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Clinicians urged to consider spironolactone in HFPEF despite TOPCAT results
Date:5/18/2014

in the spironolactone group (18.6%) and 351 of 1723 patients in the placebo group (20.4%) (hazard ratio [HR]=0.89; 95% confidence interval [CI]=0.77 to 1.04; p=0.14).

One component of the primary endpoint, time to heart failure hospitalisations, was reduced significantly. It occurred in 12.0% patients in the spironolactone group and 14.2% in the placebo group (HR=0.83; 95% CI=0.69 to 0.99; p=0.04).

In patients treated with spironolactone there was an associated increase in serum creatinine and the rate of hyperkalemia doubled. But Professor Pitt said: "These alterations did not have adverse affects. There were no deaths attributable to hyperkalemia and no increase in renal failure."

He continued: "The overall results of the trial were negative in that the primary endpoint was not reduced significantly. But when we examine the results by geographical region they tell a different story."

Post-hoc analysis showed that patients recruited from Russia and Georgia had an extremely low placebo event rate that was not compatible with prior HFPEF studies. In contrast, patients from the Americas had an increased placebo event rate that was compatible with previous studies. In the Americas there was a significant reduction in the primary endpoint, including cardiovascular mortality and hospitalisations for heart failure.

Professor Pitt said: "The low placebo event rate in patients from Russia and Georgia was equal to that of patients with hypertension or another cardiovascular risk factor, not heart failure. We suspect that many of the patients from these countries did not have HFPEF, but had shortness of breath due to obesity or lung disease and were misclassified as heart failure. Whereas patients in the Americas did have HFPEF."

He concluded: "My view is that spironolactone works very well in HFPEF patients and our results were diluted by the inclusion of patients without HFPEF. Clinicians should look at our data and mak
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Contact: ESC Press Office
press@escardio.org
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European Society of Cardiology
Source:Eurekalert

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