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      Adult- and late-onset male hypogonadism: the clinical practice guidelines of the Italian Society of Andrology and Sexual Medicine (SIAMS) and the Italian Society of Endocrinology (SIE)

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          Abstract

          Purpose

          To provide the evidence-based recommendations on the role of testosterone (T) on age-related symptoms and signs remains.

          Methods

          The Italian Society of Andrology and Sexual Medicine (SIAMS) and the and the Italian Society of Endocrinology (SIE) commissioned an expert task force to provide an updated guideline on adult-onset male hypogonadism. Derived recommendations were based on Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system.

          Results

          Clinical diagnosis of adult-onset hypogonadism should be based on a combination of clinical and biochemical parameters. Testosterone replacement therapy (TRT) should be offered to all symptomatic subjects with hypogonadism after the exclusion of possible contraindications. T gels and the long-acting injectable T are currently available preparations showing the best efficacy/safety profile. TRT can improve all aspects of sexual function, although its effect is limited in more complicated patients. Body composition (reducing fat mass and increasing lean mass) is improved after TRT, either in subjects with or without metabolic syndrome or type 2 diabetes. Conversely, the role of TRT in improving glycometabolic control is more conflicting. TRT can result in increasing bone mineral density, particularly at lumbar site, but no information on fracture risk is available. Limited data support the use of TRT for improving other outcomes, including mood frailty and mobility.

          Conclusions

          TRT can improve sexual function and body composition particularly in less complicated adult and in aging subjects with hypogonadism. When hypogonadism is adequately diagnosed, T appropriately prescribed and subjects correctly followed up, no short-term increased risk of adverse events is observed. Longer and larger studies are advisable to better clarify TRT long-term efficacy/safety profile.

          Supplementary Information

          The online version contains supplementary material available at 10.1007/s40618-022-01859-7.

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          Most cited references173

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          EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer—2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent

          Nicolas Mottet, Roderick van den Bergh, Erik Briers … (2020)
          To present a summary of the 2020 version of the European Association of Urology (EAU)-European Association of Nuclear Medicine (EANM)-European Society for Radiotherapy and Oncology (ESTRO)-European Society of Urogenital Radiology (ESUR)-International Society of Geriatric Oncology (SIOG) guidelines on screening, diagnosis, and local treatment of clinically localised prostate cancer (PCa).
          Article 0 comments Cited 755 times – based on 0 reviews     Review now
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            Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline

            Shalender Bhasin, Juan Brito, Glenn Cunningham … (2018)
            To update the "Testosterone Therapy in Men With Androgen Deficiency Syndromes" guideline published in 2010.
            Article 0 comments Cited 341 times – based on 0 reviews     Review now
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              Adverse events associated with testosterone administration.

              Shehzad Basaria, Andrea D. Coviello, Thomas Travison … (2010)
              Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied. Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group. A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load. In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy. (ClinicalTrials.gov number, NCT00240981.) 2010 Massachusetts Medical Society
              Article 0 comments Cited 332 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                G. Corona:
                ORCID: http://orcid.org/0000-0002-9894-2885
                jocorona@libero.it
                Journal
                Journal ID (nlm-ta): J Endocrinol Invest
                Journal ID (iso-abbrev): J Endocrinol Invest
                Title: Journal of Endocrinological Investigation
                Publisher: Springer International Publishing (Cham )
                ISSN (Print): 0391-4097
                ISSN (Electronic): 1720-8386
                Publication date (Electronic): 26 August 2022
                Pages: 1-19
                Affiliations
                [1 ]GRID grid.7841.a, Department of Experimental Medicine, , Sapienza University of Rome - Policlinico Umberto I Hospital, ; Rome, Italy
                [2 ]GRID grid.411489.1, ISNI 0000 0001 2168 2547, Department of Experimental and Clinical Medicine, , University Magna Graecia of Catanzaro, ; Catanzaro, Italy
                [3 ]GRID grid.8158.4, ISNI 0000 0004 1757 1969, Department of Clinical and Experimental Medicine, , University of Catania, ; Catania, Italy
                [4 ]GRID grid.5608.b, ISNI 0000 0004 1757 3470, Unit of Andrology and Reproductive Medicine, Department of Medicine, , University of Padova, ; Padua, Italy
                [5 ]GRID grid.158820.6, ISNI 0000 0004 1757 2611, Andrology Unit, Department of Clinical Medicine, Public Health, Life and Environmental Sciences, , University of L’Aquila, ; L’Aquila, Italy
                [6 ]GRID grid.7605.4, ISNI 0000 0001 2336 6580, Division of Endocrinology, Andrology and Metabolism, Humanitas Gradenigo, Department of Medical Sciences, , University of Turin, ; Turin, Italy
                [7 ]GRID grid.4691.a, ISNI 0000 0001 0790 385X, Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Unità di Andrologia e Medicina della Riproduzione e della Sessualità Maschile e Femminile, , Università Federico II di Napoli, ; Naples, Italy
                [8 ]GRID grid.4691.a, ISNI 0000 0001 0790 385X, Staff of UNESCO Chair for Health Education and Sustainable Development, Federico II University, ; Naples, Italy
                [9 ]GRID grid.7548.e, ISNI 0000000121697570, Unit of Endocrinology, Department of Biomedical, Metabolic and Neural Sciences, , University of Modena and Reggio Emilia, ; Modena, Italy
                [10 ]GRID grid.414090.8, ISNI 0000 0004 1763 4974, Endocrinology Unit, Medical Department, , Azienda Usl Bologna Maggiore-Bellaria Hospital, ; Largo Nigrisoli, 2, 40133 Bologna, Italy
                [11 ]GRID grid.8404.8, ISNI 0000 0004 1757 2304, Endocrinology Unit, Department of Experimental, Clinical and Biomedical Sciences, , University of Florence, ; Florence, Italy
                Author information
                http://orcid.org/0000-0002-9894-2885
                Article
                Publisher ID: 1859
                DOI: 10.1007/s40618-022-01859-7
                PMC ID: 9415259
                PubMed ID: 36018454
                SO-VID: 5b887e9e-cc4a-461c-a2c2-b1a3e8fdf1f9
                Copyright © © The Author(s), under exclusive licence to Italian Society of Endocrinology (SIE) 2022
                License:

                This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

                History
                Date received : 19 May 2022
                Date accepted : 29 June 2022
                Categories
                Subject: Consensus Statement

                Keywords: late-onset hypogonadism,testosterone,hypogonadism,erectile dysfunction,obesity,metabolic syndrome,bone mineral density
                Data availability:
                Keywords: late-onset hypogonadism, testosterone, hypogonadism, erectile dysfunction, obesity, metabolic syndrome, bone mineral density

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