August 30th, 2011

New Results from EMPHASIS-HF Show Big Benefits For High-Risk Subgroups Taking Eplerenone

Last November the main results of the EMPHASIS-HF trial demonstrated that eplerenone was significantly better than placebo in reducing the risk for death and hospitalization in patients with systolic heart failure and mild symptoms. Now a new analysis of the trial, presented by Bertram Pitt at the European Society of Cardiology meeting in Paris, reinforces the earlier findings — and demonstrates an especially dramatic benefit in multiple high-risk subgroups.

Because EMPHASIS-HF was terminated early for efficacy, there was a possibility that the observed effect seen in the trial might have been exaggerated. In some countries, however, where eplerenone was not commercially available, the blinded study continued. Pitt therefore showed the results for the primary endpoint for an additional 10 months, in which no discernible attenuation of effect was observed:

  • CV death or hospitalization for heart failure until March 2011: 21.1% for eplerenone versus 28.5% for placebo (HR 0.66, CI 0.57-0.77, p<0.0001)

Pitt also presented the results for high-risk subgroups, showing large reductions in the primary endpoint:

  • Age 75 or older: 23.6% versus 32.7%, HR 0.66, CI 0.49-0.88, p=0.004
  • Type 2 diabetes: 21.6% versus 35.3%, HR 0.54, CI 0.42-0.70, p<0.0001
  • Renal impairment: 24.4% versus 34.5%, HR 0.62, CI 0.49-0.79, p<0.0001
  • Systolic BP below median: 20.6% versus 29.4%, HR 0.63, CI 0.51-0.79, p<0.0001
He also reported that although potassium levels increased in patients on eplerenone in the high-risk subgroups, there were no significant increases in serious hyperkalemia or other related problems.

One Response to “New Results from EMPHASIS-HF Show Big Benefits For High-Risk Subgroups Taking Eplerenone”

  1. Shaumik Adhya, MBBS BSc MRCP CCDS says:

    The more patients I see, I realise that NYHA class correlates poorly with LV systolic function. It makes sense to me therefore that treatments proven to be useful in systolic heart failure apply to all patients with systolic LV dysfunction regardless of symptoms. You just need to follow patients up for longer if they’re well to start with, and treatments might be futile in changing the course of disease in really sick patients

    Competing interests pertaining specifically to this post, comment, or both: