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'No clinical improvement' with spironolactone

Patients with heart failure with preserved ejection fraction have improved diastolic function when taking spironolactone, compared with placebo, but no significant change in clinical outcomes.

The study

Some 422 patients aged 50 or over with HFPEF were randomised to receive either spironolactone 25 mg/day or placebo. All patients had symptoms consistent with New York Heart Association class II or III and a left ventricular ejection fraction of 50% or greater. They were followed for 12 months, with physical examination, echocardiography and exercise testing occurring at baseline, six months and 12 months.

The findings

Spironolactone significantly improved diastolic function when compared with placebo. The echocardiographic estimate of filling pressure declined from 12.7 E/e’ to 12.1 E/e’ at 12 months in the spironolactone group, compared to an increase in the placebo group from 12.8 E/e’ to 13.6 E/e’. This difference was evident also evident at six months. However, these results did not translate into improvements in quality of life, depressive symptoms or heart failure symptoms, with no significant differences between groups for these outcomes.

What does it mean for GPs?

The German authors noted that spironolactone ‘is the first drug to show an improvement in diastolic function among patients with HFPEF in a randomised, double-blind, placebo-controlled trial,’ but added that the ‘beneficial effects of spironolactone on diastolic function were not associated with any clinical improvement.’

Expert comment

Dr Clare J Taylor, academic GP in Edgbaston and research fellow in cardiovascular disease at the University of Birmingham: ‘Whilst echo findings were improved, the important clinical outcome of symptoms and quality of life was similar for both groups. Although the improvement in echocardiographic parameters is of some interest, the authors correctly conclude that this study does not provide evidence for use of spironolactone clinically in patients with diastolic heart failure. The search for effective therapies to improve patient’s symptoms, and survival rates, continues.’

JAMA 2013, online 26 February

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