Italian guidelines for the management of adult individuals with primary hypothyroidism outside pregnancy

Rinaldo Guglielmi^#¹, Caterina Mian^#², Roberto Novizio^{3

4}, Agostino Paoletta⁵, Agnese Persichetti^{6

7}, Irene Samperi⁸, Alessandro Scoppola⁹, Marcello Bagnasco¹⁰, Ernesto De Menis^{11

12}, Maria Luisa De Rimini¹³, Marco Raffaelli^{14

15}, Maria Gabriella Rugiu¹⁶, Claudio Andreoli¹⁷, Marco Boniardi¹⁸, Giulia Fiorentini¹⁹, Pietro Locantore^{14

20}, Enrico Papini¹, Federica Presciuttini²¹, Silvia Rizzati²², Marsida Teliti²³, Doris Tina²⁴, Vincenzo Triggiani²⁵, Annibale Versari²⁶, Camilla Virili²⁷, Marina Vitillo²⁸, Michele Basile²⁹, Fabio Cruciani³⁰, Zuzana Mitrova³⁰, Rosella Saulle³⁰, Ilaria Valentini²⁹, Mirco Bartolomei³¹, Giulia Bertino³², Pietro Giorgio Calò³³, Federica D'Aurizio³⁴, Caterina Di Cosmo³⁵, Andrea Frasoldati³⁶, Massimo Marchetti³⁷, Rosa Elisa Miceli³⁸, Salvatore Monti³⁹, Alfredo Pontecorvi^{14

20}, Mario Rotondi²³, Roberto Attanasio⁴⁰

Affiliations

¹ Lifenet Health Group, Endocrinology, Regina Apostolorum Hospital, Albano Laziale, RM, Italy.
² Endocrinology, Department of Medicine DIMED, University of Padua, Padua, Italy.
³ Catholic University of the Sacred Heart, Rome, Italy. robertonovizio@gmail.com.
⁴ Endocrinology Unit, AORN A. Cardarelli, Naples, Italy. robertonovizio@gmail.com.
⁵ Endocrinology, ULSS6 Euganea, Padua, Italy.
⁶ Ministry of Interior - Department of Firefighters, Public Rescue and Civil Defense, Rome, Italy.
⁷ Department of Human Sciences and Promotion of the Quality of Life, San Raffaele Roma Open University, Rome, Italy.
⁸ Endocrinology, ASL Novara, Novara, Italy.
⁹ UOSD Endocrinologia, ASL Roma 1, Rome, Italy.
¹⁰ AIT President, Endocrinology Unit, Department of Internal Medicine and Medical Specialties (DiMI), University of Genoa, Genoa, Italy.
¹¹ Internal Medicine 2, Treviso Hospital, Treviso, Italy.
¹² Functional Department of Endocrinology and Metabolism, AULSS 2 Veneto, Veneto, Italy.
¹³ AIMN President, Nuclear Medicine Unit, AORN Ospedali Dei Colli, Naples, Italy.
¹⁴ Catholic University of the Sacred Heart, Rome, Italy.
¹⁵ Endocrine and Metabolic Surgery Unit, Center for Research in Endocrine Gland and Obesity Surgery, Agostino Gemelli IRCCS University Polyclinic Foundation, Rome, Italy.
¹⁶ SOC di Otorinolaringoiatria, Ospedale di San Daniele e Tolmezzo, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
¹⁷ Azienda ULSS 9 Scaligera, Verona, Italy.
¹⁸ Endocrine Surgery Unit, General Oncologic and Mini-invasive Surgery Department, ASST Grande Ospedale Metropolitano di Niguarda, Milan, Italy.
¹⁹ IRCCS San Raffaele, Rome, Italy.
²⁰ Endocrinology Unit, Agostino Gemelli IRCCS University Polyclinic Foundation, Rome, Italy.
²¹ UOC Medicina - ASL, Rome, Italy.
²² UOC Medicina Interna, Ospedale S. Maria della Misericordia, Rovigo, Italy.
²³ Unit of Endocrinology and Metabolism, Department of Internal Medicine and Therapeutics, ICS Maugeri Pavia, University of Pavia, Pavia, Italy.
²⁴ UOC Malattie Endocrine e Diabetologia, PO Atri (TE), Milan, Italy.
²⁵ Interdisciplinary Department of Medicine, Endocrinology, Geriatrics and Rare Diseases, University of Bari "Aldo Moro", Bari, Italy.
²⁶ Nuclear Medicine, Azienda Unità Sanitaria Locale-IRCCS di, Reggio Emilia, Reggio Emilia, Italy.
²⁷ Endocrinology Unit, Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.
²⁸ Clinical Pathology Unit, Laboratories Department, ASL Roma 1, Rome, Italy.
²⁹ High School of Economy and Management of Health Systems, Catholic University of Sacred Heart, Rome, Italy.
³⁰ Department of Epidemiology, Lazio Regional Health Service, ASL Roma 1, Rome, Italy.
³¹ Onco-Hematology Department, Nuclear Medicine Unit, University Hospital of Ferrara, Ferrara, Italy.
³² Department of Otorhinolaryngology, Head and Neck Surgery, University of Pavia, Foundation IRCCS Policlinico San Matteo, Pavia, Italy.
³³ Department of Surgical Sciences, SIUEC Past President, University of Cagliari, Cagliari, Italy.
³⁴ Institute of Clinical Pathology, Department of Laboratory Medicine, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
³⁵ Endocrinology, Ospedale Unico della Versilia, Azienda USL Toscana Nord Ovest, Pisa, Italy.
³⁶ Endocrinology, Arcispedale S. Maria Nuova IRCCS, ASL Reggio Emilia, Reggio Emilia, Italy.
³⁷ Department of Internal Medicine, Hospital Alto Vicentino (AULSS-7 Veneto), Santorso, VI, Italy.
³⁸ Private Practice, Rome, Italy.
³⁹ Facoltà di Medicina e Psicologia, UOS Endocrinologia - UOC Medicina Specialistica Endocrino -Metabolica, AOU Sant'Andrea, Sapienza Università di Roma, Rome, Italy.
⁴⁰ AME Scientific Committee, Milan, Italy.

^# Contributed equally.

PMID: 40699541
PMCID: PMC12518491
DOI: 10.1007/s40618-025-02652-y

Italian guidelines for the management of adult individuals with primary hypothyroidism outside pregnancy

Rinaldo Guglielmi et al. J Endocrinol Invest. 2025 Oct.

. 2025 Oct;48(10):2295-2313.

doi: 10.1007/s40618-025-02652-y. Epub 2025 Jul 23.

Authors

Affiliations

¹ Lifenet Health Group, Endocrinology, Regina Apostolorum Hospital, Albano Laziale, RM, Italy.
² Endocrinology, Department of Medicine DIMED, University of Padua, Padua, Italy.
³ Catholic University of the Sacred Heart, Rome, Italy. robertonovizio@gmail.com.
⁴ Endocrinology Unit, AORN A. Cardarelli, Naples, Italy. robertonovizio@gmail.com.
⁵ Endocrinology, ULSS6 Euganea, Padua, Italy.
⁶ Ministry of Interior - Department of Firefighters, Public Rescue and Civil Defense, Rome, Italy.
⁷ Department of Human Sciences and Promotion of the Quality of Life, San Raffaele Roma Open University, Rome, Italy.
⁸ Endocrinology, ASL Novara, Novara, Italy.
⁹ UOSD Endocrinologia, ASL Roma 1, Rome, Italy.
¹⁰ AIT President, Endocrinology Unit, Department of Internal Medicine and Medical Specialties (DiMI), University of Genoa, Genoa, Italy.
¹¹ Internal Medicine 2, Treviso Hospital, Treviso, Italy.
¹² Functional Department of Endocrinology and Metabolism, AULSS 2 Veneto, Veneto, Italy.
¹³ AIMN President, Nuclear Medicine Unit, AORN Ospedali Dei Colli, Naples, Italy.
¹⁴ Catholic University of the Sacred Heart, Rome, Italy.
¹⁵ Endocrine and Metabolic Surgery Unit, Center for Research in Endocrine Gland and Obesity Surgery, Agostino Gemelli IRCCS University Polyclinic Foundation, Rome, Italy.
¹⁶ SOC di Otorinolaringoiatria, Ospedale di San Daniele e Tolmezzo, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
¹⁷ Azienda ULSS 9 Scaligera, Verona, Italy.
¹⁸ Endocrine Surgery Unit, General Oncologic and Mini-invasive Surgery Department, ASST Grande Ospedale Metropolitano di Niguarda, Milan, Italy.
¹⁹ IRCCS San Raffaele, Rome, Italy.
²⁰ Endocrinology Unit, Agostino Gemelli IRCCS University Polyclinic Foundation, Rome, Italy.
²¹ UOC Medicina - ASL, Rome, Italy.
²² UOC Medicina Interna, Ospedale S. Maria della Misericordia, Rovigo, Italy.
²³ Unit of Endocrinology and Metabolism, Department of Internal Medicine and Therapeutics, ICS Maugeri Pavia, University of Pavia, Pavia, Italy.
²⁴ UOC Malattie Endocrine e Diabetologia, PO Atri (TE), Milan, Italy.
²⁵ Interdisciplinary Department of Medicine, Endocrinology, Geriatrics and Rare Diseases, University of Bari "Aldo Moro", Bari, Italy.
²⁶ Nuclear Medicine, Azienda Unità Sanitaria Locale-IRCCS di, Reggio Emilia, Reggio Emilia, Italy.
²⁷ Endocrinology Unit, Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.
²⁸ Clinical Pathology Unit, Laboratories Department, ASL Roma 1, Rome, Italy.
²⁹ High School of Economy and Management of Health Systems, Catholic University of Sacred Heart, Rome, Italy.
³⁰ Department of Epidemiology, Lazio Regional Health Service, ASL Roma 1, Rome, Italy.
³¹ Onco-Hematology Department, Nuclear Medicine Unit, University Hospital of Ferrara, Ferrara, Italy.
³² Department of Otorhinolaryngology, Head and Neck Surgery, University of Pavia, Foundation IRCCS Policlinico San Matteo, Pavia, Italy.
³³ Department of Surgical Sciences, SIUEC Past President, University of Cagliari, Cagliari, Italy.
³⁴ Institute of Clinical Pathology, Department of Laboratory Medicine, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
³⁵ Endocrinology, Ospedale Unico della Versilia, Azienda USL Toscana Nord Ovest, Pisa, Italy.
³⁶ Endocrinology, Arcispedale S. Maria Nuova IRCCS, ASL Reggio Emilia, Reggio Emilia, Italy.
³⁷ Department of Internal Medicine, Hospital Alto Vicentino (AULSS-7 Veneto), Santorso, VI, Italy.
³⁸ Private Practice, Rome, Italy.
³⁹ Facoltà di Medicina e Psicologia, UOS Endocrinologia - UOC Medicina Specialistica Endocrino -Metabolica, AOU Sant'Andrea, Sapienza Università di Roma, Rome, Italy.
⁴⁰ AME Scientific Committee, Milan, Italy.

^# Contributed equally.

PMID: 40699541
PMCID: PMC12518491
DOI: 10.1007/s40618-025-02652-y

Abstract

Aim: The present guideline (GL) is aimed to improve and standardize the treatment of primary hypothyroidism in non-pregnant adults and to offer all the patients the best possible care across the Italian country.

Target population: Non-pregnant adults with hypothyroidism.

Excluded population: This GL does not cover the treatment of hypothyroidism in children and adolescents under 18 years of age, in women who are pregnant or breastfeeding, nor in subjects with central hypothyroidism. Also patients who require suppressive therapy with levothyroxine after thyroidectomy for thyroid cancer and those with transient iatrogenic hypothyroidism were not considered in this GL.

Methods: The direct costs and the utilization of resources over time were evaluated for the implementation of the appropriate management within the National Health Service. Recommendations were based on the analysis, according to the GRADE methodology, of the evidence from literature. Patients preferences were collected and verified by means of specific bibliographic research and the active participation of two patients' representatives in the GL development group.

Results: The present GL provides 4 formal graded recommendations and 16 ungraded indications for good clinical practice. An elevated agreement was consistently obtained among the panel members.

Conclusions: The present GL provides operative recommendations-based on the best available evidence and cost-effectiveness analysis-for the treatment of adult patients with primary hypothyroidism. The expected benefits from the dissemination, application and implementation of this GL are the improvement of the quality of care, its homogenization across the national territory and the rationalization of health expenditure in the respect of patient preferences.

Keywords: Desiccated thyroid extracts; Hypothyroidism; Quality of life; Thyroid; Thyroxine; Triiodothyronine.

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Conflict of interest statement

Declarations. Conflict of interest: CM was a recipient of a grant by IBSA. CV has been a consultant for IBSA and has been the scientific director in a CME course with non-conditioning funding by Merck. The other authors and the members of the panel declare no potential conflict of interest to be disclosed.

References

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1. Beck-Peccoz P, Rodari G, Giavoli C, Lania A (2017) Central hypothyroidism - a neglected thyroid disorder. Nat Rev Endocrinol 13:588–598. 10.1038/nrendo.2017.47 - PubMed
1. Garmendia Madariaga A, Santos Palacios S, Guillén-Grima F, Galofré JC (2014) The incidence and prevalence of thyroid dysfunction in Europe: a meta-analysis. J Clin Endocrinol Metab 99:923–931. 10.1210/jc.2013-2409 - PubMed
1. De Angelis S, Medda E, Rotondi D, Masocco M, Minardi V, Contoli B et al (2024) Fifteen years of iodine prophylaxis in Italy: results of a nationwide surveillance (period 2015–2019). J Clin Endocrinol Metab 109:e495–e507. 10.1210/clinem/dgad593 - PMC - PubMed
1. Burch HB (2019) Drug effects on the thyroid. N Engl J Med 381:749–761. 10.1056/NEJMra1901214 - PubMed

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Italian guidelines for the management of adult individuals with primary hypothyroidism outside pregnancy

Affiliations

Italian guidelines for the management of adult individuals with primary hypothyroidism outside pregnancy

Authors

Affiliations

Abstract

Conflict of interest statement

References

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical