ALLHAT Study Overview: CHD Coronary Heart Disease MI Myocardial Infarction

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial
ALLHAT study overview

Double-blind, randomized trial to determine whether the occurrence of fatal CHD or nonfatal MI is lower for high-risk hypertensive patients treated with newer agents (amlodipine, lisinopril, or doxazosin) compared with a diuretic (chlorthalidone)
Cohort
42,418 patients (55 years old) from 623 sites in North America Stage 1 or 2 hypertension 1 additional risk factor for CHD Comparisons between chlorthalidone and amlodipine and chlorthalidone and lisinopril have been reported together, excluding the doxazosin arm (n=9,062), which was terminated early
CHD=coronary heart disease; MI=myocardial infarction ALLHAT Research Group. JAMA. 2002;288:2981-2997.
www.hypertensiononline.org
ALLHAT Study Design

Doxazosin n=9,062
Discontinued early at 3.3 yrs
Randomized n=42,418 Amlodipine n=9,048

1,357 (16.5%) stopped drug
Chlorthalidone n=15,255 YEAR 1

Lisinopril n=9,054
n=13,854
n=8,215
n=8,158
YEAR 5
Intent-toTreat Analysis
n=6,210
n=3,769
n=3,605
339 (2.2%) lost to follow-up 80 (0.5%) refused follow-up
n=15,255
n=9,048
n=9,054
ALLHAT Research Group. JAMA. 2002;288:2981-2997.
ALLHAT Endpoints
Primary endpoint Composite of fatal coronary heart disease (CHD) or nonfatal myocardial infarction (MI) Other predefined endpoints all-cause mortality stroke combined CHD nonfatal MI, CHD death, coronary revascularization, hospitalized angina combined cardiovascular disease combined CHD, stroke, lower extremity revascularization, treated angina, fatal/ hospitalized/treated congestive heart failure, hospitalized or outpatient peripheral arterial disease other renal
ALLHAT Baseline Characteristics

Chlorthalidone n=15,255
Mean BP (mmHg) Treated (90%) Untreated (10%) Mean age (yrs) Black (%) Women (%) Current smoking (%) 146 145 156 67 35 47 22 84 83 89
Amlodipine n=9,048
146 145 157 67 36 47 22 84 83 90
Lisinopril n=9,054
146 145 156 67 36 46 22 84 84 89
systolic diastolic systolic diastolic systolic diastolic
History of CHD (%)

Type 2 diabetes (%)
26
36
24
37
25
36
BP=blood pressure CHD=coronary heart disease ALLHAT Research Group. JAMA. 2002;288:2981-2997.
ALLHAT Mean Systolic and Diastolic Blood Pressure During Follow-up

Chlorthalidone Chlorthalidone
Systolic BP (mmHg)
Lisinopril
Diastolic BP (mmHg)
150 145 140 135 130
Amlodipine
90 85 80 75 70
Amlodipine Lisinopril
Compared to chlorthalidone: DBP significantly lower in amlodipine group (~1 mmHg).
Compared to chlorthalidone: SBP significantly higher in amlodipine (~1 mmHg) and lisinopril (~2 mmHg) groups.
6 0 1 Follow-up, yrs
SBP=systolic blood pressure DBP=diastolic blood pressure ALLHAT Research Group. JAMA. 2002;288:2981-2997. www.hypertensiononline.org Copyright 2002, American Medical Association.
ALLHAT BP Controlled to <140/90 mmHg

Chlorthalidone Amlodipine Lisinopril
70
% Patients with BP <140/90 mmHg
60 50 40 30 20 10 0 Baseline Year 1
*
Year 2
Year 3
Year 4
Year 5
*P<0.001 for amlodipine vs chlorthalidone P<0.001 for lisinopril vs chlorthalidone ALLHAT Research Group. JAMA. 2002;288:2981-2997.
ALLHAT Treatment and Blood Pressure Control

1 Drug 2 Drugs
1.7
3 Drugs
2.0
100
Average # of drugs
Patients (%)
80
1.3
1.4
1.6 1.2 0.8 0.4 0
60 40 20 0
6 mos
49.8%
1 yr
55.2%
3 yr
62.3%
5 yr
65.6%
Blood pressure controlled <140/90 mmHg
Cushman WC, et al. J Clin Hypertens. 2002;4:393-405.
ALLHAT Primary Outcome by Treatment Group

Cumulative Fatal CHD and Nonfatal MI event rate (%)
20 16 12 8 4 0
Chlorthalidone Amlodipine
Lisinopril
1
14477 8576 8535
2
13820 8218 8123
No. at Risk Chlorthalidone Amlodipine Lisinopril
3 4 5 Time to event, yrs

13102 7843 7711 11362 6824 6662 6340 3870 3832
6
2956 1878 1770
7
209 215 195
15255 9048 9054
ALLHAT Research Group. JAMA. 2002;288:2981-2997. Copyright 2002, American Medical Association.
ALLHAT CHD Death and Nonfatal MI

Relative Risk Favors Relative Risk Favors (95% CI) amlodipine chlorthalidone (95% CI) Favors Favors lisinopril chlorthalidone
TOTAL Age <65 Age 65 Men Women
0.98 (0.90-1.07) 0.99 (0.85-1.16)
0.99 (0.91-1.08) 0.95 (0.81-1.12)
0.97 (0.88-1.08)
0.98 (0.87-1.09) 0.99 (0.85-1.15) 1.01 (0.86-1.18) 0.97 (0.87-1.08) 0.99 (0.87-1.13) 0.97 (0.86-1.09)
1.01 (0.91-1.12)
0.94 (0.85-1.05) 1.06 (0.92-1.23) 1.10 (0.94-1.28) 0.94 (0.85-1.05) 1.00 (0.87-1.14) 0.99 (0.88-1.11)
Black
Nonblack Diabetic Nondiabetic
0.5
0.5
ALLHAT All-Cause Mortality

0.96 (0.89-1.02) 0.96 (0.83-1.10)
1.00 (0.94-1.08) 0.93 (0.81-1.08)
0.96 (0.88-1.03)
0.95 (0.87-1.04) 0.96 (0.86-1.07) 0.97 (0.87-1.09) 0.94 (0.87-1.03) 0.96 (0.87-1.07) 0.95 (0.87-1.04)
1.03 (0.95-1.12)
0.99 (0.91-1.08) 1.02 (0.91-1.13) 1.06 (0.95-1.18) 0.97 (0.89-1.06) 1.02 (0.91-1.13) 1.00 (0.91-1.09)
Black
0.5
0.5
ALLHAT Combined CV Disease

1.04 (0.99-1.09) 1.03 (0.94-1.12)
1.10 (1.05-1.16) 1.05 (0.97-1.15)
1.05 (0.99-1.12)
1.04 (0.98-1.11) 1.04 (0.96-1.13) 1.06 (0.96-1.16) 1.04 (0.97-1.10) 1.06 (0.98-1.15) 1.02 (0.96-1.09)
1.13 (1.06-1.20)
1.08 (1.02-1.15) 1.12 (1.03-1.21) 1.19 (1.09-1.30) 1.06 (1.00-1.13) 1.08 (1.00-1.17) 1.12 (1.05-1.19)
Black
0.5
0.5
ALLHAT Stroke by Treatment Group

Cumulative event rate (%)
10 8 6 4 2 0
Chlorthalidone Amlodipine
Lisinopril
No. at Risk 14515 13934 13309 11570 Chlorthalidone 15255 9048 8617 8271 7949 6937 Amlodipine 9054 8543 8172 7784 6765 Lisinopril ALLHAT Research Group. JAMA. 2002;288:2981-2997. Copyright 2002, American Medical Association.

6385 3845 3891
6
3217 1813 1828
7
567 506 949
ALLHAT Stroke
0.93 (0.82-1.06) 0.93 (0.73-1.19)
1.15 (1.02-1.30) 1.21 (0.97-1.52)
0.93 (0.81-1.08)
1.00 (0.85-1.18) 0.84 (0.69-1.03) 0.93 (0.76-1.14) 0.93 (0.79-1.10) 0.90 (0.75-1.08) 0.96 (0.81-1.14)
1.13 (0.98-1.30)
1.10 (0.94-1.29) 1.22 (1.01-1.46) 1.40 (1.17-1.68) 1.00 (0.85-1.17) 1.07 (0.90-1.28) 1.23 (1.05-1.44)
Black
0.5
0.5
ALLHAT Heart Failure by Treatment Group

Cumulative event rate (%)
15 12 9 6 3 0
Chlorthalidone Amlodipine Lisinopril
P<0.001 for chlorthalidone vs amlodipine and chlorthalidone vs lisinopril
No. at Risk Chlorthalidone Amlodipine Lisinopril
1
14528 8535 8496
2
13898 8185 8096
15255 9048 9054

13224 7801 7689 11511 6785 6698
6
3016 1780 1837
7
384 210 313
6369 3775 3789
ALLHAT Heart Failure

1.38 (1.25-1.52) 1.51 (1.25-1.82)
1.20 (1.09-1.34) 1.23 (1.01-1.50)
1.33 (1.18-1.49)
1.41 (1.24-1.61) 1.33 (1.14-1.55) 1.47 (1.24-1.74) 1.33 (1.18-1.51) 1.42 (1.23-1.64) 1.33 (1.16-1.52)
1.20 (1.06-1.35)
1.19 (1.03-1.36) 1.23 (1.05-1.43) 1.32 (1.11-1.58) 1.15 (1.01-1.30) 1.22 (1.05-1.42) 1.20 (1.04-1.38)
Black
0.5
0.5
ALLHAT Conclusions
Better control of systolic BP was achieved with chlorthalidone than with amlodipine or lisinopril There were no differences in risk for CHD death/nonfatal MI between chlorthalidone and amlodipine or lisinopril In secondary endpoints, chlorthalidone was associated with lower risk for stroke, combined CVD, and HF compared with lisinopril HF compared with amlodipine
MI=myocardial infarction CHD=coronary heart disease ALLHAT Research Group. JAMA. 2002;288:2981-2997. HF=heart failure www.hypertensiononline.org
ALLHAT Implications
Unless contraindicated, or unless specific indications are present that would favor use of another drug class, diuretics should be the initial drug of choice in antihypertensive regimens Only 30 percent of patients achieve both systolic BP <140 mmHg and diastolic BP <90 mmHg on monotherapy
Many high-risk hypertensive patients will require 2 or more drugs for BP control

ALLHAT Study Overview: CHD Coronary Heart Disease MI Myocardial Infarction

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The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial

ALLHAT study overview

ALLHAT Study Design

Randomized n=42,418 Amlodipine n=9,048

Chlorthalidone n=15,255 YEAR 1

1,873 (30.2%) stopped drug

1,052 (27.9%) stopped drug

1,399 (38.8%) stopped drug

339 (2.2%) lost to follow-up 80 (0.5%) refused follow-up

200 (2.2%) lost to follow-up 58 (0.6%) refused follow-up

218 (2.4%) lost to follow-up 58 (0.6%) refused follow-up

ALLHAT Research Group. JAMA. 2002;288:2981-2997.

ALLHAT Baseline Characteristics

systolic diastolic systolic diastolic systolic diastolic

History of CHD (%)

ALLHAT Mean Systolic and Diastolic Blood Pressure During Follow-up

150 145 140 135 130

ALLHAT BP Controlled to <140/90 mmHg

ALLHAT Treatment and Blood Pressure Control

1.6 1.2 0.8 0.4 0

Blood pressure controlled <140/90 mmHg

Cushman WC, et al. J Clin Hypertens. 2002;4:393-405.

ALLHAT Primary Outcome by Treatment Group

No. at Risk Chlorthalidone Amlodipine Lisinopril

3 4 5 Time to event, yrs

15255 9048 9054

ALLHAT CHD Death and Nonfatal MI

TOTAL Age <65 Age 65 Men Women

0.98 (0.90-1.07) 0.99 (0.85-1.16)

0.99 (0.91-1.08) 0.95 (0.81-1.12)

ALLHAT All-Cause Mortality

TOTAL Age <65 Age 65 Men Women

0.96 (0.89-1.02) 0.96 (0.83-1.10)

1.00 (0.94-1.08) 0.93 (0.81-1.08)

ALLHAT Combined CV Disease

TOTAL Age <65 Age 65 Men Women

1.04 (0.99-1.09) 1.03 (0.94-1.12)

1.10 (1.05-1.16) 1.05 (0.97-1.15)

ALLHAT Stroke by Treatment Group

3 4 5 Time to event, yrs

TOTAL Age <65 Age 65 Men Women

0.93 (0.82-1.06) 0.93 (0.73-1.19)

1.15 (1.02-1.30) 1.21 (0.97-1.52)

ALLHAT Heart Failure by Treatment Group

No. at Risk Chlorthalidone Amlodipine Lisinopril

15255 9048 9054

3 4 5 Time to event, yrs

6369 3775 3789

ALLHAT Heart Failure

TOTAL Age <65 Age 65 Men Women

1.38 (1.25-1.52) 1.51 (1.25-1.82)

1.20 (1.09-1.34) 1.23 (1.01-1.50)

ALLHAT Research Group. JAMA. 2002;288:2981-2997.

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