Today s Recommendations
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1 Today s Recommendations 2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk (45 pages) 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults (14 pages) 2013 ACC/AHA Guidleine on the Treatment of Blood Cholesterol to Reduce Athereosclerotic Cardiovascular Risk in Adults (85 pages) Controversy! The HTN guidelines have not been accepted by all groups American Society of Hypertension and the International Society of Hypertension JNC leading the way since 1976
2 You must unlearn what you have learned -Yoda Previously published guidelines were not as based in evidence as current JNC 7 Published over 10 years ago Current guidelines used only best evidence from random controlled studies with limited input from meta analysis, expert opinion, and observational studies Gold standard for efficacy and effectiveness ATP III Goal guided treatment LDL Basis of Healthy Change Every health focused change begins with diet and exercise Both lipid and BP publications refer to the Lifestyle Management Guideline as a foundation for change What s for dinner? DASH Diet, AHA diet, USDA Food Pattern All emphasize increased consumption of fruits, vegetables, whole grains, low fat dairy, poultry, fish, legumes, non tropical oils, and nuts Limit red meat, sweets, and sugary beverages Always adjust caloric goal based on patient 5-6% of calories from saturated fat Average American consumes about 11% or more
3 DASH Diet Highest quality evidence Compared to the average 1990 s American diet Lower BP by 5-6/3 mmhg Lower LDL by 11 mg/dl Mediterranean Diet Increased fruits, vegetables (root and green), whole grains, fatty fish (salmon), low fat dairy, olive and canola oils, nuts (walnuts, almonds, hazelnuts) Little red meat Moderate fat intake 32-35% of total calories Low saturated fat 9-10% of total calories High fiber gm/day Mediterranean Diet Low quality evidence to support, but gaining popularity In patients with Type II DM or 3+ CVD risk factors Reduced BP by 6-7/2-3 mmhg No effect on LDL
4 Sodium Only nutrient focused on because it rarely occurs naturally in food Easiest to manipulate because primarily added General recommendation less then 2400 mg/day Decreasing intake by 1gm/day reduces CV events by 30% Reduction by 1150 mg/day reduced BP by 3-4/1-2 mmhg Effect was greater in those with HTN Decreased sodium intake along with DASH lowers BP more then reduced sodium alone Sweat is Fat Crying Aerobic Exercise 3-4 times per week 40 minute sessions of moderate to vigorous intensity Decrease BP by 2-5/1-4 mmhg Reduced LDL by 3-6 mg/dl, non HDL by 6 mg/dl No consistent effect on trigs, HDL
5 Blood Pressure European Society of HTN and European Society of Cardiology define HTN as >140/90 Point found when anti HTN meds provide most benefit Most significant risk factor for CV death at 40% Smoking 13% Diet 13% Sedentary lifestyle 12% Hyperglycemia 8.8% Taking BP Positioning does make a difference Sitting position, back supported Arm should be at level of heart Lower position can falsely raise DBP 6 mmhg Crossing legs can increase SBP 2-8 mmhg Large cuff provides false low, Small cuff provides false high
6 JNC 7 Guidelines were based on consensus of experts and addressed multiple issues Started almost everyone with a thiazide diuretic Goal BP <140/90 for average population Goal BP for those with DM or CKD <130/80
7 2014 Guidelines Focus Questions 9 recommendation statements In adults with HTN Does initiating anti-htn pharmacologic therapy at a specific BP threshold improve health outcomes? Does treatment to a specific BP goal lead to improvements in health outcomes? Do various anti-htn drugs or classes differ in comparative benefit or harm on specific health outcomes? Criteria of studies reviewed All were RCT with patients, multi-centered, and a major study in HTN Excluded if enrolled pre HTN or non HTN pts Must include HTN and its relationship to: Overall mortality, CVD mortality, or CKD mortality MI, HF, HF hospitalization, CVA CAD or PAD with revascularization CKD with doubling of Cr or 50% reduction of GFR Recommendation #1 60+ yo treat at 150/90 to goal less then 150/90 Grade A If treatment results in lower BP with no adverse effects no need to adjust treatment Expert opinion Goal less then 150/90 decreases risk of CVA, HF, CAD
8 Recommendation #2 Ages initiate treatment at DBP 90 to treat to <90 Grade A Ages same recommendation expert opinion No further benefit shown with DBP <80 in CVA, HF, and overall mortality Recommendation #3 Patients less then 60 years old treat at SBP 140 to goal less then 140 Expert opinion Based on DBP trials, SBP was usually <140 Insufficient evidence for recommendations in ages >60 Recommendation #4 Ages with CKD (GFR <60 or 30 mg Albumin/gm Cr at any GFR) initiate treatment at SBP 140 or DBP 90 Expert Opinion No trials showed better ASCVD outcomes with BP <140/90 Improved renal outcomes with BP <130/80 No evidence with population >70 with GFR <60
9 Recommendation #5 18 years and older with DM initiate treatment to keep BP <140/90 No trials with lower goal Supported by control group in ACCORD Recommendation #6 Non black population initial treatment should include: Thiazide diuretic CCB ACE or ARB All 4 classes had comparable effect in overall mortality, CVS (except HF), CVA, and renal outcomes No recommendation for BB-resulted in more complications then ARB in trial No alpha blockers as initial-resulted in worse outcomes then diuretic Rec #6 cont. No RCT compared the following so no recommendation could be made: Dual Alpha/BB- carvedilol Vasodilator BB- nebivolol Central alpha adrenergic agonist- clonidine Direct vasodilators- hydralazine Aldosterone antagonist- spironolactone Loop diuretics- furosemide
10 Recommendation #7 In the general black population initial treatment should include thiazide diuretic or CCB Grade B Thiazide had improved outcomes compared to ACE including with DM ACE correlated with 51% higher rate of stroke as initial therapy and was less effective in attaining goal No difference in thiazide and CCB except in HF Recommendation #8 Patients 18 years and older with CKD and HTN Initial or secondary med should be ACEi or ARB regardless of race or DM Grade B Related to improved renal outcomes, not CVS Over 75 thiazide, CCB, or ACE Monitor Serum Creatnine and potassium Wait you just said. Recommendations 7 and 8 contradict each other What if your patient is black with CKD? You can use ACEi or ARB as initial treatment because of likelihood to progress to ESRD If no proteinuria- thiazide, CCB, ACEi to start Will likely need more than one agent anyway
11 Recommendation #9 If goal is not attained within one month Increase dose Add another drug Never use ACEi s and ARBs together If BP requires 3+ drugs refer to HTN specialist Heart Failure No specific guidelines addressing heart failure patients Thiazides and ACEi showed improved HF outcomes 2013 European Society of HTN and Society of Cardiology suggested for 1) ACE 2) Aldosterone blockers 3) BB 4) Loop diuretics Additional thoughts Guidelines should not outweigh clinical judgement Most patients will require more than one drug to get to goal European council felt renal denervation is a promising prospect Recently stopped Simplicity trial due to lack of evidence to support
12 2013 Lipid Management Guidelines Focus of treatment is to reduce atherosclerotic cardiovascular disease (ASCVD) High level of evidence found statins reduce total mortality Clinical ASCVD is defined as acute coronary syndrome, stable or unstable angina, any arterial revascularization, stroke, TIA, or PAD Come right out and say this is not comprehensive and is not a replacement for clinical judgement What changed? Three year deliberation to switch from goal guided treatment to fixed dose RCT were fixed dose trials, not titrating Max dose therapy recommended Goal guided therapy may result in under treating
13 First Steps Implement previously discussed lifestyle management Prior to initiating treatment check: Fasting lipid panel ALT CK if history or muscle disease A1c if DM status is in question Statin Intensity High intensity- lowers LDL by >50% Atorvastatin mg Rosuvastatin mg Moderate intensity- lowers LDL by 30-50% Atorvastatin mg Rosuvastatin 5-10 mg Simvastatin mg Pravastatin mg Lovastatin 40mg Low intensity- lowers LDL by <30% Simvastatin 10 mg Pravastatin mg Lovastatin 20 mg Populations 1) LDL <190 without DM or ASCVD 2) Known ASCVD 3) LDL >190 4) Age with DM and LDL
14 Risk Calculator Evaluates 10 year ASCVD risk for non fatal/fatal MI or stroke Factors used to assess risk Gender Age Ethnicity Total cholesterol HDL SBP Diabetic, Smoker, HTN Controversy! Test patients populated into risk calculator that by most standards would not require treatment, do require treatment when evaluated with this tool Dr. Nissen s editorial in JACC 47 yom, LDL 88, controlled BP on HCTZ-7.6% 58 yom, LDL 92, no HTN or DM- 7.5% 44 yom, fam hx CVS dz, LDL 182, No HTN- 5.0% LDL <190 Age with no known ASCVD or DM and LDL of should be treated based on risk calculation regardless of sex, race, or ethnicity Risk > 7.5% Moderate to high intensity Risk 5-7.5% Moderate intensity Risk <5% has little benefit
15 Known ASCVD Less then 75 years high intensity statin should be initiated as first line treatment unless contraindicated If there are contraindications moderate intensity statin should be used Over age 75 if they are tolerating it continue but evaluate: Drug-drug interactions Risk reduction benefit Adverse effects Consider moderate therapy-no clear benefit with higher doses in trials, but strong evidence to continue treatment LDL >190 Ages 21 and older with LDL >190 should be treated with high intensity statin or maximum tolerated dose High lifetime risk due to high lifetime exposure Each incremental decrease of 39 mg/dl LDL equated to 20% risk reduction Goal is >50% reduction in LDL with maximum tolerated therapy If patient is not on max tolerated tx and has not gotten >50% reduction, increase dosage
16 How does someone get their LDL >190 Primary cause- Genetics Need family screening Secondary causes-eval for if LDL >190 or trigs >500 Diet- high in sat or trans fats, alcohol, weight gain, anorexia Drugs- diuretics, cyclosporine, glucocorticoids, amiodarone Diseases- bilary obstruction, nephrotic syndrome Disorders- Hypothyroidism, obesity, pregnancy Most common secondary causes are excessive alcohol, uncontrolled DM, and albuminuria Diabetic Patients Ages with ASCVD risk >7.5% High intensity All adult diabetic patients with risk less then 7.5% Moderate intensity Patient younger then 40 or older then 75 Use risk calculator Clinical judgement Other Groups No recommendations for NYHA class II-IV or ESRD on HD Insufficient studies available to make recommendations No primary prevention data for ages Very little primary prevention data for ages >75 Most ASCVD events occur after age 70 giving them the greatest potential for risk reduction
17 Other Groups Family history of premature ASCVD in first degree male <55 years or female <65 years ABI <0.9 High sensitivity CRP >2 mg/dl Maintenance Recheck fasting lipid panel in 4-12 weeks to establish compliance Recheck every 3-12 months as indicated If patient presents with side effects attributable to drug: decrease dose Switch statins Check CK or ALT if presents with muscle or hepatic issues Adverse Reactions Pregnancy Category X Not to be used when lactating Always new findings coming out Consult pharmacy and prescribing info Predisposing factors Impaired renal or hepatic function Muscle disorders Unexplained ALT elevation >3x ULN >75 yo
18 Adverse Reactions Myopathy risk 1 in Hemorrhagic stroke risk- 1 in High intensity therapy in patients with 10 yr risk of 5-7.5% without comorbidities -risk may outweigh benefit Moderate intensity- benefit outweighs risk Myalgias Obtain thorough history of muscle symptoms prior to initiation If mild to mod muscle symptoms occur DC statin until exam can be done Eval for hypothyroid, renal/hepatic issues, rheumatologic issues, and vitamin D deficiency If resolve restart statin at lower dose If causal relationship is found use low intensity as tolerated and gradually increase Statin induced DM Long term adverse effects of DM are less then MI, stroke or ASCVD death Moderate intensity therapy-1 in 1000 risk High intensity- 3 in 1000 risk Only screen for DM according to current adult guidelines
19 Non Statin Therapy These guidelines focus on ASCVD risk Non statin therapy does not have great impact on ASCVD risk High risk patients with less then ideal results may consider addition of non statin Insufficient data to evaluate efficacy of ezetimibe Do not use Bile Acid sequestrants with trigs >300 and cautiously with trigs Triglycerides Do not use gemfibrozil with statins due to increased risk for myalgias and myopathy Fenofibrate may be used with low or moderate intensity statin only if trigs are >500 and benefit outweighs risk Cannot use if GFR <30 Use 54 mg if GFR DC if GFR drops below 30 during treatment ACCORD subgroup analysis indicates fenofibrate may reduce ASCVD risk in pts with DM and high trigs but more testing is needed Niacin AIM-HIGH trial there was additional reduction of non-hdl and increase in HDL with niacin Immediate release niacin (2gm dose) showed 10% reduction in total cholesterol and 27% decrease in trigs, but significantly elevated risk of AF, flushing and GI distress Less flushing with sustained release (2.4gm), but associated with increased ALT, CK, Uric acid, and homocysteine levels Alleviate flushing by taking with food, starting low, titrating up, and premedicate with ASA 30 min prior Contraindicated if LFT s 2-3x ULN Persistent flushing, hyperglycemia, gout, GI distress New onset AF or weight loss
20 Cliff Notes 1) 10 yr risk >7.5%-high intensity, 5-7.5%- moderate 2) Known ASCVD: High intensity 3) LDL>190: High intensity 4) DM with LDL <189 1) 10 yr risk >7.5- high intensity 2) 10 yr risk <7.5- moderate intensity Future Research Subgroups of HF and ESRD Significance of Lp(a) for guiding treatment Long term effects of statin assoc DM Pharmacogenetic testing Hypertriglyceridemia Non statin drugs and ASCVD risk reduction The End
21 References Davis, L. (2013). Using the latest evidence to manage hypertension. Journal for Nurse Practitioners, 9(10), Eckel RH, Jakicic JM, Ard JD, Miller NH, Hubbard VS, Nonas CA, de Jesus JM, Sacks FM, Lee I- M, Smith Jr SC, Lichtenstein AH, Svetkey LP, Loria CM, Wadden TW, Millen BE, Yanovski SZ, 2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk, Journal of the American College of Cardiology (2013), doi: /j.jacc Eighth Joint National Committee. (2013) Evidence-based guideline for the management of high blood pressure in adults. JAMA. Retrieved from JNC 7 s classification of hypertension, retrieved on January 2, 2014, from 9FF7BBFD6374D058699D306066E922A7. Nissen, S. (2013). Prevention guidelines: The good, the bad, and the ugly. JACC. Retrieved on January 8, 2014, from News/2013/December/Prevention-Guidelines-The-Good-the-Bad-and-the-Ugly.aspx Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Lloyd-Jones DM, Blum CB, McBride P, Eckel RH, Schwartz JS, Goldberg AC, Shero ST, Gordon D, Smith Jr SC, Levy D, Watson K, Wilson PWF, 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults, Journal of the American College of Cardiology (2013), doi: /j.jacc
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