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June 26, 1991, Vol 265, No. 24 >
ARTICLE | June 26, 1991

Prevention of Stroke by Antihypertensive Drug Treatment in Older Persons With Isolated Systolic Hypertension: Title and subTitle BreakFinal Results of the Systolic Hypertension in the Elderly Program (SHEP) FREE

[+] Author Affiliations

See the end of the article for a list of the principal investigators of the Systolic Hypertension in the Elderly Program.

Reprint requests to Clinical Trials Branch, Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute, Federal Building, Room 5C-10B, 7550 Wisconsin Ave, Bethesda, MD 20892 (Dr Jeffrey L. Probstfield).


JAMA. 1991;265(24):3255-3264. doi:10.1001/jama.1991.03460240051027
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Article
References

Objective.—  To assess the ability of antihypertensive drug treatment to reduce the risk of nonfatal and fatal (total) stroke in isolated systolic hypertension.

Design.—  Multicenter, randomized, double-blind, placebo-controlled.

Setting.—  Community-based ambulatory population in tertiary care centers.

Participants.—  4736 persons (1.06%) from 447 921 screenees aged 60 years and above were randomized (2365 to active treatment, 2371 to placebo). Systolic blood pressure ranged from 160 to 219 mm Hg and diastolic blood pressure was less than 90 mm Hg. Of the participants, 3161 were not receiving antihypertensive medication at initial contact, and 1575 were. The average systolic blood pressure was 170 mm Hg; average diastolic blood pressure, 77 mm Hg. The mean age was 72 years, 57% were women, and 14% were black.

Interventions.—  Participants were stratified by clinical center and by antihypertensive medication status at initial contact. For step 1 of the trial, dose 1 was chlorthalidone, 12.5 mg/d, or matching placebo; dose 2 was 25 mg/d. For step 2, dose 1 was atenolol, 25 mg/d, or matching placebo; dose 2 was 50 mg/d.

Main Outcome Measures.—  Primary.—Nonfatal and fatal (total) stroke. Secondary.— Cardiovascular and coronary morbidity and mortality, all-cause mortality, and quality of life measures.

Results.—  Average follow-up was 4.5 years. The 5-year average systolic blood pressure was 155 mm Hg for the placebo group and 143 mm Hg for the active treatment group, and the 5-year average diastolic blood pressure was 72 and 68 mm Hg, respectively. The 5-year incidence of total stroke was 5.2 per 100 participants for active treatment and 8.2 per 100 for placebo. The relative risk by proportional hazards regression analysis was 0.64 (P=.0003). For the secondary end point of clinical nonfatal myocardial infarction plus coronary death, the relative risk was 0.73. Major cardiovascular events were reduced (relative risk, 0.68). For deaths from all causes, the relative risk was 0.87.

Conclusion.—  In persons aged 60 years and over with isolated systolic hypertension, antihypertensive stepped-care drug treatment with low-dose chlorthalidone as step 1 medication reduced the incidence of total stroke by 36%, with 5-year absolute benefit of 30 events per 1000 participants. Major cardiovascular events were reduced, with 5-year absolute benefit of 55 events per 1000. (JAMA. 1991;265:3255-3264)

REFERENCES

1 +
The Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group.  Rationale and design of a randomized clinical trial on prevention of stroke in isolated systolic hypertension . J Clin Epidemiol. 1988;;41:1197-1208.
2 +
Veterans Administration Cooperative Study Group on Antihypertensive Agents.  Effects of treatment on morbidity in hypertension: results in patients with diastolic blood pressure averaging 115 through 129 mm Hg . JAMA. 1967;;202:1028-1034.
3 +
Veterans Admistration Cooperative Study Group on Antihypertensive Agents.  Effects of treatment on morbidity in hypertension, II: results in patients with diastolic blood pressure averaging 90 through 114 mm Hg . JAMA. 1970;;213:1143-1152.
4 +
Wolff FW, Lindeman RD.  Effects of treatment in hypertension: results of a controlled study . J Chronic Dis. 1966;;19:227-240.
5 +
US Public Health Service Hospitals Cooperative Study Group.  Treatment of mild hypertension: results of a 10 year intervention trial . Circ Res. 1977;;40( (suppl 1) ):98-105.
6 +
Veterans Administration/National Heart, Lung, and Blood Institute Study Group for Cooperative Studies on Antihypertensive Therapy: Mild Hypertension.  Treatment of mild hypertension: preliminary results of a 2-year feasibility trial . Circ Res. 1977;;40( (suppl 1) ):180-187.
7 +
Veterans Administration/National Heart, Lung,and Blood Institute Study Group for Evaluating Treatment in Mild Hypertension.  Evaluation of drug treatment in mild hypertension: VANHLBI feasibility trial . Ann NY Acad Sci. 1978;; 304:267-288.
8 +
Hypertension Detection and Follow-up Program Cooperative Group.  Five-year findings of the Hypertension Detection and Follow-up Program, I: reduction in mortality in persons with high blood pressure, including mild hypertension . JAMA. 1979;;242:2562-2571.
9 +
Hypertension Detection and Follow-up Program Cooperative Group.  Five-year findings of the Hypertension Detection and Follow-up Program, II: mortality by race-sex and age . JAMA. 1979;;242:2572-2576.
10 +
Hypertension Detection and Follow-up Program Cooperative Group.  Five-year findings of the Hypertension Detection and Follow-up Program, III: reduction in stroke incidence among persons with high blood pressure . JAMA. 1982;;247: 633-638.
11 +
Hypertension Detection and Follow-up Program Cooperative Group.  The effect of treatment on mortality in 'mild' hypertension . N Engl J Med. 1982;;7:976-980.
12 +
Hypertension Detection and Follow-up Program Cooperative Group.  Effect of stepped care on the incidence of myocardial infarction and angina pectoris . Hypertension. 1984;;6( (suppl 1) ):198-206.
13 +
Helgeland A.  Treatment of mild hypertension: a 5-year controlled drug trial: the Oslo Study . Am J Med. 1980;;69:725-732.
14 +
Leren P, Helgeland A.  Oslo hypertension study . Drugs. 1986;;31( (suppl 1) ):41-45.
15 +
Australian National Blood Pressure Management Committee.  The Australian therapeutic trial in mild hypertension . Lancet. 1980;;1:1261-1267.
16 +
Medical Research Council Working Party.  MRC trial of treatment of mild hypertension principal results . BMJ. 1985;;291:97-104.
17 +
Hypertension-Stroke Cooperative Study Group.  Effect of antihypertensive treatment on stroke recurrence . JAMA. 1974;;229:409-418.
18 +
Barraclough M, Bainton 0, Cochrane AL, et al.  Control of moderately raised blood pressure: report of a cooperative randomized controlled trial . BMJ. 1973;;3:434-436.
19 +
Amery A, Birkenhager W, Brixko P, et al.  Mortality and morbidity results from the European Working Party on High Blood Pressure in the Elderly trial . Lancet. 1985;;1:1349-1354.
20 +
Coope J, Warrender TS.  Randomized trial of treatment of hypertension in the elderly in primary care . BMJ 1986;;293:1145-1151.
21 +
Carter AB.  Hypotensive therapy in stroke survivors . Lancet. 1970;;1:485-489.
22 +
Garland C, Barrett-Connor E, Suarez L, Criqui MH.  Isolated systolic hypertension and mortality after age 60 years . Am J Epidemiol. 1983;;118: 365-376.
23 +
Probstfield JL, Furberg CD.  Systolic hypertension in the elderly: controlled or uncontrolled . In: Frohlich ED, ed. Preventive Aspects of Coronary Heart Disease . Philadelphia, Pa: FA Davis Co Publishers; 1990;:65-84.
24 +
Colandrea MA, Friedman GD, Nichaman MZ, Lynd CN.  Systolic hypertension in the elderly: an epidemiologic assessment . Circulation. 1970;;41: 239-245.
25 +
Shekelle RB, Ostfeld AM, Klawans HL.  Hypertension and risk of stroke in an elderly population . Stroke. 1974;;5:71-75.
26 +
Dyer AR, Stamler J, Shekelle RB, Schoenberger JA, Farinaro E.  Hypertension in the elderly . Med Clin North Am. 1977;;61:513-529.
27 +
Rutan GH, Kuller LH, Neaton JD, Wentworth DN, McDonald RH, Smith WM.  Mortality associated with diastolic hypertension and isolated systolic hypertension among men screened for the Multiple Risk Factor Intervention Trial . Circulation. 1988;;77:504-514.
28 +
Stamler J, Neaton JD, Wentworth D.  Blood pressure (systolic and diastolic) and risk of fatal coronary heart disease . Hypertension. 1989;;13( (suppl I) ):2-12.
29 +
Hulley SB, Furberg CD, Gurland B, et al.  Systolic Hypertension in the Elderly Program (SHEP): antihypertensive efficacy of chlorthalidone . Am J Cardiol. 1985;;56:913-920.
30 +
Borhani NO, Applegate WB, Cutler JA, et al.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample, I: rationale and design . Hypertension. 1991;;17( (suppl II) ):2-15.
31 +
Black HR, Curb JD, Pressel S, Probstfield JL, Stamler J, eds.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample . Hypertension. 1991;;17( (suppl II) ):1-171.
32 +
Wittes J, Davis B, Berge K, et al.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample, X: analysis . Hypertension. 1991;;17( (suppl II) ):162-167.
33 +
Petrovitch H, Byington R, Bailey G, et al.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample, II: screening and recruitment . Hypertension . 1991;;17( (suppl II) ):16-23.
34 +
Labarthe DR, Blaufox MD, Smith WM, et al.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample, V: baseline blood pressure and pulse rate measurements . Hypertension. 1991;;17( (suppl II) ): 62-76.
35 +
Weiler PG, Camel GH, Chiappini M, et al.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample, IX: behavioral characteristics . Hypertension. 1991;;17( (suppl II) ):152-161.
36 +
Gurland B, Golden RR, Teresi JA, Challop J:  The SHORT-CARE: an efficient instrument for the assessment of depression, dementia and disability . J Gerontol. 1984;;39:166-169.
37 +
SHEP Manual of Operations . Revised ed. Houston, Tex: University of Texas School of Public Health; 1990;.
38 +
American Psychiatric Association, Committee on Nomenclature and Statistics. Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition . Washington, DC: American Psychiatric Association; 1987;.
39 +
Mantel N.  Evaluation of survival data and two new rank order statistics arising in its consideration . Cancer Chemother Rep. 1966;;50:163-170.
40 +
Cox DR.  Regression models and life tables . J R Stat Soc B. 1972;;34:187-220.
41 +
Lan KKG, Wittes J.  The B-value: a tool for monitoring data . Biometrics. 1988;;44:579-585.
42 +
Davis BR, Hardy RJ.  Upper bound for type I error and type II error rates in conditional power calculations . Commun Stat . 1990;;19:3571-3584.
43 +
Hypertension Detection and Follow-up Program Cooperative Research Group.  Mortality findings for stepped-care and referred-care participants in the Hypertension Detection and Follow-up Program, stratified by other risk factors . Prev Med . 1985;;14:312-335.
44 +
Perry HM Jr. Smith WM, McDonald RH, et al.  Morbidity and mortality in the Systolic Hypertension in the Elderly Program (SHEP) Pilot Study . Stroke . 1989;;20:4-13.
45 +
Collins R, Peto R, MacMahon S, et al.  Blood pressure, stroke and coronary heart disease, II: short-term reductions in blood pressure: overview of randomised drug trials in their epidemiological context . Lancet . 1990;;335:827-838.
46 +
The Multiple Risk Factor Intervention Trial Research Group.  Relationship among baseline resting ECG abnormalities, antihypertensive treatment and mortality in the Multiple Risk Factor Intervention Trial . Am J Cardiol. 1985;;55:1-15.
47 +
Multiple Risk Factor Intervention Trial Research Group.  Mortality after 10 1/2 years for hypertensive participants in the Multiple Risk Factor Intervention Trial . Circulation. 1990;;82:1616-1628.
48 +
Joint National Committee.  The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure . Arch Intern Med. 1988;;148:1023-1038.
49 +
Drug Topics Red Book . Oradell, NJ: Medical Economics Books; 1990;.
50 +
Kostis JB, Prineas R, Curb JD, et al.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample, VIII: electrocardiographic characteristics . Hypertension. 1991;;17( (suppl II) ):123-151.
51 +
Prineas RJ, Crow RS, Blackburn H. The Minnesota Code Manual of Electrocardiographic Findings: Standards and Procedures for Measurement and Classification . Littleton, Mass: John Wright-PSG Inc; 1982;.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
The Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group.  Rationale and design of a randomized clinical trial on prevention of stroke in isolated systolic hypertension . J Clin Epidemiol. 1988;;41:1197-1208.
2 +
Veterans Administration Cooperative Study Group on Antihypertensive Agents.  Effects of treatment on morbidity in hypertension: results in patients with diastolic blood pressure averaging 115 through 129 mm Hg . JAMA. 1967;;202:1028-1034.
3 +
Veterans Admistration Cooperative Study Group on Antihypertensive Agents.  Effects of treatment on morbidity in hypertension, II: results in patients with diastolic blood pressure averaging 90 through 114 mm Hg . JAMA. 1970;;213:1143-1152.
4 +
Wolff FW, Lindeman RD.  Effects of treatment in hypertension: results of a controlled study . J Chronic Dis. 1966;;19:227-240.
5 +
US Public Health Service Hospitals Cooperative Study Group.  Treatment of mild hypertension: results of a 10 year intervention trial . Circ Res. 1977;;40( (suppl 1) ):98-105.
6 +
Veterans Administration/National Heart, Lung, and Blood Institute Study Group for Cooperative Studies on Antihypertensive Therapy: Mild Hypertension.  Treatment of mild hypertension: preliminary results of a 2-year feasibility trial . Circ Res. 1977;;40( (suppl 1) ):180-187.
7 +
Veterans Administration/National Heart, Lung,and Blood Institute Study Group for Evaluating Treatment in Mild Hypertension.  Evaluation of drug treatment in mild hypertension: VANHLBI feasibility trial . Ann NY Acad Sci. 1978;; 304:267-288.
8 +
Hypertension Detection and Follow-up Program Cooperative Group.  Five-year findings of the Hypertension Detection and Follow-up Program, I: reduction in mortality in persons with high blood pressure, including mild hypertension . JAMA. 1979;;242:2562-2571.
9 +
Hypertension Detection and Follow-up Program Cooperative Group.  Five-year findings of the Hypertension Detection and Follow-up Program, II: mortality by race-sex and age . JAMA. 1979;;242:2572-2576.
10 +
Hypertension Detection and Follow-up Program Cooperative Group.  Five-year findings of the Hypertension Detection and Follow-up Program, III: reduction in stroke incidence among persons with high blood pressure . JAMA. 1982;;247: 633-638.
11 +
Hypertension Detection and Follow-up Program Cooperative Group.  The effect of treatment on mortality in 'mild' hypertension . N Engl J Med. 1982;;7:976-980.
12 +
Hypertension Detection and Follow-up Program Cooperative Group.  Effect of stepped care on the incidence of myocardial infarction and angina pectoris . Hypertension. 1984;;6( (suppl 1) ):198-206.
13 +
Helgeland A.  Treatment of mild hypertension: a 5-year controlled drug trial: the Oslo Study . Am J Med. 1980;;69:725-732.
14 +
Leren P, Helgeland A.  Oslo hypertension study . Drugs. 1986;;31( (suppl 1) ):41-45.
15 +
Australian National Blood Pressure Management Committee.  The Australian therapeutic trial in mild hypertension . Lancet. 1980;;1:1261-1267.
16 +
Medical Research Council Working Party.  MRC trial of treatment of mild hypertension principal results . BMJ. 1985;;291:97-104.
17 +
Hypertension-Stroke Cooperative Study Group.  Effect of antihypertensive treatment on stroke recurrence . JAMA. 1974;;229:409-418.
18 +
Barraclough M, Bainton 0, Cochrane AL, et al.  Control of moderately raised blood pressure: report of a cooperative randomized controlled trial . BMJ. 1973;;3:434-436.
19 +
Amery A, Birkenhager W, Brixko P, et al.  Mortality and morbidity results from the European Working Party on High Blood Pressure in the Elderly trial . Lancet. 1985;;1:1349-1354.
20 +
Coope J, Warrender TS.  Randomized trial of treatment of hypertension in the elderly in primary care . BMJ 1986;;293:1145-1151.
21 +
Carter AB.  Hypotensive therapy in stroke survivors . Lancet. 1970;;1:485-489.
22 +
Garland C, Barrett-Connor E, Suarez L, Criqui MH.  Isolated systolic hypertension and mortality after age 60 years . Am J Epidemiol. 1983;;118: 365-376.
23 +
Probstfield JL, Furberg CD.  Systolic hypertension in the elderly: controlled or uncontrolled . In: Frohlich ED, ed. Preventive Aspects of Coronary Heart Disease . Philadelphia, Pa: FA Davis Co Publishers; 1990;:65-84.
24 +
Colandrea MA, Friedman GD, Nichaman MZ, Lynd CN.  Systolic hypertension in the elderly: an epidemiologic assessment . Circulation. 1970;;41: 239-245.
25 +
Shekelle RB, Ostfeld AM, Klawans HL.  Hypertension and risk of stroke in an elderly population . Stroke. 1974;;5:71-75.
26 +
Dyer AR, Stamler J, Shekelle RB, Schoenberger JA, Farinaro E.  Hypertension in the elderly . Med Clin North Am. 1977;;61:513-529.
27 +
Rutan GH, Kuller LH, Neaton JD, Wentworth DN, McDonald RH, Smith WM.  Mortality associated with diastolic hypertension and isolated systolic hypertension among men screened for the Multiple Risk Factor Intervention Trial . Circulation. 1988;;77:504-514.
28 +
Stamler J, Neaton JD, Wentworth D.  Blood pressure (systolic and diastolic) and risk of fatal coronary heart disease . Hypertension. 1989;;13( (suppl I) ):2-12.
29 +
Hulley SB, Furberg CD, Gurland B, et al.  Systolic Hypertension in the Elderly Program (SHEP): antihypertensive efficacy of chlorthalidone . Am J Cardiol. 1985;;56:913-920.
30 +
Borhani NO, Applegate WB, Cutler JA, et al.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample, I: rationale and design . Hypertension. 1991;;17( (suppl II) ):2-15.
31 +
Black HR, Curb JD, Pressel S, Probstfield JL, Stamler J, eds.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample . Hypertension. 1991;;17( (suppl II) ):1-171.
32 +
Wittes J, Davis B, Berge K, et al.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample, X: analysis . Hypertension. 1991;;17( (suppl II) ):162-167.
33 +
Petrovitch H, Byington R, Bailey G, et al.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample, II: screening and recruitment . Hypertension . 1991;;17( (suppl II) ):16-23.
34 +
Labarthe DR, Blaufox MD, Smith WM, et al.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample, V: baseline blood pressure and pulse rate measurements . Hypertension. 1991;;17( (suppl II) ): 62-76.
35 +
Weiler PG, Camel GH, Chiappini M, et al.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample, IX: behavioral characteristics . Hypertension. 1991;;17( (suppl II) ):152-161.
36 +
Gurland B, Golden RR, Teresi JA, Challop J:  The SHORT-CARE: an efficient instrument for the assessment of depression, dementia and disability . J Gerontol. 1984;;39:166-169.
37 +
SHEP Manual of Operations . Revised ed. Houston, Tex: University of Texas School of Public Health; 1990;.
38 +
American Psychiatric Association, Committee on Nomenclature and Statistics. Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition . Washington, DC: American Psychiatric Association; 1987;.
39 +
Mantel N.  Evaluation of survival data and two new rank order statistics arising in its consideration . Cancer Chemother Rep. 1966;;50:163-170.
40 +
Cox DR.  Regression models and life tables . J R Stat Soc B. 1972;;34:187-220.
41 +
Lan KKG, Wittes J.  The B-value: a tool for monitoring data . Biometrics. 1988;;44:579-585.
42 +
Davis BR, Hardy RJ.  Upper bound for type I error and type II error rates in conditional power calculations . Commun Stat . 1990;;19:3571-3584.
43 +
Hypertension Detection and Follow-up Program Cooperative Research Group.  Mortality findings for stepped-care and referred-care participants in the Hypertension Detection and Follow-up Program, stratified by other risk factors . Prev Med . 1985;;14:312-335.
44 +
Perry HM Jr. Smith WM, McDonald RH, et al.  Morbidity and mortality in the Systolic Hypertension in the Elderly Program (SHEP) Pilot Study . Stroke . 1989;;20:4-13.
45 +
Collins R, Peto R, MacMahon S, et al.  Blood pressure, stroke and coronary heart disease, II: short-term reductions in blood pressure: overview of randomised drug trials in their epidemiological context . Lancet . 1990;;335:827-838.
46 +
The Multiple Risk Factor Intervention Trial Research Group.  Relationship among baseline resting ECG abnormalities, antihypertensive treatment and mortality in the Multiple Risk Factor Intervention Trial . Am J Cardiol. 1985;;55:1-15.
47 +
Multiple Risk Factor Intervention Trial Research Group.  Mortality after 10 1/2 years for hypertensive participants in the Multiple Risk Factor Intervention Trial . Circulation. 1990;;82:1616-1628.
48 +
Joint National Committee.  The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure . Arch Intern Med. 1988;;148:1023-1038.
49 +
Drug Topics Red Book . Oradell, NJ: Medical Economics Books; 1990;.
50 +
Kostis JB, Prineas R, Curb JD, et al.  Systolic Hypertension in the Elderly Program (SHEP): baseline characteristics of the randomized sample, VIII: electrocardiographic characteristics . Hypertension. 1991;;17( (suppl II) ):123-151.
51 +
Prineas RJ, Crow RS, Blackburn H. The Minnesota Code Manual of Electrocardiographic Findings: Standards and Procedures for Measurement and Classification . Littleton, Mass: John Wright-PSG Inc; 1982;.

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