HYPERTENSION: EVIDENCE-BASED UPDATE, 2013 (Waiting for JNC-8, Still!)
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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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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.
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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 J Hum Hypertension 2008; 22:63 Hypertension 2007; 50:1006
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NEWLY RECOGNIZED CONSEQUENCES OF HTN
Framingham cerebral MRI study (cross-sectional):– 579 subjects, mean age = 39.2y
White-matter microstructural damage
• Anterior corpus callosum
Systolic BP: • Pre-HTN • HTN
• Fronto-occipital fasciuli
• Fronto-thalamic fibers
Temporal lobe grey matter atrophy
SBP before age 50 damages cerebral loci associated with cognitive dysfunction!
Lancet Neurology 2012; 11:1039
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HTN PREVALENCE, 2010: NHANES
% BP 140/90
All 30%
• Age 60y 67%
• White 29%
• Black 42%
• Hispanic 27%
- No change in HTN prevalence since 2000• 75 million Americans have HTN
JACC 2012; 60:599
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HTN CONTROL (< 140/90) RATES: 1988-2010 NHANES
1988
2001
2010
All 27% 29% 47%
• White --- 30% 50%
• Black --- 25% 41%
• Hispanic --- 25% 34%
• CVD --- --- 55%
• DM < 130/80 --- --- 42%
• CKD < 130/80 --- --- 39%
(40% M, 56% W)
Healthy People 2020 Goal
61%
---
---
---
---
---
---
Canada 2010
VA 2010
65% 76%
--- ---
--- ---
--- ---
--- ---
--- ---
--- ---
‒ No U.S. improvement since 2007!
Circulation 2012; 126:2105 CMAJ 2011; 183:1007 Circulation 2012; 125:2462 JACC 2012; 60:599
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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
Screening Access to care
• Work, CC’s, church
• Insurance • Availability
Media outreach
Pseudo-HTN • Control for BP variability • Measure BP accurately • Detect WCH
Rx inertia • 65% on 1-2 drugs
Rx efficiency
Pt adherence
MMWR 2012; 61:703 MMWR 2011; 60:103 Circulation 2011; 124:1046 Can J Card 2012; 28:375
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HOW LOW TO GO? TARGET BP, 2013Guideline General Age 80 CKD DM
JNC-7, 2003 < 140/90 --- < 130/80 < 130/80
CHEP, 2013 < 140/90 < 150 < 140/90 < 130/80
NKF-KDIGO, 2012 --- --- <140/90if ACR <30 130/80 if ACR ≥ 30
< 140/90if ACR <30 130/80if ACR ≥ 30
NICE, 2011 < 140/90 < 150/90 --- ---
ACCF/AHA, 2011 --- 140-145* --- ---
ADA, 2013 --- --- --- < 140/80**
JNC-8, 2013 ? ? ? ?
*Initiate Rx if SBP 150 mm Hg** <130/80 in younger/↑ stroke risk pts
Can J Card 2013; online 3/25 BMJ 2011; 343:d4891 Circulation 2011; 123:2434Diabetes Care 2013; 36:Suppl 1:S11 Kid Int 2012; supplement 2:341
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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%
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
PlaceboIndapamide ACE-I
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GOAL BP: HOW LOW FOR AGE 80y?
• INVEST RCT: BP Rx in 22,576 CAD pts
Circulation 2011; 123:2434
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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
• Subgroup with proteinuria 300-1000 mg/d*: HR
CVD events NSCKD progression 24-39%
Ann Int Med 2011; 154:541
130-139/80-89< 130/80
*Low quality evidence
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DIABETES MELLITUS: HOW LOW TO GO?Meta-analysis: 13 RCTs, mean achieved systolic BP
< 140
37,736 pts 135
130
Risk Reduction vs < 140
135 130
Total mortality 10% NS
Stroke 17% 47%
MI NS NS
ESRD/2X Cr NS NS
• Target BP = 130-135 reduces mortality/stroke?• Target BP 130 reduces stroke?
Circulation 2011; 123:2799
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GOAL BP: HOW LOW TO GO?
< 140/90: Low enough?
< 130-135?
< 110-120/60-70: Too low, J-
curve?
1 Prevention vs 2 Prevention?
SPRINT: 9000 patients, 2018 completion • High CVD risk • CKD • Age 75
PODCAST, SPSSS, SHOS: Post-stroke/TIA
PLOS Medicine 2012; 9:e1001293 Hypertension 2012; 59: Circulation 2011; 124:1700
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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%
Am J Hypertens 2011; 24:1073 Ann Int Med 2011; 154:781 J Gen Int Med 2012; 27:623
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BP MEASUREMENT: KEY TECHNIQUES BP (mm Hg) if not done
Rest ≥ 5 min, quiet 12/6
Seated, back supported 6/8
Cuff at midsternal level 2/inch
Correct cuff size 6-18/4-13 if too small
7/5 if too large
Bladder center over artery 3-5/2-3
Deflate 2 mm Hg/sec SBP/ DBP
No talking during measurement 17/13
If initial BP > goal BP: 1st reading higher
3 readings, 1 min apart • “Alerting response”
Discard 1st, average last 2 • Reclassify 18-34% as normotensive with last 2 readings
J Clin Hypertens 2012;14:751 Hypertension 2005; 45:142 J Gen Int Med 2012; 27:623 J Hypertens 2005; 23:697 Can J Card 2012; 28:270
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RESEARCH QUALITY vs ROUTINE OFFICE BP Study
# of pts
Routine Clinical Practice BP
Research Quality Office BP
Difference
Myers, 1995 147 146/87 140/83 - 6/4
Brown, 2001 611 161/95 152/85 -9/10
Myers, 2009 309 152/87 140/80 -12/5
Graves, 2003 104 152/84 138/74 -14/8
Gustavsen, 2003 420 165/104 156/100 -9/4
Campbell, 2005 107 150/91 139/86 -11/5
Head, 2010 6817 150/89 142/82 -8/7
Burgess, 2011 181 145/85 132/79 -12/6
Powers, 2011 444 145/- 129/- -16/-
Accurate measurement BP by 10/7 mm Hg
2X improved HTN control rate (Powers, Burgess, 2011)
Ann Int Med 2011; 154:781 Am J Hypertens 2005; 18:1522 Hypertension 2010; 55:195
BMJ 2010; 340:1104 JASH 2011; 5:484
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OUT-OF-OFFICE BP MEASUREMENT TO DX HTN?
CHEP, 2005 2013; AHA, 2008: optional OBPM vs ABPM vs HBPM
2 Office Visits: BP ≥ 180/110or ≥ 140/90 and CVD, DM, or CKD
R/O White-coat HTN: 20-33%
Dx HTNYes
No: BP = 140-179/90-99 and low risk
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 HTNCan J Card 2012; 28:270
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HOME BPM: PROS AND A FEW CONS!
Pros vs Office BPM:• More accurate HTN Dx in 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
J Hypertens 2012; 30:449, 463, 1289 Hypertens Res 2012; 35:750 AHRQ, 2012; #45
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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 averagesOsc R arm/Ausc L arm Ausc R arm/Osc L arm
• Esp. elderly, DM, CKD, obese (tronco-conical arm)
Hypertension 2008; 52:13 Hypertension Res 2012; 35:777
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HBPM: RECOMMENDED MONITORING PROTOCOL
Morning Work Evening
1h post-awaken ? 6-9 PM
Post-micturition ---
Pre-breakfast Pre-supper (or pre-bed?)
Pre-BP med Pre-BP med
Rest quietly 3-5 min Rest quietly 3-5 min
Measure X 2, 1 min apart Measure X 2, 1 min apart
• 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 mo vs ongoing 3d/wk
J Hum Hypertens 2010; 24:779 Hypertension 2011; 57:9081 Hypertens Res 2012; 35:777
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HBPM: NEW BP DX THRESHOLDS, 2013AHA/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
Office BP
AHA/ESH Home BP
IDHOCO 2012 Home BP
160/100 ? 145/90
140/90 135/85 130/85
130/85 ? 125/80
120/80 ? 120/75
Hypertension Res 2012; 35:1072 Hypertension 2013; 61:27
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HBPM: DOCUMENTATION/COMMUNICATION/ACTION
AM/PM BP X 3-7 days
Paper: Horizontal logbook to gestalt mean BP
Device with Printer:
• Bring all print-outs
Circuit memory: • Transfer via computer
• Record all values
Documentation: avoid inaccurate/selected readings
Regular/Timely Communication of Data: • Office visit, mail, FAX, computer
Action by Clinician/Team
• Dx • Rx adjustment, prnHypertension Res 2012; 35:777
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Home BP Log: Horizontal Orientation
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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
Can J Card 2012; 28:341 J Hypertens 2012; 30:1894
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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
Can J Card 2012; 28:341 J Hypertens 2012; 30:1894
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SEQUENTIAL BpTRU READINGS IN 284 PATIENTS IN PRIMARY CARE
Reading No. AOBP 1 (observer present) 147/822 (observer absent) 140/79
3 “ 136/78 4 “ 134/77 5 “ 132/76 6 “ 133/77Mean 2-6 136/78
What does this pattern mean?
BMJ 2011; 342:d286
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AOBP ON ISOLATED PATIENTS: WHITE COAT HTN
Routine Office BP
BpTRU AOBP
Daytime ABPM
Beckett, 2005 151/83 140/80 142/80
• 481 pts
Myers, 2009 152/87 132/75 134/77
309 pts
Myers, 2010 150/89 133/80 135/81
254 pts
*Godwin, 2011 149/83 138/80 141/80
654 pts
*Myers, 2011 150/81 136/78 133/74
303 pts
AOBP, isolated pt, is close to daytime ABPM: reduces WCH
Can J Card 2012; 28:341 Hypertension 2010; 55:195 BMJ 2011; 342:d286 Fam Pract 2011; 28:110
* 1 care
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EQUIVALENT BPs TO DX HYPERTENSION
BP, mm Hg
Routine office BP ?
Research quality office BP* 140/90
Daytime ABPM* 135/85 • 24 hour ABPM* 130/80
Home BP for 3-7 days* 135/85 (130/85?)
AOBP, isolated patient** 135/85?
*Supported by CVD outcome data**Superior to routine BP for LV mass, CIMT, albuminuria but CVD outcome data pending (CAMBO RCT)
J Hypertens 2012; 30:1894 J Hypertens 2012; 30:1906Hypertension 2012; 11/5 epub Am J Hypertens 2012; 25:969 Am J Hypertens 2011; 24:661
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TREATMENT OF HYPERTENSION
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LIFESTYLE MODIFICATION: OLD AND NEW
BP, mm Hg
Wt loss/Kg: diet 1/1
• 4 kg: diet 6/-
• 4 kg: orlistat 2.5/-
• 4 kg: sibutramine 0/0
• 16%, 10y: bariatric surgery 0.5/ 2.6
Exercise:
• Land-based, to 90 min/wk 5/3
- benefit in elderly
• Swimming RCT, 45 min, 3-4d/wk, x 3 mo
9/4
Eur Heart J 2011; 32:3081 Am J Card 2012; 109:1005
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LIFESTYLE MODIFICATION: OLD AND NEW
BP, mm Hg
DASH diet RCT: 11/6
• Fruit, veggies, low fat dairy, low sat fat
Black tea RCT: 2/2
• 3 cups/d X 6 mo
Coffee: 0.5/0.5 (NS)
• 10 RCT; 5 cohort studies
Alcohol meta-analysis:
• 2 drinks/d 0/0
• 3-5 drinks/d 3/2
Eur Heart J 2011; 32:3081 Arch Int Med 2012; 172:186J Hypertens 2012; 30:2245 J Clin Hypertens 2012; 14:792
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LIFESTYLE MODIFICATION: OLD AND NEWOutcome
Sugar-sweetened drinks: HTN 13%
Artificially-sweetened drinks: HTN 14%
• 3 prospective cohorts, 223,891 pts
Vitamin D:
• 2 meta-analyses No BP effect
• RCT, winter months RCT, blacks
¯ 4/3 if Vit D < 32 ng/ml¯ 4/2
Dark Chocolate:
• RCT, 6.3 g, 30 cal/d 3/2
• RCT, 100 g, 500 cal/d 5/3
J Gen Int Med 2012; 27:1197 Eur Heart J 2011; 32:3081Hypertension 2013; 61:779 Am J Hypertens 2012; 25:1215 Am J Hypertens 2012; 23:97
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LIFESTYLE MODIFICATION 2012; “SALT WARS”
Dietary Na < 1500 – 2300 mg/d (IOM, DHSS, AHA 2012)
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-curveNEJM 2013; 368:1229 Circulation 2012; 126:2880
Am J Med 2012; 125:443 Am J Hypertens 2012; 25:727
Benefits ?? Adverse effects
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“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.”
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“SALT WARS”: THE MEDIA/INDUSTRY RESPONSE
NY Times, June 2012: “Now, salt is safe to eat.”
London Daily Express, 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.”
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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
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OPTIMAL 1st DRUG RX FOR HTN? RECOMMENDATIONS FROM RECENT GUIDELINES
Preferred
ACE-I
• Esp. age < 55, white─ ↓ BP
Thiazides
• Esp. age > 65, or blacks─ ↓ BP
•Chlorthalidone?─ ↓ BP
CCB
Acceptable
ARB
• Concern with MI protection in 2011/2012 meta-analyses
Less Useful
Alpha-blockers
• HF, stroke protection
Beta-blockers
• stroke, MI protection age > 60
DRI (aliskiren)
• stroke in ALTITUDE
Can J Card 2012; 28:270 BMJ 2011; 343:d4891 www.heartfoundation.org.auJ Gen Int Med 2012; 27:618 BMJ 2011; 342;d2234 Eur Heart J 2012; 33:2088
JAMA 2012; 208:1340 BMJ 2009; 338:b1665
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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 Am J Med 2012; 125:1229.e1
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HCTZ vs CHLORTHALIDONE: CHOICE GIVEN MOSTLY INDIRECT EVIDENCE?
Efficacy to reduce CVD events: indirect comparisonsRisk Reduction CTDN vs HCTZ
p
value
Network meta-analysis: 21% < 0.0001
• 3 HCTZ RCTs;
6 CTDN RCTs
MRFIT post-hoc analysis 21% 0.002
Observational Cohort 7% NS
( Hosp. for K, Na)
Ann Int Med 2013; 158:447 Hypertension 2012; 59:1110 Hypertension 2011; 57:689
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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)
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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)
Curr Opin Neph Hypertens 2012; 21:486
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OPTIMAL 2-DRUG RX FOR HTN?AMERICAN SOCIETY OF HYPERTENSION,
2010*Preferred
ACE-I (ARB)/CCB
• ACCOMPLISH RCT: 2008, 2010
ACE-I (ARB)/D
*Based on BP, side effects, or CVD-CKD outcomes
Acceptable
CCB/D
• Esp. AAs
BB/D
• DM
BB/DHP-CCB
Dual CCB
DRI/D or CCB
Less Acceptable
ACE-I/ARB
• No CVD, little BP, side effects
ACE-I (ARB)/BB
• Little BP
DRI/ACE-I (ARB)
• stroke in ALTITUDE
BB/Clonidine or non-DHP-CCB
• Bradycardia
J Am Soc HTN 2010; 4:42 Eur Heart J 2011; 32:2499
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ACE-I/CCB vs ACE-I/DIURETIC?ACCOMPLISH, 2008: 11,056 high CVD risk patients x 36 mo
Benazepril/Amlodipine vs Benazepril/HCTZ
Others OthersACE-I/CCB ACE-I/D HR CI
CVD events 9.6% 11.8% 0.80 0.72-0.90
CKD events 2.0% 3.7% 0.52 0.41-0.65
• 2X Cr
• Dialysis
• No difference in CVD events in obese
• No difference in CKD events in AAs
Kid Int 2012; 81:568 ASH, 2012 abst. NEJM 2008; 359:2417 Lancet 2010; 375:1173
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PREFERRED 3-DRUG HTN RX?EXPERT CONSENSUS ONLY
• Diuretic/ACE-I (ARB)/CCB
• Diuretic/BB/DHP-CCB
• ACE-I/CCB/alpha-blocker (ASCOT RCT)
Can J Card 2012; 28:270
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1 HTN DRUG AT BEDTIME: CHRONOTHERAPY?
• 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!
J Am Soc Neph 2011; 22:2313 Diabetes Care 2011; 34:1270 Diabetes Care 2013; 36:(Suppl 1):S11
2 RCTs: 448 pts, T2DM HTN 661 pts, CKD HTN
All HTN meds AM
1 HTN med HS
5.4y
5.4y
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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 Curr Opin Card 2012; 27:386
1994 2004 2008
8.8% 14.5% 20.7%
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SUSPECT RESISTANT HTN: • BP ≥ 140/90 (AOBP ≥ 135/85) x 3 mo – accurately measured
• ≥ 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
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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
J Hum Hypertens 1997; 11:285 Blood Press Monit 2003; 8:97
Clinical suspicion high
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RULE-OUT PSEUDO-RESISTANT HTN for White-coat resistant HTN: 24h ABPM or HBPMStudy # Patients % White-Coat RHRedon, 1998 86 33%
Brown, 2001 118 28%
Pierdomenico, 2005 276 49%
Hermida, 2005 700 17%
Oikawa, 2006 528 16%
Salles, 2008 556 37%
Douma, 2008 2302 29%
De la Sierra, 2011 8295 38%
• 1/3 with office RH have white-coat RH!
Nat Rev Nephrol 2013; 9:51
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RULE-OUT PSEUDO-RESISTANT HTN
for optimal 3-drug Rx – maximal tolerated doses of:
• CCB ACE-I (ARB) diuretic eGFR
eGFR
Furosemide/bumetanide bid (8AM, 5PM) Chlorthalidone 25 mg/d
or
Torsemide qd
Titrate dose to 4-5 lb wt loss only
Monitor creatinine/potassium carefully
*22% not on diuretic 1y after Dx of RH in Kaiser system! 57% not maximally dosed on meds!
≥ 30 ml/min< 30 ml/min
total body Na
Eur Heart J 2013; on-line 2/5, Messerli BMJ 2012; 345:e7473 Hypertension 2012; 60:303
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RULE-OUT PSEUDO-RESISTANT HTN
for low Rx adherence to medication:
“Drugs don’t work in people who don’t take them.”C.E. Koop, M.D.
• Ask the patient: occurs in only 30% of visits with BP• Pharmacy refill rates: < 80% possession ratio• Epidemiologic clues: young, male, non-white, depression, >
qd dosing, branded meds, side-effect worries• Difficult to confirm objectively:
Toxicologic urine screening in
RH pts in Germany 37% non-adherent
J Hypertension 2013; 31:766
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TRUE RESISTANT HTN: CONSIDER 2 ETIOLOGIES
Drugs that BP Primary Aldosteronism
Renovascular HTN
OSA
• NSAIDS: SBP 5 mm Hg, ≥ 10 mm Hg in 10%• OCPs: age ≥ 35, obese, smoke, AA• Epogens: in 20%, Hct• Corticosteroids: in 15-20%• Calcineurin inhibitors: cyclosporine, tacrolimus• Antiangiogenic cancer Rx agents• Stimulant/anorexic drugs for ADD, wt loss• Herbals: ephedra, ginseng, bitter orange• ETOH > 4 drinks/d, cocaine, amphetamines
J Clin Hypertens 2008; 10:556 Am Heart J 2013; 165:477
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TRUE RESISTANT HTN: CONSIDER 2 ETIOLOGIES
Drugs that BP Primary Aldosteronism
Renovascular HTN
OSA
• 10-20% of RH pts• < 40% have K+
• Aldosterone: independent CV toxin - 3-6X more CVD than essential HTN• AHA, 2008: screen all RH patients - Spironolactone Rx for all to CVD - Evaluate a few for adenoma – adrenal vein cath
Hypertension 2008; 51:1403 J Clin Endo Metab 2008; 93:3266
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PRIMARY ALDOSTERONISM: EVALUATION
Aldosterone/Renin Ratio (ARR): AM sitting blood draw
• No K+ - sparing diuretic x 4 wks • Normokalemic
3d Na oral loading, 200 mEq/d
• Early AM PRA
• 24h urine: aldosterone, Na, creatinine
PRA < 1.0 ug/ml/h and urine aldosterone ≥ 12 ug/d and urine Na > 200 mEq
PASpironolactone Rx vs Surgical evaluation:
CT adrenal vein cath
No PA
ARR < 20ARR ≥ 20
NoYes
Hypertension 2008; 51:1403
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TRUE RESISTANT HTN: CONSIDER 2 ETIOLOGIES
Drugs that BP Primary Aldosteronism
Renovascular HTN
OSA
Women age 50y Refractory HTN
with RH
Progressive eGFR, spontaneous or if Rx
Screen with MRA/CTA or
• 50% curable • 30% improved
Recurrent HF
Screen with MRA/CTA/US
• Uncertain benefits - Θ in ASTRAL, STAR - CORAL pends
Fibromuscular Dysplasia Atherosclerotic RAS
Kidney International 2012; 83:28
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TRUE RESISTANT HTN: CONSIDER 2 ETIOLOGIES
Drugs that BP
Primary Aldosteronism
Renovascular
HTN
OSA
• Prevalence in RH: 71-85% (vs 38-55% in non-RH)• CPAP efficacy to SBP: - Non-RH: 1.6-2.5 mm Hg (4 meta-analyses) - RH: 7-9 mm Hg?? (small observational studies)
J Hypertension 2012; 30:633
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MEDIATORS OF RH: ALDOSTERONE/VOLUME
RH pts Control pts p value
Plasma aldosterone (ng/dl) 13.0 8.4 < 0.001
24h urine aldosterone (ug/24h) 13.0 9.7 0.02
ARR 22 6 < 0.001
BNP (pg/ml) 37.2 22.5 0.007
ANP (pg/ml) 95.9 54.8 0.001
Gaddam, 2008; 249 RH pts vs 53 controls (controlled HTN, normal BP)
RH mediated by:
• Relative aldosterone excess
• Persistent ECF volume expansion
Arch Int Med 2008; 168:1159
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INTENSIFY LIFESTYLE RX FOR RESISTANT HTN
Lower Dietary Na:• 12 pts with RH: mean BP = 146/84 on 3 meds
‒ Very low Na diet BP 23/9 mm Hg
Aerobic Exercise:• 50 pts with RH: mean BP = 141/78 on 4 meds
1g Na x 7d 6g Na x 7d
Final BP 123/75 146/84
8-12 wks treadmill exercise
BP 6/3 mm Hg
Hypertension 2009; 54:475 Hypertension 2012; 60:653
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RESISTANT HTN: ALDOSTERONE BLOCKADE
Study Type # Patients Office BP, mm Hg
Spironolactone:
Retrospective: 2 studies 386 -25/12
Prospective obs.: 5 studies 1803 -22/10
RCT (Alvarez-Alvarez, 2010) 41 -32/11
RCT (Parthsarathy, 2011) 141 -27/12
RCT (Vaclavik, 2011) 111 -15/7
Eplerenone:
Prospective obs.: 52 -18/8
• Spironolactone side effects: hyperkalemia (3-5%); breast tenderness (5-10%)
Ann Pharmacother 2010; 44:1762 J Hypertens 2010; 28:2329 J Am Soc HTN 2010; 4:290J Hypertens 2011; 29:980 Hypertension 2011; 57:1069
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RESISTANT HTN: 4-5 DRUG RX?
ACE-I (ARB) DHP-CCB Thiazide (chlorthalidone)
K < 4.5 and eGFR 45 HR > 84-90/min K 4.5 or eGFR < 45; HR < 84-90
“Sequential nephron blockade” • Spironolactone, 12.5-25 mg/d
Beta-Blocker (? vasodilating)
Alpha-blocker: BP 16/9, obs. study
Non-DHP CCB: BP 10/10, obs. study
• Furosemide, 20-40 mg/d
• Amiloride, 5 mg/d Beta-blocker alpha-blocker: Controlled 25%, obs. study
RCT: BP 18/13, controlled 58%
Device Therapy?
Rev Esp Card 2009; 62:158 J Clin Hypertens 2005; 7:50 Am J Hypertens 2011; 24:863 J Hypertension 2012; 30:1656J Clin Hypertens 2012; 14:191 BMJ 2012; 345:e7473 J Clin Hypertens 2012; 14:191
BP > goal
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DEVICE RX FOR RESISTANT HTN: HOPE OR HYPE?Rationale: Inhibit Sympathetic NS
Renal Sympathetic Overactivity: Activate Carotid Baroreceptors:
• PTRA sympathetic nerve ablation • CS electrical stimulators
SYMPLICITY HTN-2 RCT Rheos Pivotal RCT
• 106 pts; mean BP = 178/96 • 265 pts; mean BP = 169/101
• Office BP, 6 mo = 32/12 • office BP, 12 mo: 25/-
• 19% HTN control rate • 42% HTN control rate • 25% minor complication rate • FU: sustained BP to 24 mo
• 25% complication rate – 5% permanent nerve deficit!
• FU: sustained BP to 22 mo
• Sub-optimal Rx regimens pre-enrollment • Short duration FU on small numbers • Based on office BP – ABPM 11/8, SYMPLICITY-2 - Suppressing primarily white-coat effect?
- SYMPLICITY HTN-3 RCT in U.S. pends
Hypertension 2012; 60:596 Lancet 2012; 380:591 Heart 2012; 98:1689J Hypertens 2012; 30:837, 874 Interven Image 2012; 93:386
CAUTION!