Applying the Intricacies of OBJECTIVES the New Hypertension and • Discuss the current hypertension guidelines • Discuss the current lipid guidelines Lipid Guidelines to Your • Given a clinical scenario, utilize the new Patients guidelines to recommend appropriate therapy Joe Anderson, PharmD, PhC, BCPS James Nawarskas, PharmD, PhC, BCPS Gretchen Ray, PharmD, PhC, BCACP University of New Mexico College of Pharmacy JOINT NATIONAL COMMITTEE (JNC) • Federally funded program to produce hypertension guidelines • Latest iteration was JNC 7 published in 2003 Hypertension Guidelines • NHLBI announced in June 2013 that it is withdrawing from guideline development, which would then be performed by “ partner organizations ” • In August 2013, NHLBI established a “ partnership ” with AHA and ACC to develop hypertension, cholesterol, and obesity guidelines. • While the cholesterol and obesity guidelines were released in November 2013, the hypertension guidelines were never developed. SO WHERE ARE OUR HYPERTENSION 2013 HTN GUIDELINES GUIDELINES GOING TO COME FROM? MAJOR CHANGE #1: BP GOALS • JNC panel wasn’t comfortable with shopping guidelines around for endorsements, so they published their work (unendorsed) in JAMA on- line in December 2013 (JAMA 2014;311:507-520) as the document we JNC-8 ASH/ISH JNC-7 or ADA* now call JNC 8 • Once it became clear that AHA and ACC could not reach an agreement < 60 yrs. old, <140/90 mmHg <140/90 mmHg <140/90 mmHg with the JNC panel, the former felt compelled to release some form of no comorbidities updated guideline for hypertension management, leading to an AHA- ACC Scientific Advisory Report released on-line November 15, 2013 (J 60-79 yrs. old, <150/90 mmHg <140/90 mmHg <140/90 mmHg Am Coll Cardiol 2014;63:1230-1238.) no comorbidities This document is NOT a guideline, however, but more of a treatment algorithm which doesn ’ t really differ much from the 2003 JNC-7 > 80 yrs. old, <150/90 mmHg <150/90 mmHg <140/90 mmHg recommendations no comorbidities The AHA-ACC Task Force on Practice Guidelines intends to continue to work with NHLBI on producing hypertension guidelines with a goal Kidney disease <140/90 mmHg <140/90 mmHg <130/80 mmHg of 2015 dissemination. Diabetes <140/90 mmHg <140/90 mmHg <140/80 mmHg* • Further complicating matters is the release of hypertension guidelines by the American Society of Hypertension & International Society of <130/80 mmHg Hypertension in December 2013 (Available at: http://www.ash- optional goal* us.org/documents/ASH_ISH-Guidelines_2013.pdf) 1
2013 HTN GUIDELINES 2013 HTN GUIDELINES MAJOR CHANGE #3: DRUG OF CHOICE FOR TREATING HTN IN A PATIENT MAJOR CHANGE #2: DRUG OF CHOICE FOR TREATING WITH DIABETES (AND NO KIDNEY DISEASE) UNCOMPLICATED HTN JNC-8 ASH/ISH JNC-7 JNC-8 ASH/ISH JNC-7 ADA 2014 < 60 yrs. old Thiazide, CCB, or ACEI/ARB Thiazide Non- Thiazide, ACEI/ARB ACEI/ARB or ACEI/ARB ACEI/ARB African- CCB, or Thiazide American ACEI/ARB > 60 yrs. old Thiazide, CCB, or Thiazide or CCB Thiazide ACEI/ARB African - Thiazide ACEI/ARB or ACEI/ARB or ACEI/ARB American or CCB Thiazide or Thiazide CCB “ A consensus means that everyone agrees to say “ A consensus means that everyone agrees to say collectively what no one believes individually. ” collectively what no one believes individually. ” - Abba Eban, Israeli diplomat and politician - Abba Eban, Israeli diplomat and politician 2013 HTN Guidelines Major change #3: Drug of choice differs based on race R.M. is a 48 yo White male with no other chronic medical conditions. At a medical appointment he is noted to have an average BP of 156/88 mmHg. Uncomplicated HTN Two weeks later, his average BP was 152/92 Stage 1 Stage 2 or SBP >20 mmHg above mmHg. The preferred antihypertensive regimen for goal or DBP > 10 mm Hg above goal R.M. would be which one of the following? non-African African-American patients American patients A. Amlodipine Start with 1 drug: Start with 1 drug: Start with 2 drugs: CCB or thiazide ASH: < 60 yrs. old: ACEI or ARB CCB or thiazide + ACEI or ARB B. Atenolol > 60 yrs. old: thiazide or CCB JNC-8: ACEI/ARB, CCB or thiazide C. Doxazosin Not at BP goal Not at BP goal Not at BP goal D. Lisinopril Increase dosage or Add a drug from one of the classes not previously selected E. HCTZ above; may use ACEI or ARB at this time for African- American patients Rationale for DBP < 80 mmHg in Diabetics GUIDELINE DISCORD • JNC-8 stance: Evidence-based medicine • ASH stance: Events per 1000 patient-years • JNC report relied almost entirely on RCT results; did not p = 0.005* include all available evidence • Other guidelines do not consider medication adverse effects • Greatest number of side effects is with thiazides, incl. impotence and questionable issue of increasing sudden cardiac death • ACEI/ARBs considered the safest • ESH stance: Getting BP to goal is what ’ s important, regardless of how one gets there * all p-values are for < 90 mmHg vs. < 80 mmHg. HOT Study. Lancet 1998;351:1755-62. 2
SBP GOALS FOR ELDERLY SBP GOALS FOR ELDERLY JNC-8 PERSPECTIVE ASH/ISH PERSPECTIVE Study Age Treatment Mean treatment Primary Study Age Treatments Treatment Results (yrs.) (placebo control) SBP Results (yrs.) SBP (mean) SHEP > 60 Chlorthalidone +/- 143 mmHg 36% reduction ALLHAT > 55 Chlorthalidone 134-136 In 19,173 patients > 65 (1991) atenolol in stroke (2002) vs. amlodipine mmHg yo: Lower risk of HF with thiazide vs. CCB & vs. lisinopril Syst-Eur > 60 Nitrendipine +/ 151 mmHg 42% reduction Lower risk of HF, CVD, (1997) Enalapril +/- in stroke CHD with thiazide vs. HCTZ ACEI HYVET > 80 Indapamide +/- 144 mmHg 30% stroke VALUE > 50 Valsartan vs. 138-139 In 9566 patients > 65 yo: No difference between (2008) perindopril reduction (2004) amlodipine mmHg ARB & CCB ACCOMPLISH > 55 Benazepril + 132 mmHg In 7640 patients > 65 yo: 19% reduction in CV There is no compelling evidence that patients over 60 (2008) amlodipine vs. events with ACEI+CCB Benazepril + years old benefit from SBP lowered below 140 mmHg HCTZ There is enough evidence to suggest that patients between 60-79 years old benefit from SBP lowered below 140 mmHg INITIAL THERAPY FOR PATIENTS >60 GUIDELINE DISCORD UNCOMPLICATED HTN Study Age Treatment % of patients (yrs.) (placebo control) receiving step 1 therapy ONLY SHEP > 60 Step 1: Chlorthalidone 46% (1991) Step 2: Atenolol Syst-Eur > 60 Step 1: Nitrendipine 46% (1997) Step 2: Enalapril Step 3: HCTZ HYVET > 80 Step 1: Indapamide 26% (2008) Step 2: Perindopril While most antihypertensive trials in the elderly utilized thiazide and CCB-based initial regimens, ACEIs were frequently used as add on therapy. Ann Intern Med 2014;160:499-503. Chlorthalidone vs. HCTZ R.W. is a 68 yo White male with no chronic medical Office BP measurements conditions. At his annual physical, he is noted to have a BP of 156/88 mmHg. A follow-up visit 2 weeks later yields the same BP readings. The decision is made to start R.W. on antihypertensive medication. Which of the following is the best initial n = 30 therapy for R.W.? A. Chlorthalidone B. HCTZ C. Lisinopril D. Benazepril + HCTZ E. Losartan + amlodipine Hypertension 2006;47:352-8. 3
Antihypertensive Efficacy of HCTZ monotherapy as CHLORTHALIDONE VS. HCTZ assessed by 24-hr ABPM RELATIVE RISK OF CV EVENTS HCTZ dose 12.5-25 mg; p < 0.001 vs. other antihypertensives. N = number of studies J Am Coll Cardiol 2011;590-600. Hypertension 2012;59:1110-1117. Thiazides Not All Thiazides Are Equal Balancing Risks and benefits 25 mg HCTZ ≈ 8.0 mg chlorthalidone ≈ 1.5 mg bendroflumethiazide Hypertension 2012;59:1104-1109. Hypertension 2012;59:1104-1109. There are over 30 commercially available single- HTN CONTROL DURING THE FIRST YEAR tablet antihypertensive combinations which incorporate HCTZ compared to only 4 which contain chlorthalidone and zero which contain Monotherapy Free combinations indapamide. The products which contain Single-pill combinations chlorthalidone incorporate it with one of the following: Atenolol • Azilsartan • Clonidine • • Reserpine Hypertension 2012;59:1124-1131. 4
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