Eight cats developed cystitis with or without urethral obstruction throughout the study in all groups. Three cats (one from each mirtazapine dose group) were isosthenuric. Polydipsia was observed in one cat in the 5.3 mg/kg group. Frank blood in the stool was infrequently observed in the vehicle control, 3.2, and 5.3 mg/kg groups. Mirtazapine administration resulted in increased vocalization, hyperactivity, attention-seeking behaviors, and tremors in all mirtazapine dose groups. Erythema, crusting, alopecia, and scabbing of the skin, mostly around the head and neck, was frequently observed in all groups and occasionally affected the tail, tarsi or carpi, likely due to spread of the ointment to these areas by self-grooming. Inner and outer pinna erythema, flaking, alopecia, and thickening were observed in all cats in all groups. A 95% confidence interval on the mean percent change in body weight for the Mirataz group is (2.77, 5.11), demonstrating that the mean percent change is statistically different from and greater than 0.Īpplication of mirtazapine and vehicle control was associated with ear flicking, head shaking, pulling away/flinching and infrequently with struggling/fractious behavior, and hypersalivation. The difference between the two groups was significant (p<0.0001) based on a two-sample t-test assuming equal variances. The primary effectiveness endpoint was the mean percent change in body weight from Day 1 to the Week 2 Visit.Īt Week 2, the mean percent increase in body weight from Day 1 was 3.94% in the mirtazapine group and 0.41% in the vehicle control group. The dosage was a 1.5-inch ribbon (approximately 2 mg/cat) mirtazapine or vehicle ointment administered topically to the inner pinna of the cat's ear.Ī total of 177 cats were determined to be eligible for the effectiveness analysis 83 cats were in the Mirataz group and 94 cats were in the vehicle control group. The cats were 2.8-24.6 years of age and weighed 2.1-9.2 kg. A total of 230 cats were enrolled and received either Mirataz (115 cats) or a vehicle control (115 cats) containing the same inert ingredients without mirtazapine. Cats were randomized to treatment groups in a 1:1 ratio of Mirataz to vehicle control. Some cats had more than one pre-existing condition. The most common pre-existing conditions included renal insufficiency, vomiting, and hyperthyroidism. The effectiveness of Mirataz (mirtazapine transdermal ointment) was demonstrated in a randomized, double-masked, vehicle-controlled, multi-site field study involving client-owned cats of various breeds.Įnrolled cats were ≥ 1 year of age and had existing documented medical history of ≥ 5% weight loss deemed clinically significant. To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Dechra at (866) 933-2472.įor additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at Following cessation of Mirataz, four cats were reported as being less social or less restless, one cat was reported as more active, and one cat was reported with increased hissing and urinating out of the litter box. Post study, follow-up was done in 199 cats (103 in the Mirataz (mirtazapine transdermal ointment) group and 96 in the vehicle control group). The BUN in the Mirataz group was 43.60 mg/dL (reference range 16-37 mg/dL) compared to 36.05 mg/dL in the vehicle control group. † At Week 2, blood urea nitrogen (BUN) values were significantly higher in the Mirataz group compared to the vehicle control group (p<0.10). Euthanasia was elected and necropsy revealed hypertrophic cardiomyopathy, bilateral parathyroid hyperplasia, and mild to moderate renal disease. The cat was enrolled with a history of chronic kidney disease. * One cat with renal insufficiency was reported with a serious adverse reaction of acute renal failure, hematuria, and pyuria at the Week 2 visit. Adverse Reactions Reported During the Field Study Adverse Reaction
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