This study is part of the European centralized marketing authorization application of PRILACTONE (Ceva Santé Animale, Libourne, France), granted in June 2007 by the European Medicines Agency (EMEA).
Efficacy of Spironolactone on Survival in Dogs with Naturally Occurring Mitral Regurgitation Caused by Myxomatous Mitral Valve Disease
Article first published online: 25 JAN 2010
Copyright © 2010 by the American College of Veterinary Internal Medicine
Journal of Veterinary Internal Medicine
Volume 24, Issue 2, pages 331–341, March/April 2010
How to Cite
Bernay, F., Bland, J.M., Häggström, J., Baduel, L., Combes, B., Lopez, A. and Kaltsatos, V. (2010), Efficacy of Spironolactone on Survival in Dogs with Naturally Occurring Mitral Regurgitation Caused by Myxomatous Mitral Valve Disease. Journal of Veterinary Internal Medicine, 24: 331–341. doi: 10.1111/j.1939-1676.2009.0467.x
- Issue published online: 1 MAR 2010
- Article first published online: 25 JAN 2010
- Submitted February 25, 2009; Revised September 21, 2009; Accepted November 30, 2009.
- Clinical trial;
- Evidence based medicine;
- Heart failure
Background: Spironolactone, an aldosterone antagonist, has been demonstrated to decrease mortality in human patients when added to other cardiac therapies.
Hypothesis: Spironolactone in addition to conventional therapy increases survival compared with conventional therapy in dogs with naturally occurring myxomatous mitral valve disease (MMVD).
Animals: Between February 2003 and March 2005, 221 dogs were recruited in Europe. Nine dogs were excluded from analysis, leaving 212 dogs with moderate to severe mitral regurgitation (MR) caused by MMVD (International Small Animal Cardiac Health Council classification classes II [n = 190] and III [n = 21]).
Methods: Double-blinded, field study conducted 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). Primary endpoint was a composite of cardiac-related death, euthanasia, or severe worsening of MR.
Results: Primary endpoint reached by 11/102 dogs (10.8%) in the spironolactone group (6 deaths, 5 worsening) versus 28/110 (25.5%) in control group (14 deaths, 8 euthanasia, 6 worsening). Risk of reaching the composite endpoint significantly decreased by 55% (hazard ratio [HR] = 0.45; 95% confidence limits [CL], 0.22–0.90; log rank test, P= .017). Risk of cardiac- related death or euthanasia significantly reduced by 69% (HR = 0.31; 95% CL, 0.13–0.76; P= .0071). Number of dogs not completing the study for cardiac and other miscellaneous reasons similar in spironolactone (67/102) and control groups (66/110).
Conclusion and Clinical Importance: Spironolactone added to conventional cardiac therapy decreases the risk of reaching the primary endpoint (ie, cardiac-related death, euthanasia, or severe worsening) in dogs with moderate to severe MR caused by MMVD.