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PubMed
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Stroke Interventions in Clinical Trials
Printable Version
ALLHAT
Antihypertensive and Lipid-Lowering Treament to Prevent Heart Attack Trial



Principal Investigator
Barry Davis

PI Address
Barry Davis University of Texas

Contact Address
Jackson T. Wright, Jr, MD, PhD
Case Western Reserve University
General Clinical Research Center
Suite 7311, Horvitz Tower
11000 Euclid ave
Cleveland, OH 44106

Contact Email
jxw20@po.cwru.edu

Sponsor



Trial Phase:Phase II
Study Size Actual:42418
Centers Actual:623
Centers Planned:625
Min Age:55
Follow-up Duration:4 Years
ISRCTN#NCT00000542
Status:
Trial complete. Results published December 2002.

Purpose:
To determine if a treatment regime based on calcium channel blocker or angiotensin-converting enzyme inhibitor lowers the incidence of coronary heart disease or other cardiovascular disease events vs diuretic treatments.

Interventions:
Antihypertensives
This category includes all BP lowering drugs in stroke prevention trials

Location(s):
United States & Canada

Year Started: 1994
Year Finished: 2002
Year Published: 2002


Design:
Randomized, double-blind, active-controlled clinical trial.

Inclusion Criteria
Patients 55 years and older with hypertension and at least one other coronary heart disease risk factor.

Exclusion Criteria
Patients with symptomatic heart failure and/or left ventricular ejection fraction of less than 35%.

Patient Involvement:
Patients were randomly assigned to receive either chlorthalidone (12.-25 mg/day, n=15255), amlodipine (2.5-10 mg/day, n=9048) or lisinopril (10-40 mg/day, n=9054). Follow-up visits were at 1 month, 3, 6, 9, 12 months, and every 4 months until the end of the trial.

Primary Outcome:
Combined fatal coronary heart disease or non-fatal myocardial infarction.

Secondary Outcome:
All causes of mortality, stroke, combined coronary heart disease, combined cardiovascular disease.

Results:
Mean follow-up was 4.9 years. The primary outcome occurred in 2956 participants, with no difference between treatments. Compared with chlorthalidone (6-year rate, 11.5%), the relative risks (RRs) were 0.98 (95% CI, 0.90-1.07) for amlodipine (6-year rate, 11.3%) and 0.99 (95% CI, 0.91-1.08) for lisinopril (6-year rate, 11.4%). Likewise, all-cause mortality did not differ between groups. Five-year systolic blood pressures were significantly higher in the amlodipine (0.8 mm Hg, P = .03) and lisinopril (2 mm Hg, P<.001) groups compared with chlorthalidone, and 5-year diastolic blood pressure was significantly lower with amlodipine (0.8 mm Hg, P<.001). For amlodipine vs chlorthalidone, secondary outcomes were similar except for a higher 6-year rate of HF with amlodipine (10.2% vs 7.7%; RR, 1.38; 95% CI, 1.25-1.52). For lisinopril vs chlorthalidone, lisinopril had higher 6-year rates of combined CVD (33.3% vs 30.9%; RR, 1.10; 95% CI, 1.05-1.16); stroke (6.3% vs 5.6%; RR, 1.15; 95% CI, 1.02-1.30); and HF (8.7% vs 7.7%; RR, 1.19; 95% CI, 1.07-1.31).

Source of Information:
JAMA 2002;288:2981-1997.

Web Links and Publications:
Heart failure with preserved and reduced left ventricular ejection fraction in the antihypertensive and lipid-lowering treatment to prevent heart attack trial.
Circulation 2008 Nov 25;118(22):2259-67

Cardiovascular outcomes in high-risk hypertensive patients stratified by baseline glomerular filtration rate.
Ann Intern Med 2006 Feb 7;144(3):172-80

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack (ALLHAT) Trial: focus on the diabetic patient.
Curr Hypertens Rep 2004 Jun;6(3):212-4

The prevalence of reduced glomerular filtration rate in older hypertensive patients and its association with cardiovascular disease: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.
Arch Intern Med 2004 May 10;164(9):969-76

Characteristics and lipid distribution of a large, high-risk, hypertensive population: the lipid-lowering component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
J Clin Hypertens (Greenwich) 2003 Nov-Dec;5(6):377-84

The verdict from ALLHAT--thiazide diuretics are the preferred initial therapy for hypertension.
JAMA 2002 Dec 18;288(23):3039-42

The ALLHAT lipid lowering trial--less is less.
JAMA 2002 Dec 18;288(23):3042-4

Major Outcomes in High-Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs Diuretic The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
JAMA

Validation of Heart Failure Events in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Participants Assigned to Doxazosin and Chlorthalidone.
Curr Control Trials Cardiovasc Med 2002 Nov 14;3(1):10

Participant recruitment in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
Control Clin Trials 2001 Dec;22(6):674-86

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT): clinical center recruitment experience.
Control Clin Trials 2001 Dec;22(6):659-73

Baseline Characteristics of Participants in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
Hypertension 2001 Jan;37(1):19-27

Operational aspects of terminating the doxazosin arm of The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
Control Clin Trials 2001 Feb;22(1):29-41

Implications of discontinuation of doxazosin arm of ALLHAT. Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.
Lancet 2000 Mar 11;355(9207):863-4

National Heart, Lung, and Blood Institute halts part of antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT)
Circulation 2000 Mar 28;101(12):E9025

Diuretics vs alpha-blockers for treatment of hypertension: lessons from ALLHAT. Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.
JAMA 2000 Apr 19;283(15):2013-4

Use of calcium channel blockers in hypertension.
Adv Intern Med 1998;43:533-62

Calcium-channel blockers for hypertension--uncertainty continues.
N Engl J Med 1998 Mar 5;338(10):679-81

ALLHAT and calcium channel blockers. ALLHAT Research Group.
Am J Hypertens 1997 Jan;10(1):142-3

What, if anything, is controversial about calcium antagonists?
Am J Hypertens 1996 Dec;9(12 Pt 2):177S-181S

The ALLHAT challenges.
J Natl Med Assoc 1996 Jun;88(6):335, 368

Rationale and design for the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT Research Group.
Am J Hypertens 1996 Apr;9(4 Pt 1):342-60

ALLHAT: the largest and most important clinical trial in hypertension ever done in the USA. Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial.
Am J Hypertens 1996 Apr;9(4 Pt 1):409-11

Experimental approaches to determining the choice of first-step therapy for patients with hypertension. The ALLHAT Research Group Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.
Clin Exp Hypertens 1996 Apr-May;18(3-4):569-79

Trends in pharmacologic management of hypertension in the United States.
Arch Intern Med 1995 Apr 24;155(8):829-37

Recruitment of African-American patients for clinical trials--the Allhat challenges. Antihypertensive and Lipid-lowering Trial to Prevent Heart Attack.
J Natl Med Assoc 1995 Aug;87(8 Suppl):627-9

ALLHAT Website

ALLHAT
ClinicalTrials.gov

This information last updated on: 10/19/2009

Reviewed on: 10/19/2009.

UID: 546

   

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