The The A A ntihypertensive and ntihypertensive and L L ipid- ipid- L L owering Treatment owering Treatment to Prevent to Prevent H H eart eart A A ttack ttack T T rial rial 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 ALLHAT Research Group. JAMA. 2002;288:2981-2997. www.hypertensiononline.org 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 Double-blind, randomized trial to determine whether.
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The The AAntihypertensive and ntihypertensive and LLipid-ipid-LLowering Treatment owering Treatment
to Prevent to Prevent HHeart eart AAttack ttack TTrialrialALLHAT study overviewDouble-blind, randomized trial to determine whether theoccurrence 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
ALLHAT Research Group. JAMA. 2002;288:2981-2997. www.hypertensiononline.orgCHD=coronary heart disease; MI=myocardial infarction
ALLHAT Study DesignALLHAT Study Design
n=13,854n=13,8542,235 (16.1%) stopped drug
Chlorthalidone Chlorthalidone n=15,255n=15,255
AmlodipineAmlodipinen=9,048n=9,048
Randomizedn=42,418
n=15,255 n=15,255 339 (2.2%) lost to follow-up80 (0.5%) refused follow-up
n=9,048n=9,048200 (2.2%) lost to follow-up58 (0.6%) refused follow-up
n=6,210n=6,2101,873 (30.2%) stopped drug
n=9,054 n=9,054 218 (2.4%) lost to follow-up58 (0.6%) refused follow-up
n=8,215n=8,215 1,357 (16.5%) stopped drug
n=3,769n=3,7691,052 (27.9%)stopped drug
YEAR 1n=8,158n=8,158
1,842 (22.6%) stopped drug
n=3,605n=3,6051,399 (38.8%) stopped
drug
LisinoprilLisinopriln=9,054n=9,054
YEAR 5
ALLHAT Research Group. JAMA. 2002;288:2981-2997. www.hypertensiononline.org
Intent-to-Treat
Analysis
Doxazosinn=9,062
Discontinuedearly at 3.3 yrs
ALLHAT EndpointsALLHAT Endpoints
Primary endpoint• Composite of fatal coronary heart disease (CHD) or nonfatal
• 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
www.hypertensiononline.orgALLHAT Research Group. JAMA. 2002;288:2981-2997.