But when we examine the results by geographical region they tell a different story.”
#TOPCAT STUDY TRIAL#
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 Professor Pitt said: “ These alterations did not have adverse affects. In patients treated with spironolactone there was an associated increase in serum creatinine and the rate of hyperkalemia doubled. 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). One component of the primary endpoint, time to heart failure hospitalisations, was reduced significantly. Nearly half of the patients were from Russia and Georgia, and the remainder were from the Americas which included Canada, the US, Argentina and Brazil.Īfter a mean follow up of 3.3 years, the primary endpoint - which was a composite of reduction in cardiovascular mortality, resuscitated cardiac arrest and hospitalisation for heart failure - was reduced but was not reduced significantly.1 It occurred in 320 of 1722 patients in the spironolactone group (18.6%) and 351 of 1723 patients in the placebo group (20.4%) (hazard ratio =0.89 95% confidence interval =0.77 to 1.04 p=0.14). Patients were recruited from 270 medical centres in 6 countries. TOPCAT randomised 3445 patients with HFPEF to receive spironolactone, a mineralocorticoid receptor antagonist, at a dose of 15-45mg per day or placebo on top of usual care. If I was a clinician I would use spironolactone in my patients with HFPEF.” I think individual clinicians around the world need to look at the data and decide for themselves.
The trial failed to meet its primary endpoint but post-hoc analysis has shown that spironolactone was beneficial in patientsįrom the Americas.
But no studies have found a benefit of these medications in HFPEF patients.” He added: “The results of TOPCAT are complicated. Professor Bertram Pitt said: “We’ve had many studies showing that ACE inhibitors, angiotensin receptor blockers, beta blockers and mineralocorticoid receptor blockers reduce mortality and hospitalisations in patients with heart failure and reduced ejection fraction (HFREF). The research was presented today at the Heart Failure Congress 2014 in Athens, Greece. The Congress is the main annual meeting of the Heart Failure Association of the European Society of Cardiology. Athens, : Clinicians have been urged to consider using spironolactone in their patients with heart failure and preserved ejection fraction (HFPEF) after a post-hoc analysis of the TOPCAT trial showed benefit in patients from the Americas.
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