Joel Handler, MD Kaiser Permanente Care Management Institute Hypertension Lead Southern California Permanente Group HYPERTENSION UPDATE: NEW JNC 8 Guideline vs OLD Federal Motor Carrier Safety Regulations Joint NationJlJ COmmittee PLEASE STAND BY – WEBINAR WILL BEGIN AT 12:00 PM PST FOR AUDIO: CALL 866-740-1260 / ACCESS CODE: 764-4915# My partner/spouse and I have no financial relationships with commercial entities producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients relevant to the content I am planning, developing, presenting, or evaluating . Conflict of Interest Disclosure
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Joel Handler, MDKaiser Permanente Care Management InstituteHypertension LeadSouthern California Permanente Group
HYPERTENSION UPDATE: NEW JNC8 Guideline vs OLD Federal Motor
PLEASE STAND BY – WEBINAR WILL BEGIN AT 12:00 PM PST
FOR AUDIO: CALL 866-740-1260 / ACCESS CODE: 764-4915#
My partner/spouse and I have nofinancial relationships with commercialentities producing, marketing, re-selling,or distributing health care goods orservices consumed by, or used on,patients relevant to the content I amplanning, developing, presenting, orevaluating.
Conflict of Interest Disclosure
Content Attestation
I, Joel Handler, hereby declare that thecontent for this activity, including anypresentation of therapeutic options, iswell balanced, unbiased, and to theextent possible, evidence-based.
Joint National Committee onPrevention, Detection,
Evaluation, & Treatment of HighBlood Pressure (JNC)
PROGRESS Placebo SystEur Placebo Coope & WarrenderPlaceboADVANCE Placebo SystChina Placebo SHEP PlaceboHYVET Placebo NORDIL BB + D STOP PlaceboCAPP BB + D INVEST BB + D STOP 2 ACE-I or CA
ASCOT BB + D CAPPP ACE-I + DACCOMPLISH ACE-I + D LIFE ARB + D
SCOPE D + placebo ALLHAT ACE-I + BBLIFE BB + D ALLHAT CA + BB
CONVINCE CA + DFEVER D + placebo ONTARGET ACE-I or ARB NORDIL ACE-I + CAELSA BB + D ALTITUDE ACE-I or ARB INVEST ACE-I + CACONVINCE BB + D ASCOT ACE-I + CAVALUE ARB + D
BB and diuretic combinationACE-I and diuretic combination ACE-I and calcium antagonist combination
Combination of two renin-angiotensin-system blockers / ACE-I +ARB or RAS
blocker + renin inhibitor
Angiotensin receptor blocker and diuretic combination
Calcium antagonist and diuretic combination
Trials in JNC 8 NOT included in ESH2013 Survey
MRC REIN-2
ANBP 2 INSIGHT
HDFP KYOTO
UKDPS CASE-J
HOT JATOS
AASK VALISH
MDRD VAH
Table 14. Compelling and possible contra-indications to the use ofantihypertensive drugs
Drug Compelling Possible
Diuretics(thiazides)
Gout Metabolic syndrome
Glucose intolerance
Pregnancy
Hypercalcemia
Hypokalemia
Beta-blockers Asthma Metabolic syndrome
A-V block (grade 2 or 3) Glucose intolerance
Athletes and physically activepatientsChronic obstructive pulmonarydisease(except for vasodilator beta-blockers)Calcium antagonist
(dihydropyridines) Tachyarrhythmia
Heart failure
Calcium antagonist A-V block (grade 2 or 3, trifascicular block)
(verapamil, diltiazem) Severe LV dysfunction
Heart failure
ACE inhibitors Pregnancy Women with child bearing potential
Angioneurotic edema
Hyperkalemia
Bilateral renal artery stenosis
Angiotensin receptor blockers Pregnancy Women with child bearing potential
Hyperkalemia
Bilateral renal artery stenosis
Mineralocorticoid receptorantagonists
Acute or severe renal failure (eGFR <30ml/min)
Hyperkalemia
Gout and Thiazide: NEJM Case Vignette
A 54 year old male with crystal-proven gout hashad 4 attacks during the previous year. Onallopurinol 300 mg daily, his serum urate is 7.2mg/dl. His BP is controlled on HCTZ. How shouldhis case be managed?
1. Increase allopurinol to 400 mg2. Stop HCTZ3. Increase allopurinol to 400 mg and stop HCTZ
Neoghi T. NEJM 2011; 364: 443-452
Table 15. Drugs to be preferred in specific conditionsCondition DrugAsymptomatic organ damage
Topic: Beta-blockers for prevention of progression if CVD in patientswith AAA
Recommendation
For patients with unrepaired abdominal aorticaneurysm (AAA),there is no recommendation for or against the use ofbetablockers to reduce the risk of cardiovascular diseaseprogression
Basis ofThere is only low quality evidence that suggest nobenefit of beta-
recommendation
blockers in reducing AAA expansion or all-causemorality. Theevidence so of insufficient quality and applicabilityto draw any
meaningfully conclusions
effects mortality; harms not reported. The balance between desirable and
undesirable effects cannot be detrmined.
Quality of Evidence Low (risk of bias, imprecision, indirectness)
Values and This recommendation places a high value on preventing cardiovascular
Preferences morbidity and mortality, and a low value on rare serious adverse effects
associated with treatment. Variability of values and preferences is
estimated to be low
Resource From the perspective of the health care delivery system, resource
implications implication for this recommendation are insignificant. Beta-blockers
are widely available at low cost, and would represent an insignificant
additional burden to the health care delivery team
Key Findings
• Among ACC/AHA GLs updated by Sept. 2008 48% (1330 to 1973) increase in recommendations
occurred, the largest number being Class II
• Of 16 current GL with Level Of Evidencerecommendations 11% (314/2711) are A 48% (1246/2711) are C
• Only 9% (245/2711) are Class I and LevelOf Evidence A
Scientific Evidence UnderlyingACC/AHA Guidelines
(JAMA. 2009; 301: 831 – 841)
How the JNC Process HasEvolved
• Strictly evidence-based• Focus only on randomized controlled trials assessing
important health outcomes (no use of intermediate/surrogatemeasures)
• Every included study is rated for quality by two independentreviewers using standardized tools
• Evidence statements graded for quality using prespecifiedcriteria
• Separate grading for recommendations• Independent methodology team to ensure objectivity of the
review• Initial set of recommendations focused on 3 key questions
Expertise Represented on JNC 8Panel
• Hypertension, primary care, cardiology,nephrology, clinical trials, research methodology,evidence-based medicine, epidemiology,guideline development and implementation,nutrition/lifestyle, nursing, pharmacology,systems of care, geriatrics, and informatics
• Panel also includes senior scientists from NHLBIand NIDDK with expertise in hypertension,clinical trials, translational research, nephrology,guideline development, and evidence-basedmethodology
Literature Review and Assessment Process
• Systematic search of literature for the CQ Citations found using inclusion/exclusion criteria Papers screened and reviewed for inclusion Result: unbiased list of studies based on a priori
criteria• Quality of each included study rated Good, Fair, Poor
• NHLBI study rating instruments Controlled randomized intervention studies
Data Abstraction andEvidence Tables
• Information from individual studies Key data abstracted into a database Evidence table for each study/paper: subjects, sample size,
intervention, comparison, results
• Evidence summaries by Critical Question Tables and text of major elements relevant to the CQ
• Graded evidence statements Multiple ESs for each CQ
• Graded recommendations based on theevidence Multiple ESs could result in a single recommendation
17
NHLBI Study Assessment Tool:Controlled Intervention Studies
Criteria Yes No Other
1.Was the study described as randomized, a randomized trial, a randomized clinicaltrial, or an RCT?
5. Were the people assessing the outcomes blinded to the participants’ groupassignments?
7. Was the overall drop-out rate from the study at its endpoint 20% or less than thenumber originally allocated to treatment?
14. Were all randomized participants analyzed in the group to which they wereoriginally assigned (i.e., did they use an intention-to-treat analysis)?
Quality Rating (Good, Fair, Poor) (see guidance)
Rater #1 initials: Rater #2 initials:
Additional Comments (If POOR, please state why):
Summary Table for Goal BP Question
NHLBI Systematic Review andGuideline Development Process
Literature Searched;All Eligible Studies
Identified
Studies Quality Rated;Evidence Tables
Developed
Evidence Summarized;
Graded by Panel w/ Methodologists
Resources Obtained;
Expert PanelEstablished
Topic Area Identified
Critical Questions, Study Eligibility
Criteria Identified
Draft ReportsWritten, Reviewed,
Revised
ReportsDisseminated &
Implemented
RecommendationsDeveloped and Graded
By Panel
*The Blue portion is the Systematic Review
This 2014 HTN evidence-based guideline focuses onthe panel’s 3 highest ranked questions related to HTN
management
1. In adults with HTN, does initiating antihypertensivepharmacologic therapy at specific BP thresholdsimprove health outcomes?
2. In adults with HTN, does treatment withantihypertensive pharmacologic therapy to aspecified BP goal lead to improvements in healthoutcomes?
3. In adults with HTN, do various antihypertensivedrugs or drug classes differ in comparative benefitsand harms on specific health outcomes?
Articles Screened =1496
Good = 8
Included = 44
Total Abstracted =26
Excluded = 1452(Did not meetprespecified
inclusioncriteria)
Poor = 18Fair = 18
Question 1: Among adults with hypertension, doesinitiating antihypertensive pharmacological therapy at specific BP
thresholds improve health outcomes?
Articles Screened =1978
Good = 17
Included = 92
Total Abstracted =56
Excluded =1886
(Did not meetprespecified
inclusioncriteria)
Poor = 36Fair = 39
Question 2: Among adults, does treatment with antihypertensivepharmacological therapy to a specified BP goal lead to improvements
in health outcomes?
Articles Screened =2662
Good = 15
Included = 101
Total Abstracted =66
Excluded =2561
(Did not meetprespecified
inclusioncriteria)
Poor = 35Fair = 51
Question 3: In adults with hypertension, do various antihypertensivedrugs or drug classes differ in comparative benefits and harms on
specific health outcomes?
In the general adult population 60 yearsof age and older, initiate pharmacologictreatment to lower blood pressure at SBP≥ 150mm Hg or DBP ≥ 90mm Hg and treatto a goal SBP <150 mm Hg and goal DBP<90mmHg.(Strong Recommendation – Grade A)
Recommendation
Why is it important not to recommend intensifyingmedication to reduce BP below the level proven in
clinical trials?
• Lower thresholds identify a much largerpopulation as having HTN and presumablyneeding drug therapy (e.g. reducing definitionof HTN from <140/90 to <120/80 doubles thosewith HTN
• Millions classified as HTN based on lowergoals require more drugs
• Treating to lower BP goals may be harmful• If neither beneficial or harmful, resources
would be wasted and patient adherence wouldsuffer
Corollary : In the general population 60 yearsof age and older, if pharmacologic treatmentfor high blood pressure results in a lowerachieved SBP (for example, less than 140mmHg) and treatment is well tolerated withoutadverse effects on health or quality of life,treatment does not need to be adjustedExpert opinion
Recommendation
Major Trials Testing SBP GoalsMajor Trials Testing SBP Goalsin General Populationsin General Populations
•Post Hoc Analyses of patients achievinglower BPs tend to identify those at lowerrisk: less LVH, lower baseline BPs, fewermeds, improved med adherence
Cochrane Database of Systematic Reviews:Treatment Blood Pressure Targets for
Hypertension 2009
“The cohort of patients with low bloodpressure as identified by achieved bloodpressure selects for patients who did nothave sustained elevated blood pressure inthe first place, for patients in whom the bloodpressure is most easily reduced, for patientswith the lowest baseline blood pressure, andfor patients who are most compliant (healthyuser effect, Dormuth 2009).”continued …
Cochrane 2009 continued
“All of these factors are mostlikely associated with a lower riskof having an adversecardiovascular event. Theapproach is thus heavily biasedfor finding less cardiovascularevents in the patients with lowerblood pressure.”
Arguedas JA, Perez MI, Wright JM
The Secondary Prevention ofSmall Subcortical Strokes (SPS3) Study
Blood-pressure Targets in Patients withRecent Lacunar Stroke:
The SPS3 Randomized Trial
SPS3 is sponsored by National Institutes of Health - NINDSSPS3 is sponsored by National Institutes of Health - NINDSNINDS: U01 NS38529NINDS: U01 NS38529
SPS3 Coordinating Center: University of British Columbia, Vancouver,SPS3 Coordinating Center: University of British Columbia, Vancouver,CanadaCanada
SPS3 Statistical Center: University of Alabama at Birmingham, USSPS3 Statistical Center: University of Alabama at Birmingham, US
SPS3 Study Group, Benavente OR,et al. Lancet. 2013(Aug 10);382:507-15.
SPS3 Design• Randomized multicenter international trial.• Lacunar strokes within 180 days (mean 62), verified by
MRI.• Randomized to 2 interventions in a factorial design:
2) Target levels of blood pressure control (open label):-”higher” 130-149 mmHg systolic (mean 138 mm Hg)-”lower” <130 mmHg systolic (mean 127 mm Hg)
• Outcomes:-Primary: recurrent stroke.-Secondary: major vascular events, cognitive decline,death.
• 3020 participants, mean follow up 3.7 years.www.clinicaltrials.govNCT00059306
Efficacy Outcomes OutcomesSPS3
*Defined as: stroke, MI, vascular deaths.
Case Scenario: J-Point?
A 74 year old female on BP medshas a blood pressure of 152/50.Goal BP should be:
A) Standing SBP less than 140B) Standing SBP less than 150C) Standing DBP no less than 55-60D) 152/50
In the general adult population less than60 years of age, initiate pharmacologictreatment to lower blood pressure at SBP≥ 140 mm Hg and treat to a goal SBP<140 mm Hg.Expert Opinion
Recommendation
In the general adult population less than60 years of age, initiate pharmacologictreatment to lower blood pressure at DBP≥ 90 mm Hg and treat to a goal DBP < 90mm Hg.For age 30-59, Strong RecommendationGrade A; For age 18-29, Expert Opinion
Recommendation
In the adult population with diabetes,initiate pharmacologic treatment to lowerblood pressure at SBP ≥ 140 mm Hg orDBP ≥ 90 mm Hg and treat to a goal SBP< 140 mm Hg and goal <90 mmHg.Expert Opinion
Recommendation
RCTs Testing BP Goals In Hypertensive Diabetic Patients
Dizziness on Standing† 217 (44) 188 (40) 0.36† Symptom experienced over past 30 days from HRQL sample ofN=969 participants assessed at 12, 36, and 48 months post-randomization
In the adult population with non-diabeticCKD, initiate pharmacologic treatment tolower blood pressure at SBP ≥ 140 mmHg or DBP ≥ 90 mm Hg and treat to a goalSBP < 140 mm Hg and goal DBP<90mmHg.Expert Opinion
Recommendation
Evidence Statement 15Regarding Goal BP in CKD
(CKD Subpopulation) In adults less than70 years of age with chronic kidneydisease, the evidence is insufficient todetermine if there is a benefit incardiovascular or cerebrovascular healthoutcomes, or mortality of treatment withantihypertensive drug therapy to a lowerblood pressure goal compared to a goalof <140/90mm Hg.
Evidence Statement 16Regarding Goal BP in CKD
(CKD Subpopulation) In adults withhypertension and chronic kidney diseasewithout diabetes, there is evidence of nobenefit on the progression of kidney diseaseof treatment with antihypertensive drugtherapy to a lower blood pressure goalcompared to a goal of <140/90mm Hg.Vote: Agree with the statement (17/17);Evidence Quality: Moderate (16/17); Low(1/17)
Evidence Statement 17Regarding Goal BP in CKD
(Proteinuria Subgroups) In adults withhypertension and proteinuria withoutdiabetes, there is insufficient evidence todetermine whether there is a benefit oftreatment with antihypertensive drug therapyto a lower blood pressure goal compared toa goal of <140/90mm Hg on cardiovascular orcerebrovascular health outcomes ormortality.Vote: Agree with the statement (17/17);Evidence Quality: Unable to determinebecause there is insufficient evidence
Recommendation
In the adult population age 18 to80 years of age with chronickidney disease and hypertension,initial antihypertensive treatmentshould include an ACE inhibitor orARB to improve kidney outcomes.
Moderate recommendation –Grade B
In the general non-black population, including thosewith diabetes, age 18 and over for whom bloodpressure medication is recommended, initialantihypertensive treatment with a single agent shouldbe with a thiazide-type diuretic, CCB, ACEI or ARB. Inthe general black population, including those withdiabetes, initial antihypertensive treatment with athiazide-type diuretic or CCB is preferred.
Recommendation
Initial Combinations of MedicationsInitial Combinations of MedicationsInitial Combinations of Medications
DiureticsDiuretics
ACE inhibitorsACE inhibitorsoror
ARBs*ARBs*
CalciumCalciumantagonistsantagonists
* Combining ACEI with ARB discouraged
ββ-blockers should be included in the regimen if-blockers should be included in the regimen ifthere is a compelling indication for a there is a compelling indication for a ββ-blocker-blocker
JATOS and VALISH compared SBP goals <160 and <150 versus<140 in elderly patients
ACCORD showed no difference comparing SBP goal < 140versus <120 in patients with diabetes, except for more sideeffects with the lower goal
SPS3 did not show a significant difference comparing goal SBP<150 versus <130 for the primary endpoint of recurrent stroke inpatients with a personal history of stroke
Current NCQA proposal forControlling High Blood Pressure
• Rate 1: Members 18-59 years withmost recent BP <140/90
• Rate 2: Members 60 and older withmost recent BP < 150/90
Common Blood Pressure ErrorsThat Raise SBP 5-10 mmHg
mmHg too high•Cuff too small 5-10•Unsupported arm 5-10•Patient talking 10•Patient actively listening 5•Back unsupported 5-10•Feet not on floor 5-10•Legs crossed 5-10•Full bladder 10•Forearm blood pressure 5-10
Is the Hypertension Real?
26
14
28
0
5
10
15
20
25
30
SBP DBP % with controlled BP
Mean differencebetween referring
doctor BP and ABP(mmHg) in patients with
resistant HTN
Percent of patients withresistant HTN who hadBP < 135/85 mmHg with