Outcomes by gender in the African-American Heart Failure Trial.

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.

• Authors: 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, A-HeFT Investigators
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 48 Issue 11 Pg. 2263-7 (Dec 05 2006) ISSN: 1558-3597 [Electronic] United States
• PMID: 17161257 (Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Vasodilator Agents
• Hydralazine
• Isosorbide Dinitrate

Topics

• Adult
• Black or African American
• Aged
• Cardiac Output, Low (drug therapy, ethnology, mortality, physiopathology)
• Drug Therapy, Combination
• Female
• Hospitalization
• Humans
• Hydralazine (therapeutic use)
• Isosorbide Dinitrate (therapeutic use)
• Male
• Middle Aged
• Quality of Life
• Randomized Controlled Trials as Topic
• Sex Factors
• Survival Analysis
• Time Factors
• Treatment Outcome
• Vasodilator Agents (therapeutic use)