HYPERTENSION: Comparison of New Guidelines

Transcription

1 HYPERTENSION: Comparison of New Guidelines L. Brian Cross, PharmD, BCACP, CDE Vice-Chair & Associate Professor Bill Gatton College of Pharmacy Department of Pharmacy Practice Associate Professor James H. Quillen College of Medicine Department of Family Medicine Objectives At the conclusion of the session, participants should be able to: Compare and contrast the 2013 ESH/ESC Hypertension Guidelines and the 2014 JNC8 Hypertension guidelines Understand the background data and development of the ESH/ESC and JNC8 guidelines Apply the recommendations to patient cases Impact of Hypertension 74.9% are treated 81.5% of patients aware of diagnosis 52.5% are controlled National Health and Nutrition Evaluation Survey

2 Evidence Timeline PEACE ACTION CAMELOT EUROPA REIN-2 JNC 7 ACCOMPLISH ONTARGET ACCORD-BP ESH/ESC HYVET AHA DREAM NICE ASTRONAUT ESH/ESC ACCF/AHA ALTITUDE NAVIGATOR JNC 8 FEVER JNC7 vs JNC8 JNC 8 Report. JAMA

3 Background/Development JNC8 Published 12/18/2013 in JAMA Evidence limited to RCTs only 3 Clinical Questions: 1 Does initiating antihypertensive therapy at a specific BP threshold improve outcomes? 2 Does treatment with antihypertensive therapy to a specific BP goal lead to improved outcomes? 3 Do various antihypertensive drugs or drug classes differ in comparative benefits and harms on specific outcomes? JNC 8 Report. JAMA 2013 Overview of JNC8 Recommendations Overview of JNC8 Recommendation Clinical Question Grade Key Trials 1 For pts >60 yo: Start tx at >150/90 with a goal of <150/90 2 For pts <60yo: start tx at >90 DBP and treat to goal of <90 DBP 3 For pts <60 yo: start tx at >140 SBP and treat to goal of <140 SBP 4 In pts >18yo with CKD, start tx at >140/90 and treat to goal of <140/90 5 For pts >18 yo with diabetes, start tx at >140/90 and treat to goal of <140/90 6 In nonblack (including diabetic) pts, initial tx should be a thiazide type diuretic, CCB, ACEI or ARB 7 In black pts (including those with diabetes), initial therapy should include a thiazide or CCB 8 For pts >18yo with CKD and hypertension, initial (or add on) tx should include an ACEI or ARB (regardless or race of DM status) 1,2 A HYVET, Syst-Eur, SHEP, JATOS, VALISH, CARDIO- SIS 1,2 A (30-59y0) E (18-29y0) HDFP, HTN-Stroke Cooperative, MRC, ANBP, VA Cooperative 1,2 E Expert Opinion 2 E Expert Opinion, AASK, MDRD, REIN-2 2 E SHEP, Syst-Eur, UKPDS, ACCORD-BP, Expert Opinion 3 B VA Cooperative, HDFP, SHEP 3 B (non-dm) C (DM pts) ALLHAT 3 B AASK 9 If goal not reached in 1 month, increase dose None E Expert Opinion or add 2 nd drug (CCB, thiazide, ACE or ARB) ACCORD-BP Intensive (SBP <120) vs. Standard (SBP <140) Randomized, open-label, multi-center trial 4,733 patients with hypertension, stable T2DM and high CV risk If established clinical CVD, years of age If 2 CV risks or subclinical CVD, years of age Achieved BP ~ 119/67 vs. 134/73 N Engl J Med 2010; 362:

4 ACCORD-BP: Efficacy N Engl J Med 2010; 362: ACCORD-BP: Safety N Engl J Med 2010; 362: HOT Trial Major Cardiovascular Events After 4 Years Hansson L, et al. Lancet 1998;351:

5 Elderly 2009 Critical analysis of designed trials Baselines mostly >160, treatment rarely attaining <140 ESH/ESC Guidelines for arterial hypertension. Eur Heart J Zanchetti A, et al. J Hypertens 2009; 27: Overview of JNC8 Recommendations Overview of JNC8 Recommendation Clinical Question Grade Key Trials 1 For pts >60 yo: Start tx at >150/90 with a goal of <150/90 2 For pts <60yo: start tx at >90 DBP and treat to goal of <90 DBP 3 For pts <60 yo: start tx at >140 SBP and treat to goal of <140 SBP 4 In pts >18yo with CKD, start tx at >140/90 and treat to goal of <140/90 5 For pts >18 yo with diabetes, start tx at >140/90 and treat to goal of <140/90 6 In nonblack (including diabetic) pts, initial tx should be a thiazide type diuretic, CCB, ACEI or ARB 7 In black pts (including those with diabetes), initial therapy should include a thiazide or CCB 8 For pts >18yo with CKD and hypertension, initial (or add on) tx should include an ACEI or ARB (regardless or race of DM status) 1,2 A HYVET, Syst-Eur, SHEP, JATOS, VALISH, CARDIO- SIS 1,2 A (30-59y0) E (18-29y0) HDFP, HTN-Stroke Cooperative, MRC, ANBP, VA Cooperative 1,2 E Expert Opinion 2 E Expert Opinion, AASK, MDRD, REIN-2 2 E SHEP, Syst-Eur, UKPDS, ACCORD-BP, Expert Opinion 3 B VA Cooperative, HDFP, SHEP 3 B (non-dm) C (DM pts) ALLHAT 3 B AASK 9 If goal not reached in 1 month, increase dose None E Expert Opinion or add 2 nd drug (CCB, thiazide, ACE or ARB) Lots of Options for First Line Therapy 2008 ACCOMPLISH CV event reduction ACEi+CCB > ACEi+Thiazide with similar BP lowering More later 2011 NICE Guidelines Limited evidence for conferred benefit of initial therapy with low dose thiazide [comparatively] 2013 ESH/ESC Guidelines Older guidance (thiazides preferred/only 1 st line) NOT supported by a more extensive review of evidence Dorsch M, et al. Hypertension 2011; 57: ESH/ESC Guidelines for arterial hypertension. Eur Heart J National Institute for Health and Clinical Excellence. Hypertension (CG127). N Engl J Med 2008; 359:

6 except Beta-blockers 2007 Cochrane Collaboration 13 RCTs (91,561 patients) Relative Risk (95% CI) Comparator CV Disease Stroke Death Placebo 0.88 ( ) 0.80 ( ) 0.99 ( ) Thiazide 1.13 ( ) 1.17 ( ) 1.04 ( ) ACEi/ARB 1.0 ( ) 1.3 ( ) 1.1 ( ) CCB 1.18 ( ) 1.24 ( ) 1.07 ( ) Cochrane Database of Systematic Reviews. 2007, Issue 1. Art No.: CD002003: ESH/ESC Guidelines for arterial hypertension. Eur Heart J Saseen J. Good Things Come to Those Who Wait? ASHP 2012 Presentation. and in African Americans JNC 8 specific considerations ALLHAT subgroup analyses Cerebrovascular, HF, and CV outcomes Thiazide diuretic > ACEi Stroke ACEi 51% higher rate than CCB All outcomes except HF prevention Thiazide diuretic = CCB However, must consider CKD Arch Intern Med 2008; 168(2): JNC 8 Report. JAMA For Diabetes 2008 DREAM & 2010 NAVIGATOR No significant improvement Diabetes Care 2008; 31: N Engl J Med 2010; 362: JNC 7 Report. JAMA

7 Thiazide means HCTZ, right? HCTZ effect on Morbidity/Mortality VA Cooperative: HCTZ 100mg + reserpine MRC: HCTZ 25-50mg + amiloride EWPHE: HCTZ + triamterene ANBP2: HCTZ dose not specified Chlorthalidone SHEP, ALLHAT Indapamide HYVET MRFIT ACCOMPLISH Messerli et al. Am J Med. 2011;124: JNC8 Algorithm- Initial Therapy JNC 8 Report. JAMA 2013 JNC8 Algorithm- Add On Therapy JNC 8 Report. JAMA

8 ESH/ESC Guidelines: Risk Assessment ESH/ESC Guidelines ESH/ESC Guidelines for arterial hypertension. Eur Heart J

9 ESH/ESC Guidelines ESH/ESC Guidelines for arterial hypertension. Eur Heart J 2013 Treatment With Compelling Indications JNC 7 ESH/ESC ESH/ESC Guidelines for arterial hypertension. Eur Heart J JNC 7 Report. JAMA Beta Blockers as First Line Therapy? Cochrane meta analysis: Beta-blockers may be inferior to some, but not all, other drug classes for some outcomes Total mortality and CV events: BB < CCB Stroke: BB < CCB and RAS blockers CHD: BB = CCB, RAS blockers and diuretics Law et al. Effective in post MI and CHF Equal to other classes in preventing coronary outcomes ESH/ESC Guidelines for arterial hypertension. Eur Heart J

10 ESH/ESC Guidelines ESH/ESC Guidelines for arterial hypertension. Eur Heart J 2013 ESH/ESC Guidelines ESH/ESC Guidelines for arterial hypertension. Eur Heart J 2013 ESH/ESC Guidelines for arterial hypertension. Eur Heart J

11 Highlighted Treatment Goal Updates Parameter JNC 7 ESH/ESC JNC 8 CKD <130/80 <140/90 <140/90 Diabetes <130/80 <140/80-85 <140/90 Elderly <140/90 fit <140/90, nonfit <150/90 <150/90 * *Achieving <140/90 is acceptable barring tolerability ESH/ESC Guidelines for arterial hypertension. Eur Heart J JNC 7 Report. JAMA JNC 8 Report. JAMA Treatment Without Compelling Indications Drug Class ESH/ESC JNC 8 ACE inhibitor non-blacks blacks ARB non-blacks blacks BB? CCB Thiazide diuretic ESH/ESC Guidelines for arterial hypertension. Eur Heart J JNC 8 Report. JAMA JNC8 vs ESH/ESC JNC 8 Report. JAMA

12 Controversy and Discord 29% of JNC-8 writers dissented Did they get the thresholds right? Performance Measures Patient Education Cases SP is a 54 yo WM who presents to your clinic for a primary care appointment. His BP today is 164/90, taken appropriately. At his last visit 3 months ago, his BP was 156/88, also taken appropriately. SP does not monitor his BP at home. Upon questioning, you find that he does not smoke, has not had any caffeine today, and took all of his morning medications. He has no complaints and is feeling well today. He has a history of T2DM, Dyslipidemia, COPD, allergic rhinitis, esophageal reflux, and osteoarthritis. What is SP s blood pressure goal? A. <130/80 B. <140/80 C. <140/90 D. <140/85 12

13 What medication, if any, would you initiate for SP s blood pressure? A. Therapeutic lifestyle changes and lisinopril 10mg daily B. Therapeutic lifestyle changes and HCTZ 25mg daily C. Therapeutic lifestyle changes and re-evaluate in 4 weeks for the need to add medication D. Therapeutic lifestyle changes and metoprolol tartrate 25mg BID How might your management change if SP were a 54yo AAM? A. Initiate therapy with lisinopril/hctz rather than lisinopril alone B. Initiate therapy with HCTZ alone C. Initiate therapy with amlodipine alone D. Initiate therapy with HCTZ and amlodipine How would your management change if SP s Scr were 2.9 (est Crcl = 28 ml/min)? A. BP goal would change to <130/80 B. Change HCTZ to furosemide C. Discontinue lisinopril D. Continue current management as all doses are appropriate for current renal function 13

14 References Mancia G, Fagard R, Narkiewicz K, et al ESH/ESC guideline for the management of arterial hypertension. J Hypertens. 2013; 31: James PA, Oparil S, Carter BL, et al Evidence-based guidlelines for the management of high blood pressure in adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2013;. doi: /jama Wright JT Jr, Bakris G, Greene T, et al. Effect of blood pressure lowering and antihypertensive drug classon progression of hypertensive kidney disease: results from the AASK trial.; African American Study of Kidney Disease and Hypertension Study Group. JAMA 2002 Nov 20;288(19): Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone: the antihypertensive and lipidlowering treatment to prevent heart attack trial (ALLHAT). ALLHAT Collaborative Research Group. JAMA 2000 Apr 19;283(15): Nakao N, Yoshimura A, Morita H et al. Combination treatment of angiotensin-ii receptor blocker and angiotensin-converting enzyme inhibitor in non-diabetic renal disease (COOPERATE): a randomised controlled trial. Lancet 2003;361: Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). The CONSENSUS Trial Study Group. N Engl J Med 1987 Jun 4;316(23): Packer M, Poole-Wilson PA, Armstrong PW, et al. Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure.atlas Study Group. Circulation 1999 Dec 7;100(23): Yusuf S, Sleight P, Pogue J, et al. The Heart Outcomes Prevention Evaluation (HOPE) Study Investigators, Effects of an Angiotensin-Converting-Enzyme Inhibitor, Ramipril, on Cardiovascular Events in High-Risk Patients. N Engl J Med : Effects of ramipril on cardiovascular & microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Heart Outcomes Prevention Evaluation Study Investigators. Lancet 2000 Jan 22;355(9200): Hansson L, Zanchetti A, Carruthers SG, et al. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT)randomised trial. HOT Study Group. Lancet 1998 Jun 13;351(9118):1755. References Pitt B, Byington RP, Furberg CD, et al. Effect of amlodipine on the progression of atherosclerosis and the occurrence of clinical events. PREVENT Investigators. Circulation 2000 Sep 26;102(13): Dickstein K, Kjekshus J. Effects of losartan and captopril on mortality and morbidity in high-risk patients after acute myocardial infarction: the OPTIMAAL randomised trial. Optimal Trial in Myocardial Infarction with Angiotensin II Antagonist Losartan.; OPTIMAAL Steering Committee of the OPTIMAAL Study Group. Lancet 2002 Sep 7;360(9335): Brenner BM, Cooper ME, de Zeeuw D, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy; RENAAL Study Investigators. N Engl J Med 2001 Sep 20;345(12): Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. Final results of the Systolic Hypertension in the Elderly Program (SHEP). SHEP Cooperative Research Group. JAMA 1991 Jun 26;265(24): Staessen JA, Fagard R, Thijs L, et al. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. The Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Lancet 1997 Sep 13;350(9080): Tuomilehto J, Rastenyte D, Birkenhager WH, et al. Effects of calcium-channel blockade in older patients with diabetes and systolic hypertension. Systolic Hypertension in Europe Trial Investigators (Syst-Eur). N Engl J Med 1999 Mar 4;340(9): Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group. BMJ 1998 Sep 12;317(7160): Cohn JN, Tognoni G. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure (Val-HeFT); Valsartan Heart Failure Trial Investigators. N Engl J Med 2001 Dec 6;345(23): Questions? [email protected] 14