This study is part of the European centralized marketing application of PRILACTONE (Ceva Santé Animale, Libourne, France), granted in June 2007 by the European Medicines Agency (EMEA). This study was supported by Ceva Santé Animale, Libourne, France.
Safety of Spironolactone in Dogs with Chronic Heart Failure because of Degenerative Valvular Disease: A Population-Based, Longitudinal Study
Article first published online: 19 JUL 2013
Copyright © 2013 by the American College of Veterinary Internal Medicine
Journal of Veterinary Internal Medicine
Volume 27, Issue 5, pages 1083–1091, September/October 2013
How to Cite
Lefebvre, H.P., Ollivier, E., Atkins, C.E., Combes, B., Concordet, D., Kaltsatos, V. and Baduel, L. (2013), Safety of Spironolactone in Dogs with Chronic Heart Failure because of Degenerative Valvular Disease: A Population-Based, Longitudinal Study. Journal of Veterinary Internal Medicine, 27: 1083–1091. doi: 10.1111/jvim.12141
- Issue published online: 13 SEP 2013
- Article first published online: 19 JUL 2013
- Manuscript Accepted: 4 JUN 2013
- Manuscript Revised: 10 APR 2013
- Manuscript Received: 24 JUL 2012
- Reference interval;
- Renal function
Spironolactone treatment in humans is associated with an increased risk of hyperkalemia and renal dysfunction.
Dogs with cardiac disease treated with spironolactone, in addition to conventional therapy, are not at higher risk for adverse events (AEs) than those receiving solely conventional therapy.
One hundred and ninety-six client-owned dogs with naturally occurring myxomatous mitral valve disease.
Prospective, double-blinded field study with dogs randomized to receive either spironolactone (2 mg/kg once a day) or placebo in addition to conventional therapy (angiotensin-converting enzyme inhibitor, plus furosemide and digoxin if needed). Safety was compared between treatment groups, using the frequency of AEs, death caused by cardiac disease, renal disease, or both, and variations in serum sodium, potassium, urea, and creatinine concentrations. For the latter, population-specific reference intervals were established and out of range values (ORV) analyzed.
The number of AEs was similar in the spironolactone and reference groups (188 and 208, respectively), when followed for median duration of 217 days (range [2–1,333]). At each study time point, the percentage of dogs showing ORV was similar between groups. There were a higher number of deaths because of cardiac disease, renal disease or both in the reference group (30.7% versus 13.7%) (P = .0043).
Conclusions and Clinical Importance
Dogs with heart failure receiving spironolactone in addition to conventional treatment are not at a higher risk for AEs, death caused by cardiac disease, renal disease, or both, hyperkalemia, or azotemia.