Outcomes by Gender in the African-American Heart Failure Trial

Anne L. Taylor, JoAnn Lindenfeld, Susan Ziesche, Mary Norine Walsh, Judith E. Mitchell, Kirkwood Adams, S. William Tam, Elizabeth Ofili, Michael L. Sabolinski, Manuel Worcel, Jay N. Cohn

Research output: Contribution to journalArticlepeer-review

41 Scopus citations

Abstract

Objectives: Previous trials testing isosorbide dinitrate/hydralazine (I/H) were performed in all-male study cohorts, and thus the efficacy of I/H in women was unknown; 40% of the A-HeFT (African-American Heart Failure Trial) cohort were women. We therefore compared outcomes by gender and treatment. Background: Fixed-dose combined I/H significantly reduced mortality and heart failure hospitalizations and improved quality of life in 1,050 black patients with heart failure treated with background neurohormonal blockade. Previous trials testing I/H were done in all-male study cohorts, and thus the efficacy of I/H in women was unknown. Methods: Baseline characteristics and medications were compared between men and women by I/H and placebo treatment. Survival, time to first heart failure hospitalization, change in quality of life, and event-free survival were compared by gender and treatment. Results: At baseline, women had lower hemoglobin and creatinine levels; less renal insufficiency; and higher body mass indexes, diabetes prevalence, and systolic blood pressures; but worse quality of life scores. All-cause mortality was lower in women than in men treated with I/H but without significant treatment interaction by gender. The primary composite score, which weighted mortality, first heart failure hospitalization, and change in quality of life at 6 months, was similarly improved by I/H in men and women. First heart failure hospitalization and event-free survival (time to death or first heart failure hospitalization) were similarly improved in both genders. Conclusions: Fixed-dose I/H improved heart failure outcomes in both men and women in A-HeFT. The I/H significantly improved the primary composite score and event-free survival as well as reduced the risk of first heart failure hospitalizations similarly in both genders. The I/H had a slightly greater mortality benefit in women, but without a significant treatment interaction by gender.

Original languageEnglish (US)
Pages (from-to)2263-2267
Number of pages5
JournalJournal of the American College of Cardiology
Volume48
Issue number11
DOIs
StatePublished - Dec 5 2006

Bibliographical note

Funding Information:
This study was sponsored by NitroMed, Inc. (Lexington, Massachusetts).

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