A Prospective, Randomized, Masked, Placebo-Controlled Clinical Study of Capromorelin in Dogs with Reduced Appetite.

Abstract

BACKGROUND: Reduced appetite is a common clinical sign in dogs. This study evaluated the effectiveness and safety of capromorelin oral solution, (ENTYCE, Aratana Therapeutics, Leawood, KS) a new drug that is a ghrelin receptor agonist, for stimulation of appetite in dogs with reduced appetite. HYPOTHESIS/OBJECTIVES: Capromorelin will increase appetite, as measured by the owner's evaluation, over 4&#xa0;days. An additional objective was to evaluate the safety of capromorelin at the labeled dose. ANIMALS: A total of 244 client-owned dogs reported by owners to be inappetent for at least 2&#xa0;days were enrolled, with 177 cases in the effectiveness analysis. METHODS: In this prospective, randomized, masked, placebo-controlled study, dogs were treated daily with capromorelin (3&#xa0;mg/kg) oral solution (n&#xa0;=&#xa0;121) or placebo oral solution (n&#xa0;=&#xa0;56). Owners completed an evaluation of appetite at days 0 and 3&#xa0;&#xb1;&#xa0;1. Success was defined as improvement in appetite at day 3. Safety was evaluated by physical examination, clinical pathology, and monitoring adverse events and owner observations. RESULTS: Capromorelin treatment improved appetite compared to placebo (68.6% and 44.6% treatment successes with 95% CI 59.7, 76.3 and 32.2, 57.8, respectively, P&#xa0;=&#xa0;.008). Mean body weight in capromorelin-treated dogs increased compared to placebo-treated dogs (1.8% with 95% CI 1.3, 2.3, and 0.1% with 95% CI 0.9, 1.1, respectively, P&#xa0;<&#xa0;.001). Adverse reactions occurring in >5% of either group were diarrhea and vomiting. CONCLUSIONS AND CLINICAL IMPORTANCE: Capromorelin oral solution is an effective treatment for stimulation of appetite in dogs and represents the first ghrelin receptor agonist shown to be effective for this indication.