A Pivotal Field Study to Support the Registration of Levothyroxine Sodium Tablets for Canine Hypothyroidism

Abstract

ABSTRACT A prospective, pivotal, multicenter field study to evaluate the dose regimen, effectiveness, and safety of levothyroxine sodium tablets, USP for the treatment of hypothyroidism and hypothyroidism-associated clinical signs in dogs was conducted. Ninety-two dogs diagnosed with primary hypothyroidism met the entrance criteria and were enrolled into the study. Levothyroxine sodium was administered to each dog on a daily basis either as the whole dose q 24 hr or as half the dose q 12 hr. Dosing started at 0.1 mg/10 lb (0.022 mg/kg) and continued for approximately 6 mo to Day 182. During this time, the thyroid status of each dog was evaluated at monthly intervals. For the determination of effectiveness, dogs classified as euthyroid at Day 182, based on their thyroid hormone values, were considered treatment successes. Results of the statistical analysis showed that there was no difference between the two dosing regimens (P = .11) and that when the data from both groups were pooled, the overall success rate was 75.64% (95% confidence interval = 66.34%). By Day 182, improvement and/or resolution of hypothyroidism-associated clinical signs was observed in all categories. No abnormal trends in the reported adverse events were observed.