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The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Heart Failure Validation Study: diagnosis and prognosis.
Am Heart J. 2007 Jan; 153(1):42-53.AH

Abstract

BACKGROUND

ALLHAT, a randomized, double-blind, active-controlled hypertension treatment trial in 42,418 patients, reported that a thiazide-type diuretic (chlorthalidone) was superior to a calcium channel blocker (amlodipine), an angiotensin-converting enzyme inhibitor (lisinopril), and an alpha1-blocker (doxazosin) in preventing the new onset of heart failure (HF). However, questions have been raised regarding the validity of the HF diagnosis.

METHODS

The ALLHAT HF Validation Study was designed to validate and elucidate the significance of HF events in ALLHAT. Records for 2778 HF hospitalizations in 1935 patients were centrally reviewed using several prespecified algorithms (based on ALLHAT and Framingham criteria) and reviewers' global clinical judgment. Percent agreement with diagnoses assigned by ALLHAT site physicians, relative risks across randomized comparisons, incidence rates, and mortality after HF hospitalization were evaluated for first events validated by each of the criteria sets.

RESULTS

Percent agreements with site physician diagnoses were 71%, 80%, and 84% for ALLHAT, Framingham, and reviewers' judgment, respectively. Using these 3 criteria, relative risks (95% CI) for new-onset HF compared with chlorthalidone were, respectively, 1.46 (1.27-1.68), 1.42 (1.25-1.62), and 1.45 (1.28-1.64) for amlodipine; 1.18 (1.02-1.28), 1.13 (0.99-1.30), and 1.15 (1.01-1.32) for lisinopril; and 1.79 (1.51-2.11), 1.71 (1.46-2.00), and 1.80 (1.55-2.10) for doxazosin.

CONCLUSIONS

An independent review of source documentation showed a high degree of agreement with the HF diagnoses assigned by site physicians and confirmed the higher risk of HF associated with first-step therapy using amlodipine, lisinopril, or doxazosin compared with chlorthalidone. Thiazide-type diuretics should be the preferred first-step therapy for prevention of HF in high-risk patients with hypertension.

Authors+Show Affiliations

National Heart, Lung, and Blood Institute, Division of Epidemiology and Clinical Applications, Bethesda, MD 20892-7936, USA. einhornp@mail.nih.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

17174636

Citation

Einhorn, Paula T., et al. "The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Heart Failure Validation Study: Diagnosis and Prognosis." American Heart Journal, vol. 153, no. 1, 2007, pp. 42-53.
Einhorn PT, Davis BR, Massie BM, et al. The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Heart Failure Validation Study: diagnosis and prognosis. Am Heart J. 2007;153(1):42-53.
Einhorn, P. T., Davis, B. R., Massie, B. M., Cushman, W. C., Piller, L. B., Simpson, L. M., Levy, D., Nwachuku, C. E., & Black, H. R. (2007). The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Heart Failure Validation Study: diagnosis and prognosis. American Heart Journal, 153(1), 42-53.
Einhorn PT, et al. The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Heart Failure Validation Study: Diagnosis and Prognosis. Am Heart J. 2007;153(1):42-53. PubMed PMID: 17174636.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Heart Failure Validation Study: diagnosis and prognosis. AU - Einhorn,Paula T, AU - Davis,Barry R, AU - Massie,Barry M, AU - Cushman,William C, AU - Piller,Linda B, AU - Simpson,Lara M, AU - Levy,Daniel, AU - Nwachuku,Chuke E, AU - Black,Henry R, AU - ,, PY - 2006/02/13/received PY - 2006/10/09/accepted PY - 2006/12/19/pubmed PY - 2007/1/26/medline PY - 2006/12/19/entrez SP - 42 EP - 53 JF - American heart journal JO - Am Heart J VL - 153 IS - 1 N2 - BACKGROUND: ALLHAT, a randomized, double-blind, active-controlled hypertension treatment trial in 42,418 patients, reported that a thiazide-type diuretic (chlorthalidone) was superior to a calcium channel blocker (amlodipine), an angiotensin-converting enzyme inhibitor (lisinopril), and an alpha1-blocker (doxazosin) in preventing the new onset of heart failure (HF). However, questions have been raised regarding the validity of the HF diagnosis. METHODS: The ALLHAT HF Validation Study was designed to validate and elucidate the significance of HF events in ALLHAT. Records for 2778 HF hospitalizations in 1935 patients were centrally reviewed using several prespecified algorithms (based on ALLHAT and Framingham criteria) and reviewers' global clinical judgment. Percent agreement with diagnoses assigned by ALLHAT site physicians, relative risks across randomized comparisons, incidence rates, and mortality after HF hospitalization were evaluated for first events validated by each of the criteria sets. RESULTS: Percent agreements with site physician diagnoses were 71%, 80%, and 84% for ALLHAT, Framingham, and reviewers' judgment, respectively. Using these 3 criteria, relative risks (95% CI) for new-onset HF compared with chlorthalidone were, respectively, 1.46 (1.27-1.68), 1.42 (1.25-1.62), and 1.45 (1.28-1.64) for amlodipine; 1.18 (1.02-1.28), 1.13 (0.99-1.30), and 1.15 (1.01-1.32) for lisinopril; and 1.79 (1.51-2.11), 1.71 (1.46-2.00), and 1.80 (1.55-2.10) for doxazosin. CONCLUSIONS: An independent review of source documentation showed a high degree of agreement with the HF diagnoses assigned by site physicians and confirmed the higher risk of HF associated with first-step therapy using amlodipine, lisinopril, or doxazosin compared with chlorthalidone. Thiazide-type diuretics should be the preferred first-step therapy for prevention of HF in high-risk patients with hypertension. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/17174636/The_Antihypertensive_and_Lipid_Lowering_Treatment_to_Prevent_Heart_Attack_Trial__ALLHAT__Heart_Failure_Validation_Study:_diagnosis_and_prognosis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(06)00904-5 DB - PRIME DP - Unbound Medicine ER -