blood pressure guidelines - …cme.baptisthealth.net/cvdprevention/documents/2015/2015...co-chair,...

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Suzanne Oparil, MDDistinguished Professor of Medicine, Professor of Cell, Developmental and Integrative BiologyDirector, Vascular Biology and Hypertension Program of the Division of Cardiovascular Disease

Co-chair, “Evidence-Based Guideline for the Management of High Blood Pressure in Adults (JNC 8)”University of Alabama at Birmingham, Birmingham, Alabama

Past President, American Heart Association (AHA)Past President, American Society of Hypertension (ASH)

13th Annual Cardiovascular Disease Prevention SymposiumBaptist Health South Florida

Miami, FloridaFebruary 20, 2015

JNC 8 JNC 8 BLOOD PRESSURE GUIDELINESBLOOD PRESSURE GUIDELINES

Faculty DisclosureFaculty DisclosureSuzanne Oparil, MDSuzanne Oparil, MD

The below relationships listed are potential conflict of interest, but are NOT considered to influence this presentation. Disclosures are listed below (previous 12 months):

Consultant/Advisory Board: AstraZeneca AB, Bayer, Daiichi Sankyo Inc., Forest Labs, Inc., Medtronic Vascular Inc., Novartis, and Takeda Global R&D.

Grant/Research Support: AstraZeneca AB (Duke Univ), Bayer Healthcare Pharma, Inc., Merck and Co., NIH/NHLBI (Brigham and Women’s Hosp. Cntr CVD Prev), Novartis

Other: Co-chair, “JNC Guidelines for the Management of High Blood Pressure in Adults – JNC 2014”; Research Support - Educational Grant for Annual Vascular Biology & Hypertension Symposium: Sponsorship received by: (2013) UAB Comprehensive Cardiovascular Center, Daiichi Sankyo, Inc., Amarin Pharma Inc., and LipoScience; and (2014) Arbor Pharmaceuticals, LLC.

JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427. Published online December 18, 2013.http://jama.jamanetwork.com/article.aspx?articleid= 1791497

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The History: Old JNCsThe History: Old JNCs

Development of clinical practice guidelines was a key role for NHLBI in those years

Joint National Committee on Prevention, Detection,

Evaluation, & Treatment of High Blood Pressure (JNC)

JNC 7: 2003JNC 6: 1997 JNC 5: 1992JNC 4: 1988 JNC 3: 1984 JNC 2: 1980 JNC 1: 1976

Detection, Evaluation, and Treatment of High Blood

Cholesterol in Adults (ATP, Adult Treatment Panel)

ATP III Update: 2004ATP III: 2002 ATP II: 1993ATP I: 1988

Clinical Guidelines on the Identification, Evaluation, &

Treatment of Overweight and Obesity in Adults

Obesity 1: 1998

5

80

85

90

95

100

105

110

115

120

125

130

JNC I JNC II JNC III JNC IV JNC V JNC VI

Considertherapy

Hyper-tensive

Mild Mild Mild

Stage 1 Stage 1

Moderate Moderate Moderate

Stage 2

Severe Severe SevereStage 3 Stage 3

Stage 2

Stage 4

High-normal

High-normal

High-normal

High-normal

Normal Normal Normal Normal

Optimal

DBP(mm Hg)

Optimal

JNC 7

Stage 1

Stage 2

Prehyper-tension

Normal

JNC IV. Arch Intern Med. 1988;148:1023-1038.JNC V. Arch Intern Med. 1993;153:154-183.JNC VI. Arch Intern Med. 1997;157:2413-2446.Chobanian AV et al. JAMA. 2003;289:2560-2572.

JNC I. JAMA. 1977;237:255-261.JNC II. Arch Intern Med. 1980;140:1280-1285.JNC III. Arch Intern Med. 1984;144:1045-1057.

Hypertension: A Moving TargetHypertension: A Moving TargetJNC BP Classifications: DBPJNC BP Classifications: DBP

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JNC V

Optimal110

120

130

140

150

160

170

180

190

200

210

220

JNC IV. Arch Intern Med. 1988;148:1023-1038.JNC V. Arch Intern Med. 1993;153:154-183.JNC VI. Arch Intern Med. 1997;157:2413-2446.Chobanian AV et al. JAMA. 2003;289:2560-2572.

JNC I JNC II JNC III JNC IV JNC VI

Border-line

ISH

Stage 1 Stage 1

Stage 2

Stage 3

High-normal

High-normal

Normal Normal

Optimal

SBP(mm Hg)

Normal

Border-line

ISH

Stage 4

No recommendations for SBP in JNC I

or JNC II

JNC 7

Stage 1

Prehyper-tension

Normal

Stage 3

Stage 2

JNC I. JAMA. 1977;237:255-261.JNC II. Arch Intern Med. 1980;140:1280-1285.JNC III. Arch Intern Med. 1984;144:1045-1057.

Hypertension: A Moving TargetHypertension: A Moving TargetJNC BP Classifications: SBPJNC BP Classifications: SBP

Stage 2

0

2

4

6

8

10

12

Inci

denc

e of

ca

rdio

vasc

ular

dis

ease

120

Does Hypertension Treatment Effect In RCTs Mirror Observational Data?

140 160 180 200 220Systolic blood pressure (mmHg)

99

New U.S. Approach to Hypertension Guideline Development

• Evidence-based

• Standardized coordinated guideline updates

• Evidence-based approach to implementation; emphasize user needs and implementabilityPrimary care, specialists, and patients/consumersUser friendly with clear focused messages

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How the Process Has Evolved

• Strictly evidence-based

• Focus only on randomized controlled trials assessing important health outcomes (no use of intermediate/surrogate measures)

• Every included study is rated for quality by two independent reviewers using standardized tools

• Evidence statements graded for quality using prespecifiedcriteria

• Separate grading for recommendations

• Independent methodology team to ensure objectivity of the review

• Initial set of recommendations focused on 3 key questions

Critical Critical Questions Questions Identified by the Identified by the PanelPanel

This 2014 HTN evidenceThis 2014 HTN evidence--based guideline based guideline focuses on the panel’s 3 highest ranked focuses on the panel’s 3 highest ranked questions related to HTN managementquestions related to HTN management

1. In adults with HTN, does initiating antihypertensive pharmacologic therapy at specific BP thresholds improve health outcomes?

2. In adults with HTN, does treatment with antihypertensive pharmacologic therapy to a specified BP goal lead to improvements in health outcomes?

3. In adults with HTN, do various antihypertensive drugs or drug classes differ in comparative benefits and harms on specific health outcomes?

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Evidence-Based Clinical Practice Guidelines for CVD PreventionEvidence-Based Clinical Practice Guidelines for CVD Prevention

Evidence Quality Grading and Recommendation Strength

Evidence QualityFor each ES

�High � Well-designed and conducted

RCTs

�Moderate � RCTs with minor limitations

� Well-conducted observational studies

�Low� RCTs with major limitations

� Observational studies with major limitations

StrengthOf each Recommendation

�A – Strong

�B – Moderate

�C – Weak

�D – Against

�E – Expert Opinion

�N – No Recommendation

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The Most Important Clinical The Most Important Clinical Questions in HypertensionQuestions in Hypertension

�Does evidence from RCTs of antihypertensive treatment support (or refute) 140/90 mm Hg as a treatment threshold or goal?

�Should the threshold or goal be lower or higher in persons with diabetes or CKD, the elderly or those with other co-morbidities or special characteristics?

� Is there RCT evidence that BP lowering treatment with a particular drug or drug class improves outcomes compared to any other drug/drug class?

James PA, Oparil S, Carter BL, et al. JAMA 2014;311(5):507-520. doi:10.1001/jama.2013.284427.

ThresholdsThresholds

The panel decided that, although some The panel decided that, although some trials had higher thresholds for trials had higher thresholds for eligibility than the goals tested, eligibility than the goals tested, translation into practice should make translation into practice should make the threshold for initiating the threshold for initiating antihypertensive treatment the same antihypertensive treatment the same as the BP treatment goal.as the BP treatment goal.

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Major Trials Testing SBP Goals in Major Trials Testing SBP Goals in General PopulationsGeneral Populations

SHEP Syst-Eur HYVET JATOS VALISH

Age > 60 > 60 > 80 65-85 >70, <85

Number 4,736 4,695 3,845 4,418 3,260

Entry SBP 160-219 160-219 160-199 ≥160 ≥160

Goal SBP <148 <150 <150 <140 <140

Achieved SBP 142 151 144 136 137

Stroke �� 36% 42% ns ns ns

CVD �� 32% 31% 34% ns ns

Mortality �� ns ns 21% ns ns

SBP = systolic blood pressure CVD = car diovascular disease

Diastolic BP Goal Trials

Several trials used DBP goal <90 mm Hg and demonstrated consistent reduction of CVD events, e.g., VA morbidity trial, HDFP, MRC trial, …

Recommendation 1

• In the general population ≥60 years of age, initiate pharmacologic treatment to lower BP at SBP ≥150 mm Hg or DBP ≥90 mm Hg and treat to a goal SBP <150 mm Hg and goal DBP <90 mm Hg.– Strong Recommendation – Grade A

• Corollary Recommendation: In the general population ≥60 years of age, if pharmacological treatment for high BP results in lower achieved SBPs (for example, <140 mm Hg) and treatment is not associated with adverse effects on health or quality of life, treatment does not need to be adjusted.– Expert Opinion – Grade E

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Why is it important not to recommend Why is it important not to recommend intensifying medications to reduce BP below the intensifying medications to reduce BP below the

level proven in trials?level proven in trials?

•• Lower thresholds/goals identify a much larger Lower thresholds/goals identify a much larger population as having population as having ““““““““HTNHTN”””””””” and presumably needing and presumably needing drug therapy. (e.g., reducing definition of HTN fro m drug therapy. (e.g., reducing definition of HTN fro m 140/90 to 120/80 mm Hg doubles those with 140/90 to 120/80 mm Hg doubles those with ““HTNHTN” ”))

•• Millions classified as Millions classified as ““““““““HTNHTN”””””””” based on higher BP based on higher BP goals require more drugs to achieve lower BP goals.goals require more drugs to achieve lower BP goals.

•• Treating to lower BP levels may be harmful Treating to lower BP levels may be harmful (J(J--curve?).curve?).

•• If neither beneficial nor harmful, resources would be If neither beneficial nor harmful, resources would be wasted and patient adherence may suffer. wasted and patient adherence may suffer.

Recommendation 2

• In the general population <60 years of age, initiate pharmacologic treatment to lower BP at DBP ≥90 mm Hg and treat to a goal DBP <90 mm Hg. – For ages 30-59 years, Strong Recommendation –

Grade A– For ages 18-29 years, Expert Opinion – Grade E

Recommendation 3• In the general population <60 years of age,

initiate pharmacologic treatment to lower BP at SBP ≥140 mm Hg and treat to a goal SBP <140 mm Hg.– Expert Opinion – Grade E




� Is there RCT evidence that BP lowering treatment with a particular drug or drug class improves outcomes compared to any other drug/drug class?


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BP Targets in Chronic Kidney BP Targets in Chronic Kidney Disease (CKD)Disease (CKD)

●● 3 RCTs (8 reports), total of 2272 participants:3 RCTs (8 reports), total of 2272 participants:

��MDRDMDRD (Modification of Diet in Renal (Modification of Diet in Renal Disease) Study Disease) Study

��AASKAASK (African American Study of Kidney (African American Study of Kidney Disease and Hypertension) Trial Disease and Hypertension) Trial

��REINREIN--22 (Ramipril Efficacy in Nephropathy 2) (Ramipril Efficacy in Nephropathy 2) trial trial

●● No conclusive evidence favoring a BP target of No conclusive evidence favoring a BP target of <125/75 to 130/80 mm Hg rather than <140/90 <125/75 to 130/80 mm Hg rather than <140/90 mm Hg. mm Hg.

Upadhyay A, et al (Tufts). Annals Intern Med 2011Upadhyay A, et al (Tufts). Annals Intern Med 2011

Recommendation 4

• In the population ≥18 years of age with CKD, initiate pharmacologic treatment to lower BP at SBP ≥140 mm Hg or DBP ≥90 mm Hg and treat to goal SBP <140 mm Hg and goal DBP <90 mm Hg.– Expert Opinion – Grade E

RCTs Testing BP Goals In Hypertensive Diabetic Patients

Trial nDuration(years)

SBP goal,mmHg

DBP goal, mmHg

Mean BP, less

intense,mmHg

Mean BP, more

intense, mmHg

OutcomeRisk Reduction

SHEP 583 5 <148 none 155/72 ° 146/68°Stroke 22% (ns)CVD 34%CHD 56%

Syst-Eur 492 2 <150 none 162/82 153/78Stroke 69%CVD 62%

HOT 1,501 3 none <80 148/85 144/81

CVD 51%MI 50%Stroke 30% (ns)CV death 67%

UKPDS 1,148 8.4 <150 <85 154/87 144/82

DM-related 34%deaths 32%Stroke 44%Microvasc 37%

ABCD 470 5.3 none <75 138/86 132/78

Renal (1º) ncMicrovasc ncDeath 49%CVD ns

ACCORD 4,733 4.7 <120 none 134 119 CVD (1º) 12% (ns)Stroke 41%

Ferrannini, Cushman. Lancet 2012;380:601-10.

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Recommendation 5

• In the population ≥18 years of age with diabetes, initiate pharmacologic treatment to lower BP at SBP ≥140 mm Hg or DBP ≥90 mm Hg and treat to a goal SBP <140 mm Hg and goal DBP <90 mm Hg. (Expert Opinion – Grade E)

The National Committee for Quality Assurance (NCQA) released the 2015 edition of the Healthcare Effectiveness Data and Information Set Healthcare Effectiveness Data and Information Set (HEDIS(HEDIS®®)), the gold standard in healthcare performance measurement. The 2015 HEDIS included changes to several existing measures.

Controlling Controlling High High BPBP: NCQA added age and condition-specific treatment goals that align with the Eighth Joint National Committee (JNC 8) hypertension guidelines :

� 18–59 years (<140/90 mm Hg) � 60–85 years with diabetes (<140/90 mm Hg) � 60–85 years without diabetes (<150/90 mm Hg)

Updated HEDIS ® Quality Measures

http://store.ncqa.org/index.php/performance-measurement/hedis-2015.html

Moran AE, et al. N Engl J Med 372:447-455, 2015. DOI: 10.1056/NEJMsa1406751.

BackgroundBackgroundOn the basis of the 2014 guidelines for hypertension therapy in the U.S., many eligible adults remain untreated. We projected the cost-effectiveness of treating hypertension in U.S. adults according to the 2014 guidelines.

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Moran AE, et al. N Engl J Med 372:447-455, 2015. DOI: 10.1056/NEJMsa1406751.

ConclusionsConclusionsThe implementation of the 2014 hypertension guidelines for U.S. adults between the ages of 35 and 74 years could potentially prevent about 56,000 CV events and 13,000 deaths annually, while saving costs. Controlling hypertension in all patients with CVD or stage 2 hypertension could be effective and cost-saving. (Funded by the NHLBI and others.)




�Is there RCT evidence that BP lowering treatment with a particular drug or drug class improves outcomes compared to any other drug/drug class?


Recommendation 6

• In the general non-Black population, including those with diabetes, initial antihypertensive treatment should include a thiazide-type diuretic, CCB, ACEI or ARB.– Moderate Recommendation – Grade B

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Initial Combinations of MedicationsInitial Combinations of MedicationsInitial Combinations of MedicationsInitial Combinations of Medications

DiureticsDiuretics

ACE inhibitorsACE inhibitorsoror

ARBs*ARBs*

CalciumCalciumantagonistsantagonists

* Combining ACEI with ARB discouraged

ββββββββ--blockers should be included in the regimen if blockers should be included in the regimen if there is a compelling indication for a there is a compelling indication for a ββββββββ--blockerblocker

Drugs to Add to Initial 2Drugs to Add to Initial 2--3 Drug 3 Drug CombinationsCombinations

•• spironolactone or amiloridespironolactone or amiloride : especially if K: especially if K ++

low or 1low or 1 °°°°°°°° aldosteronism.aldosteronism.•• alpha blockeralpha blocker : especially if LUTS: especially if LUTS•• alternative CCBalternative CCB : don: don ’’’’’’’’t combine nont combine non--DHP c BBDHP c BB•• betabeta--blockerblocker : safe to combine (except c non: safe to combine (except c non--

DHP CCB), but doesnDHP CCB), but doesn ’’’’’’’’t add much efficacy to t add much efficacy to RAS blocker.RAS blocker.

•• vasodilatorvasodilator : hydralazine or minoxidil: hydralazine or minoxidil•• alphaalpha--beta blockerbeta blocker : labetolol or carvedilol: labetolol or carvedilol•• central agonistcentral agonist : most side effects frequency: most side effects frequency

1.29 (0.94 1.29 (0.94 -- 1.75)1.75)ESRDESRD

1.32 (1.11 1.32 (1.11 -- 1.58)1.58)Heart FailureHeart Failure

1.40 (1.17 1.40 (1.17 -- 1.68)1.68)StrokeStroke

1.19 (1.09 1.19 (1.09 -- 1.30)1.30)Combined CVDCombined CVD

1.06 (0.95 1.06 (0.95 -- 1.18)1.18)MortalityMortality

1.10 (0.94 1.10 (0.94 -- 1.28)1.28)CHDCHD

Favors FavorsFavors FavorsLisinopril ChlorthalidoneLisinopril Chlorthalidone

0.500.50 11 22

0.93 (0.67 0.93 (0.67 -- 1.30)1.30)

1.15 (1.01 1.15 (1.01 -- 1.30)1.30)

1.00 (0.85 1.00 (0.85 -- 1.17)1.17)

1.06 (1.00 1.06 (1.00 -- 1.13)1.13)

0.97 (0.89 0.97 (0.89 -- 1.06)1.06)

0.94 (0.85 0.94 (0.85 -- 1.05)1.05)

0.50 1 2 0.50 1 2

Only Subgroup Differences:Only Subgroup Differences:Lisinopril vs Chlorthalidone in Lisinopril vs Chlorthalidone in

Blacks/NonBlacks/Non--Blacks for CVD & Stroke Blacks for CVD & Stroke

BlacksBlacks NonNon--BlacksBlacks

Favors FavorsFavors FavorsLisinopril ChlorthalidoneLisinopril Chlorthalidone

ALLHAT

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Recommendation 7

• In the general Black population, including those with diabetes, initial antihypertensive treatment should include a thiazide-type diuretic or CCB.– For general Black population: Moderate

Recommendation – Grade B– For Blacks with diabetes: Weak

Recommendation – Grade C

Recommendation 8

• In the population ≥18 years of age with CKD and HTN, initial (or add-on) antihypertensive treatment should include an ACEI or ARB to improve kidney outcomes. This applies to all CKD patients with HTN regardless of race or diabetes status.– Moderate Recommendation – Grade B

Recommendation 9

• The main objective of HTN treatment is to attain and maintain goal BP.

• If goal BP is not reached within a month of treatment, increase the dose of the initial drug or add a 2nd drug from one of the classes in Recommendation 6 (thiazide-type diuretic, CCB, ACEI or ARB). Continue to assess BP and adjust the treatment regimen until goal BP is reached.

• If goal BP cannot be reached with 2 drugs, add and titrate a 3 rd drug from the list provided. Do not use an ACEI and an ARB together in the same patient.

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Recommendation 9, cont

• If goal BP cannot be reached using the drugs in Recommendation 6 because of a contraindication or the need to use more than 3 drugs to reach goal BP, antihypertensive drugs from other classes can be used.

• Referral to a hypertension specialist may be indicated for patients in whom goal BP cannot be attained using the above strategy or for the management of complicated patients where additional clinical consultation is needed.– Expert Opinion – Grade E

2014 Hypertension Guideline 2014 Hypertension Guideline Management Algorithm Management Algorithm

JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427. Published online December 18, 2013.

http://jama.jamanetwork.com/article.aspx?articleid= 1791497

JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427Copyright © 2014 American Medical Association. All rights reserved.

Figure Legend: SBP=systolic blood pressure; DBP=diastolic blood pressure; ACEI=angiotensin-converting enzyme; ARB=angiotensin receptor blocker; and CCB=calcium channel blocker. a ACEIs and ARBs should not be used in combination. b If blood pressure fails to be maintained at goal, reenter the algorithm where appropriate based on the current individual therapeutic plan.

2014 Hypertension Guideline Management Algorithm 2014 Hypertension Guideline Management Algorithm

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JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427 Copyright © 2014 American Medical Association. All rights reserved



JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427 Copyright © 2014 American Medical Association. All rights reserved



Question 4Question 4When should one start with single drug therapy and step up the dose (and how high should one go) vs. switch ing to a new drug vs. addition of a new drug vs. starti ng with 2 or more drugs vs. using fixed ‐‐‐‐dose combination drug formulations?

Do these choices depend on:

� Level of initial BP?� Other risk factors and overall CVD risk?� Other co‐morbid conditions?� Sex, race, or age?

SupplementalSupplemental QuestionsQuestions


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Question 5Question 5What are the roles of home BP monitoring, office ‐‐‐‐based BP monitoring and 24-hr ABPM in the diagnosis and management of hypertension?

o Is home-based BP monitoring for patients who are well controlled + as needed office-based monitoring as good as regular office-based follow up?

o How frequently should BP be monitored for high BP in patients controlled and uncontrolled?

SupplementalSupplemental QuestionsQuestions


Thank you!Thank you!

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