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Page 1: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS
Page 2: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

EPIDEMIOLOGY OF HTN & AGING•BETWEEN 1999 & 2004, THE PREVALENCE OF HTN IN THE ADULT US

POPULATION WAS 27% FOR BOTH MEN AND WOMEN•FRAMINGHAM HEART STUDY SHOWED THAT 90% OF STUDY PARTICIPANTS

WITH NORMAL BP AT AGE 55 EVENTUALLY DEVELOPED HTN•PEOPLE AGED > 65 CURRENTLY COMPRISE ~ 13% OF THE US POPULATION•ITS ESTIMATED THAT BY 2030, THIS COHORT WILL INCREASE BY ALMOST

80%, AND ~ 1 IN 5 AMERICANS WILL BE > 65

Page 3: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

EPIDEMIOLOGY OF HTN & AGING

•HTN IS THE MOST IMPORTANT RISK FACTOR FOR CARDIOVASCULAR DISEASE• ASSOC. W/ DIABETES MELLITUS, ATRIAL FIBRILLATION & CKD

•FROM 1995 TO 2005, DEATHS RELATED TO HTN INCREASED ~ 25%• LIKELY DUE TO THE INCREASING NUMBER OF OLDER AMERICANS WITH HTN

•TOTAL DIRECT & INDIRECT COSTS ATTRIBUTED TO HTN ~ $73.4 BILLION (‘09)

Page 4: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

PATHOPHYSIOLOGY• LARGE VESSELS (E.G., AORTA) BECOME LESS DISTENSIBLE • BLUNTED ELASTICITY OF STIFFER AORTA AND OTHER ARTERIES CAUSES:

• DECREASED EXPANSION IN DIASTOLE & DECREASED CONTRACTILITY IN SYSTOLE

• RESULT IS A DECLINE OF DIASTOLIC BP WITH AGING• AORTIC STIFFNESS DECREASES CORONARY FLOW RESERVE DURING TIMES OF

INCREASED MYOCARDIAL CONTRACTILITY, ENDOCARDIAL FLOW BECOMES IMPAIRED, RESULTING IN SUB-ENDOCARDIAL ISCHEMIA

Page 5: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

ISOLATED SYSTOLIC HTN (ISH)• INCREASING AORTIC STIFFNESS CAUSES SYSTOLIC BP TO RISE THROUGHOUT LIFE • DIASTOLIC BP PEAKS & PLATEAUS IN LATE MIDDLE-AGE• PROPORTION OF PATIENTS W ISOLATED SYSTOLIC HTN INCREASES WITH AGE

• AGE > 60: ESTIMATED 65% HAVE ISH• AGE > 70: ESTIMATED 90% HAVE ISH

• PULSE PRESSURE IS A STRONGER RISK FACTOR FOR THE DEVELOPMENT OF CVD THAN SBP, DBP OR MEAN PRESSURE IN OLDER ADULTS

Page 6: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

FUNDAMENTALS OF BP MEASUREMENT• BP SHOULD BE MEASURED AFTER THE PATIENT HAS EMPTIED THEIR BLADDER AND BEEN

SEATED FOR 5 MINUTES WITH BACK SUPPORTED AND LEGS RESTING ON THE GROUND• ARM USED FOR MEASUREMENT SHOULD REST ON A TABLE, AT HEART LEVEL• AN AUTOMATED ELECTRONIC DEVICE WITH THE CORRECT SIZE ARM CUFF IS PREFERRED• TAKE 2 READINGS, 1-2 MINUTES APART, AND USE AVERAGE• MEASURE BP IN BOTH ARMS AT INITIAL EVALUATION • USE THE ARM WITH HIGHER READINGS THEREAFTER

Page 7: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

WHICH MEASUREMENT IS MORE CONCERNING - SYSTOLIC OR DIASTOLIC?

Franklin SS et al. Circulation. 2001;103(9):1245 NHANES III, Hypertension. 2001;37(3):869

•DBP IS THE MAJOR PREDICTOR UNDER AGE 50•ALL THREE INDICES WERE EQUAL PREDICTORS BETWEEN THE AGES OF

50 AND 59 •SBP AND PULSE PRESSURE APPEAR TO BE THE MAJOR PREDICTORS OF

CORONARY DISEASE IN THE ELDERLY

Page 8: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

PSEUDOHYPERTENSION• FALSELY INCREASED SYSTOLIC BP THAT RESULTS FROM SCLEROTIC ARTERIES THAT DO

NOT COLLAPSE DURING INFLATION OF BP CUFF• CLINICAL SUSPICION IS KEY TO MAKING THIS DIAGNOSIS BECAUSE CONFIRMATION

REQUIRES DIRECT INTRA-ARTERIAL MEASUREMENT OF BP• SUSPECT IN OLDER PATIENTS WITH REFRACTORY HTN, NO ORGAN DAMAGE AND/OR

SYMPTOMS OF OVERMEDICATION• OSLER’S MANEUVER

Page 9: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS
Page 10: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

CLINICAL EVALUATION•ASSESS FOR ORGAN DAMAGE AND MODIFIABLE CVD RISK

FACTORS:•TOBACCO SMOKING•HYPERCHOLESTEROLEMIA•DIABETES MELLITUS•EXCESSIVE ALCOHOL INTAKE

Page 11: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

CLINICAL EVALUATION•THE AMERICAN HEART ASSOCIATION RECOMMENDS:

•URINALYSIS, ESPECIALLY ALBUMIN/MICROALBUMIN•ELECTROLYTES & RENAL FUNCTION•LIPID PANEL•FASTING BLOOD SUGAR, HBA1C IF APPLICABLE•ECG

Page 12: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

HYPERTENSION THROUGH THE DECADESWHAT THE STUDIES HAVE TOLD US

Page 13: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

HYPERTENSION THROUGH THE DECADES• FRAMINGHAM HEART STUDY 1948

• SYSTOLIC HYPERTENSION IN ELDERLY (SHEP) 19911

• THE SYSTOLIC HYPERTENSION IN EUROPE (SYST-EUR) 1997

• THE ANTIHYPERTENSIVE AND LIPID-LOWERING TREATMENT TO PREVENT HEART ATTACK TRIAL (ALLHAT) 2002

• HYPERTENSION IN THE VERY ELDERLY TRIAL (HYVET)2

2008

• ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES (ACCORD) 2010

• JOINT NATIONAL COMMITTEE (JNC-8)3 2014

• SYSTOLIC BLOOD PRESSURE INTERVENTION TRIAL (SPRINT) 20154

• ACC/AHA/AAPA/ACPM/ACPMAGS/APHAASK/ASPC/NMA/ PCNA GUIDELINE (ACC/AHAGUIDELINE) 20175

• ACP/AAFP GUIDELINE 20176

1. Prevention of Stroke by Antihypertensive Drug Treatment in Older Persons With Isolated Systolic HypertensionFinal Results of the Systolic Hypertension in the Elderly Program (SHEP). JAMA.1991;265(24):3255–3264. doi:10.1001/jama.1991.03460240051027

2. Beckett M.B., Peters R. et al. Treatment of Hypertension in Patients 80 Years of Age or Older. N Engl J Med 2008 358(18): 1887-18983. James P.A., Oparil, S., Carter BL., et al. 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):507-5204. SPRINT Research Group. A randomized trial of intensive versus standard blood-pressure control. NEJM 2015; 373:2103=21165. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/ NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High

Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 20176. Quaseem A., wilt T.J. et al Pharmacologic Treatment of Hypertension in Adult Aged 60 Years or Older to Higher versus Lower Blood Pressure Targets: a Clinical Practice Guidelne from

the ACP & AAFP. AnnInt Med 2017 ;166(6):430-437

Page 14: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

SYSTOLIC HYPERTENSION•STUDIES HAVE SHOWN THAT, IN THE VERY OLD, ALL-CAUSE MORTALITY WAS

INVERSELY ASSOCIATED WITH SYSTOLIC PRESSURE•SURVIVAL APPEARED TO BE THE HIGHEST AT SYSTOLIC PRESSURES FROM 140

TO 160 MMHG, WITH ONE STUDY SHOWING A U-SHAPED RELATIONSHIP (GREATER MORTALITY RISK WITH SYSTOLIC PRESSURES LOWER THAN 120 MMHG AND HIGHER THAN 160 MMHG)1

2. Oates DJ, Berlowitz DR, Glickman ME et al. Blood pressure and survival in the oldest old. J Am Geriatr Soc 2007;55:383–388.3. Molander L, Lovheim H, Norman T et al. Lower systolic blood pressure is associated with greater mortality in people aged 85 and older. J Am Geriatr Soc 2008;56:1853–1859

1. Okimura K., Matsubayashi K. et al. J Am Ger Soc 1999; 47 (12):1415-1421

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1991 SYSTOLIC HYPERTENSION ELDERLY PROGRAM (SHEP)•4376 ELDERLY PATIENTS (MEAN AGE 72)•MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED•RANDOMLY ASSIGNED TO ANTIHYPERTENSIVE THERAPY VS. PLACEBO •PRIMARY OUTCOMES: INCIDENCE OF FATAL AND NONFATAL STROKE

Perry Jr, H. M., Davis, B. R., Price, T. R., Applegate, W. B., Fields, W. S., Guralnik, J. M., ... & Probstfield, J. L. (2000). Effect of treating isolated systolic hypertension on the risk of developing various types and subtypes of stroke: the Systolic Hypertension in the Elderly Program (SHEP). JAMA 284(4), 465-471.

Page 16: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

SHEP OUTCOMES• BASELINE BP: 170/77 MMHG - GOAL: LOWER SBP BY 20 MMHG

(TO 150)• CLORTHALIDONE 12.5 INITIAL DOSE ( ADDITIONAL AGENTS: ATENOLOL/RESERPINE)• STROKE INCIDENCE AT FOUR TO FIVE YEARS OUT: 5.5 IN TREATMENT GROUP VERSUS

8.2 PERCENT WITH PLACEBO

•CONCLUSION: IN PERSONS > 60 YEARS AND WITH ISOLATED SYSTOLIC HYPERTENSION, TREATMENT ↓ TOTAL INCIDENCE OF STROKE BY 36%

Perry Jr, H. M., Davis, B. R., Price, T. R., Applegate, W. B., Fields, W. S., Guralnik, J. M., & Probstfield, J. L. (2000). Effect of treating isolated systolic hypertension on the risk of developing various types and subtypes of stroke: the Systolic Hypertension in the Elderly Program (SHEP). JAMA 284(4), 465-471

Page 17: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

2003 JNC 7 ALGORITHM

www.medicographia.com

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2008 HYPERTENSION IN THE VERY ELDERLY TRIAL (HYVET)• 3845 PATIENTS FROM EUROPE, CHINA, AUSTRALASIA, AND TUNISIA > 80 YEARS OF AGE • BASELINE SBP HAD TO BE 160MM HG OR GREATER

• SEATED SYSTOLIC BP 160-199 MMHG AND SEATED DIASTOLIC BP < 110 MMHG

• RANDOMLY ASSIGNED TO PLACEBO VS TREATMENT*• USED INDAPAMIDE (ADDING PERINDOPRIL) TO ACHIEVE THE TARGET BLOOD PRESSURE OF

150/80 MM HG • PRIMARY END POINT WAS FATAL OR NONFATAL STROKE

Beckett N.B., Peters R. et al. Treatment of Hypertension in Patients 80 Years of Age or Older. N Engl J Med 2008 358(18): 1887-1898

Page 19: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

HYVET EXCLUSION CRITERIA• KNOWN ACCELERATED HTN (RETINAL HEMORRHAGES OR EXUDATES

OR PAPILLOEDEMA)

• OVERT CLINICAL CHF REQUIRING TREATMENT WITH A DIURETIC OR ACE INHIBITOR ( ALLOWED IF TREATED WITH DIGOXIN ONLY)

• RENAL FAILURE (SERUM CREATININE OF MORE THAN 150 ΜMOL/L).

• PREVIOUS DOCUMENTED CEREBRAL OR SUBARACHNOID HEMORRHAGE IN THE LAST 6 MONTHS. (ISCHEMIC CEREBRAL AND CARDIAC EVENTS DO NOT EXCLUDE, ALTHOUGH THE PATIENT MUST BE NEURO & CARDIO STABLE)

• CONDITION EXPECTED TO SEVERELY LIMIT SURVIVAL, E.G. TERMINAL ILLNESS

• UNABLE TO STAND UP OR WALK

• GOUT

• KNOWN SECONDARY HTN (E.G. RENAL ARTERY STENOSIS, CHRONIC RENAL INSUFFICIENCY, AND ENDOCRINE CAUSE)

• CLINICAL DIAGNOSIS OF DEMENTIA

• RESIDENT IN A NURSING HOME, I.E. WHERE THE DEPENDENCY AND CARE REQUIREMENTS OF THE PATIENTS ARE SUCH THAT THEY REQUIRE THE REGULAR INPUT OF QUALIFIED NURSES AND THEREFORE THE MAJORITY OF STAFF IN THE HOME ARE NURSES (OTHER FORMS OF RESIDENTIAL CARE ARE ACCEPTABLE)

• PARTICIPATION IN A DRUG TRIAL WITHIN THE PAST MONTH PRECEDING SELECTION

• ALCOHOL OR DRUG ABUSE

• LESS THAN 2 MONTHS PLACEBO RUN-IN

• CONTRAINDICATIONS TO USE OF TRIAL DRUGS

Page 20: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

HYVET OUTCOMES• TREATMENT WAS ASSOCIATED WITH A 30% REDUCTION IN THE RATE OF FATAL OR

NONFATAL STROKE• 39% REDUCTION IN THE RATE OF DEATH FROM STROKE• 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE• FEWER SERIOUS ADVERSE EVENTS WERE REPORTED IN THE ACTIVE-TREATMENT GROUP

THAN IN THE PLACEBO GROUP (358 VS. 448; P=0.001)

Beckett N.B., Peters R. et al. Treatment of Hypertension in Patients 80 Years of Age or Older. N Engl J Med 2008 358(18): 1887-1898

Page 21: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

2010 ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES (ACCORD)• 10,251 PTS BETWEEN THE AGES OF 40 - 79 WHO HAD TYPE 2 DIABETES FOR AN AVERAGE OF 10 YEARS

• FACTORIAL DESIGN W/ SEVERAL ARMS: HBA1C, BLOOD PRESSURE AND LIPID TARGETS

• BP STUDY ENROLLED 4,744 WITH MEAN FOLLOW-UP OF 4.7 YEARS

•INVESTIGATED WHETHER THERAPY TARGETING NORMAL SYSTOLIC PRESSURE (I.E., < 120 MM HG) REDUCES MAJOR CARDIOVASCULAR (CV) EVENTS IN PARTICIPANTS WITH TYPE 2 DM AT HIGH RISK FOR CV EVENTS

The Accord Study Group. Effects of Intensive Blood-Pressure Control in Type 2 Diabetes Mellitus N Engl J Med 2010; 362:1575-1585

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”ACCORD CONCLUSIONS

IN PATIENTS WITH TYPE 2 DIABETES AT HIGH RISK FOR CARDIOVASCULAREVENTS, TARGETING A SYSTOLIC BLOOD PRESSURE OF LESS THAN 120 MM HG, AS COMPARED WITH LESS THAN 140 MM HG, DID NOT REDUCE THE RATE OF A

OUTCOME OF FATAL & NONFATAL MAJOR CARDIOVASCULAR EVENTS

Page 23: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

2013 JOINT NATIONAL COMMITTEE (JNC) 8 • IN THE GENERAL POPULATION AGED ≥60 YEARS, (WITHOUT DM2 OR CKD):

• INITIATE PHARMACOLOGIC TREATMENT TO LOWER BLOOD PRESSURE (BP) AT SYSTOLIC BLOOD PRESSURE (SBP) ≥150 MM HG OR DIASTOLIC BLOOD PRESSURE (DBP) ≥90 MM HG

• TREAT TO A GOAL SBP <150 MM HG AND GOAL DBP <90 MM HG • (STRONG RECOMMENDATION – GRADE A)

• COROLLARY RECOMMENDATION: IN THOSE ≥60 YEARS, IF PHARMACOLOGIC TREATMENT FOR HIGH BP RESULTS IN LOWER ACHIEVED SBP (EG, <140) AND WELL TOLERATED AND WITHOUT ADVERSE EFFECTS ON HEALTH OR QUALITY OF LIFE, TREATMENT DOES NOT NEED TO BE ADJUSTED • (EXPERT OPINION – GRADE E)James P.A., Oparil, S., Carter BL., et al. 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

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

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JNC 8 RECOMMENDATIONS SUMMARY•IN THE GENERAL POPULATION < 60 YEARS ( WITHOUT DM OR CKD):

• INITIATE PHARMACOLOGIC TREATMENT TO LOWER BP AT SBP ≥ 140 MM HG; TREAT TO GOAL SBP < 140 MM HG•FOR AGES 30 - 59 (STRONG – GRADE A)•FOR AGES 18 - 29 (EXPERT OPINION – GRADE E)

•4 CLASSES OF MEDICATIONS SHOULD BE CONSIDERED AS FIRST LINE (AND LATER) TREATMENTS:

• THIAZIDE-TYPE DIURETIC • CALCIUM CHANNEL BLOCKER (CCB) • ACE-I & ARB

Page 26: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

JNC 8 RECOMMENDATIONS•IN THE POPULATION AGED < 60 YEARS:

• INITIATE PHARMACOLOGIC TREATMENT TO LOWER DBP ≥ 90 MM HG OR DBP ≥ 90 MM HG AND TREAT TO GOAL DBP < 90 MM HG AND GOAL DBP < 90 MM HG.

•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 MMHG (EXPERT OPINION – GRADE E)

Page 27: EPIDEMIOLOGY OF HTN & AGINGNONFATAL STROKE • 39% REDUCTION IN THE RATE OF DEATH FROM STROKE • 21% REDUCTION IN THE RATE OF DEATH FROM ANY CAUSE • FEWER SERIOUS ADVERSE EVENTS

2015 SYSTOLIC BP INTERVENTION TRIAL (SPRINT)*• N = 9,361 SUBJECTS AGED 50 YEARS AND OLDER W/OUT DIABETES

• RESEARCHERS WERE PERMITTED TO SCREEN IN CHOOSING DRUG REGIMENS – INTENSIVE AND STANDARD TREATMENT PATIENTS REQUIRED AVERAGES OF 3 AND 2 DRUGS RESPECTIVELY

• PRIMARY OUTCOME MEASURES (TIME FRAME - 6 YEARS) : • ACUTE CORONARY SYNDROME (ACS) OR CVD DEATH • FIRST OCCURRENCE OF A MYOCARDIAL INFARCTION (MI)• HEART FAILURE (HF) • STROKE

*PRIMARY SPONSORSHIP BY THE NHLBI

SPRINT Research Group. A randomized trial of intensive versus standard blood-pressure control. NEJM 2015; 373:2103=2116

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MAJOR INCLUSION CRITERIA

•≥50 YEARS OLD

•SYSTOLIC BP : 130 – 180 MM HG (TREATED OR UNTREATED)

•AT LEAST ONE ADDITIONAL CARDIOVASCULAR DISEASE (CVD) RISK• CLINICAL OR SUBCLINICAL CVD (EXCLUDING STROKE)• CHRONIC KIDNEY DISEASE (CKD), DEFINED AS EGFR 20 – <60

ML/MIN/1.73M2 • FRAMINGHAM RISK SCORE FOR 10-YEAR CVD RISK ≥ 15%• AGE ≥ 75 YEARS

SPRINT Research Group. A randomized trial of intensive versus standard blood-pressure control. NEJM 2015; 373:2103=2116

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SYSTOLIC BP INTERVENTION TRIAL (SPRINT)

•CONTROVERSY OVER WHETHER A LOWER SYSTOLIC BLOOD PRESSURE MAKES SENSE

•METHODS:• RANDOMIZED TRIAL THAT INCLUDED 9301 HIGH RISK NONDIABETIC HYPERTENSIVES• AVERAGE SYSTOLIC BP EQUAL TO 121.5 MM HG IN THE INTENSIVE GROUP AND 134.6

MM HG IN THE STANDARD GROUP

SPRINT Research Group. A randomized trial of intensive versus standard blood-pressure control. NEJM 2015; 373:2103=2116

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CAVEATS• SEVERAL SERIOUS ADVERSE EVENTS SLIGHTLY MORE COMMON WITH INTENSIVE TREATMENT

• HYPOTENSION (1%) & ACUTE KIDNEY INJURY (2%); ELECTROLYTE ABNORMALITIES (1%)

• BP RECORDED W/ 3 READINGS SEPARATED BY SEVERAL MINUTES, NO CLINICIAN IN THE ROOM • MAY YIELD SUBSTANTIALLY LOWER BLOOD PRESSURE READINGS THAN WITH A TYPICAL SINGLE RUSHED BP

OFFICE MEASUREMENT

• REMEMBER, ACCORD BP TRIAL TREATED HYPERTENSIVE DIABETICS INTENSIVELY TO SYSTOLIC BP TARGET OF < 120 MM HG, BUT IT DID NOT IMPROVE OUTCOMES COMPARED W/ TREATMENT TO A STANDARD OF < 140 MM HG – HENCE, DIABETICS NOT STUDIED IN SPRINT

NEJM JW Gen Med Apr. 15 2010 and NEJM 2010:362:1575

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TotalN=9361

IntensiveN=4678

StandardN=4683

Mean (SD) age, years 67.9 (9.4) 67.9 (9.4) 67.9 (9.5)

% ≥75 years 28.2% 28.2% 28.2%

Female, % 35.6% 36.0% 35.2%

White, % 57.7% 57.7% 57.7%

African-American, % 29.9% 29.5% 30.4%

Hispanic, % 10.5% 10.8% 10.3%

Prior CVD, % 20.1% 20.1% 20.0%

Mean 10-year Framingham CVD risk, % 20.1% 20.1% 20.1%

Taking antihypertensive meds, % 90.6% 90.8% 90.4%

Mean (SD) number of antihypertensive meds

1.8 (1.0) 1.8 (1.0) 1.8 (1.0)

Mean (SD) Baseline BP, mm HgSystolic 139.7 (15.6) 139.7 (15.8) 139.7 (15.4)

Diastolic 78.1 (11.9) 78.2 (11.9) 78.0 (12.0)

Demographic and Baseline Characteristics

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SUMMARY AND CONCLUSIONS• SPRINT EXAMINED EFFECTS OF MORE INTENSIVE ANTIHYPERTENSIVE THERAPY THAN HAD

BEEN CURRENTLY RECOMMENDED• PARTICIPANTS WERE US ADULTS ≥ 50 YEARS WITH HTN & ADDITIONAL RISK FOR CVD• RAPID AND SUSTAINED DIFFERENCE IN SBP ACHIEVED BETWEEN THE TWO TREATMENT ARMS• INCIDENCE OF PRIMARY OUTCOME (COMPOSITE OF CVD EVENTS) 25% LOWER IN INTENSIVE

COMPARED TO STANDARD GROUP AND ALL-CAUSE MORTALITY REDUCED BY 27%• NNT* TO PREVENT PRIMARY OUTCOME EVENT OR DEATH WERE 61 AND 90, RESPECTIVELY

*Number needed to treat

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SPRINT CONCLUSION• THE TRIAL WAS STOPPED AFTER AN AVERAGE FOLLOW-UP OF 3.3 YEARS:

INCIDENCE OF PRIMARY OUTCOME (COMPOSITE OF NONFATAL VS FATAL CV EVENTS) WAS SIGNIFICANTLY LOWER W/ INTENSIVE THAN W/ STANDARD TREATMENT (5.2% VERSUS 6.8%)

• AIMING FOR SYSTOLIC < 120 INSTEAD OF < 140 PREVENTS ONE MORE CV EVENT FOR ONE OUT OF EVERY 185 PATIENTS WITH CV RISK TREATED/YEAR

• BENEFIT MAY NOT APPLY TO PATIENTS WITH DIABETES, CHF, OR PREVIOUS STROKE • OVERALL, BENEFITS OF MORE INTENSIVE BP LOWERING EXCEEDED THE POTENTIAL FOR HARM

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2017 ACC/AHA GUIDELINE•GLOBAL MORTALITY AND MORBIDITY ASSOCIATED WITH

SYSTOLIC > 140MM HG HAS INCREASED FROM 1990-2015•NEW GUIDELINES DEFINE HYPERTENSION AS A BLOOD PRESSURE

≥ 130 MMHG SYSTOLIC AND/OR ≥ 80 MMHG DIASTOLIC AND PROVIDE A LOWER BLOOD PRESSURE GOAL OF < 130 /< 80 MMHG

Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/ NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017.

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ACC/AHA GUIDELINE 2017• PHARMACOLOGIC THERAPY IS RECOMMENDED FOR ALL HYPERTENSIVE PATIENTS WITH

HIGHER CARDIOVASCULAR RISK, AND FOR LOWER-RISK PATIENTS WHO HAVE A BLOOD PRESSURE ≥ 140 MMHG SYSTOLIC OR ≥ 90 MMHG DIASTOLIC

• THE ADA’S GUIDELINES FOR 2018 STILL STATE THAT MOST ADULTS WITH DIABETES AND HYPERTENSION SHOULD HAVE A TARGET BLOOD PRESSURE OF < 140/90 MMHG AND THAT RISK-BASED INDIVIDUALIZATION THAT LOWERS TARGETS, SUCH AS TO 130/80 MMHG, MAY BE APPROPRIATE IN SOME PATIENTS

• ACCURATE BP MEASUREMENTS AND LIFESTYLE CHANGES ARE EMPHASIZED

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COMMON EVALUATION AND MANAGEMENT ISSUES • FOR STAGE 1 WITHOUT CV DISEASE, DIABETES AND CKD (130-189/80-89 MMHG)

ACC-AHA RECOMMENDS CALCULATION OF ESTIMATED 10 YEAR RISK OF CV DISEASE• HTTP://TOOLS.ACC.ORG/ASCVD-RISK-ESTIMATOR

• IF < 10% THEN REASONABLE TO USE LIFESTYLE RECOMMENDATIONS FOR 3-6 MONTHS ALONE

• FOR STAGE 2 OR PREEXISTING CONDITIONS OR > 10% NEED BOTH MEDS AND LIFESTYLE

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COMMON EVALUATION AND MANAGEMENT ISSUES •GUIDELINES EMPHASIZE AT LEAST 2 BP MEASUREMENTS ON AT LEAST TWO

OCCASIONS ON VALIDATED EQUIPMENT•CORRECT SIZE, CORRECT POSTURE, STANDARDIZED MEASUREMENT•CONSIDER AUTOMATED DEVICES WITH 2-6 SERIAL MEASUREMENTS TO

DETERMINE A MEAN•NEED TO CONSIDER COMORBID CONDITIONS

Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/ NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017.

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RECOMMENDATIONS FOR PRIMARY PREVENTION WITH STATINS IN APPARENTLY HEALTHY PEOPLE HANDLING OF INDIVIDUALS >65 YEARS OF AGE DIFFERS SUBSTANTIALLY AMONG CONTEMPORARY

EUROPEAN AND NORTH AMERICAN GUIDELINES, PARTLY BECAUSE OF THE PERFORMANCE (APPLICABILITY) OF THE RISK MODEL USED.

ACC/AHA = AMERICAN COLLEGE OF CARDIOLOGY/AMERICAN HEART ASSOCIATION; CCS = CANADIAN CARDIOVASCULAR SOCIETY; ESC/EAS = EUROPEAN SOCIETY OF CARDIOLOGY/EUROPEAN ATHEROSCLEROSIS SOCIETY; FRS = FRAMINGHAM RISK SCORE FOR GENERAL CARDIOVASCULAR DISEASE; NICE = NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE;

PCE = POOLED COHORT EQUATION; SCORE = SYSTEMATIC CORONARY RISK EVALUATION; USPSTF = U.S. PREVENTIVE SERVICES TASK FORCE

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2017 ACC/AHA GUIDELINE :QUESTIONS AND CONTROVERSY

• AMERICAN COLLEGE OF CARDIOLOGY (ACC)/AMERICAN HEART ASSOCIATION (AHA) DEFINES HYPERTENSION AS BLOOD PRESSURES ABOVE 130/80 MM HG

• 45.6% OF POPULATION ARE HYPERTENSIVE ACCORDING TO THE 2017 ACC/AHA GUIDELINE COMPARED WITH 31.6% PER THE OLD JNC-7 DEFINITION

• ABSOLUTE INCREASE OF 23% AND A MORE THAN DOUBLING IN NUMBERS OF PEOPLE CLASSIFIED AS HYPERTENSIVE

• ALMOST HALF THE POPULATION IS NOW CONSIDERED TO BE HYPERTENSIVE

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2017 ACC/AHA GUIDELINE CAVEATS• CONTROVERSIAL IS THE GUIDELINE’S SUPPORT OF A CARDIOVASCULAR RISK-BASED

DECISION ALGORITHM • AAFP DID NOT SUPPORT THIS GUIDELINE FOR MULTIPLE REASONS INCLUDING:

• MOST OF THE RECOMMENDATIONS WERE NOT BASED ON A SYSTEMATIC REVIEW• QUALITY ASSESSMENTS OF INDIVIDUAL STUDIES WERE NOT SUFFICIENTLY THOROUGH• TOO MUCH WEIGHT WAS GIVEN TO THE SPRINT TRIAL*• NOW ALMOST HALF THE POPULATION WILL BE LABELED WITH A DISEASE WHICH MAY LEAD TO

OVERTREATMENT

*9633 people who met strict criteria: > 50 years old having existing cardiac disease or 10 year cardiovascular risk > 15%

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AAFP’S LACK OF ENDORSEMENT OF AHA/ACC GUIDELINE - SPECIFICS• STRUCTURED REVIEW PROCESS BY AAFP’S COMMISSION ON HEALTH OF THE PUBLIC AND SCIENCE

(CHPS)*

• CITED LACK OF SYSTEMATIC REVIEW AND POTENTIAL CONFLICTS OF INTEREST

• DISAGREEMENT W/ STRONG RECOMMENDATION FOR USING THE “UNVALIDATED” ATHEROSCLEROTIC CVD RISK ASSESSMENT TOOL – NO EVIDENCE THAT USE OF THIS TOOL IMPROVES OUTCOMES

• CONTINUE TO ENDORSE THE 2014 EVIDENCE-BASED GUIDELINES FOR THE MANAGEMENT OF HIGH BP IN ADULTS DEVELOPED BY PANEL MEMBERS APPOINTED TO THE EIGHTH JOINT NATIONAL COMMITTEE

*David O’Guirek, MD, CHPS Chair; jamanetwork.com

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VIEWPOINT: DX & TX OF HTN IN THE REAL WORLD• ACC/AHA GUIDELINES MEAN AN ADDITIONAL 31 MILLION INDIVIDUALS IN U.S. NOW NEED TX FOR HTN

• 481 PAGE “STELLAR” REPORT

• EARLY TRIAL TERMINATION MAY PROVIDE EXAGGERATED ESTIMATE OF BENEFITS AND MAY BE UNABLE TO ACCURATELY EVALUATE HARMS

• HYPOTENSION, SYNCOPE, ELECTROLYTE ABNORMALITIES AND 1.21% /YR VERSUS 0.35%/YR IN THE CONTROL GROUP OF ACUTE KIDNEY INJURY OR FAILURE IN SPRINT

• SPRINT INCLUDED PTS W/ ALREADY ESTABLISHED HTN (140/90) AND MEAN AGE 68 YRS – UNCLEAR HOW THESE RESULTS TRANSLATE TO THE MILLIONS OF YOUNGER ADULTS NEWLY LABELLED AS HYPERTENSIVE

• DECISION TO TX BASED ON > 10% 10-YR CVD RISK; CRITICISM OF THE ACC/AHA RISK CALCULATOR AS LACKING PROPER CALIBRATION AND OVERESTIMATION OF RISK

• SHIFTING THE HEALTH CARE SYSTEM TOWARD PREVENTION IS A WELCOME MOVE . . .

Ioannidis J. JAMA 2017; E1-E2. jama.com

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2017 ACP/AAFP CLINICAL GUIDELINE• INITIATE TX IN ADULTS AGED 60 YEARS OR OLDER W/ SYSTOLIC BP PERSISTENTLY > 150 MMHG TO

ACHIEVE A TARGET SYSTOLIC BP OF < 150 MMGHG TO REDUCE THE RISK FOR STROKE, CARDIAC EVENTS AND POSSIBLY MORTALITY (GRADE: STRONG RECOMMENDATION, HIGH QUALITY EVIDENCE)

• INITIATE OR INTENSIFY PHARMACOLOGIC TX IN SOME ADULTS AGED 60 YEARS OR OLDER W/ HIGH CVD RISK BASED ON INDIVIDUALIZED ASSESSMENT TO ACHIEVE A TARGET BP OF LESS THAN 140MMHG SYSTOLIC (GRADE: WEAK RECOMMENDATION, LOW QUALITY EVIDENCE)

• SELECT TX GOALS BASED ON PERIODIC DISCUSSION OF THE BENEFITS AND HARMS OF SPECIFIC BPTARGETS WITH THE PATIENT

Qaseem A, Wilt TJ,Rich R et al. Pharmacologic treatment of hypertension in adults aged 60 years or older to higher versus lower blood pressure targets:A clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Int Med. 2017;166:430-437

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HOW CAN THESE DIFFERENCES BE RESOLVED?CAN WE FIND MIDDLE GROUND?

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THREE POTENTIAL UNINTENDED CONSEQUENCES• LABELING: INDIVIDUALS WHO ARE TOLD THEY ARE SICK MAY BEGIN TO ACT SICK• ADVERSE EFFECTS:

• BENEFIT OF PHARMACOLOGIC TX IS ALWAYS LESS IN A LOW-RISK POPULATION, BUT SIDE EFFECTS ARE NOT

• PATIENTS 20 TO 45 Y/O WHO NOW CARRY THE DIAGNOSIS OF HYPERTENSION WILL HAVE THE SAME RISK OF SIDE EFFECTS AS THE GROUP STUDIED IN SPRINT, BUT A 7-FOLD LOWER LIKELIHOOD OF BENEFIT

• INCREASED INSURANCE PREMIUMS

Skolnick N. Circulation. 2018;137:1097–1099. DOI: 10.1161/CIRCULATIONAHA.117.033219

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POTENTIAL LESSONS• THE LESSON OF ICARUS IS THAT OF HUBRIS, TO BE AWARE OF EXCESSIVE SELF-

CONFIDENCE• TO BE AWARE THAT FLYING TOO HIGH CAN INTERFERE WITH FLIGHT ITSELF• THE ARTIST’S WORK IMPLIES THAT WE SHOULD NOT BE SO FOCUSED ON WHERE WE ARE

GOING THAT WE NO LONGER SEE THE SUFFERING OF THOSE NEARBY• “FOR US IN MEDICINE, THE LESSON MAY BE THAT PREVENTION, WHEN TAKEN TOO FAR,

MAY CAUSE UNNOTICED ILLNESS OF OUR OWN MAKING”*

*Neil Skolnick, MD. Circulation 2018;137:1097-1099.

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