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document
Clinical evaluation of imidapril in congestive heart failure in dogs : results of the EFFIC study . 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 .
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Intervention_Pharmacological
imidapril
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Intervention_Pharmacological
imidapril
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Intervention_Pharmacological
imidapril
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Intervention_Pharmacological
imidapril
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Intervention_Pharmacological
benazepril
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Intervention_Pharmacological
imidapril
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Intervention_Pharmacological
benazepril
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Outcome_Other
efficacy and safety
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Outcome_Physical
evolution of the New York Heart Association stage
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Outcome_Physical
" functional signs " score
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Outcome_Other
success rate
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Outcome_Adverse-effects
adverse event .
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Outcome_Adverse-effects
serious adverse
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Participant_Condition
congestive heart failure in dogs :