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 ID: 805447
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Slide1
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
Slide2ObjectivesReview 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
Slide3Hypertension 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)
Slide4Development of JNC-8Commissioned 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
Slide5Development of JNC-8And then we waited…and waited…
Slide6Development of JNC-8
also got known as JNC-Late
Slide7Slide8JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427
2014 Evidence-Based Guideline for the Management of High Blood Pressure in
Adults
Slide9New Hypertension Guidelines in 2013A 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
)
Slide10Comparison of RecentGuideline Statements
Adapted from Salvo M et al.
Ann
Pharmacother
2014;48:1242-8.
Slide11Recommendation 1Patients 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
Slide12Hypertension in the ElderlyFastest 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)
Slide13JNC-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%)
Slide14The Data Behind the JNC 8 Recommendations
Slide15Slide16International
, multi-centre,
randomised, double-blind, placebo-controlled
Inclusion Criteria: Exclusion Criteria:
Aged 80 or more, Standing SBP < 140mmHg
Systolic BP; 160 -199mmHg
Stroke
in last 6 months
+ diastolic BP; <110 mmHg, Dementia
Informed consent Need daily nursing care
Primary Endpoint:
All strokes (fatal and non-fatal)
Target blood pressure
150/80 mmHg
HY
pertension in the
V
ery
E
lderly
T
rial
Slide170
2
0.5
0.2
0.1
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
Slide18Hypertension in the ElderlyHYVET 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?
Slide19Hypertension in the ElderlyTrials – Stroke, HF, & CHD Reduction
SHEP
Syst-Eur
Year
1991
1997
Sample Size (N)
4, 736
4,695
Sample
Characteristics
Adults ≥60
yo
SBP 160-219
DBP <90
Adults ≥60
yo
SBP 160-219
DBP <95GoalsSBP >180: <160
SBP 160-179: ↓20SBP <150 AND↓≥20
Median f/u4.5 years2 years
Quality Rating
Good*
Good*
JAMA. 2013;():doi:10.1001/jama.2013.284427.
*Good = least risk of bias, results considered valid
Slide20Results – 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.
Slide21Trials Addressing SBP <150 vs <140
JATOS*
VALISH**
Year
2008
2010
Sample Size (N)
4,418
3,260
Sample
Characteristics
Adults 65-85
SBP
≥ 160
DBP <120
Adults 70-85
SBP ≥160
DBP <90
Goals
Strict: <140
Moderate: ≥140-<160
Strict: SBP <140
Moderate:
≥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
Slide22Japanese Trial to Assess Optimal SBP (JATOS)
Hypertens
Res. 2008;31(12):2115-2127
Slide23Valsartan in Elderly Isolated Systolic Hypertension
Hypertension
. 2010;56(2):196-202
Slide24Dissension among the ranks!
Wright JT Jr et al.
Ann Intern Med
2014;160:499-504
.
Slide25JNC 8 Methodology Excluded Most StudiesConducted 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”
Slide26Other 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
Slide27Achieved 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
yo
SBP 160-219
DBP <90
Adults ≥60
yo
SBP 160-219
DBP <95
Adults ≥80
yo
SBP ≥160
DBP <110
Goals
SBP >180
:
<160
SBP 160-179: ↓20
SBP <150
AND↓≥20
<150/80
BP achieved
143 mm Hg
150 mm Hg
144 mm Hg
Median 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
Slide28Problems with JATOS and VALISH StudiesPerformed 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: 0.89
P=0.383
HR: 0.68
P=o.237
Slide29Lack of Harm with SBP < 140VALISHJATOS
HYVET
SHEP
Slide30The age group 60 years and older is a high risk population
Slide31Ann 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
Slide32Ann Intern Med. 2014;160(7):499-503. doi:10.7326/M13-2981
Slide33Population Impact of Changing BP Goals <150 for Age 60 or OlderHigh 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
Slide34What will resolve the controversy?BP< 140/90 or < 150/90
More data is needed
Slide35BP 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
Ri
sk
of under-treatment
Despite
existing guideline goals/PM’s, <50% of public reaches goal!
Slide36SummarySignificant 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