Economic evaluation of the randomized aldactone evaluation study (RALES): Treatment of patients with severe heart failure

Purpose: To use data from the Randomized Aldactone Evaluation Study (RALES) to compare clinical outcomes and costs as part of the assessment of the economic implications of spironolactone treatment of advanced heart failure. Methods: RALES was a randomized, double-blinded, placebo-controlled trial that enrolled participants who had severe heart failure and a left ventricular ejection fraction of no more than 35% and who were receiving standard therapy, including an angiotensin-converting enzyme inhibitor, a loop diuretic, and, in some cases, digoxin. We used a decision analytic model that incorporated data from participants in RALES as well as cost data from five countries that participated in the study. Costs were calculated for nonfatal hospitalizations, ambulatory care, spironolactone therapy, and death. The primary health outcome was quality-adjusted life-years saved (QALYS). Outcomes were evaluated for the first 35 months of observation in RALES. Results: Spironolactone therapy during the first 35 months of follow-up in RALES increased quality-adjusted survival time (0.13 QALYS, 95% CI, 0.07 to 0.18) without increasing costs ($713 savings, 95% CI, $2123 savings to $783 in costs). Spironolactone therapy either dominated placebo or had a ratio of cost per QALYS that was unlikely to exceed $20,300. These results were robust in both one-way and multiway sensitivity analyses. Conclusions: Even after implementation of current clinical guidelines, addition of spironolactone therapy provides an opportunity to further reduce the large clinical and economic burden of patients with heart failure.