blood pressure control by randomized drug group in allhat william c. cushman, charles e. ford, paula...
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Blood Pressure Control Blood Pressure Control
By Randomized Drug By Randomized Drug
Group In ALLHATGroup In ALLHAT
William C. Cushman, Charles E. William C. Cushman, Charles E. Ford, Paula T. Einhorn, Jackson T. Ford, Paula T. Einhorn, Jackson T.
Wright, Jr., Richard A. Preston, Wright, Jr., Richard A. Preston, Barry R. Davis, and Jan N. Basile Barry R. Davis, and Jan N. Basile
for the ALLHAT Collaborative for the ALLHAT Collaborative Research GroupResearch Group
ALLHATALLHAT
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Disclosure InformationDisclosure Information
William C. Cushman, William C. Cushman, MDMDThe following relationships exist that may be The following relationships exist that may be
related to this presentation:related to this presentation:
Research/grant support:Research/grant support: Astra-Zeneca, Kos, Astra-Zeneca, Kos, Aventis Pharma, King Pharmaceuticals, Aventis Pharma, King Pharmaceuticals, Boehringer-Ingelheim, Sanofi, BMS, Biovail, Boehringer-Ingelheim, Sanofi, BMS, Biovail, AbbottAbbott
Consultant and/or lectures:Consultant and/or lectures: Sanofi, Novartis, Sanofi, Novartis, Pfizer, Sankyo, Forest, Biovail, Abbott, Reddy, Pfizer, Sankyo, Forest, Biovail, Abbott, Reddy, First HorizonFirst Horizon
Others (stock, etc):Others (stock, etc): NoneNone
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The Antihypertensive and The Antihypertensive and Lipid-Lowering Treatment to Lipid-Lowering Treatment to Prevent Heart Attack Trial Prevent Heart Attack Trial
(ALLHAT)(ALLHAT)Sponsored by the National Heart, Sponsored by the National Heart,
Lung, and Blood Institute Lung, and Blood Institute (NHLBI) in Collaboration with the (NHLBI) in Collaboration with the Department of Veterans Affairs Department of Veterans Affairs
(VA)(VA)www.allhat.orgwww.allhat.org
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90% previously treated10% untreated
42,418 high-riskhypertensive patients
Chlorthalidone12.5-25 mg
Amlodipine2.5-10 mg
Lisinopril10-40 mg
Doxazosin1-8 mg
N=15,255 N=9,048 N=9,054 N=9,061
Atenolol28.0%
Clonidine10.6%
Reserpine4.3%
Hydralazine10.9%
Hypertension TrialHypertension TrialALLHAT
STEP 2 AND 3 AGENTSSTEP 2 AND 3 AGENTS
STEP 1 AGENTS (Double-blind)STEP 1 AGENTS (Double-blind)
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90% previously treated10% untreated
42,418 high-riskhypertensive patients
Chlorthalidone12.5-25 mg
Amlodipine2.5-10 mg
Lisinopril10-40 mg
Doxazosin1-8 mg
N=15,255 N=9,048 N=9,054 N=9,061
STEP 2 AND 3 AGENTSSTEP 2 AND 3 AGENTS
Atenolol28.0%
Clonidine10.6%
Reserpine4.3%
Hydralazine10.9%
Hypertension TrialHypertension TrialALLHAT
STEP 1 AGENTS (Double-blind)STEP 1 AGENTS (Double-blind)
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Inclusion CriteriaInclusion Criteria
Men and women aged Men and women aged >> 55 years 55 years
Seated blood pressure (2 categories):Seated blood pressure (2 categories):
1) Treated for @ least 2 months:1) Treated for @ least 2 months:
BP BP <<160/100 mm Hg160/100 mm Hg
2) Not on drugs or on drugs < 2 months:2) Not on drugs or on drugs < 2 months:
SBP 140-180 mm Hg or DBP 90-110 mm HgSBP 140-180 mm Hg or DBP 90-110 mm Hg
Additional risk factor or target organ damage.Additional risk factor or target organ damage.
ALLHATALLHAT
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Baseline Baseline CharacteristicsCharacteristics
CC AA LL AllAll
Sample SizeSample Size 15,25515,255 9,0489,048 9,0549,054 33,35733,357
Mean SBP/DBPMean SBP/DBP 145 / 83145 / 83 145 / 83145 / 83 145 / 83145 / 83 145 / 83145 / 83
Mean age, yearsMean age, years 6767 6767 6767 6767
Black, %Black, % 3535 3636 3535 3535
Women, %Women, % 4747 4747 4646 4747
Current smoking %Current smoking % 2222 2222 2222 2222
ASCVD, %ASCVD, % 4747 4646 4747 4747
Type II diabetes, %Type II diabetes, % 3636 3737 3535 3636
LVH by ECG, %LVH by ECG, % 33 33 33 33
Mean BMI, kg/mMean BMI, kg/m22 3030 3030 3030 3030
ALLHATALLHAT
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144.8
134.1134.0134.9136.0136.8138.6
145.0
136.0135.7136.7
138.5140.0
141.9
83.2
74.775.876.477.878.780.0 75.576.777.478.779.9
81.283.4
0 12 24 36 48 60
Mean Systolic and Diastolic BP by Mean Systolic and Diastolic BP by Treatment Group Over TimeTreatment Group Over Time
Months of Follow-up
mm Hg
ALLHATALLHAT
70
75
80
85
90
135
140
145
150
~~
Systolic BPSystolic BP
Diastolic BPDiastolic BP
ChlorthalidoneChlorthalidone
AmlodipineAmlodipine
LisinoprilLisinopril
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Percentage of Participants Percentage of Participants Receiving Blinded Study Drug or Receiving Blinded Study Drug or
Same ClassSame Class
888888899091 888888899092
8188
82 82 8185
0
20
40
60
80
100
6 12 24 36 48 60
Months of Follow-up
Per
cen
t
ALLHATALLHAT
ChlorthalidoneChlorthalidone AmlodipineAmlodipine LisinoprilLisinopril
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Number of Antihypertensive Drugs Used Number of Antihypertensive Drugs Used and BP Control (<140/90 mm Hg)and BP Control (<140/90 mm Hg)
6867646158
53
28
6665635755
48
28
626359545146
27
1.9-2.11.8-2.0
1.7-1.81.5-1.7
1.4-1.51.3
0
20
40
60
80
100
0 6 12 24 36 48 60
Months of Follow-up
Per
cen
t
0
0.5
1
1.5
2
ALLHATALLHAT
ChlorthalidoneChlorthalidone
AmlodipineAmlodipine
LisinoprilLisinopril
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BP Control (<140/90 mm Hg) and BP Control (<140/90 mm Hg) and Mean BP by Randomized Group and Mean BP by Randomized Group and
Race at 5 YearsRace at 5 Years
626870
64 65
54
0
20
40
60
80
Black Non-Black
Per
cen
t
Chlorthalidone Amlodipine Lisinopril
135/78135/78 136/76136/76 139/79139/79 133/74133/74 134/74134/74 134/74134/74
ALLHATALLHAT
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0%
20%
40%
60%
80%
100%
Not on Drugs On 1 Drug On 2 Drugs On 3 Drugs On 4+ Drugs
Number of Antihypertensive Number of Antihypertensive Drugs PrescribedDrugs Prescribed
Months of Follow-UpMonths of Follow-Up
Per
cen
tP
erce
nt
ALLHATALLHAT
1212 3636 6060
CC CC CCAA AA AALL LL LL
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Percent Controlled (BP < 140/90) Percent Controlled (BP < 140/90) at Five Years by Number of Drugs at Five Years by Number of Drugs
PrescribedPrescribed
68
3
11
2428
66
411
24 26
61
612
1824
0
10
20
30
40
50
60
70
80
1 2 3 4+ ALL
Number of Prescribed Drugs
Per
cen
tALLHATALLHAT
ChlorthalidoneChlorthalidone
AmlodipineAmlodipine
LisinoprilLisinopril
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Cumulative Percent Controlled (BP Cumulative Percent Controlled (BP < 140/90) at Five Years by < 140/90) at Five Years by
Number of Drugs PrescribedNumber of Drugs Prescribed
63
52
28
1
61
50
1
24
54
42
24
2
0
10
20
30
40
50
60
70
0 1 1 or 2 1, 2, or 3
Number of Prescribed Drugs
Per
cen
tALLHATALLHAT
ChlorthalidoneChlorthalidone
AmlodipineAmlodipine
LisinoprilLisinopril
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Number of Drugs Needed to Control BP Number of Drugs Needed to Control BP (<140/90 mm Hg) in ALLHAT After 5 Years(<140/90 mm Hg) in ALLHAT After 5 Years
• 26% of participants were controlled on 1 drug 26% of participants were controlled on 1 drug (another 2% were untreated):(another 2% were untreated): therefore, at least 72% received or needed ≥ 2 therefore, at least 72% received or needed ≥ 2
drugs.drugs.
• 49% were controlled on 1 or 2 drugs (12% more 49% were controlled on 1 or 2 drugs (12% more were uncontrolled on 1 drug or untreated): were uncontrolled on 1 drug or untreated): therefore, at least 39% received or would therefore, at least 39% received or would
have needed ≥ 3 drugs to control BP.have needed ≥ 3 drugs to control BP.
• 60% were controlled on 3 or fewer drugs:60% were controlled on 3 or fewer drugs: therefore, at least 16% received or needed ≥ 4 therefore, at least 16% received or needed ≥ 4
drugs to control BP.drugs to control BP.
ALLHATALLHAT
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Conclusions - 1Conclusions - 1
BP was well controlled in the BP was well controlled in the
majority of participants in ALLHAT.majority of participants in ALLHAT.
Average BP was well below 140/90 Average BP was well below 140/90
mm Hg for participants in each mm Hg for participants in each
randomized group.randomized group.
More participants were controlled More participants were controlled
with chlorthalidone than the other with chlorthalidone than the other
two agents as monotherapy.two agents as monotherapy.
ALLHATALLHAT
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However, <30% of participants could be However, <30% of participants could be controlled on any of the drugs as a single controlled on any of the drugs as a single agent. agent.
At least 2 medications were required for At least 2 medications were required for most participants to achieve BP control. most participants to achieve BP control.
These ALLHAT data support the These ALLHAT data support the recommendations of JNC 7 promoting recommendations of JNC 7 promoting multidrug regimens and the initial multidrug regimens and the initial selection of thiazide-type diuretics for selection of thiazide-type diuretics for most patients to improve BP control most patients to improve BP control rates.rates.
Conclusions - 2Conclusions - 2ALLHATALLHAT
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BMI BMI ≥ 30 kg/m≥ 30 kg/m22
Factors Related to Blood Pressure Factors Related to Blood Pressure Control at 36 Months of Follow-upControl at 36 Months of Follow-up
ChlorthalidoneChlorthalidone AmlodipineAmlodipine
ALLHATALLHAT
Prior BP TreatmentPrior BP Treatment
SmokerSmoker
Type II Type II DiabeticDiabetic
nonBlacknonBlack
Age Per Decade Age Per Decade ↑↑
Baseline SBP Baseline SBP (10 mm Hg (10 mm Hg ↑)↑)
Cr Cr ≥ 1.5 mg/dL≥ 1.5 mg/dL
MaleMale
BP Control BP Control BP Control BP Control Worse BetterWorse Better
0.500.50 11 22
0.80 (0.78, 0.83)
0.93 (0.88, 0.98)
1.10 (1.02, 1.20)
1.28 (1.17, 1.39)
0.88 (0.81, 0.96)
1.03 (0.93, 1.14)
0.87 (0.80, 0.95)
0.69 (0.60, 0.80)
0.79 (0.67, 0.94)
BP Control BP Control BP Control BP Control Worse BetterWorse Better
0.500.50 11 22
0.81 (0.78, 0.84)
0.91 (0.84, 0.98)
0.98 (0.88, 1.09)
1.56 (1.39, 1.74)
0.83 (0.74, 0.92)
0.96 (0.84, 1.09)
0.88 (0.79, 0.98)
0.66 (0.55, 0.81)
0.83 (0.65, 1.07)
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Prior BP TreatmentPrior BP Treatment
BMI BMI ≥ 30 kg/m≥ 30 kg/m22
SmokerSmoker
Type II DiabeticType II Diabetic
nonBlacknonBlack
Age Per Decade Age Per Decade ↑↑
Factors Related to Blood Pressure Factors Related to Blood Pressure Control at 36 Months of Follow-upControl at 36 Months of Follow-up
ChlorthalidoneChlorthalidone LisinoprilLisinopril
ALLHATALLHAT
Baseline SBP Baseline SBP (10 mm Hg (10 mm Hg ↑)↑)
Cr Cr ≥ 1.5 mg/dL≥ 1.5 mg/dL
MaleMale
BP Control BP Control BP Control BP Control Worse BetterWorse Better
0.500.50 11 22
0.80 (0.78, 0.83)
0.93 (0.88, 0.98)
1.10 (1.02, 1.20)
1.28 (1.17, 1.39)
0.88 (0.81, 0.96)
1.03 (0.93, 1.14)
0.87 (0.80, 0.95)
0.69 (0.60, 0.80)
0.79 (0.67, 0.94)
BP Control BP Control BP Control BP Control Worse BetterWorse Better
0.500.50 11 22
0.78 (0.75, 0.81)
0.89 (0.83, 0.96)
1.19 (1.07, 1.33)
1.56 (1.39, 1.75)
0.89 (0.80, 1.00)
0.93 (0.81, 1.06)
0.91 (0.81, 1.01)
0.62 (0.51, 0.75)
0.91 (0.72, 1.15)
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Multiple Logistic Regression Analysis: Multiple Logistic Regression Analysis: Relative Odds (95% CI) of Relative Odds (95% CI) of BP ControlBP Control at 36 Monthsat 36 Months
ALLHATALLHAT
BP Control Better
0.5 0.6 0.7 0.8 0.9 1 1.1 1.2
Age (10 year Age (10 year ↑) ↑)
Baseline SBP (10 mmHg Baseline SBP (10 mmHg ↑)↑) **
MaleMale **BlackBlack
Type 2 DiabeticType 2 Diabetic
SmokerSmoker ASCVDASCVD **
BMI BMI ≥ 30 kg/m≥ 30 kg/m22 **Prior RxPrior Rx **Cr Cr ≥ 1.5 mg/dL≥ 1.5 mg/dL **ECG LVHECG LVH **Clinic Research Exp.Clinic Research Exp. **
BP Control WorseMoreMore ( (**) or) or lessless ( () likely to be ) likely to be on 2+ drugson 2+ drugs
Cushman, et al. J Clinical Hypertens 2002; 4:393-404Cushman, et al. J Clinical Hypertens 2002; 4:393-404
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Logistic Regression Analysis of Logistic Regression Analysis of Relative Odds (95% CI) of Relative Odds (95% CI) of Being On 2+ Being On 2+ DrugsDrugs at 36 Months at 36 Months
ALLHATALLHAT
Age (10 year Age (10 year ↑)↑)
BlackBlack
SmokerSmoker
Prior RxPrior Rx
0.7 0.9 1.1 1.3 1.5 1.7 1.9 2.1 2.3
More Likely To Be On 2+ Drugs
Baseline SBP (10 mmHg Baseline SBP (10 mmHg ↑)↑)
MaleMale
Type 2 DiabeticType 2 Diabetic
ASCVDASCVD
BMI BMI ≥ 30 kg/m2≥ 30 kg/m2
Cr Cr ≥ 1.5 mg/dL≥ 1.5 mg/dLECG LVHECG LVHClinic Research Exp.Clinic Research Exp.
Less Likely To Be On 2+ Drugs
Cushman, et al. J Clinical Hypertens 2002; 4:393-404Cushman, et al. J Clinical Hypertens 2002; 4:393-404
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BP Control (<140/90 mm Hg) by BP Control (<140/90 mm Hg) by Randomized Group and RaceRandomized Group and Race
59 5651
66 6763
555860
42
5054
656870
54
6264
0
20
40
60
80
Chlor Amlo Lisin Chlor Amlo Lisin
1 year 3 years 5 years
BlackBlack Non-BlackNon-Black
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Number of Drugs Needed to Control BP Number of Drugs Needed to Control BP (<140/90 mm Hg) in ALLHAT After 5 Years(<140/90 mm Hg) in ALLHAT After 5 YearsALLHATALLHAT
No. of No. of DrugsDrugs
ChlorthalidoneChlorthalidone
N = 5670N = 5670
AmlodipineAmlodipine
N = 3400N = 3400
LisinoprilLisinopril
N = 3191N = 3191
ALLALL
N = 12,261N = 12,261
<140/90<140/90 ≥≥140/90140/90 <140/90<140/90 ≥≥140/90140/90 <140/90<140/90 ≥≥140/90140/90 <140/90<140/90 ≥≥140/90140/90
00 1.31.3 0.70.7 1.01.0 0.60.6 1.71.7 0.60.6 1.31.3 0.70.7
11 28.128.1 9.69.6 24.124.1 9.89.8 23.923.9 9.49.4 25.925.9 9.69.6
1 or 1 or 22 52.452.4 21.521.5 49.749.7 22.622.6 41.841.8 21.521.5 48.948.9 21.821.8
1 - 1 - 33 63.163.1 28.428.4 60.960.9 29.729.7 53.753.7 31.731.7 60.060.0 29.629.6
1 - 4+1 - 4+ 66.566.5 31.531.5 65.265.2 33.233.2 59.459.4 38.338.3 64.364.3 33.833.8
TotalTotal 67.867.8 32.232.2 66.266.2 33.833.8 61.161.1 38.938.9 65.665.6 34.434.4