RESUMEN
OBJECTIVES: The clinical efficacy and safety of imidapril were evaluated in dogs that presented with mild to severe congestive heart failure (New York Heart Association stage II to IV) by comparing the success rate of imidapril with a positive control by a non-inferiority approach. METHODS: This good, clinical practice compliant, multicentre study (EFFIC study) enrolled 142 client-owned dogs and was conducted in 20 locations in France, Belgium and Germany. Dogs of various breed, age and weight were included in the study. These dogs were randomised into two groups that were treated for 84 days with either the test product, imidapril, or the positive control, benazepril, and followed up in parallel over this period. Both treatments were administered at a dose of 0.25 mg/kg once a day with the possibility of doubling this dose to 0.5 mg/kg if considered necessary from a clinical point of view. In addition, concomitant treatment was given to dogs presenting with pulmonary oedema and/or ascites, supraventricular tachyarrhythmia and/or dilated cardiomyopathy. The evolution of the New York Heart Association stage and the "functional signs" score were evaluated as primary efficacy criteria. RESULTS: The success rate in the imidapril group was 66 compared with 68 per cent in the benazepril group. Regarding safety, 35 dogs in each group experienced at least one adverse event. Nine dogs in each group experienced at least one serious adverse event. The difference between these results was not statistically significant. CLINICAL SIGNIFICANCE: Imidapril is as efficacious and safe as the reference product, benazepril.