Outcomes by gender in the African-American Heart Failure Trial.
OBJECTIVE
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.
Taylor
Anne L
AL
Department of Medicine, University of Minnesota, Minneapolis, Minnesota 55455, USA. taylo135@umn.edu
Lindenfeld
JoAnn
J
Ziesche
Susan
S
Walsh
Mary Norine
MN
Mitchell
Judith E
JE
Adams
Kirkwood
K
Tam
S William
SW
Ofili
Elizabeth
E
Sabolinski
Michael L
ML
Worcel
Manuel
M
Cohn
Jay N
JN
D000328:Adult; D001741:Black or African American; D000368:Aged; D002303:Cardiac Output, Low / Q000188:drug therapy* / Q000208:ethnology* / Q000401:mortality / Q000503:physiopathology; D004359:Drug Therapy, Combination; D005260:Female; D006760:Hospitalization; D006801:Humans; D006830:Hydralazine / Q000627:therapeutic use*; D007548:Isosorbide Dinitrate / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012737:Sex Factors; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use*
D014665:Vasodilator Agents; D006830:Hydralazine; D007548:Isosorbide Dinitrate