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The Relationship of Systolic and Diastolic Blood Pressure to Cardiovascular Disease Risk: Observational Data.

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Presentation on theme: "The Relationship of Systolic and Diastolic Blood Pressure to Cardiovascular Disease Risk: Observational Data."— Presentation transcript:

1 The Relationship of Systolic and Diastolic Blood Pressure to Cardiovascular Disease Risk: Observational Data

2 Prevalence of Hypertension in the US Percent hypertensive Based on NHANES III (phase 1 and 2) Hypertension defined as blood pressure 140/90 mmHg or treatment Age 3 % 9 % 18 % 38 % 51 % 66 % 72 % JNC-VI. Arch Intern Med. 1997;157:

3 Risk of hypertension (%) Residual lifetime risk of developing hypertension among people with blood pressure <140/90 mmHg Years Lifetime Risk of Developing Hypertension Beginning at Age 65 MenWomen Vasan RS, et al. JAMA. 2002; 287: Copyright 2002, American Medical Association.

4 Mortality According to Blood Pressure in Men Age 50 to 69 Society of Actuaries. Blood Pressure Study, Ratio (%) of actual to expected mortality Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg)

5 Age-adjusted annual incidence of CHD per 1000 Based on 30 year follow-up of Framingham Heart Study subjects free of coronary heart disease (CHD) at baseline Systolic blood pressure (mmHg) Blood Pressure and Risk for Coronary Heart Disease in Men Diastolic blood pressure (mmHg) Age Age Age Age Framingham Heart Study, 30-year Follow-up. NHLBI, 1987.

6 Relative risk of CHD mortality He J, et at. Am Heart J. 1999;138: Copyright 1999, Mosby Inc. <112 <71 Risk of CHD Death According to SBP and DBP in MRFIT Decile >151 >98 (lowest 10%)(highest 10%) SBP (mmHg) DBP (mmHg) Systolic blood pressure (SBP) Diastolic blood pressure (DBP) CHD=coronary heart disease

7 Relative risk of stroke death <112 <71 Risk of Stroke Death According to SBP and DBP in MRFIT Decile >151 >98 (lowest 10%)(highest 10%) SBP (mmHg) DBP (mmHg) Systolic blood pressure (SBP) Diastolic blood pressure (DBP) He J, et at. Am Heart J. 1999;138: Copyright 1999, Mosby Inc.

8 Age-adjusted annual CVD event rate per 1000 Wilking SV et al. JAMA. 1988;260: MenWomen Isolated Systolic Hypertension and CVD Risk in Framingham ISH BP 160/<95 mmHg BP <140/95 mmHg CVD=cardiovascular disease ISH=isolated systolic hypertension P<0.001 for difference between both men and women with ISH and blood pressure (BP) <140/95 mmHg

9 The Relationship of Hypertension Treatment to CVD Risk Reduction: Introduction

10 Incidence of cardiovascular disease 120 Hypertension Treatment Effect Mirrors Observational Data Observational Data Treatment Effect Systolic blood pressure (mmHg)

11 Landmark Clinical Trials Hypertension Treatment and Cardiovascular Disease Outcomes 1967 – VA Cooperative Study on DBP – VA Cooperative Study on DBP – HDFP 1980 – Australian Trial, Oslo Trial 1985 – MRC I, EWPHE 1991 – SHEP, STOP-Hypertension 1992 – MRC II in the elderly 1997 – Syst-Eur 2002 – LIFE 2002 – ALLHAT

12 Veterans Administration, 1967 Veterans Administration, 1970 Hypertension Stroke Study, 1974 USPHS Study, 1977 EWPHE Study, 1985 Coope and Warrender, 1986 SHEP Study, 1991 STOP-Hypertension Study, 1991 MRC Study, 1992 Syst-Eur Study, 1997 Total Relative Risk for Coronary Heart Disease Odds ratios and 95% confidence intervals (0.69 to 0.90) He J, et al. Am Heart J. 1999; 138: Copyright 1999, Mosby, Inc. Active treatment better than placebo Active treatment worse than placebo

13 Veterans Administration, 1967 Veterans Administration, 1970 Hypertension Stroke Study, 1974 USPHS Study, 1977 EWPHE Study, 1985 Coope and Warrender, 1986 SHEP Study, 1991 STOP-Hypertension Study, 1991 MRC Study, 1992 Syst-Eur Study, 1997 Total Relative Risk for Stroke (0.55 to 0.72) Odds ratios and 95% confidence intervals Active treatment better than placebo Active treatment worse than placebo He J, et al. Am Heart J. 1999; 138: Copyright 1999, Mosby, Inc.

14 The Veterans Administration Cooperative Study on Antihypertensive Agents

15 The VA Cooperative Study, 1967 Cohort143 men Mean age51 years EligibilityDiastolic BP mmHg DesignDouble blind; placebo control TherapyHCTZ, reserpine, hydralazine Duration1.5 years BP change-43/30 mmHg VA Cooperative Study Group. JAMA. 1967;202: HCTZ=hydrochlorothiazide

16 -1212 The VA Cooperative Study, 1967: Change in Systolic and Diastolic Blood Pressure Change in Systolic BP (mmHg) Percent of patients Change in Diastolic BP (mmHg) Decrease (-)(+) Increase Active drugs Placebo Active drugs Placebo VA Cooperative Study Group. JAMA. 1967;202: Copyright ©1967, American Medical Association Decrease (-)(+) Increase

17 The VA Cooperative Study, 1967: Assessable Morbid/Fatal Events Placebo n=70 Active Rx* n=73 Accelerated hypertension120 Stroke41 Coronary event20 CHF20 Renal damage20 Deaths40 VA Cooperative Study Group. JAMA. 1967;202: *P<0.001 active drug therapy vs placebo

18 The VA Cooperative Study, 1967: Conclusions The actively treated group experienced a reduction in multiple hypertension-related endpoints 21 morbid/fatal events on placebo 1 morbid/fatal event on active therapy VA Cooperative Study Group. JAMA. 1967;202:

19 The VA Cooperative Study, 1970 Cohort380 men Mean age50 years EligibilityDiastolic BP mmHg DesignDouble blind; placebo control TherapyHCTZ, reserpine, hydralazine Duration5.5 years (mean=3.8 yrs) BP changeDiastolic BP -19 mmHg VA Cooperative Study Group. JAMA. 1970;213:

20 Placebo n=194 Active Rx* n=186 Accelerated hypertension40 Stroke205 Total coronary event1311 Fatal coronary event116 Congestive heart failure110 Renal damage30 Deaths198 The VA Cooperative Study, 1970: Assessable Morbid/Fatal Events VA Cooperative Study Group. JAMA. 1970;213: *P<0.001 active drug therapy vs placebo

21 The VA Cooperative Study, 1970: Conclusions Active treatment reduced fatal and nonfatal endpoints A subsequent analysis revealed that benefits were statistically significant only for those with baseline diastolic blood pressure mmHg VA Cooperative Study Group. Circulation. 1972; 45 (5): VA Cooperative Study Group. JAMA. 1970;213:

22 The European Working Party on High Blood Pressure in the Elderly, 1985

23 Cohort840; 30% men Age> 60 yrs old; mean 72 yrs old Eligibility Systolic BP mmHg; diastolic BP mmHg DesignDouble blind; placebo control TherapyHCTZ, triamterene Duration4.7 years BP change-21/10 mmHg at 5 years Amery A, et al. Lancet. 1985;1:

24 Survival free of event (%) Year of follow-up EWPHE Cardiovascular Mortality On-Treatment Analysis Active (n=416) Placebo (n=424) P= Amery A, et al. Lancet. 1985;1: Reprinted with permission from Elsevier Science. EWPHE=European Working Party on High Blood Pressure in the Elderly

25 EWPHE Conclusions Active treatment reduced cardiovascular (CV) mortality, largely due to a reduction in cardiac mortality Older patients (>60 yrs old) with combined systolic and diastolic hypertension who received active therapy experienced 29 fewer CV events and 14 fewer CV deaths per 1,000 patient-years of treatment Amery A, et al. Lancet. 1985;1: EWPHE=European Working Party on High Blood Pressure in the Elderly

26 The Hypertension Detection and Follow-up Program, 1979

27 Cohort10,940; 54% men; 44% black Age 3069 yrs old; mean 50.8 yrs old Eligibility Diastolic BP 90 mmHg DesignStepped Care vs Referred Care TherapyChlorthalidone (reserpine, methyldopa) Duration5 years BP change5 mmHg (Stepped Care vs Referred Care) HDFP Cooperative Group. JAMA. 1979;242:

28 Cumulative mortality (%) 0136 Year of follow-up HDFP Mortality Rates HDFP Mortality Rates Entire Cohort 245 Referred Care Stepped Care HDFP=Hypertension Detection and Follow-up Program *P<0.01 HDFP Cooperative Group. JAMA. 1979;242: (n=5,456) (n=5,485) *

29 Cumulative mortality (%) HDFP Mortality Rates HDFP Mortality Rates Diastolic BP mmHg Referred Care Stepped Care HDFP=Hypertension Detection and Follow-up Program Year of follow-up *P<0.01 HDFP Cooperative Group. JAMA. 1979;242: (n=3,822) (n=3,903) * BP=blood pressure

30 HDFP Conclusions Overall, stepped care (SC) compared to referred care (RC) reduced total mortality by 17% (6.4 vs. 7.7%; P<0.01) In patients with baseline diastolic blood pressure mmHg (n=7,725), mortality was reduced by 20% with SC vs. RC (5.9% vs. 7.4%; P<0.01) Aggressive treatment of SC patients with the lowest baseline diastolic blood pressures (9094 and 9599 mmHg) reduced mortality HDFP=Hypertension Detection and Follow-up Program HDFP Cooperative Group. JAMA. 1979;242:

31 The Systolic Hypertension in the Elderly Program, 1991

32 SHEP Research Group. JAMA. 1991;265: Cohort4,736; 43% men Age 60 yrs old; mean 71.6 yrs old Eligibility Systolic BP mmHg and Diastolic BP <90 mmHg DesignDouble blind; placebo control TherapyChlorthalidone (atenolol as step 2) Duration4.5 years BP changeSystolic BP –12 mmHg BP=blood pressure

33 Change in BP (mmHg) Years SHEP Change in Blood Pressure Placebo (n=2,371) Active Rx (n=2,365) Years Systolic BP Diastolic BP SHEP Research Group. JAMA. 1991;265: Copyright ©1991, American Medical Association. BP=blood pressure SHEP=Systolic Hypertension in the Elderly Program Placebo (n=2,371) Active Rx (n=2,365)

34 Blood pressure (mmHg) Months of follow-up SHEP Average Blood Pressure During Follow-up SHEP=Systolic Hypertension in the Elderly Program SHEP Research Group. JAMA. 1991;265: Copyright ©1991, American Medical Association.

35 Cumulative stroke rate per 100 persons Months of follow-up SHEP Cumulative Stroke Rate P= Placebo (n=2,371) Active Rx (n=2,365) SHEP=Systolic Hypertension in the Elderly Program SHEP Research Group. JAMA. 1991;265: Copyright ©1991, American Medical Association.

36 Relative risk (95% CI) StrokeCHD Active Therapy vs. Placebo CHFDeath CVD 0.75 SHEP Cardiovascular Disease Endpoints SHEP Research Group. JAMA. 1991;265: SHEP=Systolic Hypertension in the Elderly Program CHD=coronary heart disease; CHF=congestive heart failure; CVD=cardiovascular disease

37 SHEP Conclusions SHEP was the first clinical trial to demonstrate that reduction of blood pressure in patients with isolated systolic hypertension reduced cardiovascular (CV) mortality The relative risk of stroke was reduced by 36% with therapy compared to placebo (P=0.0003) The 5-year absolute benefits were a reduction in 30 strokes and 55 major CV disease events per 1,000 persons SHEP Research Group. JAMA. 1991;265: SHEP=Systolic Hypertension in the Elderly Program

38 The Systolic Hypertension in Europe (Syst-Eur) Trial, 1997

39 The Systolic Hypertension in Europe Trial, 1997 Cohort4,695; 67% women Age 60 yrs old Eligibility Systolic BP 160–219 mmHg and diastolic BP <95 mmHg DesignDouble blind; placebo control TherapyNitrendipine (enalapril, HCTZ as Step 2) DurationMedian 2 yrs (1-97 months) BP difference -10/5 mmHg Staessen JA, et al. Lancet. 1997;350:

40 Systolic BP (mmHg) Syst-Eur Mean Sitting Systolic Blood Pressure 0 Placebo (n=2,297) Active treatment (n=2,398) 1234 Years since randomization Staessen JA, et al. Lancet. 1997;350: Reprinted with permission from Elsevier Science. Syst-Eur=Systolic Hypertension in Europe Trial P<0.001

41 Syst-Eur Mean Sitting Diastolic Blood Pressure Diastolic BP (mmHg) Placebo (n=2,297) Active treatment (n=2,398) P<0.001 Years since randomization Staessen JA, et al. Lancet. 1997;350: Reprinted with permission from Elsevier Science. Syst-Eur=Systolic Hypertension in Europe Trial

42 Events per 100 patients Syst-Eur Primary Endpoint Fatal and Nonfatal Stroke Placebo (n=2,297) Active treatment (n=2,398) P=0.003 Years since randomization Staessen JA, et al. Lancet. 1997;350: Reprinted with permission from Elsevier Science. Syst-Eur=Systolic Hypertension in Europe Trial

43 Percentage relative risk reduction (95% CI) StrokeMI Active therapy vs. placebo CHFDeath 42% P= % 31% P< % All CVD 30% Syst-Eur Cardiovascular Disease Endpoints Staessen JA, et al. Lancet. 1997;350: MI=myocardial infarction; CHF=congestive heart failure; CVD=cardiovascular disease Syst-Eur=Systolic Hypertension in Europe Trial

44 Syst-Eur Conclusions Older men and women with isolated systolic hypertension who received active treatment with a dihydropyridine calcium channel blocker experienced fewer strokes and cardiovascular disease (CVD) events than those receiving placebo. Treatment of 1,000 patients for 5 years with this type of regimen could prevent 29 strokes or 53 major CVD endpoints. Staessen JA, et al. Lancet. 1997;350: Syst-Eur=Systolic Hypertension in Europe Trial

45 The Australian National Blood Pressure (ANBP) Study, 1980

46 The Australian National Blood Pressure Study, 1980 The Australian Study Committee. Lancet. 1980;1: Cohort3,427; 80% men Age30–69 yrs old EligibilityDiastolic BP 95–109 mmHg DesignSingle blind; placebo control TherapyChlorothiazide (methyldopa, beta blocker) Duration4 yrs BP difference -6 mmHg

47 The Australian Study Mean Diastolic Blood Pressure Diastolic blood pressure (mmHg) The Australian Study Committee. Lancet. 1980;1:

48 The Australian Study Incidence of Trial Endpoints (TEP)* Intention-to-treat Placebo (n=1,706)Active (n=1,721) No.RateNo.Rate Total Fatal TEP Cardiovascular Non-cardiovascular Non-fatal TEP All TEP *Rates per 1,000 person-years exposure to risk. P<0.05 P<0.025 The Australian Study Committee. Lancet. 1980;1:

49 The Australian Study Intention-to-Treat Trial Endpoints No. of events Placebo n=1,706 Active n=1,721 Ischemic heart disease Fatal115 Nonfatal myocardial infarction2228 Nonfatal other7665 Cerebrovascular events Fatal63 Nonfatal Hemorrhage or thrombosis1610 Transient cerebral ischemic attacks94 Other fatal1817 Other nonfatal106 The Australian Study Committee. Lancet. 1980;1:

50 The Australian Study On-Treatment Trial Endpoints (TEP) Number of trial endpoints Days in trial All TEP P<0.01 All Fatal TEP P<0.05 Active (n=1,721) Placebo (n=1,706) The Australian Study Committee. Lancet. 1980;1: Reprinted with permission from Elsevier Science.

51 The Australian Study Conclusions The actively treated compared to placebo group experienced 30 fewer trial endpoints endpoints (P<0.05) There was a significant reduction in mortality in the actively treated group, mostly due to a reduction in death from cardiovascular disease (P<0.025) The Australian Study Committee. Lancet. 1980;1:


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