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)

Isidori AM; Aversa A; Calogero A; Ferlin A; Francavilla S; Lanfranco F; Pivonello R; Rochira V; Corona G; Maggi M

doi:10.1007/s40618-022-01859-7

Clinical Guidelines and Standards · Guidelines by Clinical Area

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)

Isidori AM, Aversa A, Calogero A, Ferlin A, Francavilla S, Lanfranco F, Pivonello R, Rochira V, Corona G, Maggi M

Published December 2022 Journal of endocrinological investigation

DOI 10.1007/s40618-022-01859-7 PMID 36018454 PMC PMC9415259

RRM Academy Synopsis

Guidelines advise testosterone therapy for symptomatic hypogonadism

Italian guidelines advise testosterone replacement therapy for men with symptoms and low testosterone. The panel first rules out unsafe conditions. Advice covers cases unlikely to reverse soon. Experts graded published research on adult and older men. The guidelines advise against therapy for men who want children soon.

Key Findings

The guideline strongly recommends testosterone replacement therapy (TRT) for symptomatic men with hypogonadism, after excluding contraindications, when the condition cannot be expected to reverse in a reasonable time-frame (low-quality evidence).
The guideline strongly recommends TRT for men with hypogonadism who have low sexual desire or erectile dysfunction, citing high-quality evidence.
In the T4DM trial, two years of TRT lowered total fat mass by 2.7 kg and raised total muscle mass by 1.7 kg over lifestyle interventions and placebo.
The guideline strongly advises against TRT for men wanting fatherhood soon. In male contraceptive trials, testosterone lowered sperm production, to varying degrees, in 100% of subjects within 24 months.
Across 35 primary studies and 5601 participants (mean age 65 years), a meta-analysis found no evidence that TRT raised short-term to medium-term cardiovascular risk in men with hypogonadism.

Interpretation

This is a consensus guideline from an expert task force. Most recommendations carry a GRADE rating for strength and evidence quality, from very low to high, and a few rest on expert opinion. The recommendation to start testosterone replacement therapy in symptomatic men rests on low-quality evidence. Existing studies ran up to three years, so long-term benefit and safety remain open. Most cognition trials and meta-analyses mixed men with normal and low testosterone. No studies yet use fractures as the main endpoint for bone. Trials on urinary symptoms excluded men with severe symptoms.

RRM Context

Men add to infertility in many couples, so restorative reproductive medicine looks at both partners. The guideline asks for weight loss in men with excess weight and stopping interfering medicines where possible, which fits a search for reversible causes first. Outside testosterone lowers sperm production, so the reason for low testosterone matters when a man wants children.

Our editorial summary of this paper, not the article's abstract.

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.

Topics

Clinical Guidelines and Standards › Guidelines by Clinical Area › Bone and Endocrine Guidelines · Therapeutics › Hormonal Agents › Androgens and DHEA · Longevity and Reproductive Aging › Hormones and Aging Tissues › Musculoskeletal Aging

PMID 36018454 36018454 DOI 10.1007/s40618-022-01859-7 10.1007/s40618-022-01859-7 Isidori et al. 2022, Isidori 2022

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)

Guidelines advise testosterone therapy for symptomatic hypogonadism

Key Findings

Interpretation

RRM Context

Abstract

Topics

By this author

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