The Latest Generation of Clinical

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1 The Latest Generation of Clinical Guidelines: HTN and HLD Dave Brackett

2 Clinical Guideline Purpose Uniform approach Awareness of key details Diagnosis Treatment Monitoring Evidence based approach Inform frontline practitioners of new information

3 History of Clinical Guidelines JNC Consensus Opinion Comprehensive and Levels of Evidence Mixture Answer every question even if no quality evidence rate the evidence

4 Levels of Evidence

5 Levels of Evidence

6 Paradigm Shift JNC JNC YEARS!!!!!! Demand the highest level of evidence Only answer questions where required level of evidence is available Acceptable to have questions left unanswered

7 NHLBI Systematic Review and Guideline Development Process Topic area identified Expert panel selected Critical questions & lit. eligibility determined Evidence tables developed; Lit. summarized Studies rated by quality Lit. search; Identify eligible studies Graded evidence recommendations dti completed External Review; Revise PRN Dissemination of guidelines

8 NHLBI Evidence Grades & Recommendation Strength High Evidence Grades Well designed and conducted RCTs Moderate Low RCTs with minor limitations Well conducted observational studies RCTs or observational studies with major limitations Recommendation Strength A Strong B Moderate C Weak D Against E Expert Opinion N No Recommendation

9 JNC 8 Guidelines for the Management of Hypertension

10 Question One In adults with hypertension, does initiating antihypertensive pharmacological therapy at specific BP thresholds improve health outcomes? BP level to start drug treatment? 1496 articles screened 1452 excluded did not meet pre specified criteria 26 of 44 articles graded good or fair and used in guidelines

11 Question 2 In adults with hypertension, does treatment with antihypertensive pharmacological therapy to a specified BP goal lead to improvements in health outcomes? What are the BP treatment targets? = 92 included 17 Good, 39 Fair, 36 Poor 56 articles used

12 Question 3 In adults with hypertension, do various antihypertensive drugs or drug classes differ in comparative benefits and harms on specific health outcomes? What medications provide the best/worst outcomes? = 101 included 15 Good, 51 Fair, 35 Poor 66 articles used

13 Recommendation 1 In the general population 60 years of age, initiate pharmacologic treatment to lower BP at SBP 150 mm Hg or DBP 90 9 mm Hg and treat to a goal SBP <150 mm Hg and goal DBP <90 mm Hg. Strong Recommendation Grade A Corollary Recommendation: In the general population 60 years of age, if pharmacological treatment for high BP results in lower achieved SBPs (for example, <140 mm Hg) and treatment is not associated with adverse effects on health or quality of life, treatment does not need to be adjusted. d Expert Opinion Grade E

14 Recommendation 2 In the general population <60 years of age, initiate pharmacologic treatment to lower BP at DBP 90 mm Hg and treat to a goal DBP <90 mm Hg. For ages years, Strong Recommendation Grade A For ages years, Expert Opinion Grade E Based heavily on studies from 1967, 1970, 1979 and 1998

15 Recommendation 3 In the general population <60 years of age, initiate pharmacologic treatment to lower BP at SBP 140 mm Hg and treat t to a goal SBP <140 mm Hg. Expert Opinion Grade E Insufficient evidence from good/fair quality RCTs to support a specific SBP threshold for goal Expert Opinion No evidence to change so keep what we have Most of the DBP <90mmHg RCTs participants = SBP <140mmHg DM/CKD SBP Goal: <140mmHg

16 Major Trials Testing SBP Goals SHEP Syst=Eur HYVET JATOS VALISH N Entry SBP Goal SBP <148 <150 <150 <140 <140 SBP Achvd Stroke 36% 42% NS NS NS CVD 32% 31% 34% NS NS Mort NS NS 21% NS NS

17 Recommendation 4 & 5 In the population 18 years of age with CKD, initiate pharmacologic treatment to lower BP at SBP 140 mm Hg or DBP 90 mm Hg and treat to goal SBP <140 mm Hg and goal DBP <90 mm Hg. Expert Opinion Grade E In the population 18 years of age with diabetes, initiate pharmacologic treatment to lower BP at SBP 140 mm Hg or DBP 90 mm Hg and treat to a goal SBP <140 mm Hg and goal DBP <90 mm Hg. Expert Opinion Grade E

18 BP Goal in CKD 3 RCTs 2272 participants MDRD AASK REIN 2 No conclusive results favoring BP target <125/75 or <130/80 vs. <140/90

19 RCTs: BP goals in HTN/DM n SBP goal DBP goal Mean BP, less intense Mean BP, more intense Outcome (risk reduction) SHEP 583 <148 None 155/72 146/78 Stroke: 22% CVD: 34% CHD: 56% Syst Eur 492 <150 None 162/82 153/78 Stroke:69% CVD:62% HOT 1501 None <80 148/85 144/81 CVD:51% MI:50% Stroke:NS CV death: 67% UKPDS 1148 <150 <85 154/87 144/82 DM related ltd death: 32% ABCD 470 None <75 138/86 132/78 Renal:NC Microvasc:NC Death: 49% CVD: NS

20 ACCORD N=4733; 4.7 years SBP goal: <120 Mean BP, less intense: 134 Mean BP, more intense: 119 Outcomes (1º): 12% (NS) Stroke: 41%

21 Secondary Prevention of Small Subcortical Strokes (SPS3) RCT, n=3020, 3.7 years With 180 days of lacunar infarct Testing antiplatelet therapy and Level of BP Control Higher: SBP (mean 138) Lower: <130 SBP (mean 127) Outcomes 1º recurrent stroke 2º major vascular events, cognitive decline, death

22 SPS3 Results HR (95% CI) P value All stroke 0.81 ( ) 0.08 Ischemic stroke 0.84 ( ) 0.19 Intracerebral bleed 0.37 ( ) 0.03 Major vasc events 0.84 ( ) 0.10 MI ( ) 1.4) Deaths 1.03 ( ) 0.82 Vasc death ( ) 1.35)

23 Systolic Blood Pressure Intervention Trial (SPRINT) Study in progress SBP Goal <120 vs <140 in high h risk iknon DM pop. Primary: composite MI, stroke, HF, ACS, CV death Other: renal, cognition/dementia, MRI changes Completed enrollment 9361 participants Started March 2013 expected completion in 4 6 years ( )

24 Recommendation 6 In the general non Black population, including those with diabetes, initial antihypertensive treatment should include a thiazide type diuretic, CCB,ACEI or ARB. Moderate Recommendation Grade B Only comparison RCTs were assessed (no placebo controlled) Also excluded specific non HTN populations (CAD, HF, etc.) All 4 classes yield comparable effects on overall mortality Evidence supported BP control rather than specific agents DM participants showed no differences in major cardiovascular or cerebrovascular outcomes from those in the general population

25 Thiazide type Diuretics Chlorthalidone Indapamide Hydrochlorothiazide concerns re: effective dosing in g trials is higher than currently accepted safe dosing range

26 Recommendation 7 In the general Black population, including those with diabetes, initial antihypertensive treatment should include a thiazide type diuretic or CCB. For general Black population: Moderate Recommendation Grade B For Blacks with diabetes: Weak Recommendation Grade C ALLHAT Subgroup Analysis: AA Subgroup Thiazide > ACEI Outcomes: Cerebrovascular, HF, & combined CV Thiazide = CCB Outcomes: Cerebrovascular, CHD, combined CV, kidney, & overall mortality Exception: HF prevention CCB > ACEI 51% rate of stroke (RR, 1.51; 95% CI, ) 22186) ACEI less effective at BP No RCTs that compared diuretics/ccbs vs βb or ARBs

27 Recommendation 8 In the population 18 years of age with CKD and HTN, initial (or add on) antihypertensive treatment should include an ACEI or ARB to improve kidney outcomes. This applies to all CKD patients with HTN regardless of race or diabetes status. Moderate Recommendation Grade B

28 Recommendation 9 The main objective of HTN treatment t t is to attain and maintain i goal BP. If goal BP is not reached within a month, increase the dose of the initial iti drug or add a 2 nd drug from thiazide type id t diuretic, CCB, ACEI or ARB. Continue to assess BP and adjust until goal BP is reached. If goal BP not reached with 2 drugs, add and titrate t a 3 rd drug from the list. Do not use an ACEI and an ARB together in the same patient. If goal BP not be reached using drugs in Recommendation 6 because of a contraindication or the need to use more than 3 drugs to reach goal, antihypertensive drugs from other classes can be used. Referral to hypertension specialist ilit may be indicated d for patients t in whom goal BP cannot be attained using the above strategy. Expert Opinion Grade E

29 JNC 8 Summary Goals: <60 <140/90 60 <150/90 Initial Therapy: Thiazide type diuretics CCB ACEI/ARB AA: Diuretic/CCB CKD: ACEI/ARB

30 Initial Frustrations After 11 years. That s it!!?? Great evidence based standard! So why all the Grade E recommendations? Have they set the bar so high that it is no longer feasible for the current methods of clinical research to achieve answers??

31 Benefits upon Further Reflection Overall simplified approach High degree of confidence in the recommendations offered Absence of bias

32 Case Study 76 yo black male in your clinic with HTN, CAD but no MI, and Stage 2 CKD w/o proteinuria (egfr 68 ml/min/1.73 m2) for follow up Meds: ASA 81 mg, atorvastatin 20 mg, HCTZ 25 mg, lisinopril 40 mg & metoprolol succinate 25 mg all daily. He reports good health w/o angina or dyspnea, denies adverse drug effects and denies orthostatic light headedness. Is active though does not exercise Exam: P= 67, BP = 108/62. BMI = 24 kg/m2 with normal findings otherwise

33 What recommendations do you have? Nothing Everything is great! Probably most in sync with JNC8 Or. Reduce the lisinopril and add CCB? Just reduce the lisinopril Would be wrong to. Just add CCB Replace lisinopril with CCB

34 Lipid Guidelines

35 Guideline Process

36 Critical Questions 1. What is evidence for LDL C and HDL C goals for secondary prevention of ASCVD? 2. What is evidence for LDL C and HDL C goals for the primary prevention of ASCVD? 3. For primary and secondary prevention, what is the impact on lipid levels, effectiveness, and safety of specific cholesterol modifying drugs in general and in selected subgroups?

37

38 Statin Intensity

39 Clinical ASCVD

40

41

42 Step by Step Age: <40, 40 75, or >75 ASCVD yes/no (clinical, LDL 190, Diabetes) ASCVD Risk Estimation: <5%,,5% 7.5%, % 75 Most patients end up in Clinical Judgment Box

43 Estimating Statin Risk Reduction Multiply estimated 10 year risk by the percent LDL lowering for given statin dosages Example: ASCVD risk level is 9% taking atorvastatin 40mg Expected >50% lowering of LDL New estimated 10 year risk = 4.5%

44 Patients >75 years Evidence does support continuing therapy in these individuals when already taking and tolerating Most data supports use of moderate intensity statins in this age group Initiation of statins for primary prevention is not supported in this age group

45 Four Statin Benefit Groups 1. Individuals with clinical ASCVD 2. Individuals with primary elevations of LDL C 190 mg/dl 3. Individuals id 40 to 75 years of age with ih diabetes and LDL C 70 to 189 mg/dl without clinical ASCVD 4. Individuals without clinical ASCVD or diabetes who are 40 to 75 years of age and have LDL C 70 to 189 mg/dl and an estimated 10 year ASCVD risk of 7.5%. 5 This requires a clinician patient discussion.

46 Frustrations No treatment goals therefore unsure of therapeutic monitoring approaches Unclear how to address those currently on therapy who may have been mismanaged as guidelines don t address reduction or cessation of statins Seems like everyone is destined to be on a statin Lack of confidence in risk calculator

47 Benefits on further reflection Equivalent therapeutic levels allowing for treatment selection based on cost Clearer and less redundant risk calculation for primary prevention Strong focus on the primacy of lifestyle changes Everyone will likely l end up on a statin tti

48 Case study 61 yo male TG=350 MI at age 59 LDL=75 Smoked until age 59 TC=180 BP controlled HDL=30 DM treated on metformin BMI=30 and sulfonylurea Glucose=140 ASA daily HbA1C=6.8%

49 Case study 61 yo male TG=350 MI at age 59 Smoked until age 59 LDL=75 TC=180 BP controlled HDL=30 DM treated on metformin BMI=30 and sulfonylurea Glucose=140 ASA daily HbA1C=6.8% And LDL=42 and TG=80 What if patient is already on atorvastatin 40mg?

50 WOSCOPS at 20 Years Original study published in men aged on pravastatin 40mg daily for 5 years demonstrated 31% reduction in risk of nonfatal MI or death from CV causes Have been following same patients for 20 years Primary endpoint risk reduction has been sustained 27% reduction in CHD mortality 13% reduction in all cause mortality 19% reduction in coronary revascularization 31% reduction in heart failure

51 Questions

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