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HYPERTENSION: EVIDENCE-BASED UPDATE, 2013 (Waiting for JNC-8, Still!)

HYPERTENSION: EVIDENCE-BASED UPDATE, 2013 (Waiting for JNC-8, Still!). Barry Stults, M.D. Division of General Medicine University of Utah Medical Center May, 2013.

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HYPERTENSION: EVIDENCE-BASED UPDATE, 2013 (Waiting for JNC-8, Still!)

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  1. HYPERTENSION: EVIDENCE-BASED UPDATE, 2013 (Waiting for JNC-8, Still!) Barry Stults, M.D. Division of General Medicine University of Utah Medical Center May, 2013

  2. This presentation has no commercial content, promotes no commercial vendor and is not supported financially by any commercial vendor. I receive no financial remuneration from any commercial vendor related to this presentation.

  3. HTN: DOMINANT CONTRIBUTOR TO GLOBAL MORTALITY Increases RR by 2.0-4.0 fold for: • CAD, stroke, HF, PAD • Renal failure, AF, dementia,  cognition Attributable risk for HTN: • Stroke 62% • MI 25% • CKD 56% • Premature death 24% • HF 49% Aftermath: • Shortens lifespan  5y • $93.5 billion/y in U.S. Circulation 2012; 125:e12 JHumHypertension 2008; 22:63 Hypertension 2007; 50:1006

  4. NEWLY RECOGNIZED CONSEQUENCES OF HTN Framingham cerebral MRI study (cross-sectional): • 579 subjects, mean age = 39.2y •  SBP before age 50 damages cerebral loci associated with cognitive dysfunction! • LancetNeurology 2012; 11:1039

  5. HTN PREVALENCE, 2010: NHANES • No change in HTN prevalence since 2000 • 75 million Americans have HTN • JACC 2012; 60:599

  6. HTN CONTROL (< 140/90) RATES: 1988-2010 (40% M, 56% W) ‒ No U.S. improvement since 2007! Circulation 2012; 126:2105CMAJ 2011; 183:1007Circulation 2012; 125:2462 JACC 2012; 60:599

  7. U.S. HTN CONTROL: 39 million  140/90!- YET 85% HAVE HEALTH INSURANCE! 40% Unaware 15% Aware, No Rx 45% Rx’d, Uncontrolled • Older, women, obese, AA, CKD, CVD, DM • Younger, men, Hispanic,  finances, 0-1 visits/y MMWR2012; 61:703 MMWR 2011; 60:103 Circulation 2011; 124:1046 CanJCard 2012; 28:375

  8. HOW LOW TO GO? TARGET BP, 2013 *Initiate Rx if SBP  150 mm Hg **  <130/80 in younger/↑ stroke risk pts CanJCard2013; online 3/25 BMJ 2011; 343:d4891 Circulation 2011; 123:2434 DiabetesCare 2013; 36:Suppl 1:S11 KidInt 2012; supplement 2:341

  9. AGE  80Y: HOW LOW TO GO? HYVET RCT, 2008: 3845 pts age  80y, SBP = 160-199 Final SBP = 157 Initial SBP = 171 Final SBP = 143 RRR Total Stroke  30% Fatal Stroke  39% Mortality  21% CHF  64% Placebo Indapamide ACE-I J-Curve concern: too low BP in very elderly? • Optimal BP, age  80y: 140/70, INVEST RCT (post-hoc) NEJM 2008; 358:1887 Circulation 2011; 123:2434

  10. GOAL BP: HOW LOW FOR AGE  80y? • INVEST RCT: BP Rx in 22,576 CAD pts Circulation 2011; 123:2434

  11. CKD: HOW LOW TO GO? Systematic review, 3 RCTs: MDRD, AASK, REIN 133-141/80-86 2272 pts 126-130/77-80 RRR CVD events NS CKD progression NS Mortality NS 130-139/80-89 < 130/80 • Subgroup with proteinuria 300-1000 mg/d*: HR CVD events NS CKD progression  24-39% AnnIntMed 2011; 154:541 *Low quality evidence

  12. DIABETES MELLITUS: HOW LOW TO GO? Meta-analysis: 13 RCTs, mean achieved systolic BP < 140 37,736 pts 135  130 • Target BP = 130-135 reduces mortality/stroke? • Target BP  130 reduces stroke? • Circulation 2011; 123:2799

  13. GOAL BP: HOW LOW TO GO? 1 Prevention vs 2 Prevention? SPRINT: 9000 patients, 2018 completion • High CVD risk • CKD • Age  75 PODCAST, SPSSS, SHOS: Post-stroke/TIA PLOSMedicine 2012; 9:e1001293 Hypertension 2012; 59: Circulation 2011; 124:1700

  14. CHALLENGES TO CLINICAL VALIDITY OF OFFICE BP Inherent BP Variability:  over min  months! • 20%  SBP  10 mm Hg over 1-2 min • 4-5 office visits for BP to stabilize Inaccurate BP Measurement: Rule, not Exception! • 93% make technical errors - Mean # errors = 4 “True” or usual BP Predicts CVD Risk Out-of-office BP  Office BP for Many! • White-coat HTN in 20-33% • Masked HTN in 10% AmJHypertens 2011; 24:1073 AnnIntMed 2011; 154:781 JGenIntMed 2012; 27:623

  15. BP MEASUREMENT: KEY TECHNIQUES

  16. RESEARCH QUALITY vs ROUTINE OFFICE BP Accurate measurement  BP by  10/7 mm Hg  2X improved HTN control rate (Powers, Burgess, 2011) AnnIntMed 2011; 154:781 AmJHypertens 2005; 18:1522 Hypertension2010; 55:195 BMJ 2010; 340:1104 JASH 2011; 5:484

  17. OUT-OF-OFFICE BP MEASUREMENT TO DX HTN? CHEP, 2005  2013; AHA, 2008: optional OBPM vs ABPM vs HBPM 2 Office Visits: BP ≥ 180/110 or ≥ 140/90 and CVD, DM, or CKD Yes Dx HTN No: BP = 140-179/90-99 and low risk R/O White-coat HTN: 20-33% Serial Office Visits: • 3 if BP  160/100 • 5 if BP = 140-159/90-99 24h ABPM: • Daytime BP  135/85 • 24h BP  130/80 Home BPM x 7d • Mean BP  135/85 BP < 135/85 Dx HTN CanJCard 2012; 28:270

  18. HOME BPM: PROS AND A FEW CONS! Pros vs Office BPM: • More accurate HTN Dxin most studies • More measurements  out-of-office measurements • Better CVD prediction: similar to ABPM • Meta-analysis: 8 studies; 17,688 pts; 3.2-10.9y FU • Improves BP control:  systolic BP 3.4-8.9 mm Hg • AHRQ 2012 systematic review: 6 high quality studies Cons vs Office BPM: • Not yet proven to  CVD events better • Expense/inadequate patient training JHypertens 2012; 30:449, 463, 1289 HypertensRes 2012; 35:750 AHRQ, 2012; #45

  19. HBPM MONITOR VALIDATION: NOT ALWAYS ACCURATE! For populations: AAMI, BHS, IP validation protocols • Omron, A&D Medical (Lifesource), MicroLife, other • Listings of validated devices: www.hypertension.ca/devices-endorsed-by-hypertension-canada www.bhsoc.org/blood_pressure_list.stm www.dableducational.org For individuals: office validation at purchase and q 1y • Sequential method, 1 arm: < 5 mm Hg diff., last 2 tests: Osc D – Osc D – Ausc D – Osc D – Ausc D • Simultaneous method, 2 arms: < 5 mm Hg diff for averages Osc R arm/Ausc L arm  Ausc R arm/Osc L arm • Esp. elderly, DM, CKD, obese (tronco-conical arm) Hypertension 2008; 52:13 HypertensionRes 2012; 35:777

  20. HBPM: RECOMMENDED MONITORING PROTOCOL • For Dx or 2wk post-med: For 3-7 days (12-28 readings) • -  drop 1st day, average last 2-6 days • - 66% adherence! • Stable BP period: For 3-7d, q 3-4 movs ongoing 3d/wk • JHumHypertens 2010; 24:779 Hypertension 2011; 57:9081 HypertensRes 2012; 35:777

  21. HBPM: NEW BP DX THRESHOLDS, 2013 AHA/ESH 2008 home BP Dx thresholds: • Statistically-based (95th percentile) from cross-sectional analyses International Database of Home Blood Pressure, 2012 Dx thresholds: • CVD outcome-based from prospective population studies • 5018 untreated patients, mean FU = 8.3y HypertensionRes 2012; 35:1072 Hypertension 2013; 61:27

  22. HBPM: DOCUMENTATION/COMMUNICATION/ACTION Documentation: avoid inaccurate/selected readings Regular/Timely Communication of Data: • Office visit, mail, FAX, computer Action by Clinician/Team • Dx • Rx adjustment, prn HypertensionRes 2012; 35:777

  23. Home BP Log: Horizontal Orientation

  24. REDEFINE OFFICE BP MEASUREMENT: AUTOMATED OFFICE BP (AOBP)? 3 validated devices automatically measure/average multiple BP’s: BpTRU 6 readings – average last 5 ($900-1100) • q 1 min: start of one  start of next Omron HEM-907 3 readings – average all 3 ($520) • q 1 min: end of one  start of next Microlife Watch BP office 3 readings – average all 3 ($1100) • q 1 min: end of one  start of next • Additional auscultatory mode • Provide comparable mean readings • Similar time to complete 6 vs 3 readings CanJCard 2012; 28:341 JHypertens 2012; 30:1894

  25. REDEFINE OFFICE BP MEASUREMENT: AUTOMATED OFFICE BP (AOBP)? 3 basic principles of AOBP: • Fully automated device Eliminates many technical errors • More accurate • Multiple measurements taken Controls for BP variability • More reproducible • Performed in isolation Reduces white-coat effect • Equivalent to daytime ABPM CanJCard 2012; 28:341 JHypertens 2012; 30:1894

  26. SEQUENTIAL BpTRU READINGS IN 284 PATIENTS IN PRIMARY CARE

  27. AOBP ON ISOLATED PATIENTS:  WHITE COAT HTN AOBP, isolated pt, is close to daytime ABPM: reduces WCH CanJCard 2012; 28:341 Hypertension 2010; 55:195 BMJ 2011; 342:d286 FamPract 2011; 28:110 * 1 care

  28. EQUIVALENT BPs TO DX HYPERTENSION *Supported by CVD outcome data **Superior to routine BP for LV mass, CIMT, albuminuria but CVD outcome data pending (CAMBO RCT) JHypertens 2012; 30:1894 JHypertens 2012; 30:1906 Hypertension 2012; 11/5 epubAmJHypertens 2012; 25:969 AmJHypertens 2011; 24:661

  29. TREATMENT OF HYPERTENSION

  30. LIFESTYLE MODIFICATION: OLD AND NEW EurHeartJ 2011; 32:3081 AmJCard 2012; 109:1005

  31. LIFESTYLE MODIFICATION: OLD AND NEW EurHeartJ 2011; 32:3081 ArchIntMed 2012; 172:186 JHypertens 2012; 30:2245 JClinHypertens 2012; 14:792

  32. LIFESTYLE MODIFICATION: OLD AND NEW JGenIntMed 2012; 27:1197 EurHeartJ 2011; 32:3081 Hypertension 2013; 61:779 AmJHypertens 2012; 25:1215 AmJHypertens 2012; 23:97

  33. LIFESTYLE MODIFICATION 2012; “SALT WARS” Benefits ?? Adverse effects •  Na intake 1.2-2.4 g/d •  SBP: • HTN: 4-7 mm Hg • NT: 2.5-3.5 mm Hg • Potentially prevent 11 million HTN cases • renin,  aldosterone  catecholamines  triglycerides  insulin resistance (?) • (esp. if abrupt, severe, or DM)  Dietary Na   CVD? • 2011-2012: 6 risk association studies 2  Benefits; 2  Harm; 2  J-curve • 2011-2012: 3 meta-analyses 1  Benefit 1  No benefit 1  J-curve NEJM 2013; 368:1229 Circulation 2012; 126:2880 AmJMed 2012; 125:443 AmJHypertens 2012; 25:727

  34. “SALT WARS”: THE SCIENTIFIC RESPONSE AHA Presidential Advisory, Dec 2012: “The evidence base supporting recommendations for reduced sodium intake to < 1500 mg/d in the general population remains robust and persuasive.” British Hypertension Society, July 2011: “The benefits of salt reduction are clear and consistent.” Reviewer commentary, AJH, Jan 2012: “Community sodium reduction: is it worth the effort?... A concerted campaign to reduce obesity and alcohol intake may be more rewarding and less risky.” Reviewer commentary, AJH, Jan 2012: “The solution to the debate is the conduct of a large-scale, long-term clinical trial.”

  35. “SALT WARS”: THE MEDIA/INDUSTRY RESPONSE NY Times, June 2012: “Now, salt is safe to eat.” London DailyExpress, July 2011: “Now salt is safe to eat – Health fascists proved wrong after lecturing us all those years.” Forbes.com, June 2011: “Campbell Soup increases sodium as new studies vindicate salt.”

  36. EDUCATION TOOLS FOR LIFESTYLE MODIFICATION Low diet Na/DASH diet: Canadian HTN Education Program www.hypertension.ca/images/2012_HealthyEatingFor HealthyBloodPressure_EN_P1017.pdf www.sodium101.ca DASH diet: www.dashdiet.org www.mayoclinic.com/health/dash-diet/H100047 In Spanish: www.wellnessproposals.com/nutrition/handouts/dash-diet/DASH-diet-eating-plan-spanish-version.pdf

  37. OPTIMAL 1st DRUG RX FOR HTN? RECOMMENDATIONS FROM RECENT GUIDELINES CanJCard 2012; 28:270 BMJ 2011; 343:d4891 www.heartfoundation.org.au JGenIntMed 2012; 27:618 BMJ 2011; 342;d2234 EurHeartJ 2012; 33:2088 JAMA 2012; 208:1340 BMJ 2009; 338:b1665

  38. HCTZ vs CHLORTHALIDONE: CHOICE GIVEN MOSTLY INDIRECT EVIDENCE? Efficacy to lower BP: • Meta-analysis: 26 RCTs; 4683 pts Dose to  SBP 10 mm Hg HCTZ 26.4 mg CTDN 8.6 mg (Similar BP reduction at maximal doses) • RCT: 609 pts on azilsartan 40 mg  12.5-25 mg thiazide SBP: CTDN-HCTZ = 5.6 mm Hg, p < 0.001 HTN control < 140/90 = 64% vs 46%, p < 0.001 Hypertension 2012; 59:1104 AmJMed 2012; 125:1229.e1

  39. HCTZ vs CHLORTHALIDONE: CHOICE GIVEN MOSTLY INDIRECT EVIDENCE?

  40. HCTZ vs CHLORTHALIDONE: CHOICE GIVEN MOSTLY INDIRECT EVIDENCE? Practical utility: • Availability: CTDN less available in retail pharmacies • Preparation: HCTZ: 12.5 mg, 25 mg tabs CTDN: unscored 25, 50 mg tabs • Fixed-dose combinations: HCTZ: 19 at 12.5 and 25 mg doses CTDN: 3 (azilsartan ($90/mo), atenolol, clonidine)

  41. INITIAL 2-DRUG vs DELAYED 2-DRUG Rx Rationale: •  75% need  2 drugs, 30% need  3 drugs • Especially if BP  160/100, obese, CKD, DM • Low-dose 2-drug vs High dose 1 drug: • Greater SBP reduction (3-4 mm Hg) • Fewer side effects Benefits in studies: •  year 1 HTN control rates 20-50% (RCTs, cohorts) •  year 1 CVD events 11-34% (cohort, case-control studies) •  health care costs 10% Caution: frail elderly, baseline orthostatic BP  Hypertension 2012; 59:1124 Hypertension 2013; 61 (Feb) CurrOpinNephHypertens 2012; 21:486

  42. OPTIMAL 2-DRUG RX FOR HTN?AMERICAN SOCIETY OF HYPERTENSION, 2010* JAmSocHTN 2010; 4:42 EurHeartJ 2011; 32:2499

  43. ACE-I/CCB vs ACE-I/DIURETIC?

  44. PREFERRED 3-DRUG HTN RX?EXPERT CONSENSUS ONLY • Diuretic/ACE-I (ARB)/CCB • Diuretic/BB/DHP-CCB • ACE-I/CCB/alpha-blocker (ASCOT RCT) CanJCard 2012; 28:270

  45.  1 HTN DRUG AT BEDTIME: CHRONOTHERAPY? 5.4y •  nocturnal BP but same daytime BP •  CVD events with  1 HTN med HS: • T2DM:  75% for CVD death  MI  stroke • CKD:  71% for CVD death  MI  stroke ADA 2013 Standard of Care: give  1 HTN med HS • Need more studies! JAmSocNeph 2011; 22:2313 DiabetesCare 2011; 34:1270 DiabetesCare 2013; 36:(Suppl 1):S11 5.4y

  46. RESISTANT HYPERTENSION Definition: • BP  140/90 x 3 mo on  3 meds (diuretic  optimal dosing) Prevalence: • Increasing in NHANES – 16 million Americans Risk factors: • Age  75, obesity, CKD, DM,  SBP, blacks/Hispanics Prognosis: • 50%  CVD/CKD events in 1st 4y (Kaiser Permanente) Circulation 2012; 125:1594, 1635 Circulation 2011; 124:1046 Hypertension 2011; 57:1045, 1076 CurrOpinCard 2012; 27:386

  47. SUSPECT RESISTANT HTN: • BP ≥ 140/90 (AOBP ≥ 135/85) x 3 mo – accuratelymeasured • ≥ 3 medications: optimal dosing  diuretic  RULE-OUT PSEUDO-RESISTANT HTN:  for non-compressible arteries: RFs  orthostatic symptoms  for white-coat resistant HTN: 24h ABPM or HBPM  for optimal 3 drug Rx: CCB  ACE-I (ARB)  diuretic  eGFR  for low Rx adherence to medication  CONSIDER ( EVALUATE) 2 CAUSES OF HTN  INTENSIFY LIFESTYLE RX:  DIET Na   EXERCISE  ADD APPROPRIATE STEP 4/5 MEDICATIONS

  48. RULE-OUT PSEUDO-RESISTANT HTN • for non-compressible arteries: • RFs:  age, ESRD, DM calcific AS, scleroderma • Orthostatic dizziness despite  standing BP Intra-arterial BP measurement JHumHypertens 1997; 11:285 BloodPressMonit 2003; 8:97 Clinical suspicion high

  49. RULE-OUT PSEUDO-RESISTANT HTN

  50. RULE-OUT PSEUDO-RESISTANT HTN • for optimal 3-drug Rx – maximaltolerateddoses of: • • CCB  ACE-I (ARB)  diuretic  eGFR  eGFR < 30 ml/min ≥ 30 ml/min  total body Na *22% not on diuretic 1y after Dx of RH in Kaiser system! 57% not maximally dosed on meds! EurHeartJ 2013; on-line 2/5, MesserliBMJ 2012; 345:e7473 Hypertension 2012; 60:303

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