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NEW GUIDELINES FOR THE MANAGEMENT OF HYPERTENSION-IS THE PRESSURE OFF?
PRANAY KATHURIA, MD, FACP, FASN, FNKF
DIRECTOR, DIVISION OF NEPHROLOGY
DIRECTOR, NEPHROLOGY FELLOWSHIP
PROFESSOR OF MEDICINE
UNIVERSITY OF OKLAHOMA COLLEGE OF MEDICINE
OBJECTIVES
• Review the 2014 evidence-based guidelines for the management of hypertension in adults for patients aged 60 years or more
• Review the “The Minority View” on targeting systolic blood pressure goal of less than 150 mmHg in patients aged 60 years or older
• Summarize relevant studies
• Comment on other hypertension guidelines
HYPERTENSION IS A MAJOR HEALTH PROBLEM
• Affects 1 billion people worldwide
• US – about 1 in 3 adults
–73 million have hypertension (SBP >140/90)
• A 55-yo normotensive person has up to a 90% lifetime risk of developing hypertension (Vasan 2001)
• Number one reason listed for office visits
• Causes/contributes to 457,000 admissions per year
• A leading cause/contributor to death (MI, stroke, vascular disease)
DEVELOPMENT OF JNC-8
Commissioned by the NHLBI in 2008• Panel members appointed• Developed focused critical questions relevant to practice
In 2013, the NHLBI decides that it will no longer publish clinical guidelines
• Proposes to work collaboratively with other organizations
The panel members appointed to the JNC-8 decided to publish their findings independently
• Published online in JAMA in December 2013• Received no endorsements from other organizations
JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427
2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults
NEW HYPERTENSION GUIDELINES IN 2013
A multitude of other hypertension guidelines were also published in 2013:
• AHA/ACC/CDC advisory algorithm• American Society of Hypertension/International
Society of Hypertension (ASH/ISH)• European Society of Hypertension and European
Society of Cardiology (ESH/ESC)• Canadian Hypertension Education Program (CHEP)
COMPARISON OF RECENTGUIDELINE STATEMENTS
Adapted from Salvo M et al. Ann Pharmacother 2014;48:1242-8.
RECOMMENDATION 1
Patients aged 60+
• Treatment threshold and BP goal 150/90+• Strong Recommendation – Grade A
If treatment achieves BP <150/90, do not step-down medication (i.e. if already controlled <140, don’t change treatment)
• Expert Opinion – Grade E
HYPERTENSION IN THE ELDERLY
Fastest growing segment of the population
Prevalence of hypertension is very high
Several issues make managing HTN unique:
• Often present with isolated systolic HTN• More likely to present with comorbidities• Many clinical trials in HTN have excluded these
patients (particularly for those 80 years and older)• Elderly are more susceptible to certain adverse
effects (orthostatic hypotension)
JNC-8 IMPLICATIONS FOR THE USA
ALL US Adults Ages 18-59 Ages 60+
JNC 7: HTN 66.6 M 32.8 M 33.8 M
Controlled 26 (39.9%) 13.3 (40.5%) 13.3 (39.3%)
JNC 8: HTN 60.8 M 30.8 M 30.0 M
Controlled 34.3 (56.4%) 14.6 (47.4%) 19.7 (65.7%)
THE DATA BEHIND THE JNC 8 RECOMMENDATIONS
Placebo
Placebo
+ Placebo
+ Placebo
Indapamide SR 1.5 mg
+ Perindopril 2 mg
+ Perindopril 4 mg
M-2 M-1 M0 M3 M6 M9 M12 M18 M24 M60
International, multi-centre, randomised, double-blind, placebo-controlled
Inclusion Criteria: Exclusion Criteria:Aged 80 or more, Standing SBP < 140mmHgSystolic BP; 160 -199mmHg Stroke in last 6 months+ diastolic BP; <110 mmHg, DementiaInformed consent Need daily nursing care
Primary Endpoint: All strokes (fatal and non-fatal)
Target blood pressure
150/80 mmHg
HYpertension in the Very Elderly Trial
0 20.50.20.1
HR 95% CI
0.70 (0.49, 1.01)
0.61 (0.38, 0.99)
0.79 (0.65, 0.95)
0.81 (0.62, 1.06)
0.77 (0.60, 1.01)
0.71 (0.42, 1.19)
0.36 (0.22, 0.58)
0.66 (0.53, 0.82)
All Stroke
Stroke Death
All cause mortality
NCV/Unknown death
CV Death
Cardiac Death
Heart Failure
CV events
HYVET: ITT ANALYSIS
HYPERTENSION IN THE ELDERLY
HYVET demonstrated that treatment of HTN to goal BP less than 150/80 mm Hg in patients >80 years old was safe and effective
But…what about a lower BP goal?
And…what about the patients age 60-80?
HYPERTENSION IN THE ELDERLYTRIALS – STROKE, HF, & CHD REDUCTION
SHEP Syst-Eur
Year 1991 1997
Sample Size (N) 4, 736 4,695
Sample Characteristics
Adults ≥60 yoSBP 160-219
DBP <90
Adults ≥60 yoSBP 160-219
DBP <95
Goals SBP >180: <160SBP 160-179: ↓20
SBP <150 AND↓≥20
Median f/u 4.5 years 2 years
Quality Rating Good* Good*
JAMA. 2013;():doi:10.1001/jama.2013.284427.
*Good = least risk of bias, results considered valid
RESULTS – CARDIOVASCULAR DISEASECombined fatal and non-fatal stroke
• SHEP ↓36% (p=0.0003)• Syst-Eur ↓42% (p=0.003)
Combined fatal and non-fatal HF
• SHEP ↓49% (p<0.001)• Syst-Eur ↓29% (p=0.12)
Combined fatal/non-fatal MI, CHD death, sudden death
• SHEP • CHD events ↓25% (95% CI 0.60, 0.94)• Non-fatal MI ↓33% (95% CI 0.47, 0.96)• Non-fatal MI+CHD death ↓27% (95% CI 0.57, 0.94)
• Syst-Eur - CHD component outcomes not significant w/o HF inclusion
JAMA. 2013;():doi:10.1001/jama.2013.284427.
TRIALS ADDRESSING SBP <150 vs <140
JATOS* VALISH**
Year 2008 2010
Sample Size (N) 4,418 3,260
Sample Characteristics Adults 65-85SBP ≥ 160DBP <120
Adults 70-85SBP ≥160DBP <90
Goals Strict: <140Moderate: ≥140-<160
Strict: SBP <140Moderate: ≥140-<150
Median f/u 2 years 2.85 years
Quality Rating Good Good
JAMA. 2013;():doi:10.1001/jama.2013.284427.
*Japanese Trial to Assess Optimal SBP (JATOS)**Valsartan in Elderly Isolated Systolic Hypertension
JAPANESE TRIAL TO ASSESS OPTIMAL SBP (JATOS)
Hypertens Res. 2008;31(12):2115-2127
VALSARTAN IN ELDERLY ISOLATED SYSTOLIC HYPERTENSION
Hypertension. 2010;56(2):196-202
Dissension among the ranks!
Wright JT Jr et al. Ann Intern Med 2014;160:499-504.
JNC 8 METHODOLOGY EXCLUDED MOST STUDIES
Conducted a systematic search of pertinent literature
• Limited to randomized controlled trials (RCTs) published between 1966 and 2009
• Included patients age 18 or older with hypertension• Sample size of 100 patients or more• Results must have included “hard” outcomes• Subsequent search of studies from 2009 to 2013 required
samples of 2000 or more patients Only 2.05% of reviewed studies formed the basis of the
recommendation
Five of the 9 guidelines were opinion-based or “by expert advise only”
OTHER TRIALS TARGETING SBP < 140 MM HG
Felodipine Event reduction (FEVER) Trial
• Chinese population; age range 50-79; mean age 62 yrs• Significant reduction in CVD, mortality, CAD, HF
Secondary Prevention of Subcortical Stroke (SPS3 Trial)
• Significant reduction in stroke
2 recent meta-analyses
Observational studies
ACHIEVED BP IN STUDIES INCLUDED BY THE JNC 8 WAS LOWER
SHEP Syst-Eur HYVET
Year 1991 1997 2008
Sample Size (N) 4, 736 4,695 3,845
Sample Characteristics
Adults ≥60 yoSBP 160-219
DBP <90
Adults ≥60 yoSBP 160-219
DBP <95
Adults ≥80 yoSBP ≥160DBP <110
Goals SBP >180: <160SBP 160-179: ↓20
SBP <150 AND↓≥20
<150/80
BP achieved 143 mm Hg 150 mm Hg 144 mm HgMedian f/u 4.5 years 2 years 2.1 years
Quality Rating Good* Good* Good*
JAMA. 2013;():doi:10.1001/jama.2013.284427.
*Good = least risk of bias, results considered valid
PROBLEMS WITH JATOS AND VALISH STUDIES
Performed in Japanese populations
Low number of events
Trial (n) Total Endpoints
Composite CVD Stroke
JATOS (n=4418)
172 Rate per 1000 patient year:22.6 vs 22.7 (p=.99)
Rate per 1000 patient year:13.7 vs 12.9
VALISH(n=3260)
99 HR: 0.89P=0.383
HR: 0.68P=o.237
LACK OF HARM WITH SBP < 140
VALISH
JATOS
HYVET
SHEP
THE AGE GROUP 60 YEARS AND OLDER IS A HIGH RISK POPULATION
Ann Intern Med. 2014;160(7):499-503. doi:10.7326/M13-2981
U.S. Cardiovascular Disease Death Rates for Persons Younger and Older Than 65 yrs
Ann Intern Med. 2014;160(7):499-503. doi:10.7326/M13-2981
Reproduced from Lackland and colleagues (4). NHANES = National Health and Nutrition Examination Survey; NHES = National Health Examination Survey.
Smoothed Weighted Frequency Distribution, Median and 50th Percentile of SBP for persons aged 60-74 years
NHANES Data Showing Progress in Treatment of Hypertension
POPULATION IMPACT OF CHANGING BP GOALS <150 FOR AGE 60 OR OLDER
High risk population
• Risk range for white and AA men aged 60 is 9-30% depending on risk profile
• Risk Range for white and AA aged 70 without known CVD or DM with SBP < 140 exceeds 20% at 10-yrs
The “Speed Limit” effect
WHAT WILL RESOLVE THE CONTROVERSY?BP< 140/90 OR < 150/90
More data is needed
BP TREATMENT TARGETS HAVE RISKS BOTH WAYS
If one votes to keep all at 140/90
PM’s and incentives may encourage over-treatment Worse symptoms, falls, costs in elderly
• If one votes to move to 150/90 in elderly
Risk of under-treatment Despite existing guideline goals/PM’s, <50% of public
reaches goal!
SUMMARYSignificant controversy over targets of initiating and goals of hypertension therapy in elderly patients
I recommend the following:
• Risk factor stratification• Frail versus non-frail• Chronologic versus physiologic age• Risk of falls• Consideration of adverse effects of anti-hypertensives and
polypharmacy