DISCLOSURE PHARMACIST OBJECTIVES 9/30/2014 JNC 8: A REVIEW OF THE LONG-AWAITED/MUCH-ANTICIPATED HYPERTENSION GUIDELINES. I have nothing to disclose.

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1 JNC 8: A REVIEW OF THE LONG-AWAITED/MUCH-ANTICIPATED HYPERTENSION GUIDELINES Tiffany Dickey, PharmD Assistant Professor, UAMS COP Clinical Pharmacy Specialist, Mercy Hospital Northwest AR DISCLOSURE I have nothing to disclose. PHARMACIST OBJECTIVES 1. Identify blood pressure goals set by JNC 8 for adult patients. 2. Compare and contrast JNC 8 recommendations with other current guidelines. 3. Recommend appropriate therapy for hypertensive patients according to JNC 8. 1

2 TECHNICIAN OBJECTIVES 1. Define hypertension. 2. Identify JNC Identify medications used to treat hypertension. THE FACTS Hypertension is the most common chronic condition addressed by primary care providers In 2010 ~78 million US adults with HTN, 50% uncontrolled Close relationship exists between blood pressure levels and the risk of cardiovascular events, strokes, and kidney disease Risk is lowest at 115/75 mmhg For every of 20 mmhg in SBP or 10 mmhg in DBP the risk of major CV and stroke events double Lack of evidence to justify treating HTN down to 115/75 The Journal of Clinical Hypertension. 2014;16: THE DRAMA Eighth Joint National Committee of Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8) Appointed in 2008 by the National Heart, Lung, and Blood Institute (NHLBI) June 2013 NHLBI announced that the agency was withdrawing from issuing guidelines itself and would instead collaborate with partner organizations August 2013 AHA and ACC reached an agreement with NHLBI to spearhead development of 3 sets of practice guidelines HTN, cholesterol, obesity 2

3 THE DRAMA CONTINUES JNC 8 panel members weren t comfortable with the idea of shopping our guideline around prior to publication and getting an endorsement. AHA/ACC failed to reach an agreement with JNC 8 panel members The big deal... Many experts with a very significant stake in the recommendations were excluded from the process of generating the guideline Guidelines published in JAMA as a Report from the Panel Members Appointed to JNC 8 Unlike the previous JNC reports, this one will be seen as interesting, but not as persuasive. THE EVIDENCE Randomized controlled trials from Adults >18 years of age with hypertension Observational studies Systematic reviews Meta-analyses Excluded if sample size <100 participants Excluded if follow-up period <1 year QUALITY RATING AND RECOMMENDATION STRENGTH Evidence quality High Well designed and executed RCTs Moderate RCTs with minor limitations Low RCTs with major limitations Strength of recommendations Grade A Strong Grade B Moderate Grade C Weak Grade D Against Grade E Expert opinion Grade N No recommendation 3

4 QUESTIONS ADDRESSED 1. In adults with hypertension, does initiating antihypertensive pharmacologic therapy at specific BP thresholds improve health outcomes? 2. In adults with hypertension, does treatment with antihypertensive pharmacologic therapy to a specified BP goal lead to improvements in health outcomes? 3. In adults with hypertension, do various antihypertensive drugs or drug classes differ in comparative benefits and harms on specific health outcomes? CLASSIFICATION OF BLOOD PRESSURE Blood pressure classification Systolic blood pressure ACCORDING TO JNC 7 Diastolic blood pressure Normal <120 mmhg and <80 mmhg Prehypertensive mmhg or mmhg Stage mmhg or mmhg hypertension Stage 2 hypertension >160 mmhg or >100 mmhg JAMA. 2003;289(19): RECOMMENDATION 1 In the general population aged >60 years, initiate pharmacologic treatment to lower blood pressure at SBP >150 mmhg or DBP >90 mmhg and treat to a goal SBP <150 mmhg and goal DBP <90 mmhg. (Strong Recommendation Grade A) In the general population aged >60 years, if pharmacologic treatment for high blood pressure results in lower achieved SBP (eg. <140 mmhg) and treatment is not associated with adverse effects on health or quality of life, treatment does not need to be adjusted. (Expert Opinion Grade E) 4

5 SUPPORTING EVIDENCE: SHEP Treatment of HTN in patients >60 years of age Goal BP for patients with SBP >180 = 160 mmhg Goal BP for patients with SBP = reduction of 20 mmhg Primary outcome: Fatal or nonfatal stroke Secondary outcomes: Cardiovascular and coronary morbidity and mortality, all cause mortality, quality of life measures JAMA. 1991;265(24): SUPPORTING EVIDENCE: SHEP P = JAMA. 1991;265(24): SUPPORTING EVIDENCE: HYVET Treatment of HTN in patients >80 years of age Primary outcome: Fatal or nonfatal stroke Secondary outcomes: Death from any cause, death from cardiovascular causes, death from stroke N Engl J Med. 2008;358(18):

6 SUPPORTING EVIDENCE: HYVET Study conclusion: The results support a target blood pressure of 150/80 mmhg in patients receiving treatment N Engl J Med. 2008;358(18): SUPPORTING EVIDENCE: JATOS Treatment of HTN in patients years of age Strict treatment: SBP <140 mmhg Mild treatment: SBP <160, >140 mmhg Primary outcome: Combined incidence of cardiovascular disease and renal failure Secondary outcomes: Total deaths, safety problems Hypertens Res. 2008;31: SUPPORTING EVIDENCE: JATOS Study conclusion: The results of our study suggest that a reduction of mean SBP to 146 mmhg may be adequate in most elderly hypertensive patients Hypertens Res. 2008;31:

7 RECOMMENDATION 2 In the general population <60 years, initiate pharmacologic treatment to lower blood pressure at DBP >90 mmhg and treat to a goal DBP <90 mmhg. (For ages years, Strong Recommendation Grade A) (For ages years, Expert Opinion Grade E) SUPPORTING EVIDENCE: HOT Assess the optimum target diastolic blood pressure in patients with baseline DBP of mmhg (ages years) <90 mmhg <85 mmhg <80 mmhg Primary outcome: Asses the association between major cardiovascular events and the target blood pressures Non-fatal MI, non-fatal stroke, cardiovascular death Lancet. 1998;351(9198): SUPPORTING EVIDENCE: HOT Lancet. 1998;351(9198):

8 RECOMMENDATION 3 In the general population <60 years, initiate pharmacologic treatment to lower blood pressure at SBP >140 mmhg and treat to a goal SBP <140 mmhg. (Expert Opinion Grade E) The panel found insufficient evidence from good- or fair-quality RCTs to support a specific SPB threshold or goal for persons younger than 60 years. no compelling reason to change the current recommendations. (SOMEWHAT) SUPPORTING EVIDENCE: HOT Assess the optimum target diastolic blood pressure in patients with baseline DBP of mmhg (ages years) <90 mmhg <85 mmhg <80 mmhg Lancet. 1998;351(9198): RECOMMENDATION 4 In the population aged >18 years with chronic kidney disease, initiate pharmacologic treatment to lower blood pressure at SBP >140 mmhg or DBP >90 mmhg and treat to goal SBP <140 mmhg and goal DBP <90 mmhg. (Expert Opinion Grade E) Chronic kidney disease: Glomerular filtration rate (estimated or measured) <60 ml/min/1.73 m 2 in people younger than 70 years of age, OR Albuminuria (>30 mg of albumin/g of creatinine at any level of GFR) in people of any age 8

9 SUPPORTING EVIDENCE: AASK Compare the effects of 2 levels of BP control on GFR Mean arterial pressure goals: mmhg (usual) <92 mmhg (lower) Primary outcome: Rate of change in GFR Clinical composite outcome Reduction in GFR by 50% or more from baseline ERSD Death Baseline data Intervention data JAMA. 2002;288(19): SUPPORTING EVIDENCE: AASK JAMA. 2002;288(19): RECOMMENDATION 5 In the population aged >18 years with diabetes, initiate pharmacologic treatment to lower blood pressure at SBP >140 mmhg or DBP >90 mmhg and treat to a goal SBP <140 mmhg and goal DBP <90 mmhg. (Expert Opinion Grade E) 9

10 SUPPORTING EVIDENCE: ACCORD BP Investigate whether therapy targeting normal systolic blood pressure reduces major cardiovascular events in patients with type 2 diabetes SBP <120 mmhg SPB <140 mmhg Primary outcome: Composite of nonfatal MI, nonfatal stroke, or death from cardiovascular causes N Engl J Med. 2010;362(17): SUPPORTING EVIDENCE: ACCORD BP NNT to prevent one stroke over 5 years = 89 N Engl J Med. 2010;362(17): SUPPORTING EVIDENCE: ACCORD BP N Engl J Med. 2010;362(17):

11 (NOT SO) SUPPORTING EVIDENCE: HOT Assess the optimum target diastolic blood pressure in patients with baseline DBP of mmhg (ages years) <90 mmhg <85 mmhg <80 mmhg Primary outcome: Asses the association between major cardiovascular events and the target blood pressures Non-fatal MI, non-fatal stroke, cardiovascular death Lancet. 1998;351(9198): (NOT SO) SUPPORTING EVIDENCE: HOT post hoc analysis of a small subgroup (8%) of the study population that was not prespecified. As a result, the evidence was graded as low quality. Lancet. 1998;351(9198): Recommendations 1 5: 11

12 RECOMMENDATION 6 In the general nonblack population, including those with diabetes, initial antihypertensive treatment should include a thiazide-type diuretic, calcium channel blocker, angiotensin-converting enzyme inhibitor, or angiotensin receptor blocker. (Moderate Recommendation Grade B) SO MUCH FOR OTHER COMPELLING INDICATIONS (heart failure, MI, stroke, high CVD risk) Thiazide, CCB, ACEI, ARB: Comparable effects on overall mortality and cardiovascular, cerebrovascular, and kidney outcomes One exception heart failure Heart failure Thiazide more effective than a CCB or ACEI, and ACEI more effective than a CCB in improving outcomes Despite this, it still doesn t get it s own compelling indication in JNC 8 WHAT ABOUT THE BETA-BLOCKERS Review of evidence 1. Performed similarly to the other drugs in some trials 2. Evidence was insufficient to make a determination in other trials 3. LIFE trial LIFE trial Losartan vs. atenolol Found a higher incidence of stroke with a beta-blocker than with an ARB Losartan n = 232 (5%) vs. atenolol n = 309 (7%), p = Lancet. 2002;359(9311):

13 RECOMMENDATION 7 In the general black population, including those with diabetes, initial antihypertensive treatment should include a thiazide-type diuretic or calcium channel blocker. (For black patients without diabetes: Moderate Recommendation Grade B) (For black patients with diabetes: Weak Recommendation Grade C) SUPPORTING EVIDENCE: ALLHAT Evidence for this population came from a prespecified subgroup in the ALLHAT trial ACEI (lisinopril) vs. CCB (amlodipine) vs. thiazide (chlorthalidone) JAMA. 2002;288(23): RECOMMENDATION 8 In the population aged >18 years with chronic kidney disease (CKD), initial (or addon) antihypertensive treatment should include an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker to improve kidney outcomes. This applies to all CKD patients with hypertension regardless of race or diabetes status. (Moderate Recommendation Grade B) Neither ACEIs nor ARBs improved cardiovascular outcomes for CKD patients compared with a β- blocker or CCB. 13

14 Recommendations 6 8: RECOMMENDATION 9 The main objective of hypertension treatment is to attain and maintain goal blood pressure. If goal BP is not reached within a month of treatment, increase the dose of the initial drug or add a second drug from one of the classes in recommendation 6 (thiazide-type diuretic, CCB, ACEI, or ARB). The clinician should continue to assess BP and adjust the treatment regimen until goal BP is reached. If goal BP cannot be reached with 2 drugs, add and titrate a third drug from the list provided. Do not use an ACEI and an ARB together in the same patient. If goal BP cannot be reached using only the drugs in recommendation 6 because of a contraindication or the need to use more than 3 drugs to reach goal BP, antihypertensive drugs from other classes can be used. Referral to a hypertension specialist may be indicated for patients in whom goal BP cannot be attained using the above strategy or for the management of complicated patients for whom additional clinical consultation is needed. (Expert Opinion Grade E) Recommendation 9: 14

15 Journal of Hypertension. 2013;31: SEEMS SIMPLE ENOUGH Population JNC ESH/ESC 2013 General >60 y <150/90 <150/90 (>80, <80 y) General <60 y <140/90 <140/90 (nonelderly) CHEP 2013 <150/90 (>80 y) <140/90 (<80 y) ADA 2013 KDIGO 2012 NICE 2011 X X <150/90 (>80 y) X X <140/90 (<80 y) Diabetes <140/90 <140/85 <130/80 <140/80 X X CKD <140/90 <140/90 (CKD with no proteinuria) <130/90 CDK with proteinuria) OR NOT <140/90 <140/90 (CKD with no proteinuria) <130/90 CDK with proteinuria) X 15