More evidence to show spironolactone reduces hospital re-admissions
A clinical trial, known as the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial, to be presented at the American Heart Association (AHA) Scientific Sessions, November 18, 2013, demonstrates that spironolactone did not reduce the primary outcome of cardiovascular death, heart failure hospitalisation, nor surviving a cardiac arrest in patients with heart failure and preserved ejection fraction. However, spironolactone did reduce the major burden faced by these patients—the risk of repeated hospitalizations for heart failure
The trial enrolled 3,445 participants from 270 medical centers in six countries. Participants were randomly assigned to receive either spironolactone (target dose of 30 milligrams/day) or matching placebo, and were followed for an average of nearly 3.5 yrs. Moreover, participants were also treated for other co-existing conditions (e.g., diabetes, high blood pressure, etc.).
According to the researchers, patients randomised to spironolactone were less likely to be hospitalised for heart failure compared to those on a placebo. At the end of the study, 206 out of 1722 patients on spironolactone 12% had been hospitalised for heart failure, compared to 245 of 1723 patients 14% given the placebo. There were no statistically significant differences between the groups in deaths or hospitalisations from any cause.
“At present, therapy for this large proportion of patients with heart failure is empiric, and there remains a huge unmet need,” said Scott Solomon, MD, director of BWH Noninvasive Cardiology, who also led the core echocardiography lab for the study.
“While these patients also suffer heart attacks and strokes, hospitalisations for heart failure represent their predominant problem, which is also a major burden to society,” said Eldrin Lewis, MD, advanced heart failure specialist, BWH Division of Cardiovascular Medicine, Department of Medicine, who chaired the TOPCAT Clinical Endpoints Committee.
“When treating our patients, clinicians are always balancing risks and benefits,” said Akshay S. Desai, MD, MPH, advanced heart failure specialist, BWH Division of Cardiovascular Medicine, Department of Medicine. “The results of TOPCAT will help inform clinicians as they make treatment decisions for this understudied population,” Added Desai, “If clinicians choose to use this therapy, they must be vigilant about monitoring for serum markers of kidney and electrolyte disorders which can be exacerbated by spironolactone.”