Disclosures. Hypertension: Nationwide Dilemma. Learning Objectives. What s Currently Recommended? Specific Concerns 3/9/2012

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1 How Should We ACCOMPLISH Good Blood Pressure Control In Our VETS? Disclosures No conflicts of interest to disclose Updates in the Management of HypertensionIn the Elderly Antoine T. Jenkins, Pharm.D., BCPS Assistant Professor of Pharmacy Practice Chicago State University College of Pharmacy Internal Medicine Pharmacy Specialist Roseland Community Hospital, Chicago, IL Learning Objectives Identify key recommendations from the ACCF/AHA 2011 Consensus Statement on Hypertension in the Elderly. Discuss the key clinical trials specific to this population of hypertensive patients. Define the role of the pharmacist in managing hypertension in patients of advanced age. Hypertension: Nationwide Dilemma Effects 1 in 3 US adults Serves as a gateway condition for more serious CV aliments Direct and indirect costs associated with HTN were ~ $73 billion Prevalence increases with aging Ethnicity Gender Circulation 2010;121:e1-e170. Circulation 2009.; 119:e Hypertension in the Elderly: Specific Concerns Isolated systolic hypertension pulse pressure Pseudohypertension Labile hypertension White coat hypertension Orthostasis Postprandial hypotension Secondary causes Drug Induced causes Hypertension In the Elderly: What s Currently Recommended? Recommendations from Internationally Published Guidelines Source Target BP Drug Selection Other Comments JNC VII None specifically Same as younger individuals. Treatment should not be withheld in stated Two drugs required for most patients Weight loss and Na + beneficial the elderly; therapy should not be withheld on the basis of age. AHA/ACC JNC-VII Complete Report 2003 NIH Publicatio Circulation 2007;115:

2 Hypertension In the Elderly: What s Currently Recommended? Recommendations from Internationally Published Guidelines Source Target BP Drug Selection Other Comments ESC/ESH < 140/90 mm Hg (if tolerated) Thiazides, CCBs, ACEs/ARBs, BBs Two drug needed for most CHEP < 140/90 mm Hg Thiazides, CCBs, ACEs/ARBs, BBs Two drug needed for most Avoid BBs (> 60 yrs as first line) Although benefits of treatment in those 80 yrs old are inconclusive, successful treatment should not be stopped Caution in frail individuals and those with orthostasis European Heart Journal (2007) 28, Hypertension in the Elderly: Review of Major Trials Major Hypertensive Trials Involving Elderly Patients Trial STOP (Swedish Ti Trial lin Old Patients with HTN) n=1627 SHEP (Systolic HTN in the Elderly Program) n=4736 (Age Range) 76 yrs (70 84 yrs) 72 yrs (60 to > 80 yrs) Starting BP (Goal BP) Treatment ( Mean Duration) Outcomes 195/102 mm Hg (<160/95 Pindolol, metoprolol, Stroke, MI, and CV death mm H) Hg) atenolol lor HCTZ + (p=0.0031) 0031) and amiloride or stroke morbidity/ placebo (65 mos) mortality (p=0.0081) 170/77 mm Hg (SBP< 160 or < 20 mm Hg from baseline) Cholrothialidone ± atenolol or placebo (4.5 yrs) fatal/nonfatlal stroke (p=0.0003). CV morbidity/ mortality Lancet 1991; 338: JAMA 1991; 265: Hypertension in the Elderly: Review of Major Trials Major Hypertensive Trials Involving Elderly Patients Trial (Age Range) Starting BP (Goal BP) Treatment (Mean Duration) Outcomes Sys Eur (Systolic (y HTN 70 yrs ( 60 yrs) 174/86 mm Hg (SBP < 150 or < Nitrendipine ± enalapril ±HCTZ total stroke by 42% in the Elderly) n= mm Hg from baseline) or placebo (2 yrs) (p=0.003). fatal/nonfatal CV endpoints by 31% (p=0.001) MRC (Medical Research Council Trial) n= yrs (65 74) 184/91 mm Hg (SBP 150 or 160 mm Hg) HCTZ or atenolol ± amiloride or placebo (5.8 yrs) total stroke and all CV events (all stat. sig) Lancet 1997; 350: BMJ 1992; 304: Questions That Still Need Answering? What is an ideal BP goal for the elderly? < 80 yrs old? 80 yrs old? Do the benefits of lowering BP outweigh hthe potential risks? When can BP lowering potentially cause harm in the elderly? What is the best treatment regimen for this population? ACCF/AHA 2011 Expert Consensus Document on Hypertension in the Elderly A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents What is an ideal BP goal for the old and the very old? Developed in Collaboration With the American Academy of Neurology, American Geriatrics Society, American Society for Preventive Cardiology, American Society of Hypertension, American Society of Nephrology, Association of Black Cardiologists, and European Society of Hypertension 2

3 Uncomplicated vs. Complicated HTN? Age of the patient? Patients yrs: BP goal < 140/90 mm Hg. Goal may differ depending on presence of compelling indications. Patients 80 yrs: SBP of mm Hg, if tolerated, is acceptable. SBP 150 maybe acceptable in some cases. Aggressive BP goals for compelling indications are still reasonable only if tolerated Ensure usage of best clinical judgment HYVET (Hypertension in the Very Elderly Trial) 3,845 patients from global study sites 80 yrs of age with sustained SBP 160 mm Hg Europe Asia Australia Africa Indapamide ± perindopril (n=1933) HYVET: Study Population/Procedures 3845 patients randomized to either active treatment or placebo BP Target: <150/80 mm Hg Key Baseline Characteristics 83 yrs Mean BP 173/90 mm Hg Presence of CVD/DM 12%/7% Placebo (n=1912) Primary Outcomes Total strokes Secondary Outcomes Death from stroke Death from any cause Death CV causes HYVET: Endpoints HYVET: Results Do elderly patients reap benefits from BP lowering therapy? 3

4 ACCOMPLISH Trial (Avoiding Cardiovascular Events in Combination Therapy in Patients Living with Systolic Hypertension) 11, 506 patients at high risk for CV events: 60 yrs of age, with a SBP 160 mm Hg or currently on antihypertensive therapy, plus with evidence of CV or renal disease or target organ damage yrs of age with evidence of two or more of CV diseases or target organ damage present N Engl J Med 2008; 359: Am J Hypertens 2004; 17: ACCOMPLISH: Study Population/ Procedures 11, 506 Patients Received Combination BP Therapy Mean BP Predominate Study Region BP Targets: < 140/90 mm Hg or < 130/80 mm Hg Key Baseline Characteristics 68 yrs 145/80 mm Hg 70% sites in United States Benazepril Amlodipine Group (n=5744) Benazepril HCTZ Group (n=5762) ACCOMPLISH: Endpoints Primary Outcomes Composite of CV events and death from CV causes Evaluation of individual components Death from CV causes Hosp. from unstable angina TtlMI Total Revascularization Total Stroke Resuscitation from cardiac arrest Prespecified subgroups (age, gender, diabetes) Secondary Outcomes Composite of death from CV events, nonfatal MI/stroke ACCOMPLISH: Results SHEP Trial Follow Up (Association Between Chlorthalidone Treatment of Systolic Hypertension and Long Term Survival) Objective: To assess the legacy effect of active treatment 22 yrs after the conclusion of the trial. Recap of SHEP Study: 4736 participants 60 yrs old with systolic HTN Baseline Characteristics: : 72 yrs old PMH: 5% had MI, ~1% had Mean BP: 170/76 mm Hg Smoking Status: 12% smoked CVA, 10% had DM JAMA 2011; 306 (23): SHEP Follow Up Trial Recap of SHEP Active Group: Chlorthalidone ± atenolol Placebo Group Length of Study: 4.5 yrs Method of analysis Evaluation of National Death Index for mortality and cause of death through Dec 2006 Primary Outcomes CV Death All Cause Mortality 4

5 SHEP Follow Up Trial: Results (Survival Free of CV Death) SHEP Follow Up Trial: Results (Survival Probability of All Cause Mortality) JAMA 2011; 306 (23): JAMA 2011; 306 (23): Hypertension In the Elderly: The J Curve When it comes to BP lowering, how much is too much? INVEST Study 2011 Consensus Recommendations: SBP < 130 mm Hg and DBP < 65 mm Hg should be avoided d in patients t 80 yrs old. Am J Med 2010; 123: How should hypertensive elderly patients be managed? Interdisciplinary Approach This management is fostered by behavioral interventions that focus on re enforcement techniques to enhance engagement of elderly individuals in their own care employing a team The team should ideally be composed of clinical pharmacists, nurses, physician assistants, clinical psychologists, and others (as necessary). 5

6 Nonpharmacologic Recommendations Weight reduction DASH eating plan Dietary sodium restriction Increased physical activity Moderation of alcohol consumption Smoking cessation JNC-VII Complete Report 2003 NIH Publication Prior to initiating pharmacotherapy, consider: QOL and cognitive function Age related physiologic changes Other meds the patient may be currently taking Initiation of drug therapy Initial drug should be started at the lowest dose and gradually depending on the BP response to the maximum tolerated dose. If BP response to the ini al drug is inadequate a er reaching full dose, a 2 nd drug from another class should be added, provided the initial drug is tolerated. Initiation of drug therapy If no therapeutic response or significant adverse effects, a drug from another class should be substituted. If a diuretic is not the initial drug, it s usually indicated as the 2 nd drug. If BP response is inadequate a er reaching the full dose of 2 classes of drugs, a 3 rd agent from another class should be added. If BP is >20/10 mm Hg above goal, drug therapy should generally be initiated with 2 agents one of which should be a thiazide diuretic; however, in the elderly, treatment must be individualized. Adjustments to meds should not be made until the following are assessed: Compliance Volume status Drug interactions Other drugs/secondary conditions that can exacerbate HTN Lifestyle factors Adverse effect profile Pseudoresistance Patients 80 yrs, SBP 150 mm Hg may be acceptable for dx HTN and treatment target If SBP <150 mm Hg can be safely achieved: May consider SBP < 140 mm Hg. Also SBP mm Hg is reasonable. If SBP 150 mm Hg with one of the following: -Regimen of 4 drugs -Intolerable adverse -effects -DBP < 65 Lowest safely achieved SBP 150 mm Hg is acceptable 6

7 TG is an 85 y/o male with a long standing h/o HTN. He takes lisinopril/hctz 10 /25 mg daily and his SBP usually ranges between mm Hg and DBP mm Hg. Which BP goal is the most appropriate? 1. < 140/90 mm Hg 2. < 130/80 mm Hg 3. < 120/80 mm Hg 4. His BP measurements are acceptable Which RCT illustrated CV benefits of a thiazide/ace inhibitor combination in an population of 80+ yr old patients with systolic HTN? 1. SHEP Trial 2. HYVET 3. ACCOMPLISH Trial 4. STOP Study KW is an 85 yr female with newly dx HTN. She was started on amlodipine 5 mg /day 6 wks ago. The medical resident wishes to to 10 mg daily for be er control. Prior to changing the dose, what should be considered? 1. Compliance 2. Able to perform lifestyle modifications 3. Other meds that she takes 4. All of the above How Should We ACCOMPLISH Good Blood Pressure Control In Our VETS? Updates in the Management of Hypertension In the Elderly Antoine T. Jenkins, Pharm.D., BCPS Assistant Professor of Pharmacy Practice Chicago State University College of Pharmacy Internal Medicine Pharmacy Specialist Roseland Community Hospital, Chicago, IL 7