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REVISITING the ROLE of BETA-BLOCKERS in the MANAGEMENT of HYPERTENSION: A CLOSER LOOK AT COMPLICATED CASES ATLANTA, GEORGIA DECEMBER 2, 2008 Educational partner:

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Page 1: REVISITING the ROLE BETA-BLOCKERS … Files/Syllabus Files_Fall08... · REVISITING the ROLE of BETA-BLOCKERS ... Evaluation, and Treatment of High Blood Pressure: the JNC 7 report

REVISITING the ROLE of BETA-BLOCKERSin the MANAGEMENT of HYPERTENSION:

A C L O S E R L O O K A T C O M P L I C A T E D C A S E S

ATLANTA, GEORGIA • DECEMBER 2, 2008

Educational partner:

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Session 5

Session 5: Revisiting the Role of Beta-Blockers in the Management of Hypertension: A Closer Look at Complicated Cases Learning Objectives

• Identify/discuss clinical considerations involved in the management of patients with complicated hypertension. • Describe at least one of the latest clinical trial results on beta-blockers and its effects on metabolic parameters.

Faculty Shawna D. Nesbitt, MD Associate Professor, Department of Internal Medicine University of Texas at Southwestern Medical Center at Dallas Dallas, Texas Shawna D. Nesbitt, MD, is associate professor of internal medicine at the University of Texas at Southwestern Medical Center at Dallas. Dr Nesbitt received her medical degree from Hahnemann University School of Medicine, Philadelphia, Pennsylvania. She completed a medical internship and residency in internal medicine at Allegheny General Hospital, Pittsburgh, Pennsylvania. Dr Nesbitt completed her medical training with a fellowship in hypertension at the University of Michigan Medical Center, Ann Arbor. Dr Nesbitt is a manuscript reviewer for American Journal of Hypertension, Ethnicity and Disease, Journal of the National Medical Association, and Hypertension. She has authored or coauthored more than 40 articles published in numerous peer-reviewed journals, including American Journal of Hypertension, Journal of Hypertension, and Journal of CardioMetabolic Syndrome. Dr Nesbitt has authored several chapters in books focusing on hypertension. She is a member of various professional societies including the Association of Black Cardiologists, American Society of Hypertension, and the International Society on Hypertension in Blacks. Dr Nesbitt has given numerous international and national lectures with a focus on hypertension over the last 15 years. Matthew J. Sorrentino, MD, FACC Associate Professor of Medicine University of Chicago Pritzker School of Medicine Department of Medicine Section of Cardiology Chicago, Illinois Matthew J. Sorrentino, MD, FACC, is associate professor of medicine at the University of Chicago Pritzker School of Medicine. Dr Sorrentino is a preventive cardiologist with clinical and research interests in hyperlipidemia and hypertension. He is an American Society of Hypertension hypertension specialist. Dr Sorrentino received his medical degree from the University of Chicago Pritzker School of Medicine. He completed his internship and residency in Internal Medicine and a fellowship in Cardiovascular Disease at the University of Chicago Hospitals. Dr Sorrentino is an abstract reviewer for the American College of Cardiology and the American Diabetes Association. He is a host on ReachMD, a satellite radio station for Medical Professionals. Dr Sorrentino has written numerous book chapters and over 70 articles published in journals such as The American Journal of Medicine, Journal of the American College of Cardiology and Journal of Geriatric Cardiology. Faculty Financial Disclosure Statements The presenting faculty reported the following: Dr Nesbitt receives honoraria for serving as a consultant/speaker from Boehringer Ingelheim Pharmaceuticals, Inc.; Bristol-Myers Squibb; and Novartis Pharmaceuticals Corporations. Dr Nesbitt receives research support from AstraZeneca Pharmaceuticals LP and Pfizer Inc.

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Session 5

Dr Sorrentino receives speaking honoraria from Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc.; and Takeda Pharmaceuticals Corporations. Education Partner Financial Disclosure Statements The content collaborators at The France Foundation have reported the following: The content collaborators at The France Foundation have nothing to disclose. Drug List Generic Trade acebutolol Sectral atenolol Tenormin bisoprolol Zebeta carvedilol Coreg labetalol Normodyne, Trandate lisinopril Prinivil, Zestril Investigational bucindolol celiprolol dilevalol

Generic Trade metoprolol Lopressor, Toprol-XL nebivolol Bystolic pindolol Visken propranolol InnoPran-XL, Inderal timolol Betimol, Blocadren, Istalol valsartan Diovan

Suggested Reading List Bell DS. Beta-adrenergic blocking agents in patients with diabetes–friend and foe. Endocr Pract. 1999;5(1):51-53.

Bristow MR. Beta-adrenergic receptor blockade in chronic heart failure. Circulation. 2000;101(5):558-569.

Calle EE, Thun MJ, Petrelli JM, et al. Body-mass index and mortality in a prospective cohort of US adults. N Engl J Med. 1999;341(15):1097-1105.

Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003;289(19):2560-2572.

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(3):356-359.

Greenlund KJ, Zheng ZJ, Keenan NL, et al. Trends in self-reported multiple cardiovascular disease risk factors among adults in the United States, 1991-1999. Arch Intern Med. 2004;164(2):181-188.

Jackson R, Lawes CM, Bennett DA, et al. Treatment with drugs to lower blood pressure and blood cholesterol based on an individual’s absolute cardiovascular risk. Lancet. 2005;365(9457):434-441.

Lewington S, Clarke R, Qizilbash N, et al; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360(9349):1903-1913.

Lindholm LH, Carlberg B, Samuelsson O. Should beta blockers remain first choice in the treatment of primary hypertension? A meta-analysis. Lancet. 2005;366(9496):1545-1553.

McFarlane SI, Banerji M, Sowers JR. Insulin resistance and cardiovascular disease. J Clin Endocrinol Metab. 2001;86(2):713-718.

Mokdad AH, Ford ES, Bowman BA, et al. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003;289(1):76-79.

Savage PD, Banzer JA, Balady GJ, Ades PA. Prevalence of metabolic syndrome in cardiac rehabilitation/secondary prevention programs. Am Heart J. 2005;149(4):627-631.

Siani A, Cappuccio FP, Barba G, et al. The relationship of waist circumference to blood pressure: the Olivetti Heart Study. Am J Hypertens. 2002;15(9):780-786.

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1

Hypertension Progression with Age and Related Risk Factors

Shawna D. Nesbitt, MD

Associate Professor, Department of Internal MedicineUniversity of Texas at Southwestern Medical Center at Dallas

Dallas, Texas

Traditional CVD Risk Factors

• Family history • Older age• Male gender• Smoking• Physical inactivity• Overweight/obesity• Total-C/LDL-C/HDL-C/TG • Hypertension • Hyperglycemia

Adapted from Stampfer MJ, et al. Circulation. 2004;109(25suppl 1):IV3-IV5.

Prevalence of CVD Risk Factors in US Adults 1961–2004

010203040506070

1960 1970 1980 1990 2000

Overweight Hypertension Smoking High Cholesterol

Perc

ent o

f Pop

ulat

ion

Year

• Hypertension: SBP > 140, DBP > 90 mm Hg, or medicated for HT• High cholesterol: > 240 mg/dl. • Overweight: BMI > 25 kg/m2

Source: NHIS for smoking, ages > 18 and NHANES for the other risk factors, ages 35–74.

Percentage of Adults With ≥ 2 Self-Reported CV Risk Factors

High BP, High Cholesterol, Diabetes, Obesity, Smoking, Physical Inactivity (2003)

Percentage of population with ≥ 2 risk factors

Greenlund KJ, et al. Arch Intern Med. 2004;164(2):181-188; Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 2005;54(5):113-117.

NA25.0% to 29.9%22.0% to 24.9%< 22% ≥ 30%

20031991

Ischemic Heart Disease Risk Increases with SBP, DBP, and Age

CI, confidence interval; IHD, ischemic heart disease. Lewington S, et al. Lancet. 2002;360(9349):1903-1913.

Systolic Blood Pressure

40-49 years

50-59 years

60-69 years

70-79 years

80-89 yearsAge at risk:

IHD mortality(floatingabsolute risk and 95% CI)

25612864

32168421

120 140 160 180Usual SBP (mm Hg)

Diastolic Blood Pressure

25612864

3216

8421

70 80 90 100 110Usual DBP (mm Hg)

Age at risk:

40-49 years

50-59 years

60-69 years

70-79 years

80-89 years

Lower Is Better!Jackson R, et al. Lancet. 2005(9457);365:434-441.

Synergistic Interaction of Traditional Multiple Risk Factors on CVD Risk

0Reference

5-year CVD risk per 100 people

TC = 270

mg/dL

Smoker HDL = 39 mg/dL

Male Diabetes 60 yearsof age

10

20

30

40

5044%

33%

24%

18%

12%

6%3%

110

SBP (mm Hg)

120130140

150160170180

<1%

TC = total cholesterolAdditive Risk Factors

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2

Protective Factor

INTERHEART: Risk of AMI Associated With Risk Factors in the Overall Population

0.91 (0.82, 1.02)24.024.5Alcohol intake

0.86 (0.76, 0.97)14.319.3Exercise

0.70 (0.62, 0.79) 35.842.4Vegetable/fruit daily

2.67 (2.21, 3.22)――Psychosocial

1.62 (1.45, 1.80)46.333.3Abdominal obesity*

1.91 (1.74, 2.10)39.021.9Hypertension

2.37 (2.07, 2.71) 18.47.5Diabetes

2.87 (2.58, 3.19)45.226.8Current smoking

3.25 (2,81, 3.76)33.520.0Apo B/Apo A

OR (99% CI) Adj. for All% Cases% ControlRisk Factor

*Upper tertile of waist circumference.Adapted from Yusuf S, et al. Lancet. 2004;364(9438):937-952.

1998

Obesity Trends Among U.S. Adults BRFSS

2006

1990

No Data < 10% 10%–14 15%–19% 20%–24% 25%–29% ≥ 30%

BMI ≥ 30

http://www.cdc.gov/nccdphp/dnpa/obesity/trend/maps/index.htm

Overweight

Elevated BMI Increases the Risk of Cardiovascular Disease Mortality

Data are from 1 million men and women (average age, 57 years) followed for 16 years who never smoked and had no history of disease at enrollment.

Calle EE, et al. N Engl J Med. 1999;341(15):1097-1105.

Normal weight Obese

Rel

ativ

e R

isk

of

CVD

Mor

talit

y

0.6

3.0

2.6

2.2

1.8

1.4

1.0

> 18 25 30 ≥40

BMI, kg/m2

WomenMen

Waist Circumference Correlates With BP and Insulin Resistance

768 men with fasting glucose ≤ 126 mg/dL (≤ 7 mmol/L)

Siani A, et al. Am J Hypertens. 2002;15(9):780-786.

P < 0.001 for trend in each parameter.

50

40

30

20

10

0I II III IV V

50

40

30

20

10

0I II III IV V

High blood pressure Insulin resistance

Quintiles of Waist Circumference

%

Hypertension Is Associated With Insulin Resistance

Adapted from Ferrannini E, et al. N Engl J Med 1987;317(6):350-357.

P < 0.001

n = 11 n = 13

Error bars = SE

0

1

2

3

4

5

6

7

8

Normotensive Hypertensive

Insu

lin S

ensi

tivity

(mg/

min

/kg)

Mokdad et al., Diabetes Care 2000;23:1278-83; J Am Med Assoc 2001;286:10.

Diabetes Among US Adults

1990 1995

2001

No Data <4% 4%-6% 6%-8% 8%-10% >10%

• Includes Gestational Diabetes • BRFSS

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3

EPIC-Norfolk Study: Every 1% Increase in HbA1c Increased CV Risk

1% Increase in HbA1c Above 5% 1% Increase in HbA1c Above 7%

*Multivariate regression: adjusted for age and risk factor; †Multivariate regression: adjusted for age, sex, and risk factor.EPIC-Norfolk: The European Prospective Investigation into Cancer in Norfolk was a prospective population study of 4662 men and 5570 women aged 45-79 years. Average follow-up time was 6.3 years.

CHD CVD Totalmortality

Incr

ease

in R

elat

ive

Ris

k (%

)*

Incr

ease

in R

elat

ive

Ris

k (%

)†

0

10

20

30

40↑ 40%

↑ 16%

↑ 26%

Men

0

5

10

15

20

25

30

Total mortality

CHD CVD

↑ 21%↑ 24%↑ 25%

Total mortality

CHD CVD

Women

↑ 21%

↑ 28%

↑ 20%

Khaw KT, et al. Ann Intern Med. 2004;141:(6)413-420.

Diagnose by presence of 3 or more risk factorsAdapted with permission from Grundy SM, et al. Circulation. 2004;109:433-438.Ford ES, et al. JAMA. 2002;287(3):356-359.

AHA/NHLBI-Modified ATP III Criteria for Metabolic Syndrome

Risk Factor Defining Level Prevalence

Abdominal obesity Waist* 39%Men > 40 inWomen > 35 in

Triglycerides, mg/dL ≥ 150 30%HDL-C, mg/dL 37%

Men < 40Women < 50

BP, mm Hg ≥ 130/≥ 85 34%**Fasting glucose, mg/dL ≥ 100 (NCEP ≥ 110) 13%**

*Lower cutpoints for Asian Americans.**Or medication use

Metabolic Syndrome: Prevalence Increases With Age

Prev

a len

ce, %

Age, yrNCEP criteria.Adapted from Ford ES, et al. JAMA. 2002(3);287:356-359.

47 million US adults (23%) have metabolic syndrome

05

1015202530354045

20-29 30-39 40-49 50-59 60-69 ≥ 70

Men (n = 4265)Women (n = 4559)

Follow-up, Years

Cum

ulat

ive

Haz

ard,

%

121086420

RR = 3.55 (95% CI, 1.96-6.43)

0

5

10

15

866288

852279

834234

292100

YesNo

Metabolic Syndrome?

Metabolic Syndrome

Controls

Reproduced with permission from Lakka HM, et al. JAMA. 2002;288(21):2709-2716.

Cardiovascular Disease Mortality and Metabolic Syndrome

Savage PD, et al. Am Heart J. 2005;149(4):627-631.Milani RV, Lavie CJ. Am J Cardiol. 2003;92(1):50-54.Curran PJ, et al. J Am Coll Cardiol. 2004;43(suppl A):249A.

Over Half of Patients Referred to Cardiologists Have Metabolic Syndrome

Cardiac Rehabilitation

N = 1912Savage, 2005

Patie

nts

With

Met

abol

ic

Synd

rom

e (%

)

5058 59

0

20

40

60

N = 235Milani, 2003

N = 85Curran, 2004

Acute MI

0 1 2 3 4 50

2

4

6

8

C-r

eact

ive

Prot

ein,

mg/

L

Components of Metabolic Syndrome, No.

Inflammation in Metabolic Syndrome

Women’s Health Study (N = 14,719)

Reproduced with permission from Ridker P, et al. Circulation. 2003;107(3):391-397.

(N = 4086)

(N = 3152)

(N = 2292)

(N = 1135)

(N = 170)

(N = 3884)

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4

Effects of Weight Loss* on Inflammatory Biomarkers

Baseline12 months

ICAM = intercellular adhesion molecule; IL-6 = interleukin 6; TNF = tumor necrosis factor; VCAM=vascular cell adhesion molecule.

Adapted from Ziccardi P, et al. Circulation. 2002;105(7):804-809.

pg/m

L

0

1

2

3

4

5

6

TNF-α IL-6

P < 0.01

P < 0.01

ng/m

L

0

100

200

300

400

500

600

700

800

P-selectin ICAM-1 VCAM-1

P < 0.01

P < 0.02

P < 0.02

*Mean decrease of 9.8+1.5 kg. 0 2 4 6 8

0.95

0.96

0.97

0.98

0.99

1.00

hsCRP < 3, No Metabolic Syndrome

hsCRP ≥ 3, No Metabolic Syndrome

hsCRP < 3, Yes Metabolic Syndrome

hsCRP ≥ 3, Yes Metabolic Syndrome

hsCRP Adds Prognostic Information to the ATP III Definition of Metabolic Syndrome

CVD

Eve

nt-F

ree

Surv

ival

Pro

babi

lity

Years of Follow-up

N = 14,719

Ridker PM, et al. Circulation. 2003;107(3):391-397.

hsCRP = high-sensitivity CRP

Association of Insulin Resistance With Cardiovascular Risk Factors and Atherosclerosis

Obesity

Glucose intolerance

• AGEsHypertension Endothelial

dysfunction• ↑ VCAM,E-selectin

• ↓ NO Impaired

thrombolysis• ↑ PAI-1• ↓ tPA

Atherosclerosis

Inflammation• ↑ CRP• ↑ IL-6

Insulin resistance

Dyslipidemia• Low HDL

• Small, dense LDL particles

• Hyper-triglyceridemia

McFarlane SI, et al. J Clin Endocrinol Metab. 2001;86(2):713-718.

Hypertension Writing GroupDefinition of Hypertension

Compared with JNC 7

SBP, systolic blood pressure; DBP diastolic blood pressure; HWG, Hypertension Writing Group.Giles TD, et al. J Clin Hypertens. 2005;7(9):505-512.

DBP(mm Hg)

JNC 7 HWG JNC 7 HWG100

120

140

160

180

200

80

100

130SBP

(mm Hg)

Normal Normal Normal Normal

Pre-hyper-tension

Stage 1or

Normal

Stage 1 or Normal

Pre-hyper-tension

Stage 2or

Stage 1Stage 1

Stage 2 Stage 3

Stage 1

Stage 2 Stage 3

Stage 2 orStage 1 90

150

†CVD designation is determined by the constellation of risk factors, early disease markers, and target-organ disease. CVD, cardiovascular disease.

Hypertension Writing Group Definition and Classification of Hypertension

Overtly present with or without CVD events

Early signs present

NoneNoneTarget-organ Disease

Overtly present with progression

Overtly presentUsually presentNone Early Disease Markers

ManyManySeveralNone or fewCardiovascular Risk Factors

Marked and sustained BP

elevationsOR

Advanced CVD†

Sustained BPelevations

ORProgressive

CVD†

Occasional or intermittent BP

elevationsOR

Early CVD†

Normal BP or rare BP elevations

ANDNo identifiable

CVD†

Descriptive Category

Stage 3 hypertension

Stage 2 hypertension

Stage 1 hypertension

NormalClassification

Giles TD, et al. J Clin Hypertens. 2005;7(9):505-512.

Summary

• The prevalence of obesity and diabetes is increasing

• Metabolic syndrome, a precursor to CVD and diabetes, is also on the rise

• Aggressive management of diabetes and other CVD risk factors is essential

• Primary care physicians are instrumental in addressing the therapeutic challenges faced by their patients with cardiometabolic risk factors

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5

Evolution of Beta-Blockade and the Management of

Complicated Hypertension

Matthew J. Sorrentino, MD, FACC

Associate Professor of MedicineUniversity of Chicago Pritzker School of Medicine

Department of MedicineSection of Cardiology

Chicago, Illinois

The Seventh Report of the The Seventh Report of the Joint National CommitteeJoint National Committee

Chobanian AV, et al. JAMA. 2003;289(19):2560-2572.

oror

oror

or

andand

≥≥ 100100≥≥ 160160Stage 2 hypertensionStage 2 hypertension

9090––9999140140––159159Stage 1 hypertensionStage 1 hypertension

80–89120–139Prehypertension

< 80< 80< 120< 120NormalNormal

Diastolic BP(mm Hg)

Systolic BP(mm Hg)

BP Classification

Resistant hypertension is the failure to reach goal BP in patients who are adhering to full doses of an appropriate 3-drug regimen that includes a diuretic.

• Caucasians 68%• African-Americans 52%• Mexican-Americans 57%• Patients ≥ 60 years old 44%• Patients with diabetes 25%

Ong KL, et al. Hypertension. 2007;49:69-75.

Percentage of Treated Patients With Percentage of Treated Patients With Hypertension at Goal 2003Hypertension at Goal 2003––20042004

Awareness, Treatment, and Control of Awareness, Treatment, and Control of Hypertension in the US Hypertension in the US

14,653 patients from NHANES database.14,653 patients from NHANES database.*P < 0.05 for the difference between 1999-2000 and 2003-2004.

6558 6057

697671

50 54

3732

30

24

3735

1020304050607080

1999-2000 2001-2002 2003-2004

Years

Control Control target for target for Healthy Healthy PeoplePeople20002000(now 2010)(now 2010)

AwarenessAwareness

Control (All)Control (All)

Control (Treated)Control (Treated)

Control (Treated, with diabetes)Control (Treated, with diabetes)

TreatmentTreatment

% (S

E)

*

**

Ong KL, et al. Hypertension. 2007;49(1):69-75.

Perceived Barriers to Optimizing Perceived Barriers to Optimizing ββ--Blocker TreatmentBlocker Treatment

•• Negative effects on lipid Negative effects on lipid metabolismmetabolism

•• Negative effects on Negative effects on glucose metabolismglucose metabolism

•• Negative effects on renal Negative effects on renal blood flowblood flow

•• Masked hypoglycemiaMasked hypoglycemia

•• FatigueFatigue•• ImpotenceImpotence•• Weight increaseWeight increase•• Peripheral Peripheral

vasoconstriction vasoconstriction (cold extremities)(cold extremities)

•• DepressionDepression*Primarily in patients with hypertension and diabetes.

Bell DS, et al. Endocr Pract. 1999;5(1):51-53. Fonarow GC. Rev Cardiovasc Med. 2003;4(suppl 6):S38-S49. Bell DSH, et al. Endocrinologist. 2003;13:116-123. Packer M. Prog Cardiovasc Dis. 1998;41(suppl 1):39-52.

Metabolic Concerns* Tolerability Concerns

Evolution of Beta-Blockade

First Generation Second Generation Third Generation Next Generation

Propranolol AtenololMetoprolol

Carvedilol Labetalol Nebivolol

Non-Selective Selective VasodilatingNon-

Selective

VasodilatingSelective

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6

ββ--Blockers Are HeterogeneousBlockers Are Heterogeneousβ-Blocker ISA Selectivity Vasodilation Dosage

Acebutolol ++ CardioselectiveCardioselective NoNo qdqd/bid/bid

Atenolol -- CardioselectiveCardioselective NoNo qdqd/bid/bid

Bisoprolol -- CardioselectiveCardioselective NoNo qdqd

Bucindolol ++ NonselectiveNonselective Likely via Likely via αα1 1 blockadeblockade bidbid

Carvedilol -- NonselectiveNonselective αα1 1 blockade blockade qdqd/bid/bid

Labetalol ++ NonselectiveNonselective αα1 1 blockadeblockade bidbid

Metoprolol -- CardioselectiveCardioselective NoNo qdqd/bid/bid

Nebivolol -- CardioselectiveCardioselective LL--arginine/NO pathwayarginine/NO pathway qdqd

Pindolol ++++ NonselectiveNonselective NoNo bidbid

Propranolol -- NonselectiveNonselective NoNo bidbid

Timolol -- NonselectiveNonselective NoNo bidbid

Adapted from López-Sendón J, et al. Eur Heart J. 2004;25(15):1341-1362.Bristow MR. Circulation. 2000;101(5):558-569.

ISA: intrinsic sympathomimetic activity

Responses Mediated byβ-Adrenergic Receptors in the Heart

β1 β2Positive chronotropic response

α1cVasoconstriction

β1 β2 α1cProarrhythmia

β1Myocyte apoptosis

Harmful effects

Beneficial effects Receptor Subtype

β1Fetal gene induction

β1 > β2 α1cMyocyte damage/myopathy

β2Fibroblast hyperplasia

β1 > β2 >> α1cCardiac myocyte growth

β1 β2Vasodilation

β1 β2 >> α1cPositive inotropic response

Adapted from Mann DL, et al. Circulation. 2005;111:2837-2849.

0

50

100

150

200

250

300

350

Nebivolol Bisoprolol Metoprolol Bucindolol Propranolol Carvedilol

β 1/β

2Se

lect

ivity

β1/β2-Receptor SelectivityAmong β-Blockers

Bristow MR, et al. Am J Hypertens. 2005;18(pt 2):51A-52A. Abstract P-121.

The Vasodilating β-Blockers

stimulation causes release/activity of NO, and vasodilation

stimulation causes vasodilation

antagonism causes vasodilation

Effect

receptors located in smooth muscle, heart

carvedilollabetalolbucindolol

α1-receptor antagonism

pathways located in blood vessel walls

nebivololL-arginine/nitric oxide pathways

receptors located in bronchi, blood vessels, gut

dilevalolceliprolol

β2-agonism

Site of ActivityAgent(s)Mechanisms

Bristow MR. Circulation. 2000;101(5):558-569. Berecek KH, Carey RM. Adrenergic and dopaminergic receptors and actions. In: Izzo JL, Black HR, eds. Hypertension Primer, Third Edition. Philadelphia, PA: Lippincott Williams & Wilkins; 2003:1-4.

0 1 2

Atenolol Increases the Risk of Stroke and All-Cause Mortality

1.26 (1.15-1.38)

1.05 (0.91-1.21)

1.08 (1.02-1.14)

Stroke

MI

All-cause mortality

Lindholm LH, et al. Lancet. 2005;366:1545-1553.

Favors OtherAntihypertensivesFavors Atenolol

Non-Atenolol β-Blockers Do Not Increase Stroke, MI, or Mortality

Lindholm LH, et al. Lancet. 2005;366:1545-1553.

1.20 (0.30-4.71)

0.86 (0.67-1.11)

0.89 (0.70-1.12)

Stroke

MI

All-cause mortality

0 1 2 3 4 5

Favors OtherAntihypertensives

Favors Non-Atenolol β-Blockers

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β-Blockers vs Diuretics: Elderly HTN

Messerli FH, et al. JAMA. 1998;279:1903-1907.

Cerebrovascular eventsDiuretics 8 222/5876 412/6661β-blockers 2 79/1521 178/2678

Stroke mortalityDiuretics 7 69/5838 122/6618β-blockers 2 25/1521 57/2678

Coronary heart diseaseDiuretics 8 365/5876 531/6661β-blockers 2 115/1521 197/2678

Cardiovascular mortalityDiuretics 7 332/5838 510/6618β-blockers 2 130/1521 230/2678

All-cause mortalityDiuretics 7 681/5838 907/6618β-blockers 2 227/1521 384/2678

0.4 0.6 0.8 1.0 1.2 1.4

Active Control events/Outcome No. of treatment events/ No. of Odds ratio andfirst drug trials No. of patients patients 95% confidence interval

β-blocker: pindolol, metoprolol, or atenolol

Diuretics

β-blockers

Clinical Outcomes With β-BlockerTherapy in Diabetes: UKPDS Study

UKPDS Group. BMJ. 1998;317:713-720.

Any diabetes-related endpoint

Diabetes-related deaths

All-cause mortality

Myocardial infarction

Stroke

Microvascular disease

1.10

1.27

1.14

1.20

1.12

1.29

Relative Risk and 95% CI0.5 1 2

FavorsACE

inhibitor

Favorsβ-blocker

RR P

.43

.28

.44

.35

.74

.30

GEMINI: Effect on Blood Pressure GEMINI: Effect on Blood Pressure and Heart Rateand Heart Rate

020406080

100120140160

Baseline Month 5 Baseline Month 5 Baseline Month 5

Carvedilol (n = 454)

Metoprolol (n = 636)

Bakris GL, et al. JAMA. 2004;292:2227-2236.

SBPSBP(mm Hg, mean)(mm Hg, mean)

Heart rateHeart rateminute, meanminute, mean

DBPDBP(mm Hg, mean)(mm Hg, mean)

Metoprolol group had higher rate of bradycardia

(4.1% vs 1.4%, P = 0.007)

`

Carvedilol(n = 454)

P P = 0.65= 0.65

P P < 0.001< 0.001M

ean

HbA

Mea

n H

bA1c

1c

(%)

(%) Treatment Treatment

DifferenceDifference

Carvedilol Carvedilol vsvs

MetoprololMetoprolol−−0.13%0.13%

((−−00.22, .22, −−00.04).04)P P = 0.004= 0.004

Metoprolol tartrate(n = 657)

Baseline Month 5 Baseline Month 5

Change in Hemoglobin AChange in Hemoglobin A1c 1c GEMINIGEMINI

7.67.6

7.47.4

7.27.2

7.07.0

1111 patients (90%) were evaluable for efficacy, having both a valid baseline and at least one on-therapy HbA1c assessment. GEMINI, Glycemic Effects in Diabetes Mellitus: Carvedilol - Metoprolol Comparison in Hypertensives. Bakris GL, et al. JAMA. 2004;292(18):2227-2236.

Change in Insulin Resistance by Homeostasis Model Assessment (HOMA)

GEMINI

5.6

5.7

5.8

5.9

6.0

6.1

6.2

6.3

Treatment Difference

Carvedilolvs

Metoprolol–7.2%

(–13.8, –0.20)P = 0.004

Carvedilol(n = 371)

Metoprolol Tartrate(n = 540)

Baseline Month 5 Baseline Month 5

P P = 0.004= 0.004

P P = NS= NS

Mea

n H

OM

A in

sulin

resi

stan

ceM

ean

HO

MA

insu

lin re

sist

ance

Bakris GL, et al. JAMA. 2004;292(18):2227-2236.von Fallois J, et al. Fortschr Med Orig. 2000;118 (suppl 2):77-82.

Mea

n ch

ange

from

bas

elin

e

GlucoseGlucose TriglyceridesTriglyceridesCholesterolCholesterol

--2020--1818--1616--1414--1212--1010--88--66--44--2200

--16%16%

--9%9%

--18%18%

Change in Glucose and LipidsChange in Glucose and Lipidsin Patients With Diabetesin Patients With Diabetes

• Observational study • Nebivolol monotherapy• 1529 centers • 6376 patients with hypertension • Period of 6 weeks

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Change in Insulin Sensitivity in Hypertensive Patients With Glucose Intolerance

N = 25. Crossover; 16-week treatments. Nebivolol 2.5-5 mg and atenolol 50-100 mg daily.*P < 0.05 vs placebo.EH, euglycemic-hyperinsulinemic; IVGTT, intravenous glucose tolerance test.

Poirier L et al. J Hypertens. 2001;19(8):1429-1435.

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

Placebo Nebivolol Atenolol

Glu

cose

dis

appe

aran

ce ra

te K

(min

-1)

Glu

cose

dis

posa

l rat

e M

(mg/

kg p

er m

in)

Insulin sensitivityEH clamp

IVGTT≈ 20%reduction

*

0

0.5

1

1.5

2

Placebo Nebivolol Atenolol

≈ 10%reduction

*

P < 0.01

Effect of β-Blockade on Insulin Level and Sensitivity in Hypertensive Patients

4.0

4.5

5.0

5.5

6.0

6.5

7.0

Insulin Sensitivity Index (M/I)*

Baseline After 1 yr ofmetoprololsuccinate

↓ 22%P = 0.0025

(M v

alue

/mU

/L ×

100)

7.0

7.5

8.0

8.5

9.0

9.5

10.0

Fasting Plasma Insulin

Baseline After 1 yr of metoprololsuccinate

(mU

/L)

P = NS

24 hypertensive patients age 21-71 years were treated with 200 mg of metoprolol succinate for one year.*M = glucose uptake per minute during steady-state phase of clamp test; I = mean insulin concentration duringsteady-state phase of clamp test.

Haenni A, et al. Metabolism. 1994;43:455-461.

Differing Effects of Differing Effects of ββ--Blockers on Blockers on Hemodynamics in Hypertensive PatientsHemodynamics in Hypertensive Patients

LV end-diastolicvolume (mL)

LV end-systolicvolume (mL)

Stroke volume (mL)

Heart rate (beats/min)

Cardiac output (L/min)

Peripheral resistance(dyne/cm-5) –13.2

5.8

7.17.1

–10.8–28.2

20.6

–1.49.2

10.65.7

Ejection fraction (%) 7.8–2.1

3.6

––24.024.0

AtenololAtenolol(100 (100 mg/d)mg/d)NebivololNebivolol(5 (5 mg/dmg/d))

––4040Percent change vs Percent change vs baseline

––3030 ––2020 –10 00 1010 2020 30

At 2 weeks.

Kamp O, et al. Am J Cardiol. 2003;92(3):344-348.

Nitric Oxide Is Nitric Oxide Is VasoprotectiveVasoprotectiveand Antiand Anti--atherogenicatherogenic

eNOS, endothelium-derived nitric oxide synthase; LDL, low-density lipoprotein; NO, nitric oxide. Adapted from John S, et al. J Hypertens. 2000;18(4):363-374.

Endothelium

InhibitsInhibits

PlateletPlateletaggregationaggregation

Smooth muscleSmooth muscleproliferationproliferation

EndothelinEndothelinproductionproduction

Smooth muscleSmooth musclecontractioncontraction

Monocyte andMonocyte andplatelet adhesionplatelet adhesion

eNOSeNOS

NONO

Oxidation ofOxidation ofLDL cholesterolLDL cholesterol

Expression ofExpression ofadhesion moleculesadhesion molecules

**

Different Effects of Different Effects of ββ--Blockade Blockade on Forearm Blood Flowon Forearm Blood Flow

N = 16 healthy men.

Cockcroft JR, et al. J Pharmacol Exp Ther. 1995;274(3)1067-1071.

Increase in forearm

blood flow(%)

**

*

100

60

20

–20

0 18 88.5 177 354 (µg/min) 00 10 50.0 100 200 (µg/min)

NebivololAtenolol

Atenolol

Nebivolol*P < 0.01

Endothelial Dysfunction Predicts Endothelial Dysfunction Predicts CV Events CV Events in Hypertensive Patientsin Hypertensive Patients

Perticone F, et al. Circulation. 2001;104(2):191-196.

0

0.2

0.4

0.6

0.8

1.0

12

225 164

Follow-up (mo)24 36 48 60 72 84

132 73 52 41 27 10Patients exposed

to risk:

Even

t-fre

e su

rviv

al

P = 0.0012(Log-rank test)

3rd tertile of FBF

2nd 2nd tertiletertile of of FBF1st 1st tertile of FBFof FBF

0

FBF, forearm blood flow

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Key Findings From Recent Key Findings From Recent LipidLipid--Lowering TrialsLowering Trials

2002 2003 2004 2005

HPSBenefit in CVD and DM regardless of baseline LDL-C

ASCOT-LLABenefit in high-

risk HTN regardless of

baseline LDL-C

CARDSBenefit in DM

TNTBenefit of

intensive vsmoderate

lipid loweringin stable CAD

ALLHAT-LLTNeutral effect in HTN

with mildlipid lowering

PROVE IT-TIMI 22Early and late benefit of intensive vs moderate lipid lowering in ACS

Primary preventionSecondary prevention (ACS)Secondary prevention (stable CAD)

4DNeutral effect

in ESRD

A to ZLate benefit of

intensive vs moderate lipid lowering in ACS

IDEALBenefit of intensive vs moderate lipid lowering

in stable CAD

Key Findings From Recent BP-Lowering Trials

2002 2003 2004 2005

ALLHATsimilar CHD outcomes for diuretic, CCB,

and ACEI; diuretic superior in preventing HF

(and stroke & CVD vs ACEI)

INVESTCCB ± ACEIequivalent to β-blocker

± diuretic in hypertension

+ CAD

VALUEARB and CCB

similar in composite 10

EP; CCB lower MI rate

ASCOT-BPLABenefit of

CCB ± ACEI vs β-blocker ± diuretic

in high-risk hypertension without CAD

CAMELOTadding CCB

reduced events in hypertension

+ CAD

β-blocker meta-analysis

Increased risk of stroke vs other

antihypertensives

Target BP (mm Hg)No. of antihypertensive agents

1Trial 2 3 4

AASK MAP < 92

UKPDS DBP < 85

ABCD DBP < 75

MDRD MAP < 92

HOT DBP < 80

IDNT SBP < 135/DBP < 85

ALLHAT SBP < 140/DBP < 90

Multiple Antihypertensive Agents Are Needed to Achieve Target BP

DBP, diastolic blood pressure; DM, diabetes mellitus; MAP, mean arterial pressure; SBP, systolic blood pressure. Bakris GL, et al. Am J Kidney Dis. 2000;36(3):646-661. Lewis EJ, et al. N Engl J Med.2001;345(12):851-860. Cushman WC, et al. J Clin Hypertens. 2002;4(6):393-404. Dahlöf B, et al. Lancet.2005;366(9489):895-906.

ASCOT < 140/90 (< 130/80 DM)

Dia

betic

CK

D

β-Blockers Associated with Sexual Dysfunction

a.No statistically significant differences in incidence of erectile dysfunction among various types of antihypertensive medications bSexual behavior in women.

Drug Incidence of Sexual Dysfunction(% of pts) Source

AtenololPlacebo

113

Wassertheil-Smoller et al. Ann Intern Med.1991;114:613.

AtenololLisinopril

173

Fogari et al.Am J Hypertens.1998;11:1244.

CarvedilolValsartan

13.50.9

Fogari et al.Am J Hypertens. 2001;14:27.

β-blockera

CCBs31.718.3

Burchardt M et al. J Urol. 2000;164(4):1188-91.

Atenololb

LisinoprilDesire (-18%)/Fantasies (-23%)Desire (+38%)/Fantasies (+51%)

Fogari et al.Am J Hypertens. 2004;17:77.

JNC 7: Algorithm for JNC 7: Algorithm for Treatment of HypertensionTreatment of Hypertension

Initial Drug Choices

Drug(s) for the compelling indications

Diuretics, ACEI, ARB, βB, or CCB as

needed.

With Compelling Indications

Stage 2 Hypertension(SBP ≥ 160 or

DBP ≥ 100 mm Hg)

2-drug combination for most. (Thiazide-type diuretic and ACEI or ARB or βB or CCB.)

Stage 1 Hypertension(SBP 140–159 or

DBP 90–99 mm Hg)

Thiazide-type diuretics for most. May consider ACEI, ARB, βB, CCB,

or combination.

Without Compelling Indications

Chobanian AV, et al. JAMA. 2003;289(19):2560-2572.

AA, aldosterone antagonist; ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotensin II-receptor blocker; βB, ß-blocker; CCB, calcium channel blocker; MI, myocardial infarction; CAD, coronary artery disease.Chobanian AV, et al. JAMA. 2003;289(19):2560-2572.

Heart failure

Post-MI

High CAD risk

Diabetes

Chronic kidneydisease

Recurrent strokeprevention

ACEI ARB CCB AADiuretic βB

The Seventh Report of the Joint National Committee

Compelling Indications

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Summary

• Some HTN studies and meta-analyses have shown inferior CV outcomes with β-blockers.

• The β-blockers are of critical importance in the management of patients with cardiovascular disease in general, and are useful in HTN.

• Vasodilating β-blockers (carvedilol, nebivolol) are associated with improved tolerability (metabolic, symptoms) and have a better hemodynamic profile.

• Future trials of newer β-blockers may clarify their role in HTN.

Case Review for Complicated Hypertension

Case: 55-Year-Old Woman With Multiple CVD Risk Factors

New patient • 55-year-old woman; smoker • Previously diagnosed with slightly elevated BP,

cholesterol, and glucose levels – Refused suggested medications

• States she is “a little overweight”– Asks to be prescribed weight loss pills

• Father died at age 62 of a heart attack • Mother, age 74, developed diabetes in her mid-50s

Case: 55-Year-Old Woman With Multiple CVD Risk Factors

• Total cholesterol: 238 mg/dL• LDL-C: 105 mg/dL• HDL-C: 32 mg/dL • Triglycerides: 350 mg/dL • Fasting glucose: 112 mg/dL• HbA1C: 7.0• Creatinine: 1.3 mg/dL• Estimated GFR (MDRD): 62

mL/min/1.73 m2

• Height: 5’5”• Weight: 196 lb• BMI: 32.6 kg/m2

• Waist: 44” (central obesity)• BP: 160/96 mm Hg• Pulse: 72 bpm• Heart: RRR without murmur

Physical exam Labs

RRR: Regular Rate and Rhythm;GFR: Glomerular Filtration Rate; MDRD: Modification of Diet in Renal Disease

ARS Question 1Assuming lifestyle intervention has beenimplemented, which of the following CV riskfactors need pharmacological treatment?

1. Blood Pressure2. Triglycerides3. Glucose4. 1 & 35. All of the Above

Patient

Patient has all 5 risk factors

Adapted with permission from Grundy SM, et al. Circulation. 2004;109:433-438.

AHA/NHLBI-Modified ATP III Criteria for Metabolic Syndrome

Risk factor Defining level

Abdominal obesity Waist circumferenceMen > 40 inWomen > 35 in

Triglycerides (mg/dL) ≥ 150HDL-C (mg/dL)

Men < 40Women < 50

BP (mm Hg) ≥ 130/≥ 85Fasting glucose (mg/dL) ≥ 100 112

44

32

350

160/96

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Case: 55-Year-Old Woman With Multiple CVD Risk Factors

Diagnosis:• Hypertension with metabolic syndrome • Dyslipidemia• Smoker

Patient is identified as being at moderate risk for a CV event by Framingham risk score (17% 10-year risk)

ARS Question 2

In addition to low dose aspirin, she agrees to take a “couple” of pills; which of these would be most useful?

1. RAS blocker/calcium antagonist 2. Calcium antagonist with a statin plus fixed dose

of a RAS blocker/diuretic3. RAS blocker/β-Blocker plus fenofibrate4. RAS blocker/calcium antagonist plus fenofibrate5. RAS blocker/calcium antagonist plus niacin

Case: 50-Year-Old Man With T2DM and CAD

• 50-year-old man• Being seen for increased triglycerides

refractory to fibrates• Past medical history:

– Diagnosed with T2DM at age 42– 5 vessel CAD with CABG at age 47

• Family history:– Father died at age 62 with CAD– Paternal grandfather died at age 65 with CAD– Mother and maternal grandmother with T2DM

T2DM: Type 2 Diabetes Mellitus; CAD: Coronary Artery Disease; CABG: Coronary Artery Bypass Graft

Case: 50-Year-Old Man With T2DM and CAD

Medications – ASA/Warfarin– Metformin 1000 BID– Glyburide 2.5 BID– Fenofibrate 145 mg/day– Metoprolol 100 mg/day– HCTZ/triamterene 25/100 mg/d– Niacin (intermittent/noncompliant)– Fish oil x 2 grams/day– Multivitamin x 1 daily

Case: 50-Year-Old Man With T2DM and CAD

• Physical exam– 220 lbs and 71 in = BMI 30.7 kg/m2

– Central obesity– CABG scars– BP: 138/86 mm Hg– P: 56 regular

Case: 50-Year-Old Man With Type 2 DM and CAD

Lab Value Normal Range

• Fasting glucose 146 mg/dL < 100 mg/dL• HbA1C 7.8% 5% (T2DM goal < 7%)• ALT 66 IU/L ≤ 60• hsCRP 1.6 mg/L < 2.0• Insulin 28.1 uU/mL < 10• Trig 289 mg/dL < 150• LDL-C 117 mg/dL < 130• HDL-C 29.9 mg/dL ≥ 40

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ARS Question 3

How should the meds/lifestyle be adjusted?

1. Taper the metoprolol and diuretics and substitute a vasodilating beta blocker and ACE inhibitor for BP

2. Stop fenofibrate and start (titrate) sustained-release niacin 2.5 g at bedtime

3. Low carbohydrate diet/increase exercise4. Increase glyburide to 5 mg BID5. All of the above

Case: 50-Year-Old Man With T2DM and CAD: Teaching Points

Multiple cardiovascular risk factors

– s/p CABG (secondary prevention)– Dyslipidemia (Trig/HDL-C)– Obesity (BMI > 27 with comorbidities)– Diabetes