Objective & Outline. How the JNC Process Has Evolved. Expertise Represented on JNC 8 Panel

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1 Implementation: Joint National Committee on High Blood Pressure JNC 8 Joel Handler, MD Kaiser Permanente Care Management Institute Hypertension Lead Southern California Permanente Group Objective & Outline Objective Consistently utilize the new JNC8 Guidelines for managing hypertension in patients age >60 years. Outline Evidence based process leading to JNC 8 guideline Recommendations of JNC 8 hypertension guideline Using the KP CMI adult Hypertension Treatment algorithm Joint National Committee on Prevention, Detection, Evaluation, & Treatment of High Blood Pressure (JNC) 3 History of NHLBI CVD Adult Clinical Guidelines JNC 7: 2003 JNC 6: 1997 JNC 5: 1992 JNC 4: 1988 JNC 3: 1984 JNC 2: 1980 JNC 1: 1976 Detection, Evaluation, & Treatment of High Blood Cholesterol in Adults (ATP, Adult Treatment Panel) ATP III Update: 2004 ATP III: 2002 ATP II: 1993 ATP I: 1988 Clinical Guidelines on the Identification, Evaluation, & Treatment of Overweight and Obesity in Adults Obesity 1: 1998 Key Findings Scientific Evidence Underlying ACC/AHA Guidelines (JAMA. 2009; 301: ) Among ACC/AHA GLs updated by Sept % (1330 to 1973) increase in recommendations occurred, the largest number being Class II Of 16 current GL with Level Of Evidence recommendations 11% (314/2711) are A 48% (1246/2711) are C Only 9% (245/2711) are Class I and Level Of Evidence A How the JNC Process Has Evolved Strictly evidence-based Focus only on randomized controlled trials assessing important health outcomes (no use of intermediate/surrogate measures) Every included study is rated for quality by two independent reviewers using standardized tools Evidence statements graded for quality using prespecified criteria 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 8 Panel 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 NHLBI and NIDDK with expertise in hypertension, clinical trials, translational research, nephrology, guideline development, and evidence-based methodology 1

2 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 NHLBI Study Assessment Tool: Controlled Intervention Studies Criteria Yes No Other 1.Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT? 5. Were the people assessing the outcomes blinded to the participants group assignments? 7. Was the overall drop-out rate from the study at its endpoint 20% or less than the number originally allocated to treatment? 14. Were all randomized participants analyzed in the group to which they were originally assigned (i.e., did they use an intention-to-treat analysis)? Quality Rating (Good, Fair, Poor) (see guidance) Rater #1 initials: Additional Comments (If POOR, please state why): Rater #2 initials: Summary Table for Goal BP Question NHLBI Systematic Review and Guideline Development Process Topic Area Identified Evidence Summarized; Graded by Panel w/ Methodologists Recommendations Developed and Graded By Panel Resources Obtained; Expert Panel Established Studies Quality Rated; Evidence Tables Developed Draft Reports Written, Reviewed, Revised Critical Questions, Study Eligibility Criteria Identified Literature Searched; All Eligible Studies Identified Reports Disseminated & Implemented *The Blue portion is the Systematic Review Question 2: Among adults, does treatment with antihypertensive pharmacological therapy to a specified BP goal lead to improvements in health outcomes? Articles Screened = 1978 Good = 17 Included = 92 Fair = 39 Poor = 36 Excluded = 1886 (Did not meet prespecified inclusion criteria) Total Abstracted = 56 2

3 Why is it important not to recommend intensifying medication to reduce BP below the level proven in clinical trials? Lower thresholds identify a much larger population as having HTN and presumably needing drug therapy (e.g. reducing definition of HTN from <140/90 to <120/80 doubles those with HTN Millions classified as HTN based on lower goals require more drugs Treating to lower BP goals may be harmful If neither beneficial or harmful, resources would be wasted and patient adherence would suffer Nadir SBP Kaiser Foundation Health Plan, Inc. For internal use only. October 7, 2014 Mean SBP in POINT Hypertension, Age 60+ Recommendation In the general adult population 60 years of age and older, initiate pharmacologic treatment to lower blood pressure at SBP 150mm Hg or DBP 90mm Hg and treat to a goal SBP <150 mm Hg and goal DBP <90mmHg. (Strong Recommendation Grade A) 15 Recommendation Recommendation Corollary : In the general population 60 years of age and older, if pharmacologic treatment for high blood pressure results in a lower achieved SBP (for example, less than 140 mmhg) and treatment is well tolerated without adverse effects on health or quality of life, treatment does not need to be adjusted Expert opinion In the general adult population less than 60 years of age, initiate pharmacologic treatment to lower blood pressure at SBP 140 mm Hg and treat to a goal SBP <140 mm Hg. Expert Opinion 3

4 Major Trials Testing SBP Goals in General Populations SHEP Syst-Eur HYVET JATOS VALISH Number 4,736 4,695 3,845 4,418 3,260 Entry SBP Goal SBP <148 <150 <150 <140 <140 Achieved SBP Stroke 36% 42% ns ns ns CVD 32% 31% 34% ns ns Mortality ns ns 21% ns SBP = systolic blood pressure ns CVD = cardiovascular disease JNC 8 Misrepresentation JNC 8 did not base it s SBP 150 recommendation on JATOS and VALISH SHEP, SystEur, and HYVET were highly rated studies Only HYVET randomized age 80 and over Why Not Use Achieved Blood Pressures? Mean achieved BPs are not Goal BPs Post Hoc Analyses of patients achieving lower BPs tend to identify those at lower risk: less LVH, lower baseline BPs, fewer meds, improved med adherence Cochrane Database of Systematic Reviews: Treatment Blood Pressure Targets for Hypertension 2009 The cohort of patients with low blood pressure as identified by achieved blood pressure selects for patients who did not have sustained elevated blood pressure in the first place, for patients in whom the blood pressure is most easily reduced, for patients with the lowest baseline blood pressure, and for patients who are most compliant (healthy user effect, Dormuth 2009). continued Cochrane 2009 continued All of these factors are most likely associated with a lower risk of having an adverse cardiovascular event. The approach is thus heavily biased for finding less cardiovascular events in the patients with lower blood pressure. Arguedas JA, Perez MI, Wright JM 4

5 Will a higher SBP goal facilitate therapeutic inertia? Clinical inertia has to be fought by other means than by recommending inappropriately low BP targets. Mancia G, Fagard R. J Hypertension 2013; 31: Goal SBP < 150 mmhg Includes High Risk Groups Recommendation 1 had the highest level of JNC 8 evidentiary support SHEP included 15% African American patients SHEP included patients with history of MI and stroke, 10% had diabetes Syst Eur included patients with history of MI and stroke HYVET included patients with MI, stroke, CKD, and HF IHD 32 mortality 16 (floating 8 absolute risk and 95% CI) Ischemic Heart Disease Mortality Rate in Each Decade of Age SBP DBP Age at risk: y y y y y Usual SBP (mm Hg) Usual DBP (mm Hg) 27 IHD, ischemic heart disease. Prospective Studies Collaboration. Lancet. 2002;360: Is Lower Better? What do the Randomized Clinical Trials Show? AASK, REIN 2, MDRD in patients with CKD ACCORD in patients with DM SPS3 in patients with a personal history of stroke JATOS and VALISH in the elderly population Adverse Events Intensive N (%) Standard N (%) P 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 Symptom experienced over past 30 days from HRQL sample of N=969 participants assessed at 12, 36, and 48 months post-randomization 5

6 The Secondary Prevention of Small Subcortical Strokes (SPS3) Study Blood-pressure Targets in Patients with Recent Lacunar Stroke: The SPS3 Randomized Trial SPS3 Study Group, Benavente OR,et al. Lancet. 2013(Aug 10);382: SPS3 Coordinating Center: University of British Columbia, Vancouver, Canada SPS3 Statistical Center: University of Alabama at Birmingham, US SPS3 is sponsored by National Institutes of Health - NINDS NINDS: U01 NS38529 SPS3 Design Randomized multicenter international trial. Lacunar strokes within 180 days (mean 62), verified by MRI. Randomized to 2 interventions in a factorial design: 1) Antiplatelet therapy (double blind): -aspirin 325 mg + placebo -aspirin 325 mg + clopidogrel 75 mg 2) Target levels of blood pressure control (open label): - higher 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 participants, mean follow up 3.7 years. NCT SPS3 Efficacy Outcomes Experimentation Trumps Observation *Defined as: stroke, MI, vascular deaths. 34 Trial RCTs Testing BP Goals In Hypertensive Diabetic Patients n Duration (years) SBP goal, mmhg DBP goal, mmhg Mean BP, less intense, mmhg Mean BP, more intense, mmhg Outcome Risk Reduction Stroke 22% (ns) SHEP <148 none 155/72 146/68 CVD 34% CHD 56% Syst-Eur <150 none 162/82 153/78 Stroke 69% CVD 62% CVD 51% HOT 1,501 3 none <80 148/85 144/81 MI 50% Stroke 30% (ns) CV death 67% UKPDS 1, <150 <85 154/87 144/82 DM-related 34% Microvasc 37% deaths 32% Stroke 44% Renal (1º) nc ABCD none <75 138/86 132/78 Microvasc nc Death 49% CVD ns ACCORD 4, <120 none CVD (1º) 12% (ns) Stroke 41% Ferrannini, Cushman. Lancet 2012;380: Evidence Statement 17 Regarding Goal BP in CKD (Proteinuria Subgroups) In adults with hypertension and proteinuria without diabetes, there is insufficient evidence to determine whether there is a benefit of treatment with antihypertensive drug therapy to a lower blood pressure goal compared to a goal of <140/90mm Hg on cardiovascular or cerebrovascular health outcomes or mortality. Vote: Agree with the statement (17/17); Evidence Quality: Unable to determine because there is insufficient evidence 6

7 Absence of data should NOT equal or assume benefit NKF KDOQI US Commentary 37 AJKD. Vol 62(2), 201; August 2013, Kidney Disease Outcomes Quality Initiative Summary of KDIGO Recommendations for Management of BP in CKD Recommend ACE I or ARB as first line therapy in adults with CKD ND and increased urine albumin excretion in whom treatment with BP lowering drugs is indicated AJKD. Vol 62(2), 201; August 2013, Kidney Disease Outcomes Quality Initiative Recommendation In the adult population age 18 to 80 years of age with chronic kidney disease and hypertension, initial antihypertensive treatment should include an ACE inhibitor or ARB to improve kidney outcomes. Moderate recommendation Grade B 2006 Meta-Analysis: Atenolol vs Other Treatments End Point Summary OR (95% CI) P Death 1.10 ( ) CV Death 1.13 ( ) MI 1.05 ( ) 0.19 Stroke 1.26 ( ) Elliott WJ. JACC. 2006;47 (Suppl):361A. 7

8 ALLHAT Final Outcomes Results Doxazosin vs. Chlorthalidone Relative Risk and 95% Confidence Intervals Initial Combinations of Medications CHD All-Cause Mortality Combined CHD Stroke 1.03 ( ) 1.03 ( ) 1.07 ( ) 1.26 ( ) Diuretics -blockers should be included in the regimen if there is a compelling indication for a -blocker Heart Failure 1.80 ( ) Combined CVD, p< ( ) Favors Doxazosin Favors Chlorthalidone Hypertension 2003;42: ACE inhibitors or ARBs* Calcium antagonists * Combining ACEI with ARB discouraged Recommendation In the general non-black population, including those with diabetes, age 18 and over for whom blood pressure medication is recommended, initial antihypertensive treatment with a single agent should be with a thiazide-type diuretic, CCB, ACEI or ARB. In the general black population, including those with diabetes, initial antihypertensive treatment with a thiazide-type diuretic or CCB is preferred. Hypertension Treatment Algorithm Begin with Lisinopril/HCTZ 8

9 Simple Algorithm: Fixed Dose Combination Based Amlodipine is Third Drug SIMPLICITY = PERFORMANCE Fewer steps Fewer pills Faster control Fewer visits/ improved access Spironolactone Preferred Fourth Drug Specific Targeted Antihypertensive Therapies for Blacks with Uncontrolled Hypertension Thiazide is cornerstone therapy, but dose is important We do not recommend HCTZ doses <25.0 mg/day in blacks (ISHIB 2010) The CMI hypertension treatment algorithm applies to all races 52 yo AA male has BP 148/82 mmhg, FBS 92, and creatinine 1.0 mg/dl. Best initial drug therapy option is: A. Lisinopril/HCTZ 10/12.5 mg B. Chlorthalidine/CCB combination 72 year old female with hypertension is taking lisinopril/hctz 20/25mgx2 and amlodipine 10mg feels well with BPs 120/70s and wants to know if she should reduce her medication as a result of the new blood pressure guideline. You should advise her: A. Reduce amlodipine 5mg B. Doing well on her current medications, the new guideline advises continuation 9

10 72 year old female with hypertension is taking lisinopril/hctz 20/25mgx2 and amlodipine 10mg but is bothered by ankle edema. Blood pressures are /80. You can advise her to: A. Reduce amlodipine to 5mg B. Reduce amlodipine to 5mg and add hydralazine 25mg 2x/day C. Wear daytime compression stockings 74 year old male with hypertension is taking lisinopril/hctz 20/25mgx2, amlodopine 10mg and atenolol 25mg. He is feeling well, but wants to know if he can decrease the number of pills he takes. BPs are / You can advise him: A. Stay on the same medications because they are working well B. Discontinue atenolol and get a followup walk-in BP in 2 weeks 58 yo male presents to clinic complaining of urinary frequency, urgency, and nocturia of moderate severity. BPs on recent clinic visits have been /90-92 mmhg. Initial treatment should consist of: Timeline for JNC 8 Implementation A. HCTZ 25 mg qam B. Terazosin 2 mg HS C. HCTZ 25 mg and terazosin 2 mhs 58 Questions? 59 10

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