Abstract
Background: Hypothyroidism is a common endocrine disorder in India. The aim of therapy in hypothyroidism is to achieve euthyroid state, assessed by measuring serum TSH levels. Despite the fact that treatment of hypothyroidism should be straight forward, a significant percentage of hypothyroid patients treated with thyroxine have TSH values outside the normal range. Objective: To assess the percentage of primary hypothyroid patients with abnormal thyroid functions despite being prescribed levothyroxine for at least 2 months prior to enrolment. Materials and Methods: This was an observational, cross sectional study which included adult patients with primary hypothyroidism, who were on treatment with stable dose of levothyroxine for at least 2 months. A total of 500 subjects,who came for routine visit, were included in the study after fulfilling inclusion criteria. A comprehensive Statistical Analysis Plan (SAP) version 11 was used for the data analysis. Result: A total of 500 patients with primary hypothyroidism were enrolled in the study. Average daily dose of levothyroxine was found to be 1.24 µg/kg/day. The majority of patients (80%) were compliant to treatment. Twelve percent patients were moderately compliant while 8% patients were non-compliant to treatment. Among the 500 patients, 280 (56%) patients were found to have abnormal thyroid function, out of 280 patients, 198 (39.6%) were under-treated and 82 (16.4%) patients were over-treated. Conclusion: This study revealed that although being largely compliant to treatment, a significant number of Indian patients with primary hypothyroidism have abnormal serum TSH values, despite being prescribed a stable dose of levothyroxine for at least 2 months.