KDIGO Guideline Debates:HYPERTENSION

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KDIGO GuidelineDebates:HYPERTENSIONSwapnil Hiremath, MD, MPH, FASN, ASH Specialist in HTUniversity of Ottawa,Canada@hswapnil

Disclosures No relevant financial disclosures Member of Canadian Hypertension Education Program (CHEP)Guideline Task Force

At the end of this talk, the participantwill Appreciate why blood pressure should be loweredin CKD Get an overview of recent literature in this area,including SPRINT Decide which patients might be eligible for moreintensive blood pressure loweringSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Blood pressure and Treatment: The HighRisk strategyRisk of strokeDistribution of Blood PressureSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Blood pressure and Treatment: Thepopulation strategyGeoffrey Rose: Sick individuals and sick populations. International Journal of Epidemiology 1985;14:32–38.Swapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Example: Statins for primary preventionSwapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioFinegold et al; Open Heart, 2016

BLOOD PRESSURE AND OUTCOMES: the reality3Increasing risk2.521.510.50110120130140150160StrokeIncreasing blood pressureSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio170CV Dz180190200210

Risk, Prevention and OutcomesGeneral populationCKDdiabetesSwapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioElderly

The state of hypertension guidelines pre-SPRINT(numbers refer to blood pressure target in mm Hg)CHEP 2015 JapanJNC 8ESH/ESCKDIGO 140/90Proteinuric CKD140/90130/80140/90140/90130/80Diabetic, nonproteinuric CKD130/80130/80140/90140/90140/90Diabetic, 150/902140/90IndividualizedElderly150/901Swapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

SPRINT Research QuestionExamine effect of more intensive high blood pressure treatment than iscurrently recommended, in high risk populations, excluding DiabetesRandomized Controlled TrialTarget Systolic BPIntensive TreatmentGoal SBP 120 mm HgStandard TreatmentGoal SBP 140 mm HgSPRINT design details available at: ClinicalTrials.gov (NCT01206062)Swapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioAmbrosius WT et al. Clin. Trials. 2014;11:532-546.

Pre-specified Subgroups of SpecialInterest Age ( 75 vs. 75 years) Gender (Men vs. Women) Race/ethnicity (African-American vs. Non African-American) CKD (eGFR 60 vs. 60 mL/min/1.73m2) CVD (CVD vs. no prior CVD) Level of BP (Baseline SBP tertiles: 132, 133 to 144, 145 mm Hg)Swapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioWright JT Jr, et.al. N Engl J Med 2015;373:2103-2116.

SPRINT: Achieved BPSwapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioWright JT Jr et.al. N Engl J Med 2015;373:2103-2116.

Primary Outcome: Cumulative HazardHazard Ratio 0.75 (95% CI: 0.64 to 0.89)Standard(319 events)Intensive(243 events)During Trial (median follow-up 3.26 years)Number Needed to Treat (NNT)to prevent a primary outcome 61Number ofParticipantsSwapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioWright JT Jr et.al. N Engl J Med 2015;373:2103-2116.

All-Cause Mortality: Cumulative HazardHazard Ratio 0.73 (95% CI: 0.60 to 0.90)During Trial (median follow-up 3.26 years)Number Needed to Treat (NNT)to Prevent a death 90Standard(210 deaths)Intensive(155 deaths)Include NNTNumber ofParticipantsSwapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioWright JT Jr, et.al. N Engl J Med 2015;373:2103-2116.

All-cause Mortality in the SixPre-specified Subgroups of Interest*Wright JT Jr et.al. N Engl J Med 2015;373:2103-2116.*p 0.34, after Hommeladjustment for multiplecomparisonsSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

SPRINT: Caveats and Criticisms Method of BP measurement Trial Stopped early Lots of Adverse events in Intensive(Low BP, 120 mm Hg) armSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

BP Measurement in SPRINT 5 Minutes quiet rest 3 BP readings, average used Reduces white coat effect BP readings 10 mm Hg lowerthan casual BP recordingsSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

BP Measurement: Reality vs ClinicalTrials BP measurement in clinical trialsis done meticulously, afterproper rest, correct technique Casual BP in routine practice :white coat effect, artifacts, nonresting BPFrom Myers et al, CAMBO trial, BMJ 2011Swapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

BP Measurement: Practical Aspect A proper auscultatory BP is ideal, but rarely done outside trials, specializedclinics Ambulatory blood pressure monitoring: ideal, but cost, logistics, patientconvenience Automated BP monitors are an alternative (eg OMRON HEM 907; BPTru): butcost, longer clinic visitDifference of 5-15 mm Hg between automated BP and casual BPSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Trial stopped earlyExtremely unlikely tochange overall benefitof intensive arm if trialcontinuedThe precision of theoutcome (eg NNT 61)is a bit uncertainSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Serious Adverse Events* (SAE) During Follow-upNumber (%) of ParticipantsIntensiveAll SAE reportsStandard1793 (38.3) 1736 (37.1)HR (P Value)1.04 (0.25)SAEs associated with Specific Conditions of InterestHypotension110 (2.4)66 (1.4)1.67 (0.001)Syncope107 (2.3)80 (1.7)1.33 (0.05)Injurious fall105 (2.2)110 (2.3)0.95 (0.71)Bradycardia87 (1.9)73 (1.6)1.19 (0.28)Electrolyte abnormality144 (3.1)107 (2.3)1.35 (0.02)Acute kidney injury or acute renal failure193 (4.1)117 (2.5)1.66 ( 0.001)*Fatal or life threatening event, resulting in significant or persistent disability, requiring or prolonginghospitalization, or judged important medical event.Swapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioWright JT Jr et.al. N Engl J Med 2015;373:2103-2116.

Adverse Events Overall adverse events similar Despite greater syncope, hypotension, injurious falls similar in2 groups Despite increase in AKI (biochemical AKI) need for dialysissimilar in both groups All-cause mortality is the most important adverse event!Swapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

SPRINT: (My Personal) take home message Strong Internal Validity Consider Intensive Lower BP (Aim SBP 120) for– Patients with high risk (eg CKD)– Not for patients who are at risk of adverse events– Using SPRINT-like BP measurement strategy– Using SPRINT-like BP lowering medications (egchlorthalidone, longer acting RAS blockers,spironolactone)– Frequent monitoring for electrolytes, symptomsSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Post-SPRINT Meta-analysisEttehad et al. Lancet 2016Swapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Risk of coronary events in people with CKD comparedwith diabetes: a population-level cohort studyNHANES 2003-200648 month FUN 1,268,029Tonelli M et.al. The Lancet 2012;380:807-812; Polonsky& Bakris Lancet 2012;380:783-785Swapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

The Paradox of Blood Pressure and TheKidney Patients with CKD are at high risk of badcardiovascular outcomes from high bloodpressure Intensive treatment of high bloodpressure in patients with CKD *may* notimprove renal outcomesSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

How about Diabetes?General populationCKDdiabetesSwapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioElderly

ACCORD BP Study:Primary and Secondary Outcomes Patients with T2D and hypertension (N 4733) Random assignment– Intensive therapy: target SBP 120 mm Hg– Standard therapy: target SBP 140 mm Hg 1 outcome: nonfatal MI, nonfatal stroke, death from CV causes Mean follow-up 4.7 yOutcomeIntensiveStandardHRP-valueSBP after 1 year (mmHg)119.3133.5NRNR1 outcome (annual rate)1.872.090.88.20Death from any cause (annual rate)1.281.191.07.55Stroke (annual rate)0.320.530.59.013.31.3NR .001AEs (rate)Swapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioThe ACCORD Study Group. N Engl J Med.2010 March 14. [Epub ahead of print].

Outcomes from SPRINT and ACCORD Trials and CombinedPerkovic V, Rodgers A. N Engl J Med 2015. DOI: 10.1056/NEJMe1513301Swapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Choice of MedicationsSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Medication algorithm choice in SPRINTStart with ACEi/ARB OR Diuretic (chlorthalidonepreferred)OR Calcium channel blockerIn 2 or 3 drug combinationPotent & Longer acting drugs:Lisinopril, Azilsartan, ChlorthalidoneSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

New Wording in UpToDate For patients with one or more of the characteristics listed above, werecommend targeting a BP of 120 to 125 mmHg if AOBP measurements areused rather than a higher goal BP (Grade 1A). For these patients, we recommend targeting a BP of 125 to 130 mmHg if othermethods of BP measurement are used. In patients with diabetes, we suggest a goal blood pressure of 120to 125 mmHg (if AOBP is used to measure blood pressure), or a goal bloodpressure of 125 to 130 mmHg (if manual ausculatory measurements are used),(Grade 2B).Swapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioForman J, Bakris G and Kaplan N UpToDate 4/2016

New recommendation: Canada For high-risk patients, aged 50 years, with systolic BP levels 130mmHg, intensive management to target a systolic BP 120 mmHgshould be considered. Intensive management should be guided byAutomated BP. Patient selection for intensive management isrecommended and caution should be taken in certain high-risk groups. What is considered high risk? At least one of:– Clinical or sub-clinical cardiovascular disease.– Chronic kidney disease (non-diabetic nephropathy, proteinuria 1 g/d, orestimated glomerular filtration rate 20-59 mL/min/1.73m2).– Estimated 10-year global cardiovascular risk 15%.– Age 75 years.Swapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioLeung et al, Can J Cardiol, 2016

New recommendation: Canada Limited or No Evidence– Heart failure (ejection fraction 35%) or recent myocardial infarction (within last 3months).– Indication for, but not currently receiving, a beta-blocker.– Frail or institutionalized elderly. Inconclusive evidence– Diabetes mellitus.– Prior stroke.– eGFR 20 mL/min/1.73 m2. Contraindications––––Patient unwilling or unable to adhere to multiple medications.Standing SBP 110 mmHg.Inability to measure SBP accurately.Known secondary cause(s) of hypertension.Swapnil Hiremath, KDIGO Symposium, CBN 2016, MaceioLeung et al, Can J Cardiol, 2016

New Recommendation: AustraliaGabb et al, Med J Australia, 2016Swapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Blood Pressure Guideline UpdateKDIGO has noted the publication of the SystolicBlood Pressure Intervention Trial (SPRINT)results and has launched a process to reviewand update its Blood Pressure Guideline,originally published in 2012.The search for an independent Evidence ReviewTeam to perform a systematic literature reviewsupport the Work Group in this update willcommence soon. This project is lead by AlfredCheung, USA, and Johannes Mann, Germany.Swapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Blood Pressure Guideline Update Work GroupGuideline Co-ChairsAlfred CheungUSAJohannes MannGermanyWork Group MembersTara ChangUSAJoachim IxUSAMark SarnakUSABill CushmanUSARoberto Pecoits-FilhoBrazilSheldon TobeCanadaFan Fan HouChinaVlado PerkovicAustraliaCharles TomsonUnited KingdomSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Intensive Blood Pressure targetsFor Whom?How?General populationThe Right measurement methodThe correct medicinesCKDdiabetesElderlyFrailSwapnil Hiremath, KDIGO Symposium, CBN 2016, Maceio

Thank you!Special thanks to KDIGO and CBN 2016 OrganisersEmail: shiremath@toh.ca Twitter @hswapnil

CHEP 2015 Japan JNC 8 ESH/ESC 2013 KDIGO 2012 Non-proteinuric CKD 140/90 140/90 140/90 140/90 140/90 Proteinuric CKD 140/90 130/80 140/90 140/90 130/80 Diabetic, non . The state of hypertension guidelines pre-SPRINT (numbers refer to blood pressure target in mm

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