Pressure Drop: The Latest Guidelines on Treating Hypertension

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1 Pressure Drop: The Latest Guidelines on Treating Hypertension Eric J MacLaughlin, Pharm.D. Joseph J Saseen, Pharm.D.

2 Target Audience: Pharmacists ACPE#: L01-P Activity Type: Application-based

3 Disclosures Dr. Saseen and Dr. MacLaughlin have no conflicts conflicts of interest to disclose. The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

4 Learning Objectives 1. Compare guidelines and consensus recommendations for the treatment of patients with hypertension (HTN). 2. Identify recommended blood pressure (BP) goals based on patient-specific characteristics. 3. Evaluate recent evidence that influences the selection of BP goals for individual patients. 4. Recommend appropriate medication regimens for the treatment of HTN based on current guidelines. 5. Formulate patient-centered treatment plans for complex patients with HTN.

5 Assessment Question #1 What blood pressure (BP) classification would be most appropriate for a patient with a 2-week average home BP reading of 136/84 mm Hg, which is consistent with clinic readings? A. Prehypertension B. Elevated C. White coat D. Masked

6 Assessment Question #2 Which of the following blood pressure (BP) goals would be most appropriate for a 65 year-old patient with history of hypertension (HTN), dyslipidemia, and coronary artery disease (CAD)? A. <120/80 mm Hg B. <130/80 mm Hg C. <140/90 mm Hg D. <150/90 mm Hg

7 Assessment Question #3 Which of the following statements regarding the SPRINT-Senior trial in patients >75 years of age is most accurate? A. Older patients did not benefit as much as young patients B. Outcomes cannot be extrapolated to nursing home patients C. Patients had worse outcomes with a BP goal of <120/80 mm Hg compared to <140/90 mm Hg D. Falls were more common in patients randomized to the more intensive BP lowering group

8 Assessment Question #4 A 55-year old black man with hypertension and type 2 diabetes is diagnosed with hypertension. BP is 135/82 mm Hg (similar to home values). He does not have albuminuria. Which of the following is the most appropriate initial regimen? A. Amlodipine 5 mg PO daily B. Carvedilol 12.5 mg PO twice daily C. Lisinopril 10 mg PO daily D. Chlorthalidone 25 mg PO daily with olmesartan 40 mg PO daily

9 Assessment Question #5 A 60-year old woman with hypertension and coronary artery disease (heart attack 2 years ago) has a BP of 140/90 mm Hg despite treatment with hydrochlorothiazide 50 mg PO daily, lisinopril 40 mg PO daily and amlodipine 10 mg PO daily. She is adherent with these medications and recommended lifestyle changes. All laboratory values are normal. Which of the following is the most appropriate addition to her regimen? A. Chlorthalidone B. Losartan C. Metoprolol D. Spironolactone

10 Understanding Why Lower Goals are Recommended Eric J MacLaughlin, Pharm.D., BCPS Professor and Chair Texas Tech University Health Sciences Center

11 Cardiovascular (CVD) Statistics in the U.S Millions of Patients HTN CKD Diabetes CHD Stroke Heart Failure Any Cancer Mozaffarian D, et al. Circulation 2016;133(4): Munter P et al. J Am Coll Cardiol doi: /j.jacc CKD, Chronic Kidney Disease CHD, Coronary Heart Disease

12 Background on New ACC-AHA 2017 Guidelines Last comprehensive US guidelines JNC 7* (2003) Lead by ACC/AHA Cardiologists, Epidemiologists, Internists, Endocrinologist, Geriatrician, Nephrologist, Nurse, Pharmacist, Physician Assistant, lay/patient representatives Representatives from: American College of Cardiology (ACC) American Heart Association (AHA) American Academy of Physician Assistants (AAPA) Association of Black Cardiologists (ABC) American College of Preventive Medicine (ACPM) American Geriatrics Society (AGS) American Pharmacists Association (APhA) American Society of Preventive Cardiology (ASPC) Preventive Cardiovascular Nurses Association (PCNA) American Society of Hypertension (ASH) National Medical Association (NMA) *Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure Whelton PK, et al. Hypertension doi: /hyp

13 Class (Strength) of Recommendations and Level (Quality) of Evidence Class I (Strong) Class IIa (Moderate) Class IIb (Weak) Class III (No Benefit) Class IV (Harm) Benefit>>> Risk Benefit >> Risk Benefit Risk Benefit = Risk Risk > Benefit Level A Level B-R Level B-NR Level C-LD Level C-EO COR, Class of Recommendation; LOE, Level of Evidence High-quality evidence ( 1 RCT, Metaanalyses) Moderatequality evidence ( 1 RCT or metaanalyses) Nonrandomized ( 1 nonrandomized studies) Limited data (randomized or nonrandomized studies with limitations) Expert Opinion Whelton PK, et al. Hypertension doi: /hyp

14 Definition of High BP COR LOE I B-NR Recommendation for Definition of High Blood Pressure BP should be categorized as Normal Elevated BP Stage 1 or 2 hypertension Whelton PK, et al. Hypertension doi: /hyp

15 BP Classification Changes SBP DBP JNC7 <120 and <80 Normal BP and <80 Prehypertension or Prehypertension or Stage or 100 Stage 2 Categorization of BP should be based on average of 2 readings on 2 occasions following a standardized protocol. SBP, Systolic Blood Pressure; DBP, Diastolic Blood Pressure Whelton PK, et al. Hypertension doi: /hyp

16 BP Classification Changes SBP DBP JNC ACC/AHA <120 and <80 Normal BP Normal BP and <80 Prehypertension Elevated BP or Prehypertension Stage or Stage 1 Stage or 100 Stage 2 Stage 2 Categorization of BP should be based on average of 2 readings on 2 occasions following a standardized protocol. SBP, Systolic Blood Pressure; DBP, Diastolic Blood Pressure Whelton PK, et al. Hypertension doi: /hyp

17 Risk of CVD Event Compared to BP <120/80 mm Hg 2.5 Elevated BP ( /80-84) Hypertension ( /85-89) Relative Risk (RR) CVD or CVD Mortality Stroke Myocardial Infarction (MI) Guo X, et al. Curr Hypertens Rep. 2013;15(6):

18 YOU GET HYPERTENSION AND YOU GET HYPERTENSION AND YOU GET HYPERTENSION EVERYONE GETS HYPERTENSION

19 HTN Statistics Updated - NHANES % 53.4% Percent of US Adults 50.0% 40.0% 30.0% 20.0% 10.0% 31.9% 45.6% 39.0% 34.3% 36.2% 0.0% Overall HTN On Meds Above Goal Recommended BP Meds JNC ACC/AHA Munter P, et al. J Am Coll Cardiol doi: /j.jacc

20 Measurement of BP COR LOE Recommendation I C-EO For diagnosis and management of high BP, proper methods are recommended for accurate measurement and documentation of BP. Appropriate technique essential Use out-of-office monitoring in diagnosis and management Home BP monitoring (HBPM) Ambulatory BP monitoring (ABPM) Detect white coat or masked HTN Whelton PK, et al. Hypertension doi: /hyp

21 Obtaining Accurate BP Readings Appropriate Device Validated and periodically calibrated Correct cuff size Devices with memory storage preferred for HBPM Bell or diaphragm can be used for auscultatory measurements Train patient on use Average 2 readings on 2 occasions Pickering, et al. Circulation. 2005;111: O Brien, et al. J Hypertens (5): Whelton PK, et al. Hypertension doi: /hyp Measurement Technique 5 minutes resting 2 readings 1 min apart Check both arms; use higher arm Empty bladder Arm heart level Cuff on bare arm No talking Support back Support feet Legs uncrossed

22 Home BP Monitoring (HBPM) COR I LOE Recommendation Out-of-office BP measurements recommended to: Confirm diagnosis of HTN A SR Titration of BP-lowering medication Used in conjunction with telehealth counseling or clinical interventions SR, Systematic review Whelton PK, et al. Hypertension doi: /hyp

23 White Coat HTN (WCH) and Masked HTN (MH) White Coat HTN In-office BP elevated Out-of-office BP normal Prevalence ~13 (up to 35%) in HTN population WCH Implications Minimal/non-significant risk of CVD 1-5%/yr. conversion to sustained HTN, esp. those with higher BPs, older, obesity, or Black race Treatment not needed Masked HTN In-office BP normal Out-of-office BP elevated Prevalence ~13% (up to 30% in some surveys) MH Implications CVD risk similar to sustained HTN Likely need treatment Prevalence with higher (normal) office BP Whelton PK, et al. Hypertension doi: /hyp

24 What threshold for drug therapy and BP goal is recommended?

25 BP Threshold for Drug Therapy COR LOE Recommendations for BP Treatment Threshold and Use of Risk Estimation* to Guide Drug Treatment of HTN I SBP: A DBP: C-EO I C-LD Secondary prevention (ASCVD): 130/80 mm Hg High Risk Primary Prevention (estimated 10-year ASCVD risk 10%): 130/80 mm Hg Primary prevention and estimated 10-year ASCVD risk <10%: 140/90 mm Hg ASCVD, Atherosclerotic Cardiovascular Disease *ACC/AHA Pooled Cohort Equations ( Plus/#!/calculate/estimate/) to estimate 10-year risk of ASCVD. Whelton PK, et al. Hypertension doi: /hyp

26 Comparison of BP Thresholds for Drug Therapy Clinical Condition(s) JNC 7 JNC ACC/AHA Clinical CVD or 10-yr <130/80 ASCVD risk 10% 140/90 140/90 No clinical CVD and 10-yr 140/90 ASCVD risk <10% Older persons 140/ (SBP)* <130 (SBP) Diabetes mellitus <130/80 140/80 <130/80 Chronic Kidney Disease <130/80 140/80 <130/80 * >60 years of age 65 years of age; noninstitutionalized, ambulatory, community-living adults James PA, et al. JAMA. 2014;311(5): Whelton PK, et al. Hypertension doi: /hyp

27 BP Goals (mm Hg) Guideline Comparisons Characteristic JNC 7 JNC ACC/AHA 2018 ADA 2012 KDIGO General <140/90 <140/90 <130/80* Older Patients <140/90 <150/90 <130/80 Diabetes <130/80 <140/90 <130/80 Chronic Kidney Disease <130/80 <140/90 <130/80 <140/90; <130/80 optional *Includes secondary and primary prevention patients at high and low ASCVD risk General population aged >60 years of age Ambulatory, community-dwelling, non-institutionalized patients 65 years of age Without albuminuria (<30 mg/24 hrs or equivalent), with and without diabetes With albuminuria (>30 mg/24 hrs or equivalent), with and without diabetes <140/90 or <130/80 James PA, et al. JAMA. 2014;311(5): Whelton PK, et al. Hypertension doi: /hyp American Diabetes Association. Diabetes Care. 2018;41(Suppl 1):S86-S104. KDIGO. Kidney Int. (Suppl.) 2012;2:

28 What is the evidence for lower BP goals?

29 Systolic Blood Pressure Intervention Trial (SPRINT) Multicenter, RCT in 9,361 patients with HTN Methods: Randomized open-label to: Intensive treatment: SBP <120 mm Hg Standard treatment: SBP <140 mm Hg Primary outcome: 1 st occurrence of MI, ACS, stroke, HF, or CVD death Hypothesis: SBP <120 mm Hg will reduce primary outcome compared to <140 mm Hg Prespecified subgroups: CKD, CVD, elderly ( 75 yr) ACS, Acute Coronary Syndrome; HF, Heart Failure; RCT, Randomized Controlled Trial Ambrosius WT, et al. ClinTrials. 2014;11(5):

30 Patients Inclusion Criteria 50 years old Systolic BP: mm Hg on 0 or 1 drugs mm Hg on up to 2 drugs mm Hg on up to 3 drugs mm Hg on up to 4 drugs ASCVD or risk Age 75 yrs CKD CVD or 15% 10-yr risk Exclusion Criteria Secondary hypertension Diabetes mellitus Previous stroke CV event within 3 months Symptomatic HF w/in 6 months or EF< 35% Proteinuria (> 1 g/day), PCKD, glomerulonephritis, egfr < 20 ml/min/1.73m2 or ESRD EF, Ejection Fraction; PCKD, polycystic kidney disease; egfr, Estimated Glomerular Filtration Rate; ESRD; End- Stage Renal Disease Ambrosius WT, et al. ClinTrials. 2014;11(5):

31 SPRINT: Patient Characteristics Baseline Characteristics Mean SBP (mm Hg) Women (%) Mean Age (yr) Age 75 yr (%) CKD (%) Black Hispanic Results: Mean SBP at 1 year (mm Hg) Mean no. BP medications The SPRINT Research Group. N Engl J Med. 2015;373(22): Intensive Treatment Standard Treatment

32 SPRINT: Primary Endpoint Result Hazard Ratio (HR) Intensive Treatment HR with Intensive Treatment 0.75 (95% CI, ) NNT=61 Standard Treatment Study Stopped Mean follow-up 3.26 yrs The SPRINT Research Group. N Engl J Med. 2015;373(22): Years

33 SPRINT-Senior Pre-planned subgroup analysis of patients 75 years Patients: Intensive group: N=1317 Standard group: N=1319 Outcomes: Primary: composite of MI, ACS not resulting in MI, nonfatal stroke, nonfatal acute decompensated HF, death from CV causes Secondary: All-cause mortality Williamson JD, et al. JAMA. 2016;315(24):

34 SPRINT-Senior Participants Funded to enhance recruitment of older patients Mean age: 79.9 years Included measures of functional status and frailty Exclusion criteria: Diagnosis of or treatment of dementia Expected survival <3 years Unintentional weight loss >10% during preceding 6 mos. SBP <110 mm Hg after 1 min of standing Nursing home resident Williamson JD, et al. JAMA. 2016;315(24):

35 Selected Outcomes: SPRINT & SPRINT-Senior Outcome CVD Primary Outcome Myocardial infarction Stroke Heart failure Death from CV cause Death from any cause Primary outcome or death SPRINT ARR, HR (95% CI)* 1.6% 0.75 ( ) 0.4% 0.83 ( ) 0.2% 0.89 ( ) 0.8% 0.62 ( ) 0.6% 0.57 ( ) 1.2% 0.73 ( ) 1.9% 0.78 ( ) SPRINT NNT SPRINT-Senior ARR, HR (95% CI) 3.5% 0.66 ( ) 1.2% 0.69 ( ) 0.5% 0.72 ( ) 1.6% 0.62 ( ) 0.8% 0.60 ( ) 2.6% 0.67 ( ) 4.6% 0.68 ( ) *Hazard ratio and 95% confidence Interval NNT over mean of years; reported CVD Primary Outcome and death from any cause indicated Nonfatal MI, ACS not resulting in MI, nonfatal stroke, nonfatal acute decompensated HF, and death from CV causes Williamson JD, et al. JAMA. 2016;315(24): SPRINT- Senior NNT

36 SPRINT Safety Outcomes Outcome Intensive Treatment N=4678; no.(%) Standard Treatment N=4683; no.(%) HR* (P-Value) NNH Serious Adverse Event (SAE) 1793 (38.3) 1736 (37.1) 1.04 (0.25) -- Individual SAEs Hypotension 110 (2.4) 66 (1.4) 1.67 (0.001) 100 Syncope 107 (2.3) 80 (1.7) 1.33 (0.05) - Bradycardia 87 (1.9) 73 (1.6) 1.19 (0.28) -- Electrolyte abnormality 144 (3.1) 107 (2.3) 1.35 (0.02) 125 Injurious fall 105 (2.2) 110 (2.3) 0.95 (0.71) -- Acute kidney injury (AKI) or 191 (4.3) 117 (2.5) 1.66 (<0.001) 56 acute renal failure (ARF) * Hazard ratio Number needed to harm over 3.3 years A serious adverse event was defined as an event that was fatal or life-threatening or that resulted in clinically significant or persistent disability SPRINT Research Group, et al N Engl J Med. 2015;373(22):

37 SPRINT Conclusions Intensive treatment reduced risk of hard CVD outcomes and death Benefit more pronounced in elderly No increased risk of fall (4.9% vs. 5.5%, p=0.6). Exploratory analysis: less fit and patients with slow gait speed benefited Lower SBP risk of hypotension, electrolyte abnormalities, and AKI or ARF Benefits of therapy outweigh risks The SPRINT Research Group, et al N Engl J Med. 2015;373(22): Williamson JD, et al. JAMA. 2016;315(24):

38 What about patients with diabetes?

39 Action to Control Cardiovascular Risk in Diabetes (ACCORD) BP Design: RCT factorial design assessing intensive vs. standard glucose and BP goals Patients: Type 2 diabetes and high CV risk (n= 4733) BP Arms: Intensive BP goal (SBP <120 mm Hg); n=2362 Standard BP goal (SBP <140 mm Hg); n=2371 Primary Outcome: composite of nonfatal MI, nonfatal stroke, or death from CV causes Cushman WC, et al. N Engl J Med. 2010;362:

40 ACCORD Selected Results Primary Composite Intensive BP Events (%/yr) n=2362 Prespecified Secondary Outcomes Standard BP Events (%/yr) n=2371 HR (95% CI) P-value NNT 208 (1.87) 237 (2.09) 0.88 ( ) Nonfatal MI 126 (1.13) 146 (1.28) 0.87 ( ) Total Stroke 36 (0.32) 62 (0.53) 0.59 ( ) Nonfatal Stroke 34 (0.30) 55 (0.47) 0.63 ( ) Total Mortality 150 (1.28) 144 (1.19) 1.07 ( ) CV Death 60 (0.52) 58 (0.49) 1.06 ( ) Cushman WC, et al. N Engl J Med. 2010;362:

41 Reconciling ACCORD-BP with SPRINT ACCORD underpowered ½ the size of SPRINT and ½ anticipated events in standard BP group (2% vs. 4%) Younger patients in ACCORD (62 vs. 68 years) Factorial study design used in ACCORD 95% CI in ACCORD included possibility of 27% lower risk Secondary analysis in combined standard glycemia and BP treatments, intensive BP treatment alone risk 26% The SPRINT Research Group. N Engl J Med. 2015;373(22):

42 Other data supporting lower BP goals?

43 Systematic Review for 2017 ACC/AHA Guidelines Studies: RCTs comparing intensive vs. standard goals Hard CV outcomes Excluded if primary intent not specifically BP lowering, observational studies, <100 randomize pts or <400 person-years follow-up, <1 year follow-up 33 publications from 15 studies Mean follow-up years Mean ages at baseline years Mean age 60 years in 8 studies Reboussin DM, et al. Hypertension doi: /hyp /-/dc2.

44 Risk of Outcomes for any Intensive BP Target vs. Standard Outcomes Studies Included (N) Study Participants Included (N) Intensive BP Events, N (%) Standard BP RR (95% CI) All-cause 15 49, (4.0) 1,001 (4.3) 0.89 (0.77, 1.02) mortality CVD 10 40, (1.3) 504 (2.5) 0.86 (0.67, 1.12) mortality Major CVD 7 23, (5.8) 828 (7.0) 0.81 (0.70, 0.94) event MI* 11 31, (2.6) 419 (2.7) 0.86 (0.76, 0.99) Stroke* 12 33, (2.3) 475 (2.9) 0.77 (0.65, 0.91) HF 8 23, (1.9) 278 (2.4) 0.75 (0.56, 0.99) Renal Events 8 18, (3.8) 353 (4.2) 1.01 (0.89, 1.15) * Fatal or nonfatal Reboussin DM, et al. Hypertension doi: /hyp /-/dc2.

45 Effects of Intensive BP lowering on CV and renal outcomes Objective: Assess safety and efficacy of intensive BP-lowering Methods: Updated systematic review and meta-analysis More intensive vs. less intensive BP lowering compared Trials and Patients: 19 trials including 44,989 participants; no age restrictions 2,496 CV events recorded during mean follow-up of 3.8 yr. Studies 6 mos. follow-up Outcomes: Major CV events, non-vascular and all-cause mortality, stroke, HF, ESRD, adverse events, albuminuria, progression of retinopathy Xie X, et al. Lancet. 2016;387(10017):

46 Intensive vs. Less Intensive BP Lowering Outcome Trials (n) BP Difference (mm Hg) RR (95% CI)* Major CV events / ( ) MI / ( ) Stroke / ( ) Heart Failure / ( ) ESRD 8 9.4/ ( ) CV Death / ( ) Non-CV Death / ( ) Overall mortality / ( ) * Confidence Interval Composite of MI, stroke, HF, or CV death Favors more intensive BP lowering Favors less intensive BP lowering Xie X, et al. Lancet. 2016;387(10017):

47 If lower BP is better, what goal should be used?

48 Effects of more vs. less intensive BP lowering and different achieved BP levels updated meta-analysis Objective: Identify ideal target BPs in antihypertensive treatment Methods: Updated meta-analysis that includes SPRINT More intensive vs. less intensive BP lowering Trials and Patients: 16 hypertension trials including 52,235 participants Studies 6 mos. follow-up Outcomes: Fatal and non-fatal events Thomopoulos C, et al. J Hypertens. 2016;34:

49 Effects of BP lowering in trials of active treatment vs. placebo and more vs. less intense treatment* Outcome Stroke CHD HF All-Cause Death Achieved SBP cutoff (mm Hg) vs vs. 140 <130 vs vs vs. 140 <130 vs vs vs. 140 <130 vs vs vs. 140 <130 vs. 130 Trials (n) Standardized RR (95% CI) 0.68 ( ) 0.62 ( ) 0.71 ( ) 0.81 ( ) 0.77 ( ) 0.86 ( ) 0.52 ( ) 0.75 ( ) 0.81 ( ) 0.89 ( ) 0.83 ( ) 0.84 ( ) Absolute RR 1000 pts/5 yr * SBP stratification by active or more intensive treatment vs. mean SBP achieved in placebo or less intense treatment Standardized RR is to a SBP/DBP difference of -10/-5 mmhg P-value for trend < Thomopoulos C, et al. J Hypertens. 2016;34:

50 SBP Reduction and Risk of CVD and Mortality A Systematic Review and Network Meta-Analysis Objective: Assess association of mean SBP levels with CVD and all-cause mortality Methods: Network meta-analysis Pool results from direct and indirect evidence from multiple different treatments Preserves benefit of randomized comparisons with trials Trials and Patients: 42 trials, including 144,220 patients Outcomes: SBP categorized across 10 levels (<120, , , , , , , 160) Bundy DJ, et al. JAMA Cardiol. 2017;2(7):

51 Network of Treatment Comparisons for CVD and Mortality by SBP Categories mm Hg mm Hg mm Hg <120 mm Hg mm Hg mm Hg mm Hg mm Hg Bundy DJ, et al. JAMA Cardiol. 2017;2(7): mm Hg mm Hg

52 Major CVD Associated With More Intensive Reductions in SBP Mean Achieved SBP, mm Hg Bundy DJ, et al. JAMA Cardiol. 2017;2(7): Hazard Ratio (95%CI) Reduction to vs ( ) vs ( ) vs ( ) vs ( ) vs ( ) vs ( ) vs ( ) vs ( ) Reduction to vs ( ) vs ( ) vs ( ) vs ( ) vs ( ) vs ( ) 0.1 Favors Lower BP Favors Higher BP 1.0 2

53 If data show benefit of SBP goal <120 mm Hg, why is <130 mm Hg the goal in the new guidelines?

54 BP Measurement in SPRINT vs. Usual Care SPRINT used Automated BP Measurement (AOBP) AOBP measurements close to awake ambulatory and HBPM AOBP Procedure Alone in room at rest 5 minutes and appropriate body position 3 automated measurements at 1-min interval averaged Usual care clinic BP measurements typically elevated AOBP ~5-10 mm Hg lower than usual clinic care Bakris GL. Circulation Aug 30. pii: /CIRCULATIONAHA

55 Conclusions New BP classification results in significant increase in patients with HTN Additional ~2% now require drug therapy Data support lower BP goal Simplified, lower SBP of <130 mm Hg likely to have significant impact on HTN-related morbidity and mortality

56 A Case-Based Approach to Treat High Blood Pressure Joseph Saseen, PharmD, BCPS, BCACP Professor University of Colorado Anshutz Medical Campus

57 Case AR 50-year-old African American man with GERD, depression, obesity Current medications: Citalopram, omeprazole Smokes 1 pack/day x 30 yrs; exercises once/week (walking); follows no particular diet Vitals/other parameters: BP 160/96, 156/96 mm Hg (150/90 mm Hg average at home) Heart rate 80 beats/min BMI 32.1 kg/m 2 Laboratory values (fasting) Total cholesterol 250 mg/dl HDL-cholesterol 30 mg/dl LDL-cholesterol 160 mg/dl Triglycerides 300 mg/dl A1C 6.4% SCr 1.1 mg/dl egfr 90 ml/min/1.73m 2 No albuminuriua All other labs are normal 10-year ASCVD Risk is 15.9%

58 2017 ACC-AHA: BP Measurements COR LOE Out-of-Office and Self-Monitoring of BP I A SR and for titration of BP-lowering medication, in conjunction with telehealth counseling or clinical Out-of-office BP measurements to confirm diagnosis interventions Whelton PK, et al. Hypertension [Epub ahead of print].

59 Corresponding BP Values Clinic HBPM Daytime ABPM Nighttime ABPM 24-Hour ABPM 120/80 120/80 120/80 100/65 115/75 130/80 130/80 130/80 110/65 125/75 140/90 135/85 135/85 120/70 130/80 160/ /90 145/90 140/85 145/90 ABPM indicates ambulatory blood pressure monitoring; BP, blood pressure; DBP diastolic blood pressure; HBPM, home blood pressure monitoring; and SBP, systolic blood pressure Whelton PK, et al. Hypertension [Epub ahead of print].

60 2017 ACC/AHA: Treatment Algorithm Normal BP < 120/80 mm Hg Elevated BP /<80 mm Hg Stage 1 HTN /80-89 mm Hg Stage 2 HTN 140/90 mm Hg Promote Optimal Lifestyle Habits NonPharm Tx Class I Clinical ASCVD or 10-yr ASCVD Risk Score 10% NonPharm Tx and Medications Class I Reassess in 1 yr Class IIa Reassess in 3-6 mo Class I No NonPharm Tx Class I Yes NonPharm Tx and Medication Class I Reassess in 1 mo Class I Reassess in 3-6 mo Class I Reassess in 1 mo Class I Whelton PK, et al. Hypertension [Epub ahead of print].

61 2017 ACC-AHA: Medication Selection COR LOE Initial Medication I A SR First-line: thiazide diuretics, CCBs, and ACE inhibitors or ARBs COR LOE Initial Monotherapy Versus Combination Therapy I C-EO 2 first-line agents of different classes in stage 2 hypertension and BP > 20/10 mm Hg above goal COR LOE Race and Ethnicity I B-R I C-LD Black patients without HF or CKD (with or without diabetes), initial treatment should include a thiazide diuretic or CCB 2+ medications are recommended to achieve a BP <130/80 mm Hg in most adults, especially in black patients Whelton PK, et al. Hypertension [Epub ahead of print].

62 Combination Therapy Thiazide diuretics Preferred Combinations Useful Combination with limitations Possible but less well tested Not Recommended Beta-blockers Angiotensin Receptor Blockers Other agents Calcium Channel Blockers ACE Inhibitors Mancia G et al. J Hypertens. 2013; 31:

63 Adding a Second Medication vs. Doubling the Dose Incremental SBP Reduction Ratio of Observed to Expected Additive Effects Thiazide Beta-Blocker ACE Inhibitor Calcium Channel Blocker Adding drug from another class Doubling dose All classes 5 times more effective Wald DS, et al. AM J Med 2009;122:

64 Quarter-Dose BP Lowering Medications Systematic review and meta-analysis 42 randomized controlled trials (n=20,284) Quarter-dose antihypertensive medications comparted to placebo and standard dosing vs Placebo Mean BP change (mm Hg) vs Standard Dose Mean BP change (mm Hg) One Drug* Two Drugs* Four Drugs* -4.7/ / /-13.1 One Drug* Two Drugs *P<0.001 Four Drugs* +3.7/ / / 7.9 *P<0.001 Bennett A, et al. Hypertension 2017;70:85-93.

65 Follow-Up, Monitoring, Adherence COR LOE Follow-Up After Initiating Drug Therapy I B-R Follow-up evaluation of adherence and response to treatment at monthly intervals until control is achieved. COR LOE Monitoring Strategies to Improve Control of BP I A Follow-up and monitoring should include systematic strategies including HBPM, team-based care, and telehealth strategies. COR LOE Medication Adherence Strategies I B-R IIa B-NR Dosing medication once daily rather than multiple times daily is beneficial to improve adherence. Combination pills rather than free individual components can be useful to improve adherence. Whelton PK, et al. Hypertension [Epub ahead of print].

66 Plan for AR

67 Case BD 60-year-old white woman with hypertension, type 2 diabetes Current medications: Lisinopril 10 mg PO daily, metformin, liraglutide, atorvastatin Does not smoke; exercises three times/week (aerobic); follows a strict diet Vitals/other parameters: BP 144/86, 142/86 mm Hg (138/84 mm Hg average at home) BMI 27.4 kg/m 2 Laboratory values (fasting) Total cholesterol 150 mg/dl HDL-cholesterol 40 mg/dl LDL-cholesterol 70 mg/dl Triglycerides 200 mg/dl A1C 6.9% SCr 1.05 mg/dl egfr 58 ml/min/1.73m 2 Persistent albuminuria All other labs are normal 10-year ASCVD Risk is 20.1%

68 2017 ACC-AHA: Compelling Indications Co-morbidity Diabetes Diabetes with albuminuria Chronic kidney disease Heart failure with reduced ejection fraction (EF) Heart failure with preserved EF Stable ischemic heart disease Secondary stroke prevention 1 st Line Agent(s) Thiazide, CCB, ACE-I or ARB ACE-I or ARB ACE-I or ARB Beta-blocker, ACE-I or ARB, mineralocorticoid receptor antagonist Beta-blocker, ACE-I or ARB Beta-blocker, ACE-I or ARB, CCB (if angina) Thiazide, ACE-I or ARB NOTE: Use either an ACEi or ARB, avoid using these two together Whelton PK, et al. Hypertension [Epub ahead of print].

69 American Diabetes Association Initial BP /90-99 mm Hg No Monotherapy: ACEi ARB CCB Diuretic Start ONE medication Albuminuria* Yes Monotherapy: ACEi ARB Lifestyle Management Initial BP 160/ mm Hg No Combination: ACEi or ARB and CCB ACEi or ARB and Diuretic CCB and Diuretic Start TWO medications Albuminuria* Yes Combination: ACEi or ARB and CCB ACEi or ARB and Diuretic *ACEi or ARB at maximum tolerated dose if urine albuminto-creatinine mg/g; strongly recommended if 300mg/g American Diabetes Association. Diabetes Care 2018;41(Suppl. 1):S86 S104

70 Case CO 45-year-old white man with no significant past medical history Current medications: none Does not smoke; exercises irregularly (skiing in the winter); follows no particular diet Vitals/other parameters: BP 138/86, 136/84 mm Hg BMI 28.9 kg/m 2 Family history of coronary artery disease (dad at 50 years, and grandfather at 40 years) Laboratory values (fasting) Total cholesterol 220 mg/dl HDL-cholesterol 25 mg/dl LDL-cholesterol 150 mg/dl Triglycerides 225 mg/dl A1C 6.0% SCr 0.9 mg/dl egfr >100 ml/min/1.73m 2 No albuminuria All other labs are normal 10-year ASCVD Risk is 6.3%

71 2017 ACC-AHA: BP Thresholds for Pharmacological Therapy Threshold, mm Hg Goal, mm Hg Clinical Condition(s) 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 yr; noninstitutionalized, ambulatory, community-living) 130 (SBP) <130 (SBP) 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 ASCVD, atherosclerotic cardiovascular disease; BP, blood pressure; CVD, cardiovascular disease; and SBP, systolic blood pressure. Whelton PK, et al. Hypertension [Epub ahead of print].

72 2017 ACC-AHA: Lifestyle Changes COR LOE Nonpharmacological Interventions I A Weight loss in adults who are overweight or obese I A Healthy diet (e.g., DASH) that facilitates achieving desirable weight I A Sodium reduction I A Potassium supplementation (preferably diet) unless contraindicated I A Increased physical activity with a structured exercise program I A Drink no more than 2 (men) or 1 (women) standard drinks/day DASH = Dietary Approaches to Stop Hypertension Whelton PK, et al. Hypertension [Epub ahead of print].

73 Plan for CO

74 Case DO 85-year-old Hispanic woman with a history of hypertension, osteoporosis, anxiety, dementia Current medications: Sertraline, alprazolam prn, alendronate, memantine Was on amlodipine but stopped after dose increased to 10 mg PO daily and experienced edema Vitals/other parameters: BP 158/78, 156/76 mm Hg BMI 22.9 kg/m 2 Laboratory values (fasting) SCr 0.80 mg/dl egfr 67 ml/min/1.73m 2 No albuminuria All other labs are normal Does not smoke or exercise; follows controlled diet in her assisted living residence

75 2017 ACC-AHA: BP Goals COR LOE Older Persons I IIa A C-EO SBP treatment goal <130 mm Hg for non-institutionalized ambulatory community-dwelling adults 65 yr 65 yr with high burden of comorbidity and limited life expectancy, clinical judgment, patient preference, and a team-based approach to assess risk/benefit for decisions regarding intensity of treatment Whelton PK, et al. Hypertension [Epub ahead of print].

76 Hypertension in the Very Elderly Trial (HYVET) 3845 patients 80 yrs with hypertension Placebo Drug Therapy Randomized, double-blind, to: Placebo or Perindopril +/- Indapamide Stopped early after 1.8 years Target BP = 150/80 mm Hg Patients (%) Primary Endpoint: Stroke P=0.06 Secondary Endpoint: Mortality P=0.02 Beckett NS, et al. N Engl J Med 2008;358:

77 Collaboration to Improve BP Control Prospective, cluster randomized, controlled trial Clinics randomized to control or intervention group where clinical pharmacists provided collaborative patient care for at least 6 months 402 patients (mean age 58.3 yr) with uncontrolled hypertension Results Control Group Intervention Group P-value Mean BP decrease (mm Hg) 6.8/ /9.7 <0.05 Patients at BP goal 29.9% 63.9% <0.001 Carter BL, et al. Arch Intern Med 2009;169:

78 Plan for DO

79 Case ER 63-year-old African American woman with hypertension, coronary artery disease Current medications: Valsartan/hydrochlorothiazide 320 mg/25 mg PO daily, metoprolol succinate 100 mg PO daily, aspirin 81 mg PO daily, nitroglycerine 0.4 mg SL prn, rosuvastatin 40 mg PO daily, ezetimibe 10 mg PO daily Adherent with medications Smokes 0.5 pack/day x 45 yrs; does not exercise (due to chest pain); follows a strict low sodium vegetarian diet Vitals/other parameters: BP 146/82, 144/84 mm Hg (140/80 mm Hg average at home) Heart rate 58 beats/min BMI 24.1 kg/m 2 Laboratory values (fasting) LDL-cholesterol 50 mg/dl SCr 0.91 mg/dl egfr 78 ml/min/1.73m 2 No albuminuriua All other labs are normal

80 Resistant Hypertension (Treatment Resistance) Office BP 130/80 mm Hg and 3 medications at optimal doses, including a diuretic, if possible or Office BP <130/80 mm Hg but requires 4 medications Exclude pseudoresistance Identify and reverse contributing lifestyle factors Discontinue or minimize interfering substances (e.g., NSAIDs, Sympathomimetics) Screen for secondary causes of hypertension Pharmacological treatment Maximize diuretic therapy Add a mineralocorticoid receptor antagonist Add other agents with different mechanisms of actions Use loop diuretics in CKD and/or patients receiving potent vasodilators (e.g., minoxidil) Whelton PK, et al. Hypertension [Epub ahead of print].

81 Antihypertensive Agents First-Line ACEi ARB CCB Thiazide Diuretic First-Line in Compelling Indications Beta-Blocker Alternatives Mineralocorticoid Receptor Antagonist Alpha Antagonist Alpha Agonist Direct Arterial Vasodilator Direct Renin Inhibitor Rauwolfia Alkaloid

82 Plan for ER

83 Conclusions Appropriate medication regimens for the treatment of HTN based on current guidelines includes first-line use of an ACEi, ARB, CCB or thiazide diuretic Combination therapy is needed in most patient, with initial combination therapy recommended when >20/10 mm Hg from goal Patient-centered treatment plans should consider patients specific needs, include robust monitoring and ideally collaborative team-based approaches

84 Assessment Question #1 1. What blood pressure (BP) classification would be most appropriate for a patient with a 2-week average home BP reading of 136/84 mm Hg, which is consistent with clinic readings? A. Prehypertension B. Elevated C. White coat D. Masked

85 Assessment Question #2 2. Which of the following blood pressure (BP) goals would be most appropriate for a 65 year-old patient with history of hypertension (HTN), dyslipidemia, and coronary artery disease (CAD)? A. <120/80 mm Hg B. <130/80 mm Hg C. <140/90 mm Hg D. <150/90 mm Hg

86 Assessment Question #3 Which of the following statements regarding the SPRINT-Senior trial in patients >75 years of age is most accurate? A. Older patients did not benefit as much as young patients B. Outcomes cannot be extrapolated to nursing home patients C. Patients had worse outcomes with a BP goal of <120/80 mm Hg compared to <140/90 mm Hg D. Falls were more common in patients randomized to the more intensive BP lowering group

87 Assessment Question #4 A 55-year old black man with hypertension and type 2 diabetes is diagnosed with hypertension. BP is 135/82 mm Hg (similar to home values). He does not have albuminuria. Which of the following is the most appropriate initial regimen? A. Amlodipine 5 mg PO daily B. Carvedilol 12.5 mg PO twice daily C. Lisinopril 10 mg PO daily D. Chlorthalidone 25 mg PO daily with olmesartan 40 mg PO daily

88 Assessment Question #5 A 60-year old woman with hypertension and coronary artery disease (heart attack 2 years ago) has a BP of 140/90 mm Hg despite treatment with hydrochlorothiazide 50 mg PO daily, lisinopril 40 mg PO daily and amlodipine 10 mg PO daily. She is adherent with these medications and recommended lifestyle changes. All laboratory values are normal. Which of the following is the most appropriate addition to her regimen? A. Chlorthalidone B. Losartan C. Metoprolol D. Spironolactone

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