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GUIDELINES FOR HYPERTENSION: FRIEND OR FOE? Henry R. Black, M.D RUSH University Medical Center

GUIDELINES FOR HYPERTENSION: FRIEND OR FOE? Henry R. Black, M.D RUSH University Medical Center Chicago, IL Oct. 18, 2005. GUIDELINES. WHY HAVE THEM? Guide ... (ance) by experts … lines (set limits for best practice). GUIDE TO GUIDELINES. Who are they for? Experts Real Imagined

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GUIDELINES FOR HYPERTENSION: FRIEND OR FOE? Henry R. Black, M.D RUSH University Medical Center

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  1. GUIDELINES FOR HYPERTENSION: FRIEND OR FOE? Henry R. Black, M.D RUSH University Medical Center Chicago, IL Oct. 18, 2005

  2. GUIDELINES WHY HAVE THEM? Guide... (ance) by experts …lines (set limits for best practice)

  3. GUIDE TO GUIDELINES • Who are they for? • Experts • Real • Imagined • Generalists • Any providers of care • Lobbyists • Lawyers • Payors • Patients • Journalists

  4. Physiology Pathophysiology Epidemiology Randomized trials Meta-analyses of randomized clinical trials Re-analysis of randomized clinical trials ON-TREATMENT ANALYSIS SERIAL MEDIAN MATCHING Non-randomized trials Meta-analyses of non-randomized clinical trials Re-analysis of non-randomized clinical trials Other non-randomized data Data Bases Outcomes research Clinical Experience Cohort studies Case-control studies Convenience samples GUIDELINES- Where could we get our data from?

  5. Guidelines should be: Easy to understand Easy to use Unbiased Science (“evidence”)-based Innovative within the science base A guide, not a law Guidelines could address: Definitions Stratification and risk benefit Pathophysiology Evaluation Practice strategies Cost and cost/benefit Treatment Lifestyle Drugs Specific populations • Provide a framework not the total picture • (the canvas and the paint brushes)

  6. GUIDE TO GUIDELINES Guidelines could be: • Focused or comprehensive • Local, national or international • Tools of social engineering • A way to translate science to public health

  7. RANDOMIZED CLINICAL TRIALS (RCT) The RCT was the result of a movement to combat • authoritarianism in clinical medicine • unproven claims on therapeutic benefits of new substances • the links of the “authoritarian godfathers” to the companies producing the substances. • Instead of relying on authority, the objective results of the randomized trial would tell us the “truth.” Vandenbroucke, et al., Lancet 175, 352:12, 1998

  8. JNC I JNC III JNC V JNC 7 EarliestGuidelines JNC II JNC IV JNC VI 1972 1973 1976 1980 1984 1988 1993 19972003 34 drugs Diuretics 50 drugs ACEI, CAs added 84 drugs 7 options NHBPEP STARTS 28 drugsDBP 105Diuretics 68 drugs Diuretics/ b-blockers 43 drugs diuretics,b-blockersAdded > 125 drugs Diuretics Development of Hypertension Guidelines: the JNCs and Drug Therapy Low-dose HR Black, 2003.

  9. HOTUKPDS HDFP Syst-EurSyst-China SCOPE CONVINCEALLHAT ANBP2LIFE VALUEASCOTACCOMPLISH VACooperative Studies EWPHE HAPPHYMAPHY MRC-1ANHBP-1 SHEP MRC-2 STOP-1 INSIGHT NORDIL CAPPPSTOP-2 TOMHSVA MONORx Clinical Trials in Hypertension Should we treat ISH in older persons? What is the goal of treatment? Should we treat DBP in older persons? What is the best way to treat HBP? Should we treat diastolic HBP? Can we prevent hypertension? 1960s 1970s 1980s 1990-1995 1996-1999 2000 2001-2003 2004-2008 TROPHY HR Black, 2003.

  10. 1990-1995 1996-1999 2000 2001 2002 2003 2004-2008 SOLVD SAVE I-PRESERVE VAL-HeFT AASK ALLHAT CHARM ASCOT IDNT RENAAL IRMA2 EPHESUSVALIANTINVEST ELITE-2 IDNT RENAAL IRMA2 EPHESUSVALIANT ACCORD DREAM NAVIGATOR CAPTOPRIL UKPDS MARVAL HOPE MARVAL RALES NAVIGATOR SCOPE EUROPA ON-TARGET PROGRESS Clinical Trials in Patients With Disorders Related to Hypertension CVA/ Dementia LVH Heart failure/ Post-MI Renal disease Diabetes Atherosclerosis Dyslipidemia LIFE HR Black, 2003.

  11. RISK STRATIFICATION - JNC VI Risk Group A No risk factors No target organ disease/clinical CVD Risk Group B At least one risk factor, not including diabetes No target organ disease/clinical CVD Risk Group C Target organ disease/clinical CVD and/or diabetes With or without other risk factors

  12. Treatment Strategies and Risk Stratification Blood Pressure Stages (mm Hg) Risk Group A Risk Group B Risk Group C High-normal Lifestyle modification Lifestyle modification Drug therapy*(130-139/85-89) Lifestyle modification Stage 1 Lifestyle modification Lifestyle modification Drug therapy140-159/90-99) (up to 12 months) (up to 6 months)† Lifestyle modification Stages 2 and 3 Drug therapy Drug therapy Drug therapy(>160/>100) Lifestyle modification Lifestyle modification Lifestyle modification *For those with heart failure, renal insufficiency or diabetes. †For those with multiple risk factors, clinicians should consider drugs as initial therapy plus lifestyle modifications.

  13. Begin or continue lifestyle modifications Not at goal BP (<140/90 mm Hg) Initial Drug Choices Uncomplicated Hypertension Compelling Indications Diuretics Type 1 diabetes ISH Beta blockers -ACE inhibitors -Diuretics CHF -LA DHP CCBs -ACE inhibitors MI -Diuretics -Beta blockers -ACE inhibitors Not at goal BP No response or troublesome side effects Inadequate response but well tolerated Substitute another drug fromdifferent class Add second agent from different class(diuretic if not already used) Not at goal BP Continue adding agents from other classes Consider referral to hypertension specialist JNC VI Treatment Algorithm ACE = angiotensin-converting enzyme LA DHP CCBs = long-actingdihydropyridine calcium-channel blockers Adapted from Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1997;157:2413-2446.

  14. Monotherapy is Inadequate in 40%–60% of Hypertensive Patients 80 60 50% response Percent response 40 20 0 Calcium antagonist Alpha2 agonist Beta- blocker Diuretic Alpha1 antagonist ACEI Placebo Response defined as DBP < 95 mm Hg after one year of treatment Materson et al. Am J Hypertens. 1993;8:189-192.

  15. TREATMENT OF HYPERTENSION – JNC VI Not at Goal Blood Pressure Initial Drug Choices Specific Indications Uncomplicated • Compelling Indications • Start at low dose and titrate upward. • Low-dose combinations may be appropriate. Not at Goal Blood Pressure

  16. JNC - VIS.O.C.O. Go For Goal And Don’t Settle For Less S.O.C.O. = Single Overriding Communications Objective

  17. GOAL OF ANTIHYPERTENSIVE THERAPY • <140 mmHg and <90 mmHg • <130 mm Hg and <85 mmHg for diabetics, patients with HF and those with CRF • <125 mmHg and <75 mmHg for those with >1 gram of proteinuria Goal is not dependent on age, gender or co-morbidity

  18. National Heart, Lung, and Blood Institute, NIH, DHHS The National High Blood Pressure Education Program

  19. 14 12 10 8 6 4 2 0 Impact of High-Normal Blood Pressure on the Risk of Cardiovascular Disease: Framingham Study Men Women High normal (130-139/85-89 mm Hg) Normal (120-129/80-84 mm Hg) Optimal (<120/80 mm Hg) High normal (130-139/85-89 mm Hg) Normal (120-129/80-84 mm Hg) Optimal (<120/80 mm Hg) 10 P=0.01 P<0.001 8 6 Cumulative Incidence (%) Cumulative Incidence (%) 4 2 0 0 2 4 6 8 10 12 14 0 2 4 6 8 10 12 14 Time (y) Time (y) Vasan et al. N Engl J Med. 2001;345:1291-1297.

  20. Stroke IHD Age at risk: Age at risk: 256 256 80-89 years 80-89 years 128 128 70-79 years 70-79 years 64 64 60-69 years 60-69 years 32 32 50-59 years 50-59 years 16 16 40-49 years 8 8 4 4 2 2 1 1 0 0 120 140 160 180 120 140 160 180 Usual Systolic BP (mm Hg) Usual Systolic BP (mm Hg) Stroke and IHD Mortality vs Usual Systolic BP by Age Mortality(Floating absolute risk and 95% CI) IHD = ischemic heart disease.Prospective Studies Collaboration. Lancet. 2002;360:1903-1913.

  21. CV Mortality Risk Doubles WithEach 20/10 mm Hg BP Increment* 8 7 6 5 CVmortalityrisk 4 3 2 1 0 115/75 135/85 155/95 175/105 SBP/DBP (mm Hg) CV, cardiovascular; DBP, diastolic blood pressure; SBP, systolic blood pressure. *Individuals aged 40-69 years, starting at BP 115/75 mm Hg. Lewington S et al. Lancet. 2002;360:1903-1913. Chobanian AV et al. JAMA. 2003;289:2560-2572.

  22. BP Reductions as Small as 2 mmHg Reduce the Risk of CV Events by Up to 10% • Meta-analysis of 61 prospective, observational studies • 1 million adults • 12.7 million person-years 7% reduction in risk of IHD mortality 2 mmHg decrease in mean SBP 10% reduction in risk of stroke mortality Prospective Studies Collaboration. Lancet. 2002;360:1903-1913.

  23. Prospective Studies Collaboration “Throughout middle and old age, usual blood pressure is strongly and directly related to vascular (and overall) mortality, without any evidence of a threshold down to at least 115/75 mm Hg.” Lancet 2002; 360:1903

  24. 32% 40% 68% 60% Combination Therapy Needed to Achieve Target Blood Pressure Enrollment Final Monotherapy CombinationTherapy SBP/DBP mm Hg 161/98 142/83 <90 mm Hg <85 mm Hg <80 mm Hg 25% 37% 32% SBP/DBPmm Hg 68% 75% 63% 144/85 142/93 140/81 Adapted from Hansson L et al for the HOT Study Group. Lancet. 1998;351:1755-1762.

  25. Multiple Antihypertensive Agents Are Often Needed to Achieve Target BP No. of Antihypertensive Agents Trial Target BP (mm Hg) 1 2 3 4 UKPDS1 DBP 85 ABCD2 DBP 75 MDRD3 MAP 92 HOT4 DBP 80 AASK5 MAP 92 IDNT6 SBP 135/DBP 85 ALLHAT7 SBP 140/DBP 90 4. Hansson L et al. Lancet. 1998;351:1755-1762.5. Kusek JW et al. Control Clin Trials. 1996;16:40S-46S. 6. Lewis EJ et al. N Engl J Med. 2001;345:851-860. 7. ALLHAT. JAMA. 2002;288:2998-3007. 1. UK Prospective Diabetes Study Group. BMJ. 1998;317:703-713. 2. Estacio RO et al. Am J Cardiol. 1998;82:9R-14R. 3. Lazarus JM et al. Hypertension. 1997;29:641-650.

  26. Events (No.) Risk reduction Favors active Favors placebo Placebo Active (95% CI) Stroke Combination 150 255 43% (30%-54%) 5% (-19%-23%) Single drug 157 165 Total 307 420 28% (17%-38%) Major vascular events Combination 231 367 40% (29%-49%) Single drug 227 237 4% (-15%-20%) Total 458 604 26% (16%-34%) 2.0 1.0 0.5 Hazard ratio PROGRESSCombination (ACEI + Diuretic) lowered BP by12/5 mm Hg Single-drug (ACEI) lowered BP by 5/3 mm Hg) Tests for homogeneity (combination vs single drug): both <0.001. PROGRESS Collaborative Group. Lancet. 2001;358:1033-1041.

  27. ALLHAT Amlodipine 2.5-10 mg (n=9048) Chlorthalidone 12.5-25 mg (n=15,255) Doxazosin 2-8 mg (n=9067) Lisinopril 10-40 mg (n=9054) High-risk hypertensive patients Consent/ Randomize (42,418) Eligible for lipid-lowering Not eligible for lipid-lowering Consent/Randomize (10,355) Pravastatin Usual care Follow for CHD and other outcomes until death or end of study (up to 8 years). Randomized Designof ALLHAT ALLHAT Collaborative Research Group. JAMA. 2002;288:2981-2997. ALLHAT Collaborative Research Group. JAMA. 2000;283:1967-1975.

  28. ALLHAT Biochemical Results – Fasting Glucose – mg/dL *p<.05 compared to chlorthalidone

  29. Study % Higher Incidence in Patients Using Diuretics, β-blockers Antihypertensive Treatments and Incidence of New-onset Diabetes CAPPP diuretics, β-blockers 13% vs captopril CHARM placebo ± SOC 16% vs candesartan ± SOC INVEST atenolol ± HCTZ or 17% vs atenolol ± HCTZ or trandolapril trandolapril INSIGHT co-amilozide ± β-blocker 30% vs nifedipine GITS LIFE atenolol 33% vs losartan ALLHAT chlorthalidone 18% vs amlodipine 43% vs lisinopril HOPE placebo ± SOC 50% vs ramipril ± SOC ALPINE HCTZ ± atenolol 720% vs candesartan ± felodipine Hansson L, et al. Lancet. 1999;353:611-16. Pfeffer MA, et al. Lancet. 2003;362:759-66. Pepine CJ, et al. JAMA. 2003;290:2805-2816. Brown MJ, et al. Lancet. 2000;356:366-72. Dahlof B, et al. Lancet. 2002;359:995-1003. ALLHAT Group. JAMA. 2002;288:2981-97. Yusuf, S, et al. N Engl J Med. 2000;342:145-53. Lindholm LH, et al. J Hypertension. 2003;21:1563-1574.

  30. Nonfatal MI + CHD Death 0.99 (0.87-1.13) All-Cause Mortality 0.96 (0.87-1.07) Stroke 0.90 (0.75 -1.08) Combined CHD 1.04 (0.94-1.14) Combined CVD 1.06 (0.98-1.15) Heart Failure 1.42 (1.23-1.52) ALLHAT Diabetes Patients Amlodipine/Chlorthalidone Relative Risk 0.5 1 2 Favors Amlodipine Favors Chlorthalidone Lisinopril/Chlorthalidone Nonfatal MI + CHD Death 1.00 (0.87-1.14) All-Cause Mortality 1.02 (0.91-1.13) Stroke 1.07 (0.90-1.28) Combined CHD 1.03 (0.93-1.14) Combined CVD 1.08 (1.00-1.17) Heart Failure 1.22 (1.05-1.42) 0.5 1 2 Favors Lisinopril Favors Chlorthalidone JAMA. 2002;288:2981-2997.

  31. Diabetes subgroup analyses Is there a difference in the treatment effect of commonly used blood pressure lowering regimens between patients with and without diabetes?

  32. Diabetes: data

  33. Cause-specific outcomes:Any active (ACE-I, CA or more intensive) compared with less active (placebo or less intensive) regimen BP (mmHg) Favors active Favors less active Trials RR(95%CI) STROKE 0.65 (0.54,0.77) Diabetes -5.0/-3.1 0.75 (0.68,0.84) No diabetes -5.8/-2.7 p homog=0.2 CORONARY HEART DISEASE 0.81 (0.67,0.97) Diabetes -5.0/-3.1 0.86 (0.74,1.00) No diabetes -4.9/-3.0 p homog=0.7 HEART FAILURE Diabetes -4.9/-3.1 0.88 (0.65,1.18) No diabetes -5.2/-3.2 0.87 (0.71,1.07) p homog=0.9 0.25 0.5 1.0 2.0 Risk ratio

  34. Composite outcomes:Any active (ACE-I, CA or more intensive) compared with less active (placebo or less intensive) regimen BP (mmHg) Favors active Favors less active RR(95%CI) Trials MAJOR CARDIOVASCULAR EVENTS Diabetes -4.9/-3.1 0.78 (0.68,0.89) No diabetes -5.2/-3.2 0.86 (0.78,0.95) p homog=0.3 CARDIOVASCULAR DEATHS 0.68 (0.56,0.83) Diabetes -4.9/-3.1 No diabetes -5.3/-3.2 0.92 (0.76,1.12) p homog=0.03 TOTAL MORTALITY 0.75 (0.67,0.85) Diabetes -4.9/-3.1 0.99 (0.91,1.07) No diabetes -5.2/-3.2 p homog<0.001 0.25 0.5 1.0 2.0 Risk ratio

  35. Stroke BP (mmHg) Favors first listed Favors second listed RR(95%CI) ACE-I vs. D/BB 1.02 (0.88,1.19) 2.2/0.3 Diabetes 1.11 (0.96,1.29) 1.4/0.2 No diabetes p homog =0.49 Overall CA vs. D/BB 0.7/-0.8 0.94 (0.81,1.09) Diabetes 1.1/-0.4 0.92 (0.83,1.01) No diabetes p homog =0.84 Overall ACE-I vs. CA 1.6/1.2 1.09 (0.88,1.36) Diabetes 1.12 (0.92,1.35) 1.3/0.9 No diabetes p homog =0.88 Overall 0.25 0.5 1 2 Risk ratio

  36. CHD BP (mmHg) Favors first listed Favors second listed RR(95%CI) ACE-I vs. D/BB 2.2/0.3 0.83 (0.62,1.12) Diabetes 1.5/0.2 0.98 (0.88,1.09) No diabetes p homog =0.33 Overall CA vs. D/BB 0.7/-0.8 1.00 (0.88,1.13) Diabetes 1.1/-0.4 1.01 (0.93,1.10) No diabetes p homog =0.86 Overall ACE-I vs. CA 1.6/1.2 0.76 (0.51,1.12) Diabetes 1.3/0.9 0.98 (0.84,1.15) No diabetes p homog =0.22 Overall 0.25 0.5 1 2 Risk ratio

  37. Heart Failure BP (mmHg) Favors first listed Favors second listed RR(95%CI) ACE-I vs. D/BB 2.5/0.4 0.94 (0.55,1.59) Diabetes 1.8/0.3 1.09 (0.95,1.25) No diabetes p homog =0.59 Overall CA vs. D/BB 0.5/-0.8 1.27 (1.01,1.61) Diabetes 0.5/-0.5 1.33 (1.16,1.52) No diabetes p homog =0.83 Overall ACE-I vs. CA 1.6/1.2 0.92 (0.67,1.27) Diabetes 1.3/0.9 0.86 (0.73,1.01) No diabetes p homog =0.67 Overall 0.25 0.5 1 2 Risk ratio

  38. Major CVD BP (mmHg) Favors first listed Favors second listed RR(95%CI) ACE-I vs. D/BB 2.2/0.3 0.90 (0.74,1.11) Diabetes 1.4/0.2 1.04 (0.98,1.04) No diabetes p homog =0.20 Overall CA vs. D/BB 0.7/-0.8 1.02 (0.95,1.10) Diabetes 1.1/-0.4 1.04 (0.99,1.10) No diabetes p homog =0.83 Overall ACE-I vs. CA 1.6/1.2 0.92 (0.79,1.07) Diabetes 1.3/0.9 0.99 (0.92,1.07) No diabetes p homog =0.37 Overall 0.25 0.5 1 2 Risk ratio

  39. DEFINITION OF THE METABOLIC SYNDROME – ALLHAT Non diabetic patients Any three of more of the following: • Hypertension (present in all) • Fasting glucoe of 100-125 • BMI > 30 kg/m2 • Fasting TG > 150 mg/dl • HDL-C < 40 mg/dl in men; < 50 mg/dl in women

  40. ALLHAT Baseline Characteristics - Participants* With and Without MetS *Randomized to chlorthalidone, amlodipine, or lisinopril. ** p<0.05

  41. ALLHAT 14 14 12 12 10 10 8 8 Cumulative CHD Event Rate, % 6 6 4 4 2 2 0 0 0 1 2 3 4 5 6 0 1 2 3 4 5 6 Years to CHD CHD by Treatment Group In Participants With MetS at Baseline Chlorthalidone Amlodipine Lisinopril

  42. ALLHAT 14 12 10 8 Cumulative CHD Event Rate, % 6 4 2 0 0 1 2 3 4 5 6 Years toCHD CHD by Treatment Group In Participants Without MetS at Baseline Chlorthalidone Amlodipine Lisinopril

  43. ALLHAT % New DM in ALLHAT Participants

  44. ALLHAT .1 .08 .06 Cumulative Stroke Rate .04 .02 0 0 1 2 3 4 5 6 7 Years to Stroke Cumulative Event Rates for Stroke by ALLHAT Treatment Group Chlorthalidone Amlodipine Lisinopril

  45. ALLHAT Total 1.15 (1.02, 1.30) Total 0.93 (0.82, 1.06) Age < 65 1.21 (0.97, 1.52) Age < 65 0.93 (0.73, 1.19) Age >= 65 1.13 (0.98, 1.30) Age >= 65 0.93 (0.81, 1.08) Men 1.10 (0.94, 1.29) Men 1.00 (0.85, 1.18) Women 1.22 (1.01, 1.46) Women 0.84 (0.69, 1.03) Black 1.40 (1.17, 1.68) Black 0.93 (0.76, 1.14) Non-Black 1.00 (0.85, 1.17) Non-Black 0.93 (0.79, 1.10) Diabetic 1.07 (0.90, 1.28) Diabetic 0.90 (0.75, 1.08) Non-Diabetic 1.23 (1.05, 1.44) Non-Diabetic 0.96 (0.81, 1.14) 0.50 1 2 0.50 1 2 LisinoprilBetterChlorthalidone Better AmlodipineBetter ChlorthalidoneBetter Stroke – Subgroup Comparisons – RR (95% CI) P = .01 for interaction

  46. ALLHAT Compared to chlorthalidone: SBP significantly higher in the amlodipine group (~1 mm Hg) and the lisinopril group (~2 mm Hg). Compared to chlorthalidone: DBP significantly lower in the amlodipine group (~1 mm Hg). BP Results by Treatment Group

  47. Without Compelling Indications With Compelling Indications Drug(s) for the compelling indications Other antihypertensive drugs (diuretics, ACEI, ARB, BB, CCB) as needed. Stage 1 Hypertension(SBP 140–159 or DBP 90–99 mmHg) Thiazide-type diuretics for most. May consider ACEI, ARB, BB, CCB, or combination. Stage 2 Hypertension (SBP >160 or DBP >100 mmHg) 2-drug combination for most (usually thiazide-type diuretic and ACEI, or ARB, or BB, or CCB) Not at Goal Blood Pressure Optimize dosages or add additional drugs until goal blood pressure is achieved.Consider consultation with hypertension specialist. Algorithm for Treatment of Hypertension Lifestyle Modifications Not at Goal Blood Pressure (<140/90 mmHg) (<130/80 mmHg for those with diabetes or chronic kidney disease) Initial Drug Choices

  48. Thiazide, BB, ACEI, ARB, Aldosterone antagonist ACC/AHA Heart Failure Guideline,MERIT-HF, COPERNICUS, CIBIS, SOLVD, AIRE, TRACE, Val-HeFT, RALES, CHARM Heart failure Post-MI BB, ACEI, Aldosterone antagonist, CCB ACC/AHA Post-MI Guideline, BHAT, SAVE, CAPRICORN, EPHESUS,INVEST High CAD risk ALLHAT, HOPE, ANBP2, LIFE, CONVINCE Thiazide, BB, ACE, CCB Compelling Indications for Individual Drug Classes Compelling Indication Initial Therapy Options Clinical Trial Basis Chobanian AV, et al. JAMA. 2003;289:2560-2572.

  49. NKF-ADA Guideline,UKPDS, ALLHAT Diabetes Thiazide, BB, ACEI, ARB, CCB Chronic Kidney Disease ACEI, ARB NKF Guideline, Captopril Trial, RENAAL, IDNT, REIN, AASK PROGRESS Recurrent Stroke Prevention Thiazide and ACEI Metabolic Syndrome ??????? ALLHAT Compelling Indications for Individual Drug Classes (continued) Compelling Indication Initial Therapy Options Clinical Trial Basis Chobanian AV, et al. JAMA. 2003;289:2560-2572.

  50. GOAL OF ANTIHYPERTENSIVE THERAPY • < 140 mm Hg and < 90 mm Hg • < 130 mm Hg and < 80 mm Hg (or maybe still lower) for diabetics, patients with HF and those with CRF • < 125 mm Hg and < 75 mm Hg for those with > 1 gram of proteinuria Goal is not dependent on age, gender or co-morbidity

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