ECE2023 Oral Communications Oral Communications 2: Thyroid (6 abstracts)
Randomized double-blind placebo-controlled trial on levothyroxine and liothyronine combination therapy: The levolio study
Giulia Brigante 1,2 , Daniele Santi 1,2 , Gisella Boselli 1 , Gianluca Margiotta 1 , Rossella Corleto 1 , Maria Laura Monzani 1,2 , Andrea Craparo 1 , Michela Locaso 1 , Samantha Sperduti 1,3 , Neena Roy 1 , Livio Casarini 1,3 , Tommaso Trenti 4 , Manuela Varani 4 , Maria Cristina De Santis 4 , Laura Roli 4 , Vincenzo Rochira 1,2 & Manuela Simoni 1,2,3
1University of Modena and Reggio Emilia, Unit of Endocrinology, Department of Biomedical, Metabolic and Neural Sciences, Modena, Italy; 2Azienda Ospedaliero-Universitaria of Modena, Unit of Endocrinology, Department of Medical Specialties, Modena, Italy; 3University of Modena and Reggio Emilia, Center for Genomic Research, Modena, Italy; 4Azienda USL Modena, Department of Laboratory Medicine and Anatomy Pathology, Modena, Italy
Introduction: Despite normal thyroid-stimulating hormone serum levels, up to 60% of hypothyroid patients are dissatisfied with the treatment. Animal studies suggest that the persistence of symptoms may derive from peripheral hypothyroidism. Combination treatment with levothyroxine and liothyronine is a theoretically plausible solution but its efficacy is still questionable.
Aim: To evaluate the effects of personalized twice-daily combination therapy on peripheral tissues and quality of life in thyroidectomized patients, considering also the influence of genetic variants of DIO2 and MCT10.
Methods: Double-blind, randomized, placebo-controlled study in which 141 thyroidectomized subjects, with serum thyroglobulin<0.2 ng/ml and negative anti-thyroglobulin antibodies, with TSH within the normal range, were randomized to study (levothyroxine+liothyronine in the morning and liothyronine in the evening; n=70) or placebo group (levothyroxine + placebo in the morning and placebo in the evening; n=71). Pituitary-thyroid axis compensation was assessed after 6, 12 and 24 weeks. Clinical parameters, quality of life (evaluated with ThyPro-39 questionnaire), tissue markers (sex hormone binding globulin, serum lipids, bone metabolism markers) were evaluated at 12 and 24 weeks. DIO2 and MCT10 single nucleotide polymorphisms were genotyped.
Results: At baseline, both groups had free triiodothyronine/thyroxine (fT3/fT4) ratio below the physiologic range, which normalized after 6 months only in the study group (0.32 ± 0.08 vs 0.26 ± 0.05, P<0.001). Combination treatment required greater dose adjustments (25% vs 54%, P<0.001), due to TSH reduction below the reference range, with no signs or symptoms of hyperthyroidism. After 6 months, the study group had improved emotionality, anxiety, depression, and overall impact of the disease on quality of life (P<0.05). However, no preference for combination therapy was recorded. Tissue markers of peripheral thyroid function and BMI did not change in either group. Genetic variants did not influence any of the analyzed outcomes.
Conclusions: Six months of combination treatment normalizes fT3/fT4 ratio, improves quality of life but does not lead to changes in known tissue markers. However, therapeutic schemes and liothyronine formulation still need to be improved.
Volume 90
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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