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Capromorelin for Appetite Stimulation in Dogs 1857

(3 mg/kg). The drug was well tolerated, and no drug independent contractor for Aratana and was also
9
accumulation was seen with daily dosing. Longer term blinded until the study database were locked.
studies will be required to demonstrate continued effec- Off-label Antimicrobial Declaration: Authors declare
tiveness over time. Another limitation of this study was no off-label use of antimicrobials.
that given the study population size, it is unlikely that
rare adverse events would have been detected. The sam-
ple size was calculated to detect a treatment effect on
appetite stimulation, not based on differences in safety Footnotes
variables. Wider clinical use is required to fully evaluate
a Ò
the risk/benefit of any new therapeutic agent. ENTYCE , Aratana Therapeutics, Leawood, KS
b TM
This study indicates that the ghrelin receptor agonist, Cerenia , Zoetis, Kalamazoo, MI
c PASS 11, NCSS, LLC, Kaysville, UT
capromorelin, when given orally once daily at 3 mg/kg d
for 4 days to dogs with a reduced appetite, results in Owner Appetite Assessment questionnaire ©2016, available at
www.aratana.com
increased appetite and body weight when compared to e Ò
SAS , Version 9.3.1, SAS Institute, Inc., Cary, NC
placebo. Furthermore, in dogs of varying ages and
breeds with concomitant medications and clinical condi-
tions, capromorelin-related adverse events were mild
and some of the adverse events were consistent with a References
restored appetite. Although serious adverse events were
documented, none were attributed to capromorelin 1. Smith RG. Development of growth hormone secretagogues.
treatment and were not unexpected in the population of Endoc Rev 2005;26:346–360.
sick, inappetent dogs enrolled in this study. These data 2. Wren AM, Seal LJ, Cohen MA, et al. Ghrelin enhances
support the conclusion that capromorelin represents a appetite and increases food intake in humans. J Clin Endocrinol
Metbol 2001;86:5992–5996.
promising new treatment modality for appetite stimula- 3. Yokoyama M, Nakahara K, Kojima M, et al. Influencing
tion in dogs. The FDA approval of capromorelin oral the between-feeding and endocrine responses of plasma ghrelin in
Ò a
solution (ENTYCE ) represents the first regulatory healthy dogs. Eur J Endocrin 2005;152:155–160.
approval, either veterinary or human, of a drug with 4. Garcia JM, Boccia RV, Graham CD, et al. Anamorelin for
this mechanism of action, that is, a ghrelin receptor patients with cancer cachexia: An integrated analysis of two phase
agonist. 2, randomised, placebo-controlled, double-blind trials. Lancet
Oncol 2015;16:108–116.
5. Carpino PA, Lefker B, Toler SM, et al. Pyrazolinone-piperi-
Acknowledgments
dine dipeptide growth hormone secretagogues (GHS): Discovery
The authors acknowledge Georgiana Syby, of capromorelin. Bioorg Med Chem 2008;11:581–590.
Jonathan Hopper, and the staff at AlcheraBio in Edi- 6. Zollers B, Rhodes L, Smith RG. Capromorelin increases
son, NJ for assistance in conducting the study, and food consumption, body weight, growth hormone and sustained
insulin-like growth factor-1 concentrations when administered to
the following investigators: A. Cistola, B. Harris, B. healthy adult Beagle dogs. J Vet Pharm Ther 2016 doi:10.1111/
Witzel, D. Bain, D. Knaak, D. Menard, E. Jezbera, jvp.12344.
H. Robinson, J. Bruening, J. DeBiasio, J. Steen, J. 7. Zollers B, Rhodes L. Capromorelin, an orally active ghrelin
Teeter, K. Rowland, M. Girone, M. Petty, R. Car- agonist, stimulates appetite and weight gain in inappetent dogs in
penter, R. Sifferman, M. Wiest, S. Baker, S. Geller, a multi-site field study. J Vet Intern Med 2014;28:1032.
S. Kingsley, S. Yoshimoto, T. Clekis, T. Newcomer, 8. Brown DC, Bell M, Rhodes L. Power of treatment success
and V. Manoharan. definitions when the Canine Brief Pain Inventory is used to evalu-
Conflict of Interest Declaration: This clinical study ate carprofen treatment for control of pain and inflammation in
was conducted at 24 veterinary hospitals throughout dogs with osteoarthritis. Am J Vet Res 2013;74:1467–1473.
9. Zollers B, Huebner M, Armintrout G, et al. Evaluation of
the United States and was funded by Aratana Thera- safety in dogs of long-term, daily oral administration of capro-
peutics in support of FDA approval of ENTYCE Ò morelin, a novel drug for stimulation of appetite. J Vet Pharm
(capromorelin oral solution). J.A. Wofford and E. Hei- Ther 2016 doi:10.1111/jvp.12358.
nen are current employees of Aratana Therapeutics,
and B. Zollers and L. Rhodes are former employees of Supporting Information
Aratana Therapeutics; all of these authors have stock,
stock options, or both in the company.
Additional Supporting Information may be found
An independent contract research organization was
online in the supporting information tab for this article:
employed to manage study conduct on behalf of the
company. As the sponsor of the study, Aratana’s
Fig S1. Distribution of Total Scores on the Owner
employees were blinded to treatment group until the
study database were locked at the end of the study. Appetite Assessment questionnaire for the capromore-
E. Heinen, B. Zollers, and L. Rhodes are on patents for lin- (n = 121) and placebo-treated (n = 56) groups on
capromorelin. L. Rhodes has retired and now serves as day 0 and day 3 1.
a consultant to Aratana. M. Huebner works as an Data S1. Dog Owner Appetite Assessment.