Effect of fixed-dose combined isosorbide dinitrate/hydralazine in elderly patients in the African-American heart failure trial

J Card Fail. 2012 Aug;18(8):600-6. doi: 10.1016/j.cardfail.2012.06.526.

Abstract

Background: Fixed-dose combined isosorbide dinitrate/hydralazine (FDC I/H) significantly improved outcomes in patients with advanced heart failure (HF) receiving background neurohormonal therapy in the African-American Heart Failure Trial (A-HeFT). In this analysis, we investigated treatment effects by age <65 or ≥65 years.

Methods and results: Time-to-event curves were produced by the Kaplan-Meier method. Hazard ratios were calculated with the Cox proportional hazards model. Baseline characteristics showed that patients ≥65 years old had less hypertensive and more ischemic HF, better quality of life (QoL) scores, higher plasma B-type natriuretic peptide and creatinine levels, and received less background neurohormonal therapy. Kaplan-Meier curves showed that FDC I/H improved mortality and event-free survival in elderly patients. The hazard ratios for mortality, first heart failure hospitalization, and event-free survival (both unadjusted and adjusted for baseline differences), were similar quantitatively and in direction of effect in both age groups.

Conclusions: In A-HeFT, FDC I/H improved outcomes in HF patients aged <65 or ≥65 years, despite significant baseline differences between these age groups. Patients aged ≥65 years, a group at greater mortality risk, had the greatest survival benefit from FDC I/H.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Age Factors
  • Aged
  • Aging
  • Black or African American / statistics & numerical data*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Health Status Indicators
  • Heart Failure / drug therapy*
  • Heart Failure / epidemiology
  • Heart Failure / mortality
  • Humans
  • Hydralazine / therapeutic use*
  • Isosorbide Dinitrate / therapeutic use*
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Nitric Oxide Donors / therapeutic use*
  • Quality of Life / psychology
  • Time
  • Treatment Outcome
  • United States / epidemiology
  • Vasodilator Agents / therapeutic use*

Substances

  • Nitric Oxide Donors
  • Vasodilator Agents
  • Hydralazine
  • Isosorbide Dinitrate