Efficacy and Safety
A faster improvement in clinical signs has been observed compared to benazepril alone 1,2,3
Improvement of heart failure symptoms: difference between the time to improvement observed in dogs treated with benazepril alone versus dogs treated with CARDALIS™ (significant difference p<0.05).
…and safe when used with concomitant therapy(e.g., furosemide)4
Renal parameters mean values:
• remained within the reference range
• did not change significantly over the 12-month study duration
The BESST Study - a pivotal efficacy study for FDA approval of CARDALIS™5
|569 dogs enrolled in the study|
* Treatment failure = occurrence of cardiac death/euthanasia due to cardiac cause or worsening/occurrence of cardiac signs
LARGEST CLINICAL TRIAL CONDUCTED TO DATE IN CARDIAC DOGS
CARDALIS resulted in a statistically significant improvement in survival times for CHF patients* in a recently completed clinical trial5.
- Data on file: Cardalis™. Marketing authorization file, CEVA Santé Animale, 2012.
- Cardalis™. CVMP assessment report. EMA. August 2012. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Public_assessment_report/veterinary/002524/WC500131472.pdf
- Cardalis™. EPAR product information. June 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/veterinary/002524/WC500131473.pdf.
- Freedom of Information Summary, NADA #141-538 (July 27, 2020), CARDALIS.
- Coffman, M Guillot, E Blondel, T, et al. Clinical efficacy of a benazepril and spironolactone combination in dogs with congestive heart failure due to myxomatous mitral valve disease: The BEnazepril Spironolactone STudy (BESST)J Vet Intern Med 2021 1 15
CARDALIS and the CARDALIS logo trademarks are the property of Ceva Santé Animale S.A.
Important Safety Information
Do not administer in conjunction with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with renal insufficiency. Do not use in dogs with hypoadrenocorticism (Addison’s disease), hyperkalemia or hyponatremia. Do not use in dogs with known hypersensitivity to ACE inhibitors or spironolactone. The safety and effectiveness of concurrent therapy of CARDALIS™ with pimobendane has not been evaluated. The safety of CARDALIS™ has not been evaluated in pregnant, lactating, breeding, or growing dogs. CARDALIS™ administration should begin after pulmonary edema is stabilized. Regular monitoring of renal function and serum potassium levels is recommended. Common side effects from a field study include anorexia, vomiting, lethargy, diarrhea and renal insufficiency.