Choosing Wisely: Hypertension Management by Guidelines and Hypertension Study Update. Hypertension and the Choosing Wisely Campaign.

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1 Choosing Wisely: Hypertension Management by Guidelines and Hypertension Study Update Rex D. Wilford, D.O., FACP, R.Ph. Core Faculty Summa Internal Medicine Residency Hypertension and the Choosing Wisely Campaign Don t screen for renal artery stenosis in patients without resistant hypertension and with normal renal function, even if known atherosclerosis is present. SVM Avoid nonsteroidal anti-inflammatory drugs (NSAIDS) in individuals with hypertension or heart failure or CKD of all causes, including diabetes. ASN Don t initiate antihypertensive treatment in individuals 60 years of age for systolic blood pressure (SBP) <150 mm Hg or diastolic blood pressure (DBP) <90 mm Hg. AMDA Don t use expensive medications when an equally effective and lower-cost medication is available. ACPM Don t prescribe a medication without conducting a drug regimen review. AGS 2 Hypertension Most common condition seen in primary care Adverse outcomes/ events: MI, Stroke, Renal Failure, Heart Failure, Death Relationship between BP and adverse outcomes is continuous, consistent, and independent of other risk factors (higher BP = greater risk) Antihypertensive therapy associated with significant reductions in events Stroke 35-40% MI 20-25% HF > 50% 3 1

2 Hypertension, Lifestyle Recommendations DASH diet (or USDA food pattern or AHA diet) 6/3 mmhg < 2.4 grams sodium daily 2/1 mmhg <1.5 grams sodium daily 7/3 mmhg Aerobic physical activity - 2 to 5 / 1 to 4 mmhg Weight reduction 5 to 20 mmhg / 10 kg Alcohol moderation 2 to 4 mmhg Evidence Based Guideline JNC 8 Multidisciplinary panel with external peer review Does initiating therapy at specific BP thresholds improve health outcomes? Does treatment to a specified BP goal lead to improvements in health outcomes? Do various medications differ in comparative benefits and harms on specific health outcomes? Randomized controlled evidence with sample sizes > 100 and followup > 1 year Studies from 1966 to % panel agreement required (except recommendations based on expert opinion, then 75%) 5 JNC 8 Recommendation 1 General population aged >/= 60 years initiate pharmacologic treatment at >/= 150/90 and treat to goal < 150/90 Grade A recommendation (strong) Corollary recommendation general population >/= 60 years old, if treatment results in SBP < 140 and treatment is well tolerated and without adverse effects on health or quality of life, treatment does not need to be adjusted Grade E recommendation (expert opinion) 6 2

3 JNC 8 Recommendations 2 and 3 General population < 60 years initiate pharmacologic treatment to lower BP at DBP >/= 90 and treat to goal < 90 Grade A (ages 30-59); Grade E (ages 18-29) General population < 60 years initiate pharmacologic treatment to lower BP at SBP >/= 140 and treat to goal < 140 Grade E 7 JNC 8 Recommendations 4 and 5 Population >/= 18 years with CKD, initiate pharmacologic treatment to lower BP at BP >/= 140/90 and treat to goal <140/90 Grade E Population >/= 18 years with diabetes, initiate pharmacologic treatment to lower BP at BP >/= 140/90 and treat to goal <140/90 Grade E 8 JNC 8 Recommendations 6 and 7 In general nonblack population, including those with diabetes, initial treatment should include a thiazide-type diuretic, calcium channel blocker, ACE inhibitor or ARB Grade B (Moderate recommendation) In general black population, including those with diabetes, initial treatment should include a thiazide-type diuretic or CCB Grade B for general black population Grade C for black patients with diabetes 9 3

4 JNC 8 Recommendation 8 Population >/= 18 years with CKD, initial treatment should include an ACE or ARB to improve kidney outcomes (applies to all CKD patients with HTN regardless of race or diabetes status) CKD defined as albuminuria > 30 grams albumin/g of creatinine at any age and/or estimated or measure GFR less than 60 ml/min/1.73 m2 in patients < 70 years old Grade B 10 JNC 8 Recommendation 9 Main objective of treatment is to attain and maintain goal BP If goal BP not reached within 1 month of treatment, increase dose or add second agent (thiazide, CCB, ACE or ARB) If goal BP not reached with 2 drugs, add and titrate a third drug. Do not use ACE and ARB together If goal BP cannot be reached with thiazide, CCB, ACE/ARB due to contraindication or need to use more than 3 drugs to reach goal BP, antihypertensives from other classes can be used Referral to hypertensive specialist may be indicated if goal BP can t be obtained using above strategy or mngt of complicated patients Grade E 11 Evidence to Fill the Cracks Combination Therapy versus Monotherapy 2 Meta-Analysis out of London give us the answer Halving dose of most anti-hypertensives reduces blood pressure-lowering effect by only approximately 20% (reduces prevalence of adverse effects as well, except ACE) Extra blood pressure reduction from combining drugs from 2 different classes is approximately 5 times greater than doubling the dose of 1 drug Expert opinion: if choice between combo agent vs increasing dose of single agent, go with combo 12 4

5 Evidence to Fill the Cracks Optimal Combination Therapy Known? ACCOMPLISH trial Randomized, double-blind 11,506 HTN patients at high risk for CV events Benazepril-amlodipine vs benazepril-hctz Primary end point composite of death form CV causes, nonfatal stroke, hospitalization for angina, sudden cardiac arrest, coronary revascularization Terminated after 36 months (pre-specified stopping rule) Absolute risk reduction 2.2%, relative risk reduction 19.6% with benazepril-amlodipine vs benazepril-hctz Subanalysis significant risk reduction limited to nonobese patient Expert opinion in nonobese HTN patient requiring 2 agents, combo ACE or ARB plus amlodipine preferred 13 Evidence to Fill the Cracks Optimal drug tx for resistant HTN Blood pressure that remains above goal despite 3 agents (ACE or ARB, CCB, diuretic) PATHWAY-2 trial September 2015 Double blind, placebo controlled crossover 12 weeks Spironolactone vs bisoprolol vs doxazosin vs placebo Spironolactone most effective add on (-12.8 mmhg vs vs -8.7 vs -4.1) Expert opinion mineralocorticoid receptor antagonist likely best add on in resistant htn (be careful, avoid if baseline K high or GFR <45; monitor potassium) 14 Possible Guideline Changer Randomized, controlled, open label trial 102 sites Sponsored by NHLBI Inclusion criteria: age at least 50, sbp , increased CV risk Increased CV risk = clinical or subclinical CV disease (except stroke), CKD (exceptions) with egfr 20-60, Framingham risk score 15% or higher, age 75 and up Exclusion criteria: DM or prior stroke (*NH residents; one minute standing SBP < 110 mmhg; EF < 35% or sx) 9361 patients Systolic BP target of either less than 140 mmhg (standard treatment group) vs less than 120 mmhg (intensive treatment group) 15 5

6 Possible Guideline Changer Treatment algorithms, with multiple antihypertensive drug choices available Participants seen monthly for first 3 months and every 3 months thereafter Intensive group meds adjusted to target SBP <120 mmhg on monthly basis Standard group medications adjusted to target SBP 135 to 139 mmhg (dose reduced if SBP < 130 on visit, or < 135 on two consecutive visits) Dose adjustments based on mean of 3 BP measurements in office while patient seated and after 5 minutes of quiet rest; measurements made with automated measurement system (Omron 907) 16 Possible Guideline Changer Primary composite outcome was MI, other ACS, stroke, heart failure or death from CV cause Stopped early after median follow-up of 3.26 years owing to significant lower rate of primary outcome in intensive treatment group Intensive treatment group 1.65% per year (mean SBP mmhg, mean # meds 2.8) Standard treatment group 2.19% per year (mean SBP mmhg, mean # meds 1.8) Hazard ratio 0.75 (p<0.001) (NNT 61) All cause mortality (secondary outcome) also lower in intensive treatment group HR 0.73 (p=0.003) 17 Possible Guideline Changer Serious adverse events possibly or definitely related to the intervention 4.7% in intensive treatment group 2.5% in standard treatment group (NNH 45) Hypotension, syncope, electrolyte abnormalities, and AKI all more common in intensive group Bradycardia and injurious falls similar in each group 18 6

7 Possible Guideline Changer Conclusion of study: intensive treatment had lower rates of fatal and nonfatal major CV events and death from any cause, but significantly higher rates of some adverse events Expert opinion: consider intensifying nondiabetic, nonstroke, functional patients over age 50 if they have high CV risk, are compliant with office visits, and are willing to accept the higher pill burden and higher risk of side effects (make sure to do appropriate BP measurement!) 19 Conclusion Hypertension is a very common (1 in 3 adults) Recommend decreased sodium, DASH diet with exercise and weight loss ACE-ARBs, thiazides, calcium channel blockers should be your first-line medications JNC 8 guidelines provide an evidence based review, but many recommendations are expert opinion, so make sure to tailor therapy to your individual patient New trials are helping us to have needed information to choose the best treatments and intensity for our patients Questions? 20 References "Choosing Wisely Clinician Lists." Choosing Wisely. ABIM, Web. 17 Feb JamesP, OparilS, CarterB, et al Evidence-Based Guideline for the Management of High Blood Pressure in Adults. Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014; 311(5): ChobanianA, BakrisG, BlackH. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. The JNC 7 Report. JAMA. 2003; 289: EckelR, JakicicJ, ArdJ, et al. AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk: a report of the ACC/AHA task force on practice guidelines. JACC. 2014; 63(25): WaldD, LawM, MorrisJ, et al. Combination Therapy versus Monotherapy in Reducing Blood Pressure: Meta-analysis on 11,000 Participants from 42 Trials. The American Journal of Medicine. 2009; 122(3): LawM, WaldN, MorrisJ, et al. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ. 2003; 326: JamersonK, WeberM, BakrisG, et al. Benazepril plus Amlodipine or Hydrochlorothiazide for Hypertension in High-Risk Patients. The New England Journal of Medicine. 2008; 359(23): WeberM, JamersonK, BakrisG, et al. Effects of body size and hypertension treatments on cardiovascular event rates: subanalysis of the ACCOMPLISH randomised controlled trial. Lancet. 2013; 381:

8 References JamersonK, DevereuxR, BakrisG. Efficacy and duration of benazepril plus amlodipine or hydrochlorothiazide on 24-hour ambulatory systolic blood pressure control. Hypertension. 2011; 57(2): WilliamsB, MacDonaldT, MorantS, et al. Spironolactone versus placebo, bisoprolol, and doxazosin too determine the optimal treatment for drug-resistant hypertension (PATHWAY-2): a randomised, double-blind, crossover trial. The Lancet. 2015; WrightJ, WilliamsonJ, WheltonP, et al (The SPRINT Research Group). A Randomized Trial of Intensive versus Standard Blood-Pressure Control. The New England Journal of Medicine. 2015; 373: