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* Randomized, double-blind, clinical trial conducted from February 1994 through March 2002. | * Randomized, double-blind, clinical trial conducted from February 1994 through March 2002. | ||
* N=33,357 randomly assigned to: chlorthalidone (n=15255); amlodipine (n=9048); or lisinopril (n=9054) | * N=33,357 randomly assigned to: chlorthalidone (n=15255); amlodipine (n=9048); or lisinopril (n=9054) | ||
* Recruited at 623 centers in US, Canada, Puerto Rico, and US Virgin Islands between February 1994 through January 1998 | |||
* Mean follow-up: 4.9 years | * Mean follow-up: 4.9 years | ||
* Intent-to-treat analysis | * Intent-to-treat analysis | ||
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==Enrollment criteria== | ==Enrollment criteria== | ||
===Inclusion criteria=== | ===Inclusion criteria=== | ||
* | * Age ≥ 55 | ||
* Stage 1 or 2 HTN with at least 1 additional risk factor for CHD events, such as: | |||
** previous (>6 months) MI or stroke | |||
** LVH demonstrated by EKG or echocardiography | |||
** History of T2DM | |||
** current cigarette smoking | |||
** HDL ≤35 mg/dL | |||
** documentation of other atherosclerotic CVD | |||
===Exclusion criteria=== | ===Exclusion criteria=== | ||
* | * History of hospitalized or treated symptomatic HF and/or known LVEF ≤35% | ||
==Procedures== | ==Procedures== | ||
* | * Participants continued any prior antihypertensive medications until they received randomized study drug, at which point they stopped taking all previous medications | ||
* Randomly assigned to chlorthalidone, amlodipine, or lisinopril in a ratio of 1.7:1:1 | |||
* Goal BP ≤140/90 mmHg achieved by: | |||
# Step 1: titrating assigned study drug | |||
*** 12.5 to 25 mg/d for chlorthalidone | |||
*** 2.5 to 10 mg/d for amlodipine | |||
*** 10 to 40 mg/d for lisinopril | |||
# Step 2: adding open-label agents (atenolol, clonidine, or reserpine) or low doses of open-label step 1 drug classes | |||
*** 25 to 100 mg/d of atenolol | |||
*** 0.05 to 0.2 mg/d of reserpine | |||
*** 0.1 to 0.3 mg BID of clonidine | |||
# Step 3: adding 25 to 100 mg BID of hydralazine | |||
==Measured outcomes and results== | ==Measured outcomes and results== | ||
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===Secondary outcomes=== | ===Secondary outcomes=== | ||
* All-cause mortality | * All-cause mortality | ||
* | * Fatal and nonfatal stroke | ||
* Combined CHD (primary outcome, coronary revascularization, or angina with hospitalization) | * Combined CHD (primary outcome, coronary revascularization, or angina with hospitalization) | ||
* Combined CVD (combined CHD, stroke, treated angina without hospitalization, HF, and peripheral arterial disease) | * Combined CVD (combined CHD, stroke, treated angina without hospitalization, HF [fatal, hospitalized, or treated nonhospitalized], and peripheral arterial disease) | ||
===Subgroup analysis=== | ===Subgroup analysis=== | ||