Effect of Spironolactone on Physical Performance in Older People with Self-reported Physical Disability

BACKGROUND: Interventions that improve muscle function may slow decline in physical function and disability in later life. Recent evidence suggests that inhibition of the renin-angiotensin-aldosterone system may maintain muscle function. We evaluated the effect of aldosterone blockade on physical performance in functionally impaired older people without heart failure. METHODS: In this parallel-group, double-blind, randomized, placebo-controlled trial, community-dwelling participants aged >= 65 years with self-reported problems with activities of daily living were randomized to receive 25 mg spironolactone or identical placebo daily for 20 weeks. The primary outcome was change in 6-minute walking distance over 20 weeks. Secondary outcomes were changes in Timed Up and Go test, Incremental Shuttle Walk Test, Functional Limitation Profile, EuroQol EQ-5D, and Hospital Anxiety and Depression Scale over 20 weeks. RESULTS: Participants' mean (standard deviation) age was 75 (6) years. Of the 93% of participants (112/120) who completed the study, 106 remained on medication at 20 weeks. There was no significant difference in change in 6-minute walking distance at 20 weeks between the spironolactone and placebo groups (mean change, -3.2 m; 95% confidence interval, -28.9 to 22.5; P =.81). Quality of life improved significantly at 20 weeks, with an increase in EuroQol EQ-5D score of 0.10 (95% confidence interval, 0.03-0.18; P < .01) in the spironolactone group relative to the placebo group. There were no significant differences in between-group change for other secondary outcomes. CONCLUSIONS: Spironolactone was well tolerated but did not improve physical function in older people without heart failure. Quality of life improved significantly, and the possible mechanisms for this require further study. (C) 2013 Elsevier Inc. All rights reserved.