Validation of heart failure events in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) participants assigned to doxazosin and chlorthalidone

Linda B. Piller, Barry R. Davis, Jeffrey A. Cutler, William Cushman, Jackson T. Wright, Jeff D. Williamson, Frans H.H. Leenen, Paula T. Einhorn, Otelio S. Randall, John S. Golden, L. Julian Haywood

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Abstract

Background: The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) is a randomized, double-blind, active-controlled trial designed to compare the rate of coronary heart disease events in high-risk hypertensive participants initially randomized to a diuretic (chlorthalidone) versus each of three alternative antihypertensive drugs: alpha-adrenergic blocker (doxazosin), ACE-inhibitor (lisinopril), and calcium-channel blocker (amlodipine). Combined cardiovascular disease risk was significantly increased in the doxazosin arm compared to the chlorthalidone arm (RR 1.25; 95% Cl, 1.17-1.33; P < .001), with a doubling of heart failure (fatal, hospitalized, or non-hospitalized but treated) (RR 2.04; 95% Cl, 1.79-2.32; P < .001). Questions about heart failure diagnostic criteria led to steps to validate these events further. Methods and Results: Baseline characteristics (age, race, sex, blood pressure) did not differ significantly between treatment groups (P < .05) for participants with heart failure events. Post-event pharmacologic management was similar in both groups and generally conformed to accepted heart failure therapy. Central review of a small sample of cases showed high adherence'to ALLHAT heart failure criteria. Of 105 participants with quantitative ejection fraction measurements provided, (67% by echocardiogram, 31% by catheterization), 29/46 (63%) from the chlorthalidone group and 41/59 (70%) from the doxazosin group were at or below 40%. Two-year heart failure case-fatalities (22% and 19% in the doxazosin and chlorthalidone groups, respectively) were as expected and did not differ significantly (RR 0.96; 95% Cl, 0.67-1.38; P = 0.83). Conclusion: Results of the validation process supported findings of increased heart failure in the ALLHAT doxazosin treatment arm compared to the chlorthalidone treatment arm.

Original languageEnglish (US)
Article number10
JournalCurrent Controlled Trials in Cardiovascular Medicine
Volume3
DOIs
StatePublished - Nov 14 2002

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Chlorthalidone
Doxazosin
Antihypertensive Agents
Heart Failure
Myocardial Infarction
Lipids
Therapeutics
Lisinopril
Adrenergic alpha-Antagonists
Amlodipine
Calcium Channel Blockers
Angiotensin-Converting Enzyme Inhibitors
Diuretics
Catheterization
Coronary Disease
Cardiovascular Diseases
Blood Pressure

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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Validation of heart failure events in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) participants assigned to doxazosin and chlorthalidone. / Piller, Linda B.; Davis, Barry R.; Cutler, Jeffrey A.; Cushman, William; Wright, Jackson T.; Williamson, Jeff D.; Leenen, Frans H.H.; Einhorn, Paula T.; Randall, Otelio S.; Golden, John S.; Haywood, L. Julian.

In: Current Controlled Trials in Cardiovascular Medicine, Vol. 3, 10, 14.11.2002.

Research output: Contribution to journalArticle

Piller, Linda B. ; Davis, Barry R. ; Cutler, Jeffrey A. ; Cushman, William ; Wright, Jackson T. ; Williamson, Jeff D. ; Leenen, Frans H.H. ; Einhorn, Paula T. ; Randall, Otelio S. ; Golden, John S. ; Haywood, L. Julian. / Validation of heart failure events in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) participants assigned to doxazosin and chlorthalidone. In: Current Controlled Trials in Cardiovascular Medicine. 2002 ; Vol. 3.
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abstract = "Background: The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) is a randomized, double-blind, active-controlled trial designed to compare the rate of coronary heart disease events in high-risk hypertensive participants initially randomized to a diuretic (chlorthalidone) versus each of three alternative antihypertensive drugs: alpha-adrenergic blocker (doxazosin), ACE-inhibitor (lisinopril), and calcium-channel blocker (amlodipine). Combined cardiovascular disease risk was significantly increased in the doxazosin arm compared to the chlorthalidone arm (RR 1.25; 95{\%} Cl, 1.17-1.33; P < .001), with a doubling of heart failure (fatal, hospitalized, or non-hospitalized but treated) (RR 2.04; 95{\%} Cl, 1.79-2.32; P < .001). Questions about heart failure diagnostic criteria led to steps to validate these events further. Methods and Results: Baseline characteristics (age, race, sex, blood pressure) did not differ significantly between treatment groups (P < .05) for participants with heart failure events. Post-event pharmacologic management was similar in both groups and generally conformed to accepted heart failure therapy. Central review of a small sample of cases showed high adherence'to ALLHAT heart failure criteria. Of 105 participants with quantitative ejection fraction measurements provided, (67{\%} by echocardiogram, 31{\%} by catheterization), 29/46 (63{\%}) from the chlorthalidone group and 41/59 (70{\%}) from the doxazosin group were at or below 40{\%}. Two-year heart failure case-fatalities (22{\%} and 19{\%} in the doxazosin and chlorthalidone groups, respectively) were as expected and did not differ significantly (RR 0.96; 95{\%} Cl, 0.67-1.38; P = 0.83). Conclusion: Results of the validation process supported findings of increased heart failure in the ALLHAT doxazosin treatment arm compared to the chlorthalidone treatment arm.",
author = "Piller, {Linda B.} and Davis, {Barry R.} and Cutler, {Jeffrey A.} and William Cushman and Wright, {Jackson T.} and Williamson, {Jeff D.} and Leenen, {Frans H.H.} and Einhorn, {Paula T.} and Randall, {Otelio S.} and Golden, {John S.} and Haywood, {L. Julian}",
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T1 - Validation of heart failure events in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) participants assigned to doxazosin and chlorthalidone

AU - Piller, Linda B.

AU - Davis, Barry R.

AU - Cutler, Jeffrey A.

AU - Cushman, William

AU - Wright, Jackson T.

AU - Williamson, Jeff D.

AU - Leenen, Frans H.H.

AU - Einhorn, Paula T.

AU - Randall, Otelio S.

AU - Golden, John S.

AU - Haywood, L. Julian

PY - 2002/11/14

Y1 - 2002/11/14

N2 - Background: The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) is a randomized, double-blind, active-controlled trial designed to compare the rate of coronary heart disease events in high-risk hypertensive participants initially randomized to a diuretic (chlorthalidone) versus each of three alternative antihypertensive drugs: alpha-adrenergic blocker (doxazosin), ACE-inhibitor (lisinopril), and calcium-channel blocker (amlodipine). Combined cardiovascular disease risk was significantly increased in the doxazosin arm compared to the chlorthalidone arm (RR 1.25; 95% Cl, 1.17-1.33; P < .001), with a doubling of heart failure (fatal, hospitalized, or non-hospitalized but treated) (RR 2.04; 95% Cl, 1.79-2.32; P < .001). Questions about heart failure diagnostic criteria led to steps to validate these events further. Methods and Results: Baseline characteristics (age, race, sex, blood pressure) did not differ significantly between treatment groups (P < .05) for participants with heart failure events. Post-event pharmacologic management was similar in both groups and generally conformed to accepted heart failure therapy. Central review of a small sample of cases showed high adherence'to ALLHAT heart failure criteria. Of 105 participants with quantitative ejection fraction measurements provided, (67% by echocardiogram, 31% by catheterization), 29/46 (63%) from the chlorthalidone group and 41/59 (70%) from the doxazosin group were at or below 40%. Two-year heart failure case-fatalities (22% and 19% in the doxazosin and chlorthalidone groups, respectively) were as expected and did not differ significantly (RR 0.96; 95% Cl, 0.67-1.38; P = 0.83). Conclusion: Results of the validation process supported findings of increased heart failure in the ALLHAT doxazosin treatment arm compared to the chlorthalidone treatment arm.

AB - Background: The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) is a randomized, double-blind, active-controlled trial designed to compare the rate of coronary heart disease events in high-risk hypertensive participants initially randomized to a diuretic (chlorthalidone) versus each of three alternative antihypertensive drugs: alpha-adrenergic blocker (doxazosin), ACE-inhibitor (lisinopril), and calcium-channel blocker (amlodipine). Combined cardiovascular disease risk was significantly increased in the doxazosin arm compared to the chlorthalidone arm (RR 1.25; 95% Cl, 1.17-1.33; P < .001), with a doubling of heart failure (fatal, hospitalized, or non-hospitalized but treated) (RR 2.04; 95% Cl, 1.79-2.32; P < .001). Questions about heart failure diagnostic criteria led to steps to validate these events further. Methods and Results: Baseline characteristics (age, race, sex, blood pressure) did not differ significantly between treatment groups (P < .05) for participants with heart failure events. Post-event pharmacologic management was similar in both groups and generally conformed to accepted heart failure therapy. Central review of a small sample of cases showed high adherence'to ALLHAT heart failure criteria. Of 105 participants with quantitative ejection fraction measurements provided, (67% by echocardiogram, 31% by catheterization), 29/46 (63%) from the chlorthalidone group and 41/59 (70%) from the doxazosin group were at or below 40%. Two-year heart failure case-fatalities (22% and 19% in the doxazosin and chlorthalidone groups, respectively) were as expected and did not differ significantly (RR 0.96; 95% Cl, 0.67-1.38; P = 0.83). Conclusion: Results of the validation process supported findings of increased heart failure in the ALLHAT doxazosin treatment arm compared to the chlorthalidone treatment arm.

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