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EMPATHY: A new tool for identifying the most suitable thyroxine formulation in hypothyroid patients

Giuseppe Bellastella, Mariangela Caputo, Maria Ida Maiorino, Miriam Longo, Lorenzo Scappaticcio, Dario Giugliano, Katherine Esposito
Thyroid: Official Journal of the American Thyroid Association 2019 April 9

Therapy of hypothyroidism is based on the administration of appropriate doses of L-thyroxine (L-T4). A failure to achieve the TSH target may be due to poor compliance with the L-T4 therapy in about 60% of cases or to malabsorption in about 40% of cases. No tools are available for detecting malabsorption disorders before the choice of the most appropriate therapy. The aim of this study is to validate the EMPATHY questionnaire and to demonstrate its usefulness in indicating the most appropriate therapy.

PATIENTS AND METHODS: EMPATHY (Evaluation of Malabsorption in PATients with HYpothyroidism) is a questionnaire consisting of seven questions that allow the evaluation of several intolerances and allergies. Three hundred (100 males and 200 females) newly diagnosed hypothyroid patients were enrolled and randomly assigned to complete an EMPATHY questionnaire (150 patients, Group 1) or to a control group (150 patients, Group 2). The choice of thyroxine formulation and dose for each group was made on the basis of the questionnaire answers or of the history. Thyroid hormones and TSH were evaluated at enrollment and every two months for six months; the number of the dose adjustments in the six months for each patient was recorded.

RESULTS: Twenty-one of 150 (14%) patients in Group 1 and 42 of 150 in Group 2 (28%, p = 0.005) needed more than two dose adjustments within six months. After six months of replacement therapy, 6 of 150 patients (4%) in Group 1 and 17 of 150 (11%) in Group 2 (p = 0.03) could not control their disease (TSH ≥ 2.5 mIU/L). We found a significant higher L-T4 final dose in the Group 2 (148±33 µg/day) than in the group 1 (136±28 µg/day; p=0.003).

CONCLUSIONS: Validation of EMPATHY provides endocrinologists with an useful tool in clinical practice, permitting a better personalization of L-T4 replacement therapy, a more rapid attainment of the target TSH levels and less need of subsequent dose adjustments.


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