Hypertension Guidelines: Lessons for Primary Care. Paul A James MD Professor and Chair Department of Family Medicine University of Washington

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1 Hypertension Guidelines: Lessons for Primary Care Paul A James MD Professor and Chair Department of Family Medicine University of Washington

2 Disclaimer and Financial Disclosure I have no financial interests to report

3 Learning Objectives: Participants will be able to: Learners will be able to : Better assess goals for hypertension treatment Explain why controversy surrounds treatment of hypertension Explain how Absolute Risk Reduction (ARR) and its relation to clinical decision making is important to practitioners Understand Relative Risk Reduction (RRR) and how this may inflate the treatment effect and is important to disease centered specialists Learners will be able to use Hypertension as an example of how our increasing focus on disease prevention expands diagnoses and treatment making more people sick and fewer healthy

4 2014 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) James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, Lefevre ML, Mackenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E James PA, Oparil S, Carter BL et al. JAMA. 2014; 311 (February 5): *4 members had relationships to disclose; 13 had no relationships to disclose. Panel members disclosed their relationships and recused themselves from voting on evidence statements and recommendations relevant to their relationships.

5 What a mess! Conflicting Guidelines Different treatment goals Based on the same scientific data

6 First Guideline Following JNC 8 was by ACP/AAFP. Annals of Internal Medicine: Vol. 166, No. 6 March 21, 2017 p

7 ACC/AHA Guidelines came later in 2017

8 Hypertension: A Moving Target JNC Classifications: Diastolic Blood Pressure Stage 4 DBP (mm Hg) Hypertensive Severe Severe Severe Moderate Moderate Moderate Stage Stage 3 3 Stage 3 Stage 2 Stage 2 Stage Consider therapy Mild Mild Mild Stage 1 Stage 1 Stage Normal Normal Normal Normal Optimal Optimal Highnormal Highnormal Highnormal Highnormal Prehypertension Normal JNC I JNC II JNC III JNC IV JNC V JNC VI JNC 7 JNC I. JAMA. 1977;237: JNC II. Arch Intern Med. 1980;140: JNC III. Arch Intern Med. 1984;144: JNC IV. Arch Intern Med. 1988;148: JNC V. Arch Intern Med. 1993;153: JNC VI. Arch Intern Med. 1997;157: Chobanian AV et al. JAMA. 2003;289:

9 Slide 8 EO1 Change the color of the font in the yellow bars to something that can be seen better, like dark blue or black like you did in Slide 5. Eduardo, 4/16/2012

10 Hypertension: A Moving Target JNC Classifications: Systolic Blood Pressure 220 Stage SBP (mm Hg) No recommendations for SBP in JNC I or JNC II ISH ISH Normal Stage 2 Stage 1 Borderline Stage 3 Stage 3 Stage 2 Stage 2 Stage 1 Stage 1 Highnormal Highnormal Normal Normal Optimal Optimal Borderline Prehypertension Normal JNC I JNC II JNC III JNC IV JNC V JNC VI JNC 7 JNC I. JAMA. 1977;237: JNC II. Arch Intern Med. 1980;140: JNC III. Arch Intern Med. 1984;144: JNC IV. Arch Intern Med. 1988;148: JNC V. Arch Intern Med. 1993;153: JNC VI. Arch Intern Med. 1997;157: Chobanian AV et al. JAMA. 2003;289:

11 2014 Goal Blood Pressures for Adults: Quick Summary For age 60 years and older without diabetes or kidney disease, strong evidence supports Goal BP < 150/90 based on Grade A level evidence For all others, we recommend Goal BP < 140/90 based on expert opinion

12 Initial Drug Treatment Recommendations for High Blood Pressure Non Black Population without DM or CKD: Thiazide type diuretic, CCB, ACEI or ARB B Level Evidence Black Population including those with DM: Thiazide type diuretic or CCB B Level Evidence for general Population and C Level Evidence for DM

13 Initial Drug Treatment Recommendations for High Blood Pressure CKD Population (Black and non Black, DM or not DM): ACEI or ARB (but not both together in any circumstance) B Level Evidence

14 Drug Therapy Recommendations BLOOD PRESSURE GOALS >60 YO: SBP <150mmHg DBP < 90mmHg <60 YO, DM, CKD: SBP < 140mmHg DBP < 90mmHg Diuretic (Thiazide Type) SPECIFIC RECOMMENDATIONS African Americans: Diuretic/CCB CKD: ACEI/ARB ACEI/ARB Initial Pharmacotherapy Selection CCB X Don t use ACEI + ARB Use evidence based dosing (HCTZ!) Only use Beta Blockers with compelling indication

15 SPRINT Planned in 2007 by NHLBI Large RCT of 9361 subjects Does treating BP to lower goal (BP <120 mmhg) compared to goal BP < 140 mmhg result in improved outcomes? A Randomized Trial of Intensive versus Standard Blood Pressure Control. SPRINT Research Group, Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. N Engl J Med Nov 26;373(22): doi: /NEJMoa Epub 2015 Nov 9. PMID:

16 SPRINT P: 50 years or older with Systolic BP mm Hg & increased CVD Risk but not stroke or diabetes (9361) I: More intensive Medication Vs Standard BP Control C: Goal BP < 120 vs BP < 140 mm Hg O: Composite Outcome of MI, ACS, stroke, HF, or CV death

17 Primary and Secondary Outcomes and Renal Outcomes. The SPRINT Research Group. N Engl J Med 2015;373:

18 SPRINT Trial: Relative Risk Reduction 25% Reduction in Composite CV Outcomes When a 25% reduction in Cardio Vascular outcomes is reported, this is the mental image that many see. 250 of 1000 lives saved from the scourge of CVD.

19 SPRINT Trial: Relative Risk Reduction 25% Reduction in Composite CV Outcomes Green: 16 (1.6% of total) patients treated will benefit from the treatment, representing a reduction in bad outcomes from 68 (6.8%) to 52 (5.2%). This is approx. 25% relative reduction in CV outcomes

20 SPRINT Results Number Needed to Treat (NNT) = 63 based on ARR of 1.6% A small minority of patients treated (1.6%) will benefit from the new goal BP < 120 mmhg

21 Harms SPRINT investigators compare the harms in this study (more frequent than the improved outcome) to the severity of the CV death, MI, ACS, HF and stroke Harms may be worthwhile if we are confident that we will see the benefit, less so if we don t.

22 SPRINT Trial: Absolute Risk Reduction 1.6% Reduction in Composite CV Outcomes Green: Positive Benefit from Treatment Red: Serious Harm from Treatment Purple: 52(5.2%) patients with poor CV Outcomes Gray: Treated with 2 3 medications without benefit

23 Relationship between the Spectrum of the Abnormality and Treatment Benefit in Hypertension Over Diagnosed. Making People Sick in the Pursuit of Health. Welch HG, Schwartz LM, Woloshin S. Beacon Press. 1/3/2012. ISBN:

24 Benefit across the Spectrum of Hypertension* Degree of Hypertension 5 year Risk of Bad Event No Treatment Treatment Chance of Benefit Number needed to Treat Severe [Diastolic BP ] Moderate 10 [Diastolic BP ] Mild [Diastolic BP ] Very Mild 11 [Diastolic BP ] Mild to Severe** [Systolic BP ] 80% 8% 72% % 12% 26% 4 32% 23% 9% 11 9% 3% 6% %* 5.2%* 1.6%* 63* *Over Diagnosed. Making People Sick in the Pursuit of Health. Welch HG, Schwartz LM, Woloshin S. Beacon Press. 1/3/2012. ISBN: **From SPRINT. No Treatment Group is Usual Treatment and Treatment Group is Intensive BP Goal< 120 mmhg and at 3.2 years instead of 5.

25 HOPE 3 Trial Tested concept of Poly pill in population at moderate risk for CV Disease Candesartan (ARB) and HCTZ versus Placebo 2 other interventions were compared: Rosuvastatin alone, and Rosuvastatin + Candesartan/HCTZ together

26 HOPE 3 Trial Randomized Controlled Clinical Trial Intermediate C V Risk patients Over 12,000 subjects Average BP reduction was Systolic 6.2 mmhg and Diastolic 3.2 mmhg

27 HOPE 3 Trial Results No benefit from lowering Blood Pressure at over 5 years

28 Summary Evidence demonstrates that for elderly without diabetes and at high CV Risk, a goal BP < 120 mmhg significantly reduces Stroke, MI, ACS, HF and CV death in a small number of patients. This effect has not been shown in those at intermediate or low risk or who are younger

29 Summary Patients and their primary care physicians must decide whether the identified benefit is worth the costs Patient preferences, values, worries and personal factors should guide your therapeutic recommendations

30 Doctor Patient Interaction on Prevention Primary Prevention Secondary Prevention Wellbeing Risk Factors Symptoms Disease Tertiary Prevention Quaternary Prevention

31 How do we apply disease based guides to patient centered care? Disease Centered Evidence based Diseasecentered Care DOCTOR Patientcentered Care Patient Centered Preferences Values Diseasecentered Care Patient centered Care Goals Multi morbidity

32 Questions?

None. Disclosure: Relationships with Industry Conflicts of Interests. Learning Objectives: Participants will be able to:

None. Disclosure: Relationships with Industry Conflicts of Interests. Learning Objectives: Participants will be able to: 2014 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) James W. Shaw, MD Memorial Lecture

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