Less is More? Updates to the Management of … to the Management of Hypertension in Adults Julia...

©2017 MFMER | slide-1

Less is More? Updates to the Management of Hypertension in AdultsJulia Shlensky, PharmDPGY2 Internal Medicine Pharmacy ResidentDecember 26, 2017


Objectives• Review current definitions and treatment

recommendations for hypertension• Outline the recently published guidelines for

management of hypertension• Review the literature impacting the newly

published hypertension definitions and treatment recommendations


Timeline of Blood Pressure Guidelines


Classification of High Blood Pressure

JNC 7 2017 GuidelinesNormal SBP: <120 mm Hg

ANDDBP: <80 mm Hg

SBP: <120 mm HgAND

DBP: < 80 mm HgPrehypertension/ Elevated

SBP: 120-139 mm HgOR

DBP: 80-89 mm Hg

SBP: 120-129 mm HgAND

DBP: <80 mm HgStage 1 Hypertension SBP: 140-159 mm Hg

ORDBP: 90-99 mm Hg

SBP: 130-139 mm HgOR

DBP: 80-89 mm HgStage 2 Hypertension SBP: ≥160 mm Hg

ANDDBP: ≥100 mm Hg

SBP: ≥ 140 mm HgOR

DBP: ≥ 90 mm HgBlood Pressure: Based on an average of ≥2 readings, on ≥2 occasionsSBP: Systolic blood pressureDBP: Diastolic blood pressureClass I (strong) recommendation; Moderate quality of evidence (non-randomized)

JAMA 2003; 289: 2560-71.J Am Coll Cardiol 2017; [Epub ahead of print].


Outline of Presentation

8.1.2• Treatment Threshold and Use of Cardiovascular

Disease (CVD) Risk to Guide Therapy

8.1.5• BP Goal for Patients with Hypertension (HTN)

9.3• Recommendations for Treatment of HTN in

Patients with Chronic Kidney Disease (CKD)

9.6• Recommendations for Treatment of HTN in

Patients with Diabetes Mellitus (DM)

10.3.1• Recommendations for Treatment of HTN in Older

Persons

J Am Coll Cardiol 2017; [Epub ahead of print].


Patient Case #1• 56 M with average BP 136/81 and ASCVD risk

score of 14.9%• PMH: Hyperlipidemia• Total cholesterol: 289 mg/dL HDL: 31 mg/dL

LDL: 145 mg/dL• Pt is currently not on any antihypertensive

medications• Based on the guidelines, does this patient have

an indication for pharmacological antihypertensive therapy?


10-year ASCVD Risk Estimator

Personal History

Diabetes Hypertension Treatment Smoker Statin Aspirin

Current Labs/Exam

Total Cholesterol HDL LDL SBP

Patient Demographics

Current Age* Sex Race

*Age must be between 40-79

ASCVD: Atherosclerotic Cardiovascular DiseaseACC. ASCVD Risk Estimator Plus. Available at: http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/content/resources/ Accessed: December 10, 2017.


BP Treatment Threshold and Use of CVD Risk Estimator

Class of Recommendation

Level of Evidence Recommendation

Class I SBP: ADBP: C-EO

1. Recommend for secondary prevention of recurrent CVD events in patients with SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg, and for primary prevention in adults with an estimated 10-year ASCVD ≥ 10% and SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg

Class I C-LD 2. Recommend for primary prevention of CVD in adults with no history of CVD and with an estimated 10-year ASCVD risk <10% and an SBP ≥ 140 mm Hg or a DBP ≥ 90 mm Hg

Level of EvidenceA: High quality evidence from more than 1 randomized clinical trialC-EO: Expert opinionC-LD: Limited dataASCVD: Atherosclerotic cardiovascular disease



Treatment of Blood Pressure

JNC 7 2017 GuidelinesNormal Recheck in 2 years Recheck in 1 yearPrehypertension/ Elevated

Recheck in 1 year Recheck in 3-6 months

Stage 1 Hypertension Confirm within 2 months

PharmacologicalTreatment

Stage 2 Hypertension Evaluate or refer to source of care within 1 month

PharmacologicalTreatment

JAMA 2003; 289: 2560-71.J Am Coll Cardiol 2017; [Epub ahead of print].


Systolic Blood Pressure Intervention Trial (SPRINT)

N = 9361Design Randomized, controlled, open-label trialPatients • ≥ 50 years of age

• SBP 130-180 mm Hg• Increased CVD risk• WITHOUT diabetes or prior stroke

Intervention Intensive treatment: SBP goal of < 120 mm Hg Standard treatment: SBP goal of < 140 mm Hg

Outcome Myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes

• First-line agents: ACE inhibitor, ARB, CCB, thiazides• Coronary artery disease: Beta-blockers

N Engl J Med 2015;373:2103-16.


SPRINT

Characteristic Intensive Treatment(N = 4678)

Standard Treatment (N = 4683)

Age ≥ 75 years 1317 (28.2%) 1219 (28.2%)

Framingham risk ≥ 15% 3556 (76.0%) 3547 (75.7%)

Framingham risk, avg. 24.8 ± 12.6 24.8 ± 12.5

Baseline blood pressureSystolicDiastolic

139.7 ± 15.878.2 ± 11.9

139.7 ± 15.478.0 ± 12.0

SBP ≥ 145 mm Hg 1606 (34.3%) 1581 (33.8%)

Antihypertensive agents(number/patient)

1.8 ± 1.0 1.8 ± 1.0

Not using antihypertensive agents 432 (9.2%) 450 (9.6%)

N Engl J Med 2015;373:2103-16.


SPRINT

Outcome Intensive (N=4678)

Standard (N=4683)

Hazard Ratio P-value

Primary Outcome 243 (5.2%) 319 (6.8%) 0.75 <0.001Myocardial Infarction 97 (2.1%) 116 (2.5%) 0.83 0.19Acute CoronarySyndrome

40 (0.9%) 40 (0.9%) 1.00 0.99

Stroke 62 (1.3%) 70 (1.5%) 0.89 0.50Heart Failure 62 (1.3%) 100 (2.1%) 0.62 0.002Death from Cardiovascular Cause

37 (0.8%) 65 (1.4%) 0.57 0.005

Death from any Cause 155 (3.3) 210 (4.5%) 0.73 0.003

N Engl J Med 2015;373:2103-16.




LDL: 145 mg/dL• Pt is currently not on any antihypertensive

medications


Assessment Question #1• (True/False): Based on the guidelines, this

patient has an indication for pharmacological antihypertensive therapy.

A. TrueB. False




LDL: 92 mg/dL• Current antihypertensive medications:

Amlodipine 5 mg daily• Based on the guidelines, how is it

recommended to treat this patient’s BP?


BP Goal for Patients with Hypertension

Class of Recommendation

Level of Evidence Recommendation

Class I SBP: B-RDBP: C-EO

1. For adults with confirmed hypertension and known CVD or 10-year ASCVD ≥ 10%, a BP target of < 130/80 mm Hg is recommended.

Class IIb SBP: B-NRDBP: C-EO

2. For adults with confirmed hypertension, without additionalmarkers of increased CVD risk, a BP target of < 130/80 mm Hg may be reasonable.

Level of EvidenceB-R: Moderate quality of evidence from 1 or more RCTsB-NR: Moderate quality of evidence from 1 or more nonrandomized studiesC-EO: Expert opinion



Systolic Blood Pressure Reduction and Risk of Cardiovascular Disease and Mortality

Systemic ReviewMeta-analysis N = 42Studies Included • Participants were randomly allocated to an

antihypertensive medication, control, or treatment target

• Sample size was ≥ 100 patients in each arm• Trial duration was ≥ 6 months• The difference in mean achieved SBP between the

comparison groups was 5 mm Hg or more• Outcomes: Major CVD, stroke, coronary heart

disease (CHD), CVD mortality, or all-cause mortalityStudies Excluded • Mean achieved SBP ≥ 160 mm Hg in both

comparison groups

JAMA Cardiol. 2017;2(7):775-781.


Systolic Blood Pressure Reduction and Risk of Cardiovascular Disease and Mortality• As reduction in BP increased, the risk for

development of CVD, stroke, and CHD decreased

• Lowest risk for CVD and all-cause mortality: SBP of 120-124 mm Hg

• Overall conclusion: More intensive treatment goal offers further prevention of CVD complications and all-cause mortality

• Limitations• No evaluation of adverse events associated

with hypotension or effects on other organsJAMA Cardiol. 2017;2(7):775-781.




LDL: 92 mg/dL• Current antihypertensive medications:

Amlodipine 5 mg daily


Assessment Question #2• Based on the guidelines, how is it

recommended to treat this patient’s BP?A. Life style modifications onlyB. Decrease to amlodipine 2.5 mg dailyC. Add lisinopril 5 mg dailyD. Increase to amlodipine 10 mg daily


Patient Case #3• 63 M with average BP 135/85 • PMH: Hyperlipidemia, type 2 diabetes (DM2),

stage 3 chronic kidney disease (CKD3)• Current antihypertensive medications:




BP Recommendations for Chronic Kidney Disease

JNC 8JNC 8

• <70 years of age, eGFR<60 ml/min/1.73m2, or albuminuria

• Initiate pharmacologic treatment at:

• SBP ≥140 mm Hg or DBP ≥90 mm Hg

• Treat to goal of: • SBP <140 mm Hg or

DBP < 90 mm Hg

2017 Guidelines2017 Guidelines

• Adults with HTN and CKD should be treated to a BP goal < 130/80 mm Hg (Class I, SBP: B-RSR, DBP: C-EO)

• In adults with hypertension and CKD ( ≥ stage 3 or stage 1 or 2 w/ albuminuria), treatment with an ACE inhibitor is reasonable (Class IIa, B-R)

Level of EvidenceB-R: Moderate quality of evidence from 1 or more RCTsC-EO: Expert opinion

JAMA 2014; 311 (5): 507-20.J Am Coll Cardiol 2017; [Epub ahead of print].


SPRINT: Participants with CKD at Baseline

Outcome Intensive Treatment(N = 1330)

Standard Treatment (N = 1316)

HazardRatio

P-value

Composite renal outcomes*

14 (1.1%) 15 (1.1%) 0.89 0.76

≥ 50% reduction in estimated GFR

10 (0.8%) 11 (0.8%) 0.87 0.75

Long-term dialysis 6 (0.5%) 10 (0.8%) 0.57 0.27

Incident albuminuria 49/526 (9.3%)

59/500 (11.8%)

0.72 0.11

*First occurrence of a reduction in the estimated GFR of 50% or more, long-term dialysis, kidney transplantation

N Engl J Med 2015;373:2103-16.


BP Recommendations for Diabetes Mellitus

JNC 8JNC 8

• ≥18 years of age with diabetes




DBP < 90 mm Hg


• Adults with DM and HTN, pharmacological treatment should be initiated at a BP of ≥ 130/80 mm Hg with a treatment goal < 130/80 mm Hg (Class I, SBP: B-RSR, DBP: C-EO)

• In adults with DM and HTN, all 1st line classes of antihypertensive agents are use and effective (Class I, ASR)

Level of EvidenceA: High quality evidence from more than 1 randomized clinical trialB-R: Moderate quality of evidence from 1 or more RCTsC-EO: Expert opinionSR: Systematic Review



Lancet• Systematic Review• Objective: More intense vs less intense BP

lowering treatment on major cardiovascular events

• 5 of the 19 trials enrolled patients with DM, 1 with a baseline BP 126/84 mm Hg

• Significant reduction in cardiovascular events with more intensive lowering arm

• Limitations: inconsistent reporting of adverse events, few outcomes relative to number of patients

Lancet 2016; 387: 435–43.


Patient Case #3• 63 M with average BP 135/85 • PMH: Hyperlipidemia, DM2, CKD3• Current antihypertensive medications:





recommended to treat this patient’s BP?A. Carvedilol 3.125 mg BIDB. Hydrochlorothiazide 12.5 mg dailyC. Lisinopril 5 mg dailyD. Life style modifications only



Amlodipine 10 mg daily and lisinopril 5 mg daily• Based on the guidelines, how is it



BP Recommendations for Older Persons

JNC 8JNC 8

• ≥60 years of age




DBP < 90 mm Hg


• Noninstitutionalized ambulatory community dwelling adults (≥65 years), SBP goal of < 130 mm Hg is recommended (Class I, A)

• For adults (≥65 years) with HTN and a high burden of comorbidity and limited life expectancy, clinical judgement to assess risk/benefit is reasonable (Class IIa, C-EO)Level of Evidence

A: High quality evidence from more than 1 randomized clinical trialC-EO: Expert opinion



HYVET

• Double-blind, placebo controlled study

• ≥80 years of age, SBP ≥160 mmHg, noninstitutionalized ambulatory community dwelling adults

• Treated with either thiazide, ACE inhibitor, or placebo

• No evidence of an interaction between treatment effect and worsening of frailness

SPRINT

• Randomized, controlled, open-label trial

• ≥75 years of age at increased risk for CVD

• Secondary analysis done to examine treatment effects by frailty status and gait speed

• Significant reduction in primary outcome with 30.9% of patients being characterized as frail at baseline

BMC Medicine 2015; 13:78.N Engl J Med 2015;373:2103-16.


SPRINT

Serious Adverse Event Intensive (N=4678)

Standard (N=4683)

Hazard Ratio

P-value

Hypotension 110 (2.4%) 66 (1.4%) 1.67 0.001Syncope 107 (2.3%) 80 (1.7%) 1.33 0.05Electrolyte abnormality 144 (3.1%) 107 (2.3%) 1.35 0.02Injurious fall* 105 (2.2%) 110 (2.3%) 0.95 0.71Acute kidney injury 193 (4.1%) 117 (2.5%) 1.66 <0.001Orthostatic hypotension, without dizziness

777 (16.6%) 857 (18.3%) 0.88 0.01

*Injurious fall was defined as a fall that resulted in evaluation in an emergency department or resulted in hospitalization

N Engl J Med 2015;373:2103-16.



Amlodipine 10 mg daily and lisinopril 5 mg daily• Based on the guidelines, how is it




recommended to treat this patient’s BP?A. Decrease dose of lisinopril or amlodipineB. Increase dose of lisinopril to 10 mg dailyC. Add on a third antihypertensive agentD. Stop all antihypertensive agents


Summary

2017 GuidelinesTreatmentthreshold

• Secondary prevention: SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg

• Primary prevention: 10-year ASCVD ≥ 10% and SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg

• Primary prevention: No history of CVD, 10-year ASCVD risk <10% and SBP ≥ 140 mm Hg or DBP ≥ 90 mm Hg

Goal BP • 10-year ASCVD ≥ 10%: BP target of < 130/80 mm HgCKD • Treatment goal < 130/80 mm Hg DM • Treatment goal < 130/80 mm Hg ≥ 65 years of age* • Treatment goal < 130/80 mm Hg * Noninstitutionalized ambulatory community dwelling adults



Less is More? Updates to the Management of Hypertension in AdultsJulia Shlensky, PharmDPGY2 Internal Medicine Pharmacy ResidentDecember 26, 2017

Less is More? Updates to the Management of … to the Management of Hypertension in Adults Julia...

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