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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.
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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
2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427
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)
HYpertension in the Very Elderly Trial International, 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
HYVET: ITT Analysis 0.1 0.2 0.5 0 2
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 *Good = least risk of bias, results considered valid JAMA. 2013;():doi:10.1001/jama.2013.284427.
Results – Cardiovascular Disease • Combined 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 • *Japanese Trial to Assess Optimal SBP (JATOS) • **Valsartan in Elderly Isolated Systolic Hypertension JAMA. 2013;():doi:10.1001/jama.2013.284427.
Japanese Trial to Assess Optimal SBP (JATOS) HypertensRes. 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 *Good = least risk of bias, results considered valid JAMA. 2013;():doi:10.1001/jama.2013.284427.
Problems with JATOS and VALISH Studies • Performed in Japanese populations • Low number of events
Lack of Harm with SBP < 140 • VALISH • JATOS • HYVET • SHEP
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
NHANES Data Showing Progress in Treatment of Hypertension Smoothed Weighted Frequency Distribution, Median and 50th Percentile of SBP for persons aged 60-74 years Reproduced from Lackland and colleagues (4). NHANES = National Health and Nutrition Examination Survey; NHES = National Health Examination Survey. Ann Intern Med. 2014;160(7):499-503. doi:10.7326/M13-2981
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!
Summary • Significant 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