11 Apr Heart Failure Treatment with Diuretic Spironolactone
MedicalResearch.com: What are the main findings of the study?
Dr. Pfeffer: We randomized 3445 patients with symptomatic heart failure and a left ventricular ejection fraction greater than or equal to 45% (heart failure with preserved ejection fraction or diastolic heart failure) to spironolactone or placebo and followed them for over 3 years. Our primary outcome the composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for management of heart failure was not significantly reduced in the group randomized to spironolactone. We did, however, observe that fewer patients in the spironolactone group were hospitalized for the management of heart failure following randomization. Spironolactone therapy was associated with higher incidence of hyperkalemia and rises in serum creatinine.
MedicalResearch.com: Were any of the findings unexpected?
Dr. Pfeffer: This NHLBI Sponsored study was conducted in six countries and we found a marked regional heterogeneity in the event rates in the placebo-treated arms. In Russia and Georgia, the prognosis of the patients randomized was more benign than in the four other countries in the Americas.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Pfeffer: With the neutral primary finding, our observation of lower risk for subsequent hospitalizations for heart failure must be considered as non-definitive. However, we believe this is a noteworthy finding for this difficult to manage population and, if physicians choose to use spironolactone, the importance of monitoring electrolytes and renal function must be underscored.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Pfeffer: Our study does highlight the heterogeneity of outcomes in patients with signs and symptoms of heart failure yet a relatively preserved ejection fraction. Attempts to better phenotype this diverse group of patients perhaps using echocardiographic measurements beyond ejection fraction and ascertainment of biomarkers such as BNP may help future studies.
Bertram Pitt, M.D., Marc A. Pfeffer, M.D., Ph.D., Susan F. Assmann, Ph.D., Robin Boineau, M.D., Inder S. Anand, M.D., Brian Claggett, Ph.D., Nadine Clausell, M.D., Ph.D., Akshay S. Desai, M.D., M.P.H., Rafael Diaz, M.D., Jerome L. Fleg, M.D., Ivan Gordeev, M.D., Ph.D., Brian Harty, M.A., John F. Heitner, M.D., Christopher T. Kenwood, M.S., Eldrin F. Lewis, M.D., M.P.H., Eileen O’Meara, M.D., Jeffrey L. Probstfield, M.D., Tamaz Shaburishvili, M.D., Ph.D., Sanjiv J. Shah, M.D., Scott D. Solomon, M.D., Nancy K. Sweitzer, M.D., Ph.D., Song Yang, Ph.D., and Sonja M. McKinlay, Ph.D. for the TOPCAT Investigators