HYPERTENSION: WHAT'S YOUR GOAL?

Transcription

1 HYPERTENSION: WHAT'S YOUR GOAL? SATURDAY/3:15-4:15PM ACPE UAN: L01-P 0.1 CEU/1.0 hr Activity Type: Application-Based Learning Objectives for Pharmacists: Upon completion of this CPE activity participants should be able to: 1. Recall the most recent guidelines and recommendations for goal blood pressures across broad populations. 2. Evaluate the latest evidence behind current guidelines and recommendations for goal blood pressures. 3. Describe how to utilize patient specific characteristics to individualize goal blood pressures. Speaker: Michael Ernst, PharmD. BCPS, FCCP, ASH-CHC Dr. Ernst is a Clinical Professor in the University of Iowa College of Pharmacy and in the Department of Family Medicine. He provides collaborative patient care and is involved in the interdisciplinary education of students from the UI Colleges of Pharmacy and Medicine and medical residents in the Family Medicine training program. He is widely-published in the field of hypertension, and in 2016 he was among a small group of pharmacists to be the first to receive the Certified Hypertension Specialist designation from the American Society of Hypertension. Speaker Disclosure: Michael Ernst reports no actual or potential conflicts of interest in relation to this CPE activity. Off-label use of medications will not be discussed during this presentation.

2 2/5/18 Hypertension: What s Your Goal? Mike Ernst, PharmD, BCPS, BCGP, FCCP ASH-Certified Hypertension Specialist Clinical Professor College of Pharmacy, The University of Iowa Disclosure Dr. Ernst reports no actual or potential conflicts of interest associated with this presentation. 1

3 Learning Objectives Upon successful completion of this activity, participants should be able to: 1. Recall the most recent guidelines and recommendations for goal blood pressures across broad populations. 2. Evaluate the latest evidence behind current guidelines and recommendations for goal blood pressures. 3. Describe how to utilize patient specific characteristics to individualize goal blood pressures. Presentation Outline Abbreviated review of the major changes and notable guideline points in the new, 471-page ACC/AHA BP guideline Published on November 13, 2017, available at: Hypertension ( and Journal of the American College of Cardiology ( The full-text guidelines are also available on the following websites: American Heart Association (AHA) ( and American College of Cardiology (ACC) ( Investigate the recent evidence (SPRINT trial) prompting the major change in recommended BP goals Food for thought in applying all of this into practice 2

4 Case Vignette A 64-year-old non-smoking female presents for general follow-up after a recent wrist fracture which occurred from a fall while participating in a hot yoga class. She walks on a treadmill three times/week for 45 minutes and follows a vegan diet. Meds: lisinopril-hct 10/12.5 mg/d; simvastatin 10 mg/d BP = 142/78 mmhg (repeated to verify) and other vital signs are normal. She reports her home BP usually ranges in the low 130s/70s. Her cardiovascular and eye exam are unremarkable. Her BMI is 30. She is not orthostatic and has no complaints. Labs: normal CBC, SCr=1.2 mg/dl (no proteinuria on urinalysis), Potassium=3.5 meq/l, Tchol=175 mg/dl, LDL=98 mg/dl, HDL = 64 mg/dl fasting glucose=103 mg/dl. SHOULD HER ANTIHYPERTENSIVE REGIMEN BE ADJUSTED? WHAT IF SHE WAS NOT PREVIOUSLY TREATED? SHOULD WE START TREATMENT? Evolution of U.S. BP Guidelines JNC-I 1977 JNC-III 1984 JNC-V 1992 JNC NHLBI exits guideline development, transfers responsibility to ACC/AHA JNC-II 1980 JNC-IV 1988 JNC-VI 1997 [JNC: Mostly expert opinion, but progressively more comprehensive based on expanding amount of observational and clinical trial evidence] 2008: NHLBI appoints panel to update guidelines. New process employed: defined questions, systematic review of evidence, grading of evidence JNC Unofficial guideline ACC/AHA 2017 JNC = Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure A committee of experts appointed through the National Heart, Lung, and Blood Institute (NHLBI), High Blood Pressure Education Program 3

5 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 Wilbert S. Aronow, MD, FACC, FAHA* Donald E. Casey, Jr, MD, MPH, MBA, FAHA Karen J. Collins, MBA Paul K. Whelton, MB, MD, MSc, FAHA, Chair Robert M. Carey, MD, FAHA, Vice Chair Bruce Ovbiagele, MD, MSc, MAS, MBA,FAHA Sidney C. Smith, Jr, MD, MACC, FAHA Crystal C. Spencer, JD Cheryl Dennison Himmelfarb, RN, ANP, PhD, FAHA Sondra M. DePalma, MHS, PA-C, CLS, AACC Samuel Gidding, MD, FACC, FAHA Kenneth A. Jamerson, MD# Daniel W. Jones, MD, FAHA Eric J. MacLaughlin, PharmD** Paul Muntner, PhD, FAHA Randall S. Stafford, MD, PhD Sandra J. Taler, MD, FAHA Randal J. Thomas, MD, MS, FACC, FAHA Kim A. Williams, Sr, MD, MACC, FAHA Jeff D. Williamson, MD, MHS Jackson T. Wright, Jr, MD, PhD, FAHA## *American Society for Preventive Cardiology Representative. ACC/AHA Representative. Lay Volunteer/Patient Representative. Preventive Cardiovascular Nurses Association Representative. American Academy of Physician Assistants Representative. Task Force Liaison. #Association of Black Cardiologists Representative. **American Pharmacists Association Representative. ACC/AHA Prevention Subcommittee Liaison. American College of Preventive Medicine Representative. American Society of Hypertension Representative. Task Force on Performance Measures Liaison. American Geriatrics Society Representative. ##National Medical Association Representative ACC/AHA Updated Categories of BP in Adults* BP Category SBP DBP Normal <120 mm Hg and <80 mm Hg Elevated mm Hg and <80 mm Hg Hypertension Stage mm Hg or mm Hg Stage mm Hg or 90 mm Hg *Individuals with SBP and DBP in 2 categories should be designated to the higher BP category. BP indicates blood pressure (based on an average of 2 careful readings obtained on 2 occasions DBP, diastolic blood pressure; and SBP systolic blood pressure. Whelton PK, et al 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: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017;ll:ellll ellll. 4

6 Estimated Prevalence of Hypertension in the U.S. Paul Muntner et al. Circulation. 2018;137: Percentage of US adults with SBP of 130 to 139 mm Hg or DBP of 80 to 89 mm Hg recommended for antihypertensive medication according to the 2017 ACC/AHA guideline. Paul Muntner et al. Circulation. 2018;137:

7 2017 ACC/AHA Hypertension Guideline Measurement of BP Major point of emphasis in 2017 guideline How s Your BP Measurement IQ? Using a cuff too small will result in an artificially reading? [higher or lower] True or False: When having BP measured, the patient s feet should touch the floor and their back be supported? How long should a patient sit before BP is measured? - A. 1 min - B. 2 min - C. 3 min - D. 4 min - E. 5 min 6

8 The Usual BP Hypothesis Assumes that the vasculature is exposed to an underlying BP level conceived as an average occurring over long periods of time. Conventional BP measurements serve as a surrogate for this true BP level. Although taken at single points in time, repeated measures over time predict risk; treatment targeted at these BPs accounts for measurable reduction in CV risk. Blood Pressure Is Highly Variable Over a 24-Hour Period Blood pressure (mmhg) Sleep Systolic BP Diastolic BP Time of awakening 80 18:00 22:00 02:00 06:00 10:00 14:00 18:00 Time of day Adapted from: Millar-Craig MW, et al. Lancet. 1978;15:

9 BP Variability Ernst ME. Pharmacotherapy 2013;33:69-83 ACTIVITY Attending a Meeting Commuting to Work SBP (mmhg) DBP (mmhg) Dressing Walking 12 6 Talking on telephone 10 7 Eating 9 10 Doing Desk Work 6 5 Reading 2 2 Watching TV BMJ 2001 Apr 14;322(7291): Checklist for Accurate Measurement of BP Key Steps for Proper BP Measurements Step 1: Properly prepare the patient. Have the patient relax, sitting in a chair (feet on floor, back supported) for >5 min. Make sure patient avoids caffeine, exercise, and smoking for at least 30 min prior Step 2: Use proper technique for BP measurements. Support the patient s arm Using the correct cuff, position the middle of the cuff on the patient s upper arm at the midpoint of the sternum Step 3: Take the proper measurements needed for diagnosis and treatment of elevated BP/hypertension. Step 4: Properly document accurate BP readings. Step 5: Average the readings. Step 6: Provide BP readings to patient. At the first visit, record BP in both arms, and use the arm with the higher reading Use a palpated estimate of radial pulse obliteration pressure for systolic BP and inflate the cuff mmhg above this level Deflate the cuff pressure 2 mmhg per second Record systolic BP at the onset of first Korotkoff sound and diastolic BP at the disappearance of all Korotkoff sounds Use an average based on 2 readings obtained on 2 occasions to estimate the individual s level of BP Provide patients the systolic/diastolic BP readings both verbally and in writing Whelton PK, et al 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: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017;ll:ellll ellll. 8

10 Only 1/159 medical students correctly performed all 11 elements in a BP check challenge with simulated patients! Out-of-Office and Self-Monitoring of BP Recommendation for Out-of-Office and Self- Monitoring of BP Out-of-office BP measurements are recommended to confirm the diagnosis of hypertension and for titration of BP-lowering medication, in conjunction with telehealth counseling or clinical interventions. To accurately record BP at home, patients should take at least 2 readings 1 minute apart each morning and evening for 7 days. This provides approximately 14 averaged readings. Whelton PK, et al 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: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017;ll:ellll ellll. 9

11 2017 ACC/AHA Hypertension Guideline Treatment of High BP Big changes here from previous guideline with regard to diagnosis thresholds and goals BP Treatment Threshold and the Use of CVD Risk Estimation to Guide Drug Treatment of Hypertension Recommendations for BP Treatment Threshold and Use of Risk Estimation* to Guide Drug Treatment of Hypertension Use of BP-lowering medications is recommended for secondary prevention of recurrent CVD events in patients with clinical CVD and an average SBP of 130 mm Hg or higher or an average DBP of 80 mm Hg or higher, and for primary prevention in adults with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk of 10% or higher and an average SBP 130 mm Hg or higher or an average DBP 80 mm Hg or higher. Use of BP-lowering medication is recommended for primary prevention of CVD in adults with no history of CVD and with an estimated 10-year ASCVD risk <10% and an SBP of 140 mm Hg or higher or a DBP of 90 mm Hg or higher. *ACC/AHA Pooled Cohort Equations ( to estimate 10-year risk of atherosclerotic CVD. Whelton PK, et al 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: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017;ll:ellll ellll. 10

12 Blood Pressure (BP) Thresholds and Recommendations for Treatment and Follow-Up BP thresholds and recommendations for treatment and follow-up Normal BP (BP <120/80 mm Hg) Elevated BP (BP /<80 mm Hg) Stage 1 hypertension (BP /80-89 mm Hg) Stage 2 hypertension (BP 140/90 mm Hg) Promote optimal lifestyle habits Nonpharmacologic therapy (Class I) Clinical ASCVD or estimated 10-y CVD risk 10%* No Yes Reassess in 1 y (Class IIa) Reassess in 3 6 mo (Class I) Nonpharmacologic therapy (Class I) Nonpharmacologic therapy and BP-lowering medication (Class I) Nonpharmacologic therapy and BP-lowering medication (Class I) *Using the ACC/AHA Pooled Cohort Equations. Note that patients with DM or CKD are automatically placed in the high-risk category. Consider initiation of pharmacological therapy for stage 2 hypertension with 2 antihypertensive agents of different classes. Reassess in 3 6 mo (Class I) Whelton PK, et al 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: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017;ll:ellll ellll. Reassess in 1 mo (Class I) BP goal met No Yes Assess and Reassess in optimize 3 6 mo adherence to (Class I) therapy Consider intensification of therapy Note once on meds, monthly follow-up/med titration until BP goal is met! 2017 ACC/AHA BP Thresholds for and Goals of Pharmacological Therapy in Patients With Hypertension According to Clinical Conditions Clinical Condition(s) BP Threshold, mm Hg BP Goal, mm Hg General Clinical CVD or 10-year ASCVD risk 10% 130/80 <130/80 No clinical CVD and 10-year ASCVD risk <10% 140/90 <130/80 Older persons ( 65 years of age; noninstitutionalized, ambulatory, 130 (SBP) <130 (SBP) community-living adults) Specific comorbidities Diabetes mellitus 130/80 <130/80 Chronic kidney disease 130/80 <130/80 Chronic kidney disease after renal transplantation 130/80 <130/80 Heart failure 130/80 <130/80 Stable ischemic heart disease 130/80 <130/80 Secondary stroke prevention 140/90 <130/80 Secondary stroke prevention (lacunar) 130/80 <130/80 Peripheral arterial disease 130/80 <130/80 Whelton PK, et al 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: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017;ll:ellll ellll. ASCVD indicates atherosclerotic cardiovascular disease; BP, blood pressure; CVD, cardiovascular disease; and SBP, systolic blood pressure. 11

13 2017 ACC/AHA Hypertension Guideline Interventions to Reduce BP Non-pharmacologic (no real changes from before) Pharmacologic (essentially no changes from before) Best Proven Nonpharmacological Interventions for Prevention and Treatment of Hypertension* Nonpharmacological Intervention Dose Weight loss Weight/body fat Best goal is ideal body weight, but aim for at least a 1-kg reduction in body weight for most adults who are overweight. Expect about 1 mm Hg for every 1-kg reduction in body weight. Healthy diet Reduced intake of dietary sodium Enhanced intake of dietary potassium DASH dietary pattern Dietary sodium Dietary potassium Consume a diet rich in fruits, vegetables, whole grains, and low-fat dairy products, with reduced content of saturated and total fat. Optimal goal is <1500 mg/d, but aim for at least a 1000-mg/d reduction in most adults. Aim for mg/d, preferably by consumption of a diet rich in potassium. Approximate Impact on SBP Hypertension Normotension -5 mm Hg -2/3 mm Hg -11 mm Hg -3 mm Hg -5/6 mm Hg -2/3 mm Hg -4/5 mm Hg -2 mm Hg Whelton PK, et al 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: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017;ll:ellll ellll. *Type, dose, and expected impact on BP in adults with a normal BP and with hypertension. DASH indicates Dietary Approaches to Stop Hypertension; and SBP, systolic blood pressure. Resources: Your Guide to Lowering Your Blood Pressure With DASH How Do I Make the DASH? Available at: Top 10 Dash Diet Tips. Available at: 12

14 Best Proven Nonpharmacological Interventions for Prevention and Treatment of Hypertension* (cont.) Physical activity Moderation in alcohol intake Nonpharmacological Dose Intervention Aerobic min/wk 65% 75% heart rate reserve Dynamic resistance min/wk 50% 80% 1 rep maximum 6 exercises, 3 sets/exercise, 10 repetitions/set Isometric resistance 4 2 min (hand grip), 1 min rest between exercises, 30% 40% maximum voluntary contraction, 3 sessions/wk 8 10 wk Alcohol consumption In individuals who drink alcohol, reduce alcohol to: Men: 2 drinks daily Women: 1 drink daily Whelton PK, et al 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: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017;ll:ellll ellll. Approximate Impact on SBP Hypertension Normotension -5/8 mm Hg -2/4 mm Hg -4 mm Hg -2 mm Hg -5 mm Hg -4 mm Hg -4 mm Hg -3 mm *Type, dose, and expected impact on BP in adults with a normal BP and with hypertension. In the United States, one standard drink contains roughly 14 g of pure alcohol, which is typically found in 12 oz of regular beer (usually about 5% alcohol), 5 oz of wine (usually about 12% alcohol), and 1.5 oz of distilled spirits (usually about 40% alcohol). Choice of Initial Medication Recommendation for Choice of Initial Medication For initiation of antihypertensive drug therapy, first-line agents include thiazide diuretics, CCBs, and ACE inhibitors or ARBs. All of the major classes of antihypertensives have been shown to reduce morbidity and mortality from hypertension Whelton PK, et al 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: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017;ll:ellll ellll. 13

15 Choice of Initial Monotherapy Versus Initial Combination Drug Therapy Recommendations for Choice of Initial Monotherapy Versus Initial Combination Drug Therapy* Initiation of antihypertensive drug therapy with 2 first-line agents of different classes, either as separate agents or in a fixed-dose combination, is recommended in adults with stage 2 hypertension and an average BP more than 20/10 mm Hg above their BP target. Initiation of antihypertensive drug therapy with a single antihypertensive drug is reasonable in adults with stage 1 hypertension and BP goal <130/80 mm Hg with dosage titration and sequential addition of other agents to achieve the BP target. Good 2 drug combos: ACEi (or ARB) + CCB ACEi (or ARB) + thiazide CCB + thiazide Whelton PK, et al 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: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017;ll:ellll ellll ACC/AHA Hypertension Guideline Special Patient Groups Emphasis on elderly major point of difference with JNC-8 14

16 Age-Related Issues Recommendations for Treatment of Hypertension in Older Persons Treatment of hypertension with a SBP treatment goal of less than 130 mm Hg is recommended for noninstitutionalized ambulatory community-dwelling adults ( 65 years of age) with an average SBP of 130 mm Hg or higher. For older adults ( 65 years of age) with hypertension and a high burden of comorbidity and limited life expectancy, clinical judgment, patient preference, and a team-based approach to assess risk/benefit is reasonable for decisions regarding intensity of BP lowering and choice of antihypertensive drugs. Whelton PK, et al 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: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017;ll:ellll ellll. The lower BP goal (especially in healthy elderly) is a major departure from the JNC8 panel report and other past guidelines. What evidence led to the change in the BP goals in the new ACC/AHA guideline? 15

17 SPRINT Research Question Examine effect of more intensive high blood pressure treatment than is currently recommended Randomized Controlled Trial Target Systolic BP Intensive Treatment Goal SBP < 120 mm Hg N=4678 Standard Treatment Goal SBP < 140 mm Hg N=4683 The SPRINT Research Group. N Engl J Med 2015;373: Major Inclusion/Exclusion Criteria INCLUSION 50 years old Systolic blood pressure : mm Hg (treated or untreated) Additional cardiovascular disease (CVD) risk (at least one) Clinical or subclinical CVD (excluding stroke) Chronic kidney disease (CKD), defined as egfr 20 <60 ml/min/1.73m 2 Framingham Risk Score for 10-year CVD risk 15% Age 75 years EXCLUSION Stroke Diabetes mellitus Polycystic kidney disease Congestive heart failure (symptoms or EF < 35%) Proteinuria >1g/d CKD with egfr < 20 ml/min/1.73m 2 (MDRD) Standing SBP <110 mmhg Adherence concerns The SPRINT Research Group. N Engl J Med 2015;373:

18 2/5/18 Systolic Blood Pressure in the Two Treatment Groups over the Course of the Trial. Year 1 Mean SBP mm Hg Mean SBP mm Hg Average SBP (During Follow-up) Standard: mm Hg Intensive: mm Hg The SPRINT Research Group. N Engl J Med 2015;373: Primary Outcome and Death from Any Cause. Primary outcome first occurrence of: Myocardial infarction (MI) Acute coronary syndrome (nonmi ACS) Stroke Acute decompensated heart failure (HF) Cardiovascular disease death The SPRINT Research Group. N Engl J Med 2015;373:

19 2/5/18 Serious Adverse Events* (SAE) During Follow-up All SAE reports Number (%) of Participants Intensive Standard HR (P Value) 1793 (38.3) 1736 (37.1) 1.04 (0.25) SAEs associated with Specific Conditions of Interest Hypotension Electrolyte abnormality 110 (2.4) 107 (2.3) 105 (2.2) 87 (1.9) 144 (3.1) 66 (1.4) 80 (1.7) 110 (2.3) 73 (1.6) 107 (2.3) 1.67 (0.001) 1.33 (0.05) 0.95 (0.71) 1.19 (0.28) 1.35 (0.020) Acute kidney injury or acute renal failure 193 (4.1) 117 (2.5) 1.66 (<0.001) Syncope Injurious fall Bradycardia *Fatal or life threatening event, resulting in significant or persistent disability, requiring or prolonging hospitalization, or judged important medical event. The SPRINT Research Group. N Engl J Med 2015;373: JD Williamson and Coauthors for the SPRINT Research Group Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged 75 Years: A Randomized Clinical Trial JAMA 2016;315: jamanetwork.com 18

20 SPRINT Age 75 Optimal SBP target especially controversial in older, frail patients Epidemiological evidence of inverse relationship between SBP and mortality Concerns regarding falls and fall-related injury due to antihypertensive therapy Cognitive and quality of life outcomes not certain SPRINT included a large number of ambulatory, community-dwelling older adults (n=2,636) Journal of the American Geriatrics Society Volume 56, Issue 10, pages , 22 SEP 2008 DOI: /j x Cumulative Hazards for SPRINT Outcomes in Participants 75 and older Primary Outcome All-Cause Mortality Primary outcome includes non-fatal myocardial infarction (MI), acute coronary syndrome not resulting in MI, non-fatal stroke, non-fatal acute decompensated heart failure, and CVD death. Findings were consistent across measures of frailty Williamson JD, et al. for the SPRINT Research Group. JAMA 2016;315:

21 Conditions of Interest for Participants > 75 Years Williamson JD, et al. for the SPRINT Research Group. JAMA 2016;315: ACC/AHA Guideline Controversies Heavy reliance on SPRINT (chair of guideline was chair of SPRINT) - AAFP and ACP published their own guideline on hypertension in adults over age 60 in Jan They continue to recommend a goal SBP of <150 mmhg (Ann Intern Med 2017;166: ) and do not endorse the new AHA guideline. Use of the 10-yr CVD risk calculator may overestimate risk in low risk individuals, and it has not been validated prospectively New classification means that 46% of US adults now have hypertension (vs 32%) - Control rates that were approaching 70% will be lower (impact on health systems measures?) - Concern that the new disease designation can become a mandate for Rx without consideration of patient s risk level! 20

22 Medications required to achieve blood pressure (BP) control in clinical trials. Omar Al Dhabyi, and George L. Bakris J Am Heart Assoc 2017;6:e SPRINT: Generalizabilty Issues to Consider BP measurement method External validity of enrolled population [healthy, community-dwelling, ambulatory] Clinical impact of absolute vs relative risk differences 21

23 Unobserved Automated Office BP (AOBP) o o o o Visit BP was the average of 3 seated office BP measurements obtained using an automated measurement device: Omron 907XL. Appropriate cuff size was determined by arm circumference. Participant was seated with back supported and arm bared and supported at heart level. Device was set to delay 5 minutes to begin 3 BP measurements research staff was trained to push start button and leave exam room during the 5 minute delay and measurements, during which time participant refrained from talking. This differs from BP measurement techniques used in many previous studies in the following: 1. Other people were out of the room during measurements and the entire resting period prior to measurements. 2. The BP measurement device was present 5 min before measurements started. 3. Few outcome trials have utilized automated or semiautomated measurement devices. Unobserved Automated Office BP (AOBP) In most clinical trials of BP, multiple readings taken and averaged. Research BPs typically run on avg. ~10/7 mmhg lower than routine office BP readings, with larger discrepancies observed at the higher end of the SBP spectrum. Applying SPRINT intensive targets based on usual office measurements would likely correspond to having achieved approx < mmhg (~132 mmhg). Parati G, et al. Hypertension 2017;69:

24 Risk Reduction: Let s Re-Look at Some Numbers from SPRINT 25% relative risk reduction Subjects in the intensive treatment goal had a 25% lower risk of the primary endpoint Primary outcome occurred in 6.8% vs 5.2% over 3.2 years = absolute risk reduction of 1.6% NNT = 1/ARR = people need to be treated to an intensive BP goal for 3.2 years to avoid 1 additional primary event The SPRINT Research Group. N Engl J Med 2015;373: Serious ADE (intervention-related) occurred in 4.7% of intensive treated group vs 2.5% of conventional group NNH = 1/ARI = 45.5 For every 46 people treated to an intensive BP goal for 3.2 years, 1 additional harm will occur The SPRINT Research Group. N Engl J Med 2015;373:

25 Extrapolating SPRINT For 1000 persons: Benefit: 1000/62.5 = 16 Harm: 1000/45.5 = 22 For 1000 persons treated over 3.2 years to systolic goal BP of <120 mmhg compared to <140 mmhg an average of 16 persons will benefit, 22 persons will be seriously harmed and 962 will not experience benefits or harms. Ortiz E, James PA. Ann Intern Med 2016 Vickers AJ, Kent DM. Ann Intern Med 2015;162: Although the treatment may be worthwhile for patients on average, it may not be worthwhile for the average patient! This is because the average patient is at less risk than the mean! 24

26 Case Vignette A 64-year-old non-smoking female presents for general follow-up after a recent wrist fracture which occurred from a fall while participating in a hot yoga class. She walks on a treadmill three times/week for 45 minutes and follows a vegan diet. Meds: lisinopril-hct 10/12.5 mg/d; simvastatin 10 mg/d BP = 142/78 mmhg (repeated to verify) and other vital signs are normal. She reports her home BP usually ranges in the low 130s/70s. Her cardiovascular and eye exam are unremarkable. Her BMI is 30. She is not orthostatic and has no complaints. Labs: normal CBC, SCr=1.2 mg/dl (no proteinuria on urinalysis), Potassium=3.5 meq/l, Tchol=175 mg/dl, LDL=98 mg/dl, HDL = 64 mg/dl fasting glucose=103 mg/dl. SHOULD HER ANTIHYPERTENSIVE REGIMEN BE ADJUSTED? WHAT IF SHE WAS NOT PREVIOUSLY TREATED? SHOULD WE START TREATMENT? ASCVD Risk Estimator Our Case Vignette Age: 64 Gender: F Race: white Tchol: 175 mg/dl HDL: 64 mg/dl LDL: 98 mg/dl SBP: 142 mmhg DM?: No On antihypertensives?: Yes Smoker?: No Statin?: Yes Aspirin?: No 10-year ASCVD Risk = - 7.1% (if treated with antihypertensives) - 5.3% (if untreated) In our case, what if past medical history included CAD? No longer primary prevention! 25

27 2/5/18 Blood Pressure Targets: Are They a Ceiling or a Floor? Not all patients need to be reduced down to the lowest levels (i.e. normal BP ) to achieve benefits. The magnitude of CVD risk reduction is generally proportional to the height of the pre-treatment BP. - Getting below 130 mmhg with drugs is not the same as being there naturally! Management of BP is only one part of the recipe to reduce CV risk! - Do not forget to concurrently manage other CV risk factors! Over-Diagnosed. Making People Sick in the Pursuit of Health. Welch HG, Schwartz LM, Woloshin S. Beacon Press. 1/3/2012. ISBN:

28 Take Home Points The 2017 ACC/AHA guideline updates the classification of blood pressure. - The importance of proper measurement is stressed. - Thresholds for treatment and BP targets are updated: Incorporation of ASCVD risk calculator to help individualize risk Correction to JNC-8 in approach to elderly (i.e., community dwelling, ambulatory) SPRINT data drive the change in guidelines but not all will benefit from intensified BP goals My opinion: focus on 140 mmhg as a ceiling, 130 mmhg as a floor, and control other concurrent CV risk factors! Remember that guidelines are just that not mandates Don t forget the importance of using your clinical reasoning to individualize BP targets!! 27

29 absolute risk is an important determinant of the need for treatment. It s reasonable to consider more aggressive treatment goals in the highest-risk patients, as SPRINT showed. But while a blood-pressure treatment target of less than 130/80 mm Hg makes sense for high-risk patients, for everyone else it seems more reasonable to continue defining hypertension as a blood pressure of 140/90 mm Hg or higher. Bakris G, Sorrentino M. N Engl J Med DOI: /NEJMp Questions? 28