Disclosure. Instead of JNC 8. Proposed Reasons for Delays. Outline 6/10/2013. Member of JNC 8 panel No other disclosures. Daniel T.

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1 An Update on The Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8): The Evidence-Based Process Disclosure Member of JNC 8 panel No other disclosures Daniel T. Lackland Instead of JNC 8 Proposed Reasons for Delays JNC Late JNC Wait JNC 9 JNC Ache Panel is lazy Panel does not know what they doing Too much wine at meetings Panel members do not like each other The epidemiologist!!!! Outline Hypertension Risks and Previous JNC Reports Evidence-based approach for JNC 8 Lifestyle Adherence Summary 3-year mortality risk ratios for elevated blood pressure controlling for age, SES, smoking, cholesterol and diabetes: Charleston and Evans County Heart Studies White Males 14/9 1.6 (1.,.) White Females 1.4 (1.1,.) Black Males.1 (1.3, 3.1) Black Females. (1.,.8) 16/ (1.3,.). (1.,.6).4 (1.5, 3.5).4 (1.6, 3.) Lackland Clinical and Experimental Hypertension,

2 IHD Mortality (absolute risk and 95% CI) Risk of increased systolic blood pressure consistent through all age groups Ischemic Heart Disease Mortality One Million Adults, 61 Prospective Studies Usual Systolic BP (mm Hg) IHD = ischemic heart disease. Lewington S et al. Lancet. ;36: Age at Risk (y) Stroke 3 Mortality (absolute 16 risk and 8 95% CI) 4 1 Stroke Mortality Usual Systolic BP (mm Hg) Age at Risk (y) CV mortality risk CV Mortality* Risk Doubles with Each /1 mm Hg BP Increment* Age 4-7 years Ref: Lancet. ; 6: JNC 7 Express. JAMA. 3;89: /75 135/85 155/95 175/15 SBP/DBP (mm Hg) Evolution of Treatment Recommendations JNC I JNC II JNC III JNC IV JNC V JNC VI JNC * # Stepped care diuretic to methyldopa reserpine, or propranolol Stepped care diuretic to adrenergicinhibiting agents Thiazide diuretics or BBs Thiazide diuretics, BBs, ACE-Is, or CCBs Thiazide diuretics or BBs Thiazide diuretics or BBs; for renoand cardioprotection ARBs recommended in patients intolerant of ACE-Is Thiazide diuretics, ARBs, ACE-Is, BBs, or CCBs; combination therapy for Stage SBP (mm Hg) Evolution of SBP Classification No recommendations for SBP in JNC I or JNC II ISH Borderline Borderline Normal Stage 3 Stage Stage 1 Stage 1 Highnormal Normal Optimal Highnormal Normal Optimal JNC I JNC II JNC III JNC IV JNC V JNC VI ISH Stage 4 Stage 3 Stage Stage Stage 1 Prehypertension Normal JNC 7 BB = β-blocker; ACE-I = angiotensin-converting enzyme inhibitor; CCB = calcium-channel blocker; ARB = angiotensin-receptor blocker. *JNC I. JAMA. 1977;37:55-61; JNC II. Arch Intern Med. 198;14:18-185; JNC III. Arch Intern Med. 1984;144: ; JNC IV. Arch Intern Med. 1988;148:13-138; JNC V. Arch Intern Med. 1993;153: ; # JNC VI. Arch Intern Med. 1997;157: ; **Chobanian AV et al. JAMA. 3;89: SBP = systolic blood pressure; ISH = isolated systolic hypertension. JNC I. JAMA. 1977;37:55-61; JNC II. Arch Intern Med. 198;14:18-185; JNC III. Arch Intern Med. 1984;144: ; JNC IV. Arch Intern Med. 1988;148:13-138; JNC V. Arch Intern Med. 1993;153: ; JNC VI. Arch Intern Med. 1997;157: ; Chobanian AV et al. JAMA. 3;89: After Intervention Population-Based Strategy SBP Distributions Reduction in BP Before Intervention Mean Systolic Blood Pressure by Time Period and JNC Report NHANES I-IV Years JNC Reports Population Average Systolic Blood Pressure mm hg mm hg JNC I (1977)/JNC II (198) 16 mm hg JNC III (1984) JNC IV (1988) 119 mm hg JNC V (1993) 11 mm hg JAMA. 3;89:56-57 Reduction in SBP mmhg 3 5 % Reduction in Mortality Stroke CHD Total JNC VI (1997) (JNC 7) 13 mm hg mm hg Lackland. CURRENT OPINION IN NEUROLOGY 6:8-1, 13.

3 Percent, % Percent Percent of Population 6/1/13 Percentage of Patients with Hypertension at Goal Prevalence Awareness Treated Controlled Controlled/treated Patients with diabetes (goal <13/8) 5%* 35%** Chronic kidney disease (goal <13/8) 18% 3% Overall (goal <14/9) 3% 51% Patients 6 yrs old (ISH) (goal <14/9) 7% 44% 6 Stroke (goal <14/9) 6% 33% JAMA 1;33:43 5. Peripheral artery disease (goal <14/9) 9% 39% Heart failure (goal <14/9) 46% 55% Coronary heart disease (goal <14/9) 49% 58% * Control, all hypertensives ** Control, all treated hypertensives Hajjar I, Kotchen TA. (3), JAMA 9():199-6 Wong, et al. submitted for publication Hypertension Prevalence, Awareness, Treatment and Control by Region P<.1 Hypertension NS Awareness NS Treatment P <.1 Control Southeast Non-Southeast Hypertension Prevalence by Age and Region P<.1 P<.1 < Age NS Southeast Non-Southeast Odds Ratio for Southeast residence adjusting for age, race and gender SPS3 Primary Outcome: Ischemic & Hemorrhagic Stroke Condition Odds Ratio 95% Confidence Interval Hypertension Prevalence ,1.9 Awareness , Treatment , 1.58 Control , 1.18 Resistant Hypertension , Higher Target Group= 15(.8%/yr) Lower Target Group= 15 (.3 %/yr) HR.81 (.64, 1.3) p value.8 Lower Higher International Stroke Conference, 13 3

4 SPS3 Ischemic Stroke & Intracerebral Hemorrhage Ischemic Stroke Higher Target Group= 131(.4%/yr) Lower Target Group= 11 (. %/yr) HR:.85 (.66, 1.1). p value:.1 Intracerebral Hemorrhage Higher Target Group= 16 (.9%/yr) Lower Target Group= 6 (.11 %/yr) HR.84 (.66, 1.9) p value.19 HR.37 (.15,.95) p value.3 SPS3 Conclusions Achieving a lower systolic blood pressure target was feasible, safe and well tolerated. Targeting a systolic blood pressure < 13 mm Hg is likely to reduce recurrent stroke by about % (caveat: p=.8). The lower blood pressure target significantly reduced intracerebral hemorrhage by two thirds. Previous trials of blood pressure lowering after stroke are consistent with our results. International Stroke Conference 13 International Stroke Conference 13 Outline Hypertension Risks and Previous JNC Reports Evidence-based approach for JNC 8 Lifestyle Adherence Summary Scientific Evidence Underlying ACC/AHA Guidelines (JAMA, 9; 31: ) AHA Level of Evidence A in Current Guidelines* AF Heart failure PAD STEMI Perioperative Secondary prevention Stable angina SV arrhythmias UA/NSTEMI Valvular disease VA/SCD PCI CABG Pacemaker Radionuclide Imaging.3% 6.4% 6.1% 11.7% 9.7% 11.% 15.3% 13.5% 1.% 19.%.9% 3.6% 6.4% *in guidelines with level of evidence 4.9% 4.8%.% 1.%.% 3.% Scientific Evidence Underlying ACC/AHA Guidelines Of 16 current GL with Level Of Evidence recommendations 11% (314/711) are A 48% (146/711) are C Only 9% (45/711) are Class I and Level of Evidence A JNC 8 Evidence-based approach Determine sufficient evidence Grade the evidence (JAMA, 9; 31: ) 4

5 Adult CVD Guidelines: NHLBI Approach Advice to NHLBI from advisory groups: Update risk factor guidelines (hypertension, cholesterol, obesity) Develop an integrated guideline Use an evidence-based approach including systematic reviews The NHLBI guideline development process Was established to assure rigor and to minimize bias Methods being used to meet many of the new IOM standards Two recent IOM reports set new standards Finding What Works in Health Care - standards for systematic reviews Clinical Practice Guidelines We Can Trust - standards for developing trustworthy CPGs How the 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 pre-specified 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 Hypertension, primary care, cardiology, nephrology, clinical trials, research methodology, evidence-based medicine, epidemiology, guideline development and implementation, nutrition/lifestyle, nursing, pharmacology, systems of care, and informatics Question selection process Panel chairs and NHLBI staff developed draft questions based on expertise, literature, and colleague discussions Panel reviewed, revised, added/deleted questions resulting in 3 questions 5 questions were identified with highest priority The 5 questions were prioritized by the panel Rationale for the Questions Interest in assessing the evidence to support 14/9 mm Hg as a treatment threshold or goal Should the treatment threshold/goal be lower in populations with diabetes, chronic kidney disease, coronary artery disease, stroke, and other co-morbidities or characteristics? Should the treatment threshold/goal be different in older adults? Use of different treatment thresholds and goals is confusing Is there evidence that treatment to lower BP with a particular drug or drug class improves outcomes compared to another? NHLBI CVD Prevention Guidelines Expert Panels and Work Groups BP Panel Evidence Review on BP Tx 3 CQs Lifestyle WG Evidence Review on Diet & Physical Activity 3 CQs (1 SR) Cholesterol Panel Evidence Review on Cholesterol Tx 3 CQs Risk Assessment WG Evidence Review & Risk Prediction Model CQs+model (1SR) Obesity Panel Evidence Review on Obesity 5 CQs ( SRs) Five Draft Reports released for public comment, one at a time Implemetation WG Implementability Guidance (GLIA) Implementation Science Review 5

6 NHLBI Evidence Quality Grading and Recommendation Strength Evidence Quality High Well-designed and conducted RCTs Moderate RCTs with minor limitations Well-conducted observational studies Low RCTs with major limitations Observational studies with major limitations Recommendation Strength A- Strong B- Moderate C- Weak D- Against E- Expert Opinion N- No Recommendation Question 1 Among adults with hypertension, does initiating antihypertensive pharmacological therapy at specific BP thresholds improve health outcomes? -When to initiate drug treatment? Question Question 3 Among adults, does treatment with antihypertensive pharmacological therapy to a specified BP goal lead to improvements in health outcomes? -How low should you go? In adults with hypertension, do various antihypertensive drugs or drug classes differ in comparative benefits and harms on specific health outcomes? -How do you get there? Inclusion/Exclusion Criteria Populations Included Randomized Controlled Trials Less bias and standard for efficacy and effectiveness 1966-present time period Minimum 1-year follow-up Studies with sample size less than 1 excluded Institutes of Medicine 11. Finding What Works in Health Care: Standards for Systematic Reviews. Washington DC. National Academies Press. Adults 18 years of age and older Prespecified subgroups including: Diabetes Chronic kidney disease Proteinuria Coronary artery disease Peripheral artery disease Previous stroke Heart failure Older Adults Men and women Racial and ethnic groups Smoking 6

7 Outcomes Overall mortality, CVD-related mortality, CKD-related mortality, myocardial infarction, heart failure, hospitalization for heart failure, stroke Coronary revascularization (includes coronary artery bypass surgery, coronary angioplasty and coronary stent placement), peripheral revascularization (includes carotid, renal, and lower extremity revascularization) End stage renal disease (i.e., kidney failure resulting in dialysis or transplant), doubling of creatinine, halving of egfr 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 rates Good, fair, poor NHLBI study rating instruments Controlled intervention studies Cohort and cross-sectional studies Case-control studies Systematic reviews and meta-analyses NHLBI Assessment Tool reviews Quality rating Reasons for poor Randomization description, blinding, etc Data Abstraction and Evidence Tables Information from individual studies (key data, sample size, intervention, results, comparisons Evidence by critical question (tables and text relevant to critical questions Graded evidence statements (multiple evidence statements for each critical question Graded recommendations (multiple evidence statements could result in one recommendation) Question 1: Among adults with hypertension, does initiating antihypertensive pharmacological therapy at specific BP thresholds improve health outcomes? Question : Among the adults, does treatment with antihypertensive pharmacological therapy to a specified BP goal lead to improvements in health outcome? Articles Screened= 1496 Articles Screened= 1978 Included= 44 Excluded= 145 (Did not meet prespecified inclusion criteria) Included= 9 Excluded= 1886 (Did not meet prespecified inclusion criteria) Good=8 Fair= 18 Poor= 18 Good=17 Fair= 39 Poor= 36 Total Abstracted= 6 Total Abstracted= 56 7

8 Question 3: In adults with hypertension, do various antihypertensive drugs or drug classes differ in comparative benefits and harms on specific health outcomes? Included= 11 Good=15 Fair= 51 Total Abstracted= 66 Articles Screened= 66 Excluded= 561 (Did not meet prespecified inclusion criteria) Poor= 35 Adult CV Guideline Report Content Methods description Critical questions With study eligibility criteria and rationale Summary of evidence for each CQ Summary tables and text (e.g. 4 studies, 1 RCTs ) Graded evidence statements (ES) Rationale for ES based on specific studies or previous systematic reviews Graded High, Medium, Low Graded recommendations Rationale for the recommendation based on the evidence Graded A, B, C, D, E, or N Reference citations Conclusion The new NHLBI-sponsored adult CV guideline reports Are strictly evidence based Will not look like the previous guidelines Will have more depth and rigor; will have less breadth Will use evidence based strategies for implementation New reports vs Previous reports The new guideline reports will not look like the previous guidelines! Recommendations are based on systematic reviews of RCTs Restricted to a few critical questions More depth, less breadth (More rigor, less comprehensive) The new guideline reports will look more similar to each other than in the past Previous reports used different methods and structure New reports are using the same methods and structure Where are we? Evidence statements and recommendations Draft report Review of the draft report by: Other federal agencies (CDC, CMS, AHRQ, HRSA, VA, etc.) Invited organizations and individuals Public Revisions based on comments received - current Final report Outline Hypertension Risks and Previous JNC Reports Evidence-based approach for JNC 8 Lifestyle Adherence Summary 8

9 Change in Blood Pressure (mm Hg) Change in Weight (kg) 6/1/13 JNC 7: Management of Hypertension by BP Level JAMA. Classification 3;89: Initial Drug Therapy BP Classification Lifestyle Modification Normal < 1/8 mm Hg Encourage Without Compelling Indication With Compelling Indica DASH Diet Benefit of Lifestyle Modifications in Hypertension Management Bp Effect 8-14 mmhg Pre-hypertension 1-139/8-89 mm Hg Yes No drug indicated Drug(s) for the compe indications Weight Loss 1Kg- 5- mmhg Stage 1 hypertension /9-99 mm Hg Yes Drug Therapy Drug Therapy Low Sodium Diet Reduce Alcohol Intake -8 mmhg -4 mmhg ACE-I = angiotensin-converting enzyme inhibitor; ARB = angiotensin-receptor blocker; BB = β-blocker; CCB = calcium-channel blocker. Stage Chobanian AV hypertension et al. JAMA. 3;89: /1 mm Hg Yes Drug Therapy Drug Therapy Regular Exercise 4-9 mmhg Dietary Approaches to Stop Hypertension The Dash Diet DASH Diet Fruit Vegetables Low Fat Foods 8 Weeks of DASH Diet Systolic 11.6 mmhg Diastolic -5.3 mmhg African Americans 8 Weeks DASH Diet Systolic -13. mmhg Diastolic mmhg Dietary Recommendations Hypertensive patients and normotensive individuals at increased risk of developing hypertension consume a diet that emphasizes fruits, vegetables and low-fat dairy products, dietary and soluble fiber, whole grains and protein from plant sources and that is reduced in saturated fat and cholesterol (Dietary Approaches to Stop Hypertension [DASH] diet) (Grade B). DASH Diet Benefit of Lifestyle Modifications in Hypertension Management Weight Loss Low Sodium Diet Reduce Alcohol Intake Regular Exercise Bp Effect 8-14 mmhg 1Kg- 5- mmhg -8 mmhg -4 mmhg 4-9 mmhg Relationship Between Change in Weight and Blood Pressure: Trials of Hypertension Prevention II Diastolic Stevens et al. Ann Intern Med 1;134:1. Systolic Quintile of Weight Change

10 Weight Reduction Benefit of Lifestyle Modifications in Hypertension Management Height, weight, and waist circumference should be measured and body mass index calculated for all adults (Grade D). Maintenance of a healthy body weight (body mass index 18.5 to 4.9 kg/m² and waist circumference less than 1 cm for men and less than 88 cm for women) is recommended for non-hypertensive individuals to prevent hypertension (Grade C) and for hypertensive patients to reduce blood pressure (Grade B). All overweight and obese hypertensive individuals should be advised to lose weight (Grade B). Weight loss strategies should employ a multidisciplinary approach that includes dietary education, increased physical activity and behavioral intervention (Grade B). DASH Diet Weight Loss Low Sodium Diet Reduce Alcohol Intake Regular Exercise Bp Effect 8-14 mmhg 1Kg- 5- mmhg -8 mmhg -4 mmhg 4-9 mmhg Sodium Facts Sodium increases the risk of heart attack and stroke in all people even those without high blood pressure. Cutting out just one gram of sodium a day, the amount found in a ½ teaspoon of salt, can decrease the risk of a heart attack or stroke by 5 percent. Most Salt Comes from Processed and Restaurant Foods Processed and restaurant foods 77% Naturally occurring 1% While eating 6% Home cooking 5% Long term effects of dietary sodium reduction on cardiovascular disease outcomes: observational follow-up of the trials of hypertension prevention (TOHP). BMJ 7;334;885; April,7. Source: Mattes, RD. Journal of American College Nutrition, 1991, 1: Most Salt Comes from Processed and Restaurant Foods Most Salt Comes from Processed and Restaurant Foods How much sodium is in a Chicken Cesar Salad at the Costco Food Court? A. 68mg B. 75 mg C. 113 mg D. 6 mg How much sodium is an order of PF Chang s, double pan fried noodles with pork? A. 15 mg B. 79 mg C. 7 mg D. 43 mg 1

11 Goal: % Reduction in Sodium Intake in 5 Years Decrease sodium content in foods by 5% over 5 years Decrease population sodium intake by ~ % over 5 years /3 LB** Double Bacon Cheese Thickburger Serving size (grams) = 46 Calories = 13 Sodium = 11 mg Reductions will vary among food categories Salt Intake Benefit of Lifestyle Modifications in Hypertension Management For prevention and treatment of hypertension, a dietary sodium intake of 15 mg (65 mmol) per day is recommended for adults age 5 years or less; 13 mg (57 mmol) per day if age 51 to 7 years; and 1 mg (5 mmol) per day if age greater than 7 years (Grade B). DASH Diet Weight Loss Low Sodium Diet Reduce Alcohol Intake Regular Exercise Bp Effect 8-14 mmhg 1Kg- 5- mmhg -8 mmhg -4 mmhg 4-9 mmhg Energy Content of Alcoholic Beverages Alcohol contains 7 kcal/g Beer 1 oz 16 calories Wine 5 oz 1 calories Margarita 8 oz 7 calories Gin and Tonic 8 oz (contains 1.7 oz gin) 19 calories 1 shot of liquor oz 18 calories Alcohol Consumption Healthy adults should limit alcohol consumption to two drinks or less per day, and consumption should not exceed 14 standard drinks per week for men and nine standard drinks per week for women (Grade B). one standard drink is considered 13.6 g or 17. ml of ethanol, or approximately 44 ml [1.5 oz] of 8 proof [4%] spirits, 355 ml [1 oz] of 5% beer or 148 ml [5 oz] of 1% wine.) 11

12 Weight Change (kg) Energy Expenditure (kcal/h) Activity (min/wk) 1 6/1/13 DASH Diet Benefit of Lifestyle Modifications in Hypertension Management Weight Loss Low Sodium Diet Reduce Alcohol Intake Regular Exercise Bp Effect 8-14 mmhg 1Kg- 5- mmhg -8 mmhg -4 mmhg 4-9 mmhg Energy Expenditure of Physical Activity All out competitive sports Running 1 mph Running 6 mph Climbing stairs Sexual intercourse Gardening Walking 4 mph Bicycling Walking mph Chewing gum (11 kcal/h) Alpers. Undergraduate Teaching Project. Nutrition: energy and protein. American Gastroenterological Association, Levine J, Baukol P, Ioannis P. The energy expended in chewing gum. N Engl J Med 1999;341:1. Effect of Low-Activity (1 kcal/wk) and High-Activity (5 kcal/wk) on Body Weight Jeffery et al. Am J Clin Nutr 3;78: Behavior therapy + Low activity P <.5 Behavior therapy + High activity Months Effect of Long vs Short Bouts of Exercise on Total Amount of Activity and Weight Loss Long Bouts P=.8 Short Bouts Long bout = one 4-min session. Short bout = four 1-min sessions. Jakicic et al. J Obes Relat Metab Disord 1995;19:893. Long Bouts P=.7 Short Bouts Weight Loss (kg) Physical Exercise For nonhypertensive individuals to prevent hypertension or for hypertensive patients to reduce their blood pressure: 3 to 6 minutes of moderate intensity dynamic exercise (such as walking, jogging, cycling or swimming) four to seven days per week in addition to the routine activities of daily living (Grade D). Higher intensities of exercise are no more effective (Grade D). For non-hypertensive or stage 1 hypertensive individuals, the use of resistance or weight training exercise (such as free weight lifting, fixed-weight lifting, or handgrip exercise) does not adversely influence BP (Grade D). Outline Hypertension Risks and Previous JNC Reports Evidence-based approach for JNC 8 Lifestyle Adherence Summary 1

13 Drugs don t work in patients who don t take them -- C. Everett Koop, MD, Former US Surgeon General What percent of prescription medications are actually taken as directed? 9% 75% 5% 5% Medication Use Continuum How Can Health Coaches Support Medication Adherence? The key to effective BP control appears to have more to do with patient and physician information exchange (or lack thereof) than with biology or drug failure. Eric D. Peterson, MD, MPH, Editorial: Is information the answer to hypertension control?, Arch Int Med. 4;168(3), RE: Ho PM, et al, Importance of therapy intensification and medication nonadherence for blood pressure control in patients with coronary disease. Arch Intern Med. 8;168(3):71-76 (KP Colorado) Outline Hypertension Risks and Previous JNC Reports Evidence-based approach for JNC 8 Lifestyle Adherence Summary Summary The hypertension control efforts have been effective JNC 8 will be evidence based and should also have an effect on control and lower disease outcomes Public health and lifestyle including sodium restriction provide an essential component of high blood pressure control Patient adherence is an important component of BP control 13