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What Is the Optimal Systolic Blood Pressure Goal in Hypertension Therapy?

What Is the Optimal Systolic Blood Pressure Goal in Hypertension Therapy?. William C. Cushman, MD Chief, Preventive Medicine Section, Memphis VA Medical Center Professor, Preventive Medicine, Medicine, and Physiology University of Tennessee Health Science Center. JNC 7: BP Classification.

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What Is the Optimal Systolic Blood Pressure Goal in Hypertension Therapy?

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  1. What Is the Optimal Systolic Blood Pressure Goal in Hypertension Therapy? William C. Cushman, MD Chief, Preventive Medicine Section, Memphis VA Medical Center Professor, Preventive Medicine, Medicine, and Physiology University of Tennessee Health Science Center

  2. JNC 7: BP Classification *Use higher value for classification. Chobanian AV et al. JAMA. 2003;289:2560-2572.

  3. Prevalence of Blood Pressure Categories in US Adults ≥20 Years of Age (NHANES 1999-2000) Greenlund, Croft, Mensah (CDC). Arch Intern Med. 2004;164:2113f

  4. Goal BP for Hypertensive Patients(mm Hg) JNC 7 VA-DoD Most patients <140/90 <140/90 Diabetes <130/80 <140/80 CKD <130/80 <140/90_ CVD (AHA): <130/80

  5. Clinical Epidemiology of Hypertension in the U.S. 1988-2008 ~75 million Americans have HTN 1988-1994 1999-2000 2001-2002 2003-2004 2005-2006 2007-2008 JAMA 2010;303:2043–2050

  6. HTN Control Rates in VA< or ≤ 140/90 mm Hg*FY08 & 09 Target 75% 1999-2009 data from: VA OQP *<140/90 mm Hg in 2003-2007 5% drop (68% to 63%) in 2003 when < 140/90 calculated 6% drop (73% to 67%) in 2004 when < 140/90 calculated

  7. High Blood Pressure and CHD Risk Lancet 2002; 360: 1903–13

  8. High Blood Pressure and Stroke Risk Lancet 2002; 360: 1903–13

  9. Why is it important not to intensify medications to reduce BP below the level proven in trials? Treating to lower BP levels may be harmful (J-curve?)

  10. Incidence of the primary outcome (first occurrence of death, nonfatal MI, or nonfatal stroke) by SBP and DBP strata in INVEST Trial Messerli, F. H. et. al. Ann Intern Med 2006;144:884-893

  11. Why is it important not to intensify medications to reduce BP below the level proven in trials? Treating to lower BP levels may be harmful (J-curve?) If neither beneficial nor harmful Adding unneeded drugs wastes patients’ and payers’ resources and time: More visits, drugs, monitoring, treating AEs More drugs may contribute to reduced adherence to other evidence-based drug treatments (e.g., statins and aspirin)

  12. SHEP Syst-EurSyst-China HYVET Entry SBP 160-219 160-219 160-219 160-199 Goal SBP <148* <150 <150 <150 Baseline 170 174 171 173 Achieved : drug 142 151 151 144 Achieved: placebo 155 161 160 159 Systolic BP in Trials Testing SBP Goals: SHEP, Syst-Eur, Syst-China, HYVET * Integrated SBP goal, personal communication, Barry Davis SBP = systolic blood pressure

  13. What should the SBP treatment goal be in patients with hypertension? • Clinical trial evidence is very consistent for SBP goal <150 mm Hg. • Indirect evidence, mostly from trials with DBP goals, suggest SBP goal <140 mm Hg may be reasonable. • Public health: SBP goal <140 mm Hg has been recommended by many guidelines for several decades.

  14. What should the Systolic BP treatment goal be in patients with diabetes mellitus?

  15. 250 Nondiabetic patients 200 Diabetic patients 150 Cardiovascular MortalityRate per 10,000 Patient-Years 100 50 0 <120 120–139 140–159 160–179 180–199 ³200 SBP (mm Hg) MRFIT Elevated SBP in Type 2 Diabetes Increases Cardiovascular Risk Elevated SBP increases risk of CV death almost twofold in diabetic vs nondiabetic patients Stamler J et al. Diabetes Care. 1993;16:434-444.

  16. ACCORD Double 2 x 2 Factorial Design Lipid BP (Systolic) Placebo Fibrate Intensive <120 mm Hg Standard <140 mm Hg Intensive Glycemic Control 1383 1374 1178 1193 5128 Standard Glycemic Control 1370 1391 1184 1178 5123 2765 2362 2371 10,251 2753 5518 4733*

  17. ACCORD BP Trial Design • Primary BP question: does a therapeutic strategy targeting systolic blood pressure (SBP) <120 mm Hg reduce CVD events compared to a strategy targeting SBP <140 mm Hg in patients with type 2 diabetes at high risk for CVD events? • 4733 participants with type 2 diabetes were randomly assigned to intensive (SBP <120 mm Hg) or standard (SBP <140 mm Hg) therapy. • Mean follow-up: 4.7 years. • 94% power for 20% reduction in primary event rate, assuming standard group rate of 4%/yr and 5.6 yrs follow-up.

  18. Primary outcome -- composite of: Nonfatal MI, nonfatal stroke, CVD death Secondary outcomes: Expanded macrovascular outcome: 1º + any revascularization and hospitalization for HF major CAD events nonfatal MI combined fatal and nonfatal stroke nonfatal stroke total mortality CV mortality HF Primary and Secondary Outcomes for ACCORD BP Trial

  19. ACCORD BP Trial Eligibility • Stable Type 2 Diabetes >3 months • HbA1c 7.5% to 11% (or <9% if on more meds) • High CVD risk = clinical or subclinical disease or ≥2 risk factors • Age (limited to <80 years after Vanguard) • ≥ 40 yrs with history of clinical CVD (secondary prevention) • ≥ 55 yrs otherwise • Systolic blood pressure • 130 to 160 mm Hg (if on 0-3 meds) • 161 to 170 mm Hg (if on 0-2 meds) • 171 to 180 mm Hg (if on 0-1 meds) • Urine protein <1.0 gm/24 hours or equivalent • Serum Creatinine ≤1.5 mg/dl

  20. ACCORD BP Protocol • Many drugs/combinations provided to achieve goal BP according to randomized assignment • Intensive Intervention: • 2-drug therapy initiated: thiazide-type diuretic + ACEI, ARB, or b-blocker • Drugs added and/or titrated at each visit to achieve SBP <120 mm Hg • At periodic “milepost” visits: addition of another drug “required” if not at goal • Standard Intervention: • Intensify therapy if SBP ≥160 mm Hg @ 1 visit or ≥140 mm Hg @ 2 consecutive visits • Down-titration if SBP <130 mm Hg @ 1 visit or <135 mm Hg @ 2 consecutive visits

  21. Baseline Characteristics *Median value

  22. Systolic Pressures (mean + 95% CI) Mean # Meds Intensive: 3.2 3.4 3.5 3.4 Standard: 1.9 2.1 2.2 2.3 Average after 1st year: 133.5 Standard vs. 119.3 Intensive, Delta = 14.2

  23. Medications Prescribed (12 Month Visit)

  24. Adverse Events • † Symptom experienced over past 30 days from HRQL sample of • N=969 participants assessed at 12, 36, and 48 months post-randomization

  25. Primary & Secondary Outcomes Also examined Fatal/Nonfatal HF (HR=0.94, p=0.67), a composite of fatal coronary events, nonfatal MI and unstable angina (HR=0.94, p=0.50) and a composite of the primary outcome, revascularization and unstable angina (HR=0.95, p=0.40)

  26. Nonfatal Stroke Total Stroke HR = 0.63 95% CI (0.41-0.96) P=0.03 HR = 0.59 95% CI (0.39-0.89) P=0.01

  27. Clinical Trials of BP Lowering in Patients with Diabetes: SBP Goals, Mean Achieved SBP, Outcomes

  28. Conclusions • The ACCORD BP trial evaluated the effect of targeting a SBP goal of 120 mm Hg, compared to a goal of 140 mm Hg, in patients with type 2 diabetes at increased cardiovascular risk. • The results provide no conclusive evidence that the intensive BP control strategy reduces the rate of a composite of major CVD events in such patients.

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