Are the New “Lenient” Hypertension Guidelines Best for Patients? Edward C. Miner, MD FACC

March 7, 2015

Updates in Cardiology, 2015

No Conflicts of Interest

#1. New Guidelines (JNC VIII)

Eleven years since JNC VII More “evidence-based” Less “expert opinion” Less aggressive treatment overall, less aggressive in subgroups.

Copyright © 2014 American Medical Association. All rights reserved.

From: 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8)

JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427

Comparison of Current Recommendations With JNC 7 Guidelines

Figure Legend:

#1. New Guidelines (JNC VIII)

In the general population aged ≥60 years, initiate pharmacologic treatment to lower blood pressure (BP) at systolic blood pressure (SBP) ≥150 mm Hg or diastolic blood pressure (DBP) ≥90 mm Hg and treat to a goal SBP <150 mm Hg and goal DBP <90 mm Hg. (Strong Recommendation – Grade A)

#1. New Guidelines (JNC VIII)

Corollary: In the general population aged ≥60 years, if pharmacologic treatment for high BP results in lower achieved SBP (eg, <140 mm Hg) and treatment is well tolerated and without adverse effects on health or quality of life, treatment does not need to be adjusted. (Expert Opinion – Grade E)

#2. New Guidelines (JNC VIII)

In the general population <60 years, 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)

#3. New Guidelines (JNC VIII)

In the general population <60 years, initiate pharmacologic treatment to lower BP at SBP ≥140 mm Hg and treat to a goal SBP <140 mm Hg. (Expert Opinion – Grade E)

#4. New Guidelines (JNC VIII)

In the population aged ≥18 years with chronic kidney disease (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)

#5. New Guidelines (JNC VIII)

In the population aged ≥18 years 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)

New Guidelines (JNC VIII)

Less aggressive treatment overall. No more goal of 130/80 in DM or CRI. Beta-blockers are NOT recommended as first line (or second line) treatment.

Figure 1, D Outcome data for atenolol versus other antihypertensive treatment

Lars Hjalmar Lindholm , Bo Carlberg , Ola Samuelsson

Should β blockers remain first choice in the treatment of primary hypertension? A meta-analysis

The Lancet, Volume 366, Issue 9496, 2005, 1545 - 1553

http://dx.doi.org/10.1016/S0140-6736(05)67573-3

Figure 1, D Outcome data for atenolol versus other antihypertensive treatment

Lars Hjalmar Lindholm , Bo Carlberg , Ola Samuelsson

Should β blockers remain first choice in the treatment of primary hypertension? A meta-analysis

The Lancet, Volume 366, Issue 9496, 2005, 1545 - 1553

http://dx.doi.org/10.1016/S0140-6736(05)67573-3

Beta blockers no longer first line

• JNC 8 recommends against using beta-blockers as first (or second!) line.

• Can add on if not achieving BP goal after 3 other medications.

• Stable CAD (normal EF, no MI/angina) not an indication for beta blocker.

HYVET Trial: Study Design

Primary Endpoint: fatal and non-fatal strokes Secondary Endpoints: death from: stroke, cardiovascular causes, cardiac causes and any cause

Active Treatment 1.5 mg Indapamide (SR) n=1933

Placebo Matching Dose n=1912

3845 patients > 80 years with continual hypertension and systolic blood pressure ≥ 160 mm Hg prior to randomization Prospective. Randomized. Double Blind. Placebo-Controlled. Mean follow-up 1.8 yr. Target blood pressure of 150/80 mmHg.

N Engl J Med 2008;358/ACC 2008

R

2 yrs. follow-up

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Characteristic Active

Treatment (n=1933)

Placebo

(n=1912) CV disease (%) 223 (11.5) 229 (12.0) Hypertension (%) 1737 (89.9) 1718 (89.9) Antihypertensive Tx (%) 1241 (64.2) 1245 (65.1) Stroke (%) 130 (6.7) 131 (6.9) Myocardial Infarction (%) 59 (3.1) 62 (3.2) Heart Failure (%) 56 (2.9) 55 (2.9) Current Smoker (%) 123 (6.4) 127 (6.6) Diabetes (%) 132 (6.8) 131 (6.9)

HYVET Trial: Baseline Characteristics

N Engl J Med 2008;358/ACC 2008 Copyleft Clinical Trial Results. You Must Redistribute Slides

End Point Rate per 1000 Patient-Yr (No. of Events)

Unadjusted Hazard Ratio

Indapamide Placebo (95% CI) p-value

No. (%)

Fatal/nonfatal stroke 12.4 (51) 17.7 (69) 0.70 (0.49-1.01) 0.06

Death from stroke 6.5 (27) 10.7 (42) 0.61 (0.38-0.99) 0.046

Death from any cause 47.2 (196) 59.6 (235) 0.79 (0.65-0.95) 0.02

Death from non-CV/ unknown causes 23.4 (97) 28.9 (114) 0.81 (0.62-1.06) 0.12

Death from CV cause 23.9 (99) 30.7 (121) 0.77 (0.60-1.01) 0.06

N Engl J Med 2008;358/ACC 2008

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HYVET Trial: Outcomes Main Fatal and Nonfatal End Points in the Intention-to-Treat Population

End Point Rate per 1000 Patient-Yr (No. of Events)

Unadjusted Hazard Ratio

Indapamide Placebo (95% CI) p-value No. (%)

Death from cardiac cause* 6.0 (25) 8.4 (33) 0.71 (0.42-1.19) 0.19

Death from heart failure 1.5 (6) 3.0 (12) 0.48 (0.18-1.28) 0.14

Any fatal or nonfatal MI 2.2 (9) 3.1 (12) 0.72 (0.30-1.70) 0.45

Any fatal or nonfatal heart failure 5.3 (22) 14.8 (57) 0.36 (0.22-0.58) <0.001

Any fatal or nonfatal cardiovascular event** 33.7 (138) 50.6 (193) 0.66 (0.53-0.82) <0.001

N Engl J Med 2008;358/ACC 2008 Copyleft Clinical Trial Results. You Must Redistribute Slides

HYVET Trial: Outcomes Main Fatal and Nonfatal End Points in the Intention-to-Treat Population

Systolic Hypertension in the Elderly Program (SHEP)

Randomized 4736 adults over age 60 with SBP >160 and DBP <90 Chlorthalidone, atenolol, reserpine OR placebo. SBP under 150 mmHg was achieved in treatment group, 37% reduction in stroke.

“The older the population, the smaller is the proportion of robust individuals. Many robust, very old individuals have hypertension. Antihypertensive treatment in those individuals is beneficial. Frail older individuals are less likely to have hypertension, and treating those who do may produce bad outcomes.” – James Goodwin, MD

SUMMARY There is very good randomized controlled trial evidence supporting treatment of significant systolic hypertension (over 160 mmHg) in healthy adults in all age groups. Treating to low target blood pressure (< 120/80 mmHg) is unproven. Being studied in SPRINT. Treating non-ambulatory patients over 65 with hypertension is possibly harmful (from NHANES data).