Hypertension targets: sorting out the confusion. Brian Rayner, Division of Nephrology and Hypertension, University of Cape Town

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1 Hypertension targets: sorting out the confusion Brian Rayner, Division of Nephrology and Hypertension, University of Cape Town

2

3 Historical Perspective The most famous casualty of this approach was the death of Franklin D Roosevelt due to malignant HT and cerebral haemorrhage after the 2 nd World War

4 Estimated Cumulative Incidence of All Morbid Events (%) Hypertension Treatment Significantly Reduced Mortality and Morbidity VA Cooperative Study Group Estimated Cumulative Incidence of All Morbid Events Over 5 Years Control - Placebo Active Treatment Groups - Diuretic-based regimen and hydralazine Years Veterans Administration Cooperative Study Group on antihypertensive agents JAMA 1970;213(7):

5 Cardiovascular Mortality Risk Doubles with Each 20/10 mmhg Increment in Systolic/Diastolic Blood Pressure* CV mortality risk 8 6 8X risk X risk 2X risk 4X risk 115/75 135/85 155/95 175/105 Systolic BP/Diastolic BP (mmhg) *Individuals aged years Lewington et al. Lancet 2002;360:

6 Cardiovascular death (%) Blood pressure and cardiovascular death Diabetics n=3,305 death rate - 5.3% Non-diabetics n=88,257 death rate - 2.2% 0 < >160 Systolic blood pressure Asia-Pacific Cohort Studies Collaboration. Diabetes Care. 2004;27:

7 Blood pressure and vascular risk in diabetes Best evidence: 2000 SBP UK Prospective Diabetes Study

8 Target in T2DM The lower the better A BP is controlled in a diabetic when they feel dizzy on standing Anonymous

9 Goals of treatment Systolic Diastolic Uncomplicated <140 <90 Diabetic <130 <80 (or any high risk patient) CKD with proteinuria <120 <70 Guidelines Subcommittee 2003

10 Percent with CAD events TARGETS FOR LDL-C 25 4S-P Secondary Prevention S Lipid-P CARE Lipid CARE-P WOS-P WOS AFCAPS AFCAPS-P Primary Prevention LDL-cholesterol (mg/dl)

11 Balancing harm vs good (glucose) Too high 1. Retinopathy 2. Nephropathy 3. Neuropathy 4. Cataracts 5. Infection Low target 1. Brain damage 2. CV death 3. Accidents

12 Balancing harm vs good (BP) Too high 1. Stroke 2. CCF 3. CKD 4. IHD 5. PVD Low target 1. Dizziness, falls 2. Electrolyte abn 3. AKI 4. CV events So what is the correct balance given that pharmacotherapy can never reproduce the physiological regulation of BP (and/or glucose control) and therefore we tend to err on side of caution? First do no harm!!

13 Figure 2 PRIMARY COMPOSITE CV Death, MI, or Stroke (Clarify Study) NB not HT study The Lancet , DOI: ( /S (16) ) Copyright 2016 Elsevier Ltd Terms and Conditions

14 DBP 68 mm Hg DBP 92 mm Hg Mortality is increased if diastolic blood pressure becomes reduced at the same SBP Staessen JA et al. Lancet 2000; 355:

15 Confounding factors Error systematic or random i.e. causality + + In health minimum diastolic perfusion pressure is 15mmHg

16 J Hypertension 2009

17 Diabetes mellitus SBP Trials HOT diastolic target < 85 mmhg Reappraisal of ESH Guidelines, J Hypertens 2009

18 * # # Level E evidence

19

20 Blood pressure and vascular risk in diabetes Best evidence: 2000 UKPDS SBP UK Prospective Diabetes Study

21 Cardiovascular Mortality Risk Doubles with Each 20/10 mmhg Increment in Systolic/Diastolic Blood Pressure* CV mortality risk 8 6 8X risk X risk 2X risk 4X risk 115/75 135/85 155/95 175/105 Systolic BP/Diastolic BP (mmhg) *Individuals aged years Lewington et al. Lancet 2002;360:

22 Published online March 14, 2010

23 ACCORD BP Trial Eligibility Stable Type 2 Diabetes >3 months HbA1c 7.5% to 11% (or <9% if on more meds) High CVD risk = clinical or subclinical disease or 2 risk factors Age (limited to <80 years after Vanguard) 40 yrs with history of clinical CVD (secondary prevention) 55 yrs otherwise Systolic blood pressure 130 to 160 mm Hg (if on 0-3 meds) 161 to 170 mm Hg (if on 0-2 meds) 171 to 180 mm Hg (if on 0-1 meds) Urine protein <1.0 gm/24 hours or equivalent Serum Creatinine 1.5 mg/dl (<132 umol/l)

24 Systolic Pressures (mean + 95% CI) Mean # Meds Intensive: Standard: Average after 1 st year: Standard vs Intensive, Delta = 14.2

25 Adverse Events Intensive N (%) Standard N (%) Serious AE 77 (3.3) 30 (1.3) < Hypotension 17 (0.7) 1 (0.04) < Syncope 12 (0.5) 5 (0.2) 0.10 Bradycardia or Arrhythmia 12 (0.5) 3 (0.1) 0.02 Hyperkalemia 9 (0.4) 1 (0.04) 0.01 Renal Failure 5 (0.2) 1 (0.04) 0.12 egfr ever <30 ml/min/1.73m 2 99 (4.2) 52 (2.2) <0.001 Any Dialysis or ESRD 59 (2.5) 58 (2.4) 0.93 Dizziness on Standing 217 (44) 188 (40) 0.36 P Symptom experienced over past 30 days from HRQL sample of N=969 participants assessed at 12, 36, and 48 months post-randomization

26 Primary & Secondary Outcomes Intensive Events (%/yr) Standard Events (%/yr) HR (95% CI) P Primary 208 (1.87) 237 (2.09) 0.88 ( ) 0.20 Total Mortality 150 (1.28) 144 (1.19) 1.07 ( ) 0.55 Cardiovascular Deaths 60 (0.52) 58 (0.49) 1.06 ( ) 0.74 Nonfatal MI 126 (1.13) 146 (1.28) 0.87 ( ) 0.25 Nonfatal Stroke 34 (0.30) 55 (0.47) 0.63 ( ) 0.03 Total Stroke 36 (0.32) 62 (0.53) 0.59 ( ) 0.01 Also examined Fatal/Nonfatal HF (HR=0.94, p=0.67), a composite of fatal coronary events, nonfatal MI and unstable angina (HR=0.94, p=0.50) and a composite of the primary outcome, revascularization and unstable angina (HR=0.95, p=0.40)

27 The SPRINT trial RCT, US adults, patients with DM or previous stroke excluded, n=9361, study stopped early: median 3.26 years Primary outcome: composite of MI, ACS not resulting in MI, acute decompensated HF, or CV death SPRINT research group. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med Nov 9. [Epub ahead of print] PMID:

28 Eligibility, Randomization, and Follow-up. >50 years Higher CV risk including CKD but no diabetes BP mmhg The SPRINT Research Group. N Engl J Med DOI: /NEJMoa

29 NICE/SA/JNC/ISHIB GUIDELINES Thiazides/indapamide*/chlorthalidone* ACEi ARB *Recommended by NICE CCB

30 Systolic Blood Pressure in the Two Treatment Groups over the Course of the Trial. Dose adjustment was based on a mean of three blood-pressure measurements at an office visit while the patient was seated and after 5 minutes of quiet rest; the measurements were made with the use of an automated measurement system (Model 907, Omron Healthcare). The SPRINT Research Group. N Engl J Med DOI: /NEJMoa

31 SBP to + 33 mmhg DBP -14 to + 23 mmhg

32 % risk reduction Intensive (SBP <120 mm Hg) vs standard treatment (SBP <140 mm Hg) The SPRINT trial: Targeting systolic BP <120 mm Hg vs <140 mm Hg significantly improves CV outcomes 0% Primary outcome All-cause mortality CV mortality Heart failure -10% -20% -30% -25% P< % P< % -50% -43% P< % P<0.002 RCT, US adults, patients with DM or previous stroke excluded, n=9361, study stopped early: median 3.26 years Primary outcome: composite of MI, ACS not resulting in MI, acute decompensated HF, or CV death SPRINT research group. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med Nov 9. [Epub ahead of print] PMID:

33 Forest Plot of Primary Outcome According to Subgroups. The SPRINT Research Group. N Engl J Med DOI: /NEJMoa

34 HR Serious Adverse Events, Conditions of Interest, and Monitored Clinical Events Expected and anticipated Adapted The SPRINT Research Group. N Engl J Med DOI: /NEJMoa

35 From: Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged 75 YearsA Randomized Clinical Trial JAMA. 2016;315(24): doi: /jama Date of download: 9/26/2017 Copyright 2016 American Medical Association. All rights reserved.

36 Outcomes Data from SPRINT and the ACCORD Trial and Combined Data from Both Trials. Perkovic V, Rodgers A. N Engl J Med DOI: /NEJMe

37 ACCORD - Medications Prescribed (12 Month Visit)

38 Figure 6 Major CV events CHD Stroke Stroke CCF CKD Mortality Copyright 2016 Elsevier Ltd Terms and Conditions The Lancet , DOI: ( /S (15) )

39 Risk of Cardiovascular Events in Patients With Diabetes Mellitus on β-blockers Novelty and Significance (in ACCORD Study) by Tetsuro Tsujimoto, Takehiro Sugiyama, Martin F. Shapiro, Mitsuhiko Noda, and Hiroshi Kajio Hypertension Volume 70(1): June 7, 2017 Copyright American Heart Association, Inc. All rights reserved.

40 Kaplan Meier survival curves for cardiovascular events and all-cause and cardiovascular deaths in patients on and not on β-blockers. Tetsuro Tsujimoto et al. Hypertension. 2017;70: Copyright American Heart Association, Inc. All rights reserved.

41 Balancing harm vs good (BP) Too high 1. Stroke 2. CCF 3. CKD 4. IHD 5. PVD Low target 1. Dizziness, falls 2. Electrolyte abn 3. AKI, no ESRD These adverse events are expected and reversible, and easily monitored. No evidence to support CV events

42 What is Brian Rayner s opinion Observational studies are only hypothesis generating and suffer from bias, reverse causality and confounding factors Many meta-analysis and observational data includes trials that unrelated to hypertension It is critical to only consider trials where subjects are randomised by intention to treat to low or conventional targets using evidence based anti-ht Large numbers of trial patients needed to show benefit of intensive treatment and studies are often underpowered Accurate automated office BP measurement is essential to avoid the confounding effects of white coating and inaccurate office BP

43 What does Brian Rayner do in his practice I use guideline based treatment namely ACE/ARB, CCBs and diuretics as first line I measure BP as per Sprint protocol i.e. automated office measurement (AOBP) unobserved wherever possible backed by Self BP and ABPM In private patients I target BP to 120/80 if tolerated and where regular monitoring including elecs and egfr is available In state sector my approach is more flexible depending on patient s and the clinic s ability to see the patient more regularly. In practice < 140/90 If AOBP (or Self BP or ABPM) is not available then < 140/90 is preferred

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