• The risk levels for CHD and diabetes may be very
  different in a patient with the metabolic
  syndrome
• Avoidance of diabetes is a strong motivator for
  patients to lose weight
• Patients without diabetes or CVD, but with 2
  major CV risk-factors need to be treated to goal
• LDL-C lt100 mg/dL, nonHDL-C lt130 mg/dL, apo B
  lt90 mg/dL
• 510 weight-loss can greatly improve a
  patients lipid profile and markedly reduce the
  risk of diabetes in a patient with IFG

CHDcoronary heart disease, CVDcardiovascular
disease, LDL-Clow-density lipoprotein
cholesterol, HDL-Chigh-density lipoprotein
cholesterol, apo Bapolipoprotein B, IFGimpaired
fasting glucose
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Key Learnings Behavioral

• Before prescribing general lifestyle advice, ask
  the patient questions to help you tailor the
  initial approach
• The most successful diet is the one to which the
  patient can adhere
• Lifestyle self-efficacythe belief that one can
  make and sustain lifestyle changesis often
  undermined by repeated failures in dieting,
  even though some of those attempts were not
  reliable approaches to weight loss
• Small, simple, consistent changes over time make
  the biggest difference