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Journal of Endocrinological Investigation
Published in: Journal of Endocrinological Investigation 6/2016

01-06-2016 | Original Article

Predictors and clinical consequences of starting androgen therapy in men with low testosterone: results from the SIAMO-NOI registry

Authors: G. Rastrelli, L. Giovannini, A. E. Calogero, D. Gianfrilli, E. Serra, A. Pizzocaro, V. A. Giagulli, G. Motta, G. Vancieri, A. Sperandio, S. Andò, R. Selice, G. Luca, F. Cocchiara, D. Canale, M. Maggi

Published in: Journal of Endocrinological Investigation | Issue 6/2016

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Abstract

Purpose

Management of late onset hypogonadism (LOH) is not homogenous. The aim of the study is to observe the management of patients with low testosterone (T) in highly specialized Italian centres.

Methods

The SIAMO-NOI is an observational longitudinal disease registry for the evaluation of the clinical management of patients with low T levels (total T < 12 nmol/L, calculated free T < 225 pmol/l or already in treatment) in 15 Italian centers members of the Italian Society for Andrology and Sexual Medicine (SIAMS). Clinical and biochemical data were collected for four visits during 12 months of observation.

Results

432 patients (mean age 50.9 ± 14.9 years) were enrolled. Of them, 247 men were receiving androgen therapy, whereas 145 were naive. After the first visit (V0), 80 men started androgen therapy, whereas 55 remained untreated during the entire observation. Younger age [odds ratio (OR) 0.57 (0.35–0.92)], total T < 8 nmol/l [OR 4.69 (1.59–13.81)], complaining at least one sexual symptom [OR 11.55 (2.01–66.35)] and reporting more severe lower urinary tract symptoms [OR 1.27 (1.01–1.60)] predicted starting an androgen therapy. Sixty-four men started therapy immediately after V0 and maintained it until the observation end. When compared to V0, they reported an increase in all the domains of the International Index of Erectile Function-15 (IIEF-15), in the sexual and physical subdomains of the Aging Male Scale as well as in the International Prostate Symptom Score. Conversely, the untreated group reported a significant improvement, although lower than the treated group, only in the erectile function domain of the IIEF-15.

Conclusions

Management of LOH in SIAMS centres is in line with the international guidelines and the newest knowledge about the role of T on prostate health. Androgen therapy is associated with an improvement in all the aspects of sexual life and in the perception of physical strength.
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Literature
1.
Maseroli E, Corona G, Rastrelli G, Lotti F, Cipriani S, Forti G, Mannucci E, Maggi M (2015) Prevalence of endocrine and metabolic disorders in subjects with erectile dysfunction: a comparative study. J Sex Med 12:956–965CrossRefPubMed
2.
Corona G, Rastrelli G, Morelli A, Vignozzi L, Mannucci E, Maggi M (2011) Hypogonadism and metabolic syndrome. J Endocrinol Invest 34:557–567CrossRefPubMed
3.
Wu FC, Tajar A, Pye SR, Silman AJ, Finn JD, O’Neill TW, Bartfai G, Casanueva F, Forti G, Giwercman A, Huhtaniemi IT, Kula K, Punab M, Boonen S, Vanderschueren D, European Male Aging Study Group (2008) Hypothalamic–pituitary–testicular axis disruptions in older men are differentially linked to age and modifiable risk factors: the European Male Aging Study. J Clin Endocrinol Metab 93:2737–2745CrossRefPubMed
4.
Rastrelli G, Carter EL, Ahern T, Finn JD, Antonio L, O’Neill TW, Bartfai G, Casanueva FF, Forti G, Keevil B, Maggi M, Giwercman A, Han TS, Huhtaniemi IT, Kula K, Lean ME, Pendleton N, Punab M, Vanderschueren D, Wu FC, EMAS Study Group (2015) Development of and recovery from secondary hypogonadism in aging men: prospective results from the EMAS. J Clin Endocrinol Metab 100:3172–3182CrossRefPubMed
5.
Rastrelli G, Corona G, Tarocchi M, Mannucci E, Maggi M (2016) How to define hypogonadism? Results from a population of men consulting for sexual dysfunction. J Endocrinol Invest (Epub ahead of print)
6.
Botella-Carretero JI, Balsa JA, Gómez-Martin JM, Peromingo R, Huerta L, Carrasco M, Arrieta F, Zamarron I, Martin-Hidalgo A, Vazquez C (2013) Circulating free testosterone in obese men after bariatric surgery increases in parallel with insulin sensitivity. J Endocrinol Invest 36:227–232PubMed
7.
Tirabassi G, Delli Muti N, Gioia A, Biagioli A, Lenzi A, Balercia G (2014) Effects of testosterone replacement therapy on bone metabolism in male post-surgical hypogonadotropic hypogonadism: focus on the role of androgen receptor CAG polymorphism. J Endocrinol Invest 37:393–400CrossRefPubMed
8.
Francomano D, Fattorini G, Gianfrilli D, Paoli D, Sgrò P, Radicioni A, Romanelli F, Di Luigi L, Gandini L, Lenzi A, Aversa A (2015) Acute endothelial response to testosterone gel administration in men with severe hypogonadism and its relationship to androgen receptor polymorphism: a pilot study. J Endocrinol Invest (Epub ahead of print)
9.
Camozzi V, Bonanni G, Frigo A, Piccolo M, Ferasin S, Zaninotto M, Boscaro M, Luisetto G (2015) Effect of a single injection of testosterone enanthate on 17β estradiol and bone turnover markers in hypogonadal male patients. J Endocrinol Invest 38:389–397CrossRefPubMed
10.
Gioia A, Ceccoli L, Ronconi V, Turchi F, Marcheggiani M, Boscaro M, Giacchetti G, Balercia G (2014) Vitamin D levels and bone mineral density: are LH levels involved in the pathogenesis of bone impairment in hypogonadal men? J Endocrinol Invest 37:1225–1231CrossRefPubMed
11.
Morelli A, Corona G, Filippi S, Ambrosini S, Forti G, Vignozzi L, Maggi M (2007) Which patients with sexual dysfunction are suitable for testosterone replacement therapy? J Endocrinol Invest 30:880–888CrossRefPubMed
12.
Wang C, Nieschlag E, Swerdloff R, Behre HM, Hellstrom WJ, Gooren LJ, Kaufman JM, Legros JJ, Lunenfeld B, Morales A, Morley JE, Schulman C, Thompson IM, Weidner W, Wu FC, International Society of Andrology (ISA); International Society for the Study of Aging Male (ISSAM); European Association of Urology (EAU); European Academy of Andrology (EAA); American Society of Andrology (ASA) (2009) Investigation, treatment, and monitoring of late-onset hypogonadism in males: ISA, ISSAM, EAU, EAA, and ASA recommendations. J Androl 30:1–9CrossRefPubMed
13.
Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM, Task Force, Endocrine Society (2010) Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 95:2536–2559CrossRefPubMed
14.
Petak SM, Nankin HR, Spark RF, Swerdloff RS, Rodriguez-Rigau LJ, American Association of Clinical Endocrinologists (2002) American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients—2002 update. Endocr Pract 8:440–456PubMed
15.
Wu FC, Tajar A, Beynon JM, Pye SR, Silman AJ, Finn JD, O’Neill TW, Bartfai G, Casanueva FF, Forti G, Giwercman A, Han TS, Kula K, Lean ME, Pendleton N, Punab M, Boonen S, Vanderschueren D, Labrie F, Huhtaniemi IT, EMAS Group (2010) Identification of late-onset hypogonadism in middle-aged and elderly men. N Engl J Med 363:123–135CrossRefPubMed
16.
Corona G, Mannucci E, Petrone L, Balercia G, Fisher AD, Chiarini V, Forti G, Maggi M (2006) ANDROTEST: a structured interview for the screening of hypogonadism in patients with sexual dysfunction. J Sex Med 3:706–715CrossRefPubMed
17.
Rastrelli G, Corona G, Bandini E, Strada C, Maseroli E, Ricca V, Faravelli C, Mannucci E, Maggi M (2013) Investigation on psychological symptoms improves ANDROTEST accuracy in predicting hypogonadism in subjects with sexual dysfunction. Int J Impot Res 25:34–39CrossRefPubMed
18.
Petrone L, Mannucci E, Corona G, Bartolini M, Forti G, Giommi R, Maggi M (2003) Structured interview on erectile dysfunction (SIEDY): a new, multidimensional instrument for quantification of pathogenetic issues on erectile dysfunction. Int J Impot Res 15:210–220CrossRefPubMed
19.
Corona G, Ricca V, Bandini E, Rastrelli G, Casale H, Jannini EA, Sforza A, Forti G, Mannucci E, Maggi M (2012) SIEDY scale 3, a new instrument to detect psychological component in subjects with erectile dysfunction. J Sex Med 9:2017–2026CrossRefPubMed
20.
Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A (1997) The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 49:822–830CrossRefPubMed
21.
Bosch JL, Hop WC, Kirkels WJ, Schröder FH (1995) The International Prostate Symptom Score in a community-based sample of men between 55 and 74 years of age: prevalence and correlation of symptoms with age, prostate volume, flow rate and residual urine volume. Br J Urol 75:622–630CrossRefPubMed
22.
Heinemann LA, Saad F, Heinemann K, Thai DM (2004) Can results of the aging males’ symptoms (AMS) scale predict those of screening scales for androgen deficiency? Aging Male 7:211–218CrossRefPubMed
23.
Vermeulen A, Verdonck L, Kaufman JM (1999) A critical evaluation of simple methods for the estimation of free testosterone in serum. J Clin Endocrinol Metab 84:3666–3672CrossRefPubMed
24.
Palmieri L, Panico S, Vanuzzo D, Ferrario M, Pilotto L, Sega R, Cesana G, Giampaoli S, Gruppo di Ricerca del Progetto CUORE (2004) Evaluation of the global cardiovascular absolute risk: the Progetto CUORE individual score. Ann Ist Super Sanita 40:393–399PubMed
25.
Corona G, Rastrelli G, Ricca V, Maggi M (2010) Testosterone deficiency in the aging male and its relationship with sexual dysfunction and cardiovascular diseases. Horm Mol Biol Clin Invest 4:509–520
26.
Corona G, Rastrelli G, Vignozzi L, Mannucci E, Maggi M (2012) How to recognize late-onset hypogonadism in men with sexual dysfunction. Asian J Androl 14:251–259CrossRefPubMedPubMedCentral
27.
Corona G, Maggi M (2015) Perspective: regulatory agencies’ changes to testosterone product labeling. J Sex Med 12:1690–1693CrossRefPubMed
28.
Vigen R, O’Donnell CI, Barón AE, Grunwald GK, Maddox TM, Bradley SM, Barqawi A, Woning G, Wierman ME, Plomondon ME, Rumsfeld JS, Ho PM (2013) Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA 310:1829–1836CrossRefPubMed
29.
Finkle WD, Greenland S, Ridgeway GK, Adams JL, Frasco MA, Cook MB, Fraumeni JF Jr, Hoover RN (2014) Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS ONE 9:e85805CrossRefPubMedPubMedCentral
30.
Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, Hede-Brierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S (2010) Adverse events associated with testosterone administration. N Engl J Med 363:109–122CrossRefPubMedPubMedCentral
31.
Corona G, Monami M, Boddi V, Cameron-Smith M, Fisher AD, de Vita G, Melani C, Balzi D, Sforza A, Forti G, Mannucci E, Maggi M (2010) Low testosterone is associated with an increased risk of MACE lethality in subjects with erectile dysfunction. J Sex Med 7:1557–1564CrossRefPubMed
32.
Corona G, Rastrelli G, Monami M, Melani C, Balzi D, Sforza A, Forti G, Mannucci E, Maggi M (2011) Body mass index regulates hypogonadism-associated CV risk: results from a cohort of subjects with erectile dysfunction. J Sex Med 8:2098–2105CrossRefPubMed
33.
Corona G, Rastrelli G, Maseroli E, Fralassi N, Sforza A, Forti G, Mannucci E, Maggi M (2014) Low testosterone syndrome protects subjects with high cardiovascular risk burden from major adverse cardiovascular events. Andrology 2:741–747CrossRefPubMed
34.
Corona G, Maseroli E, Rastrelli G, Isidori AM, Sforza A, Mannucci E, Maggi M (2014) Cardiovascular risk associated with testosterone-boosting medications: a systematic review and meta-analysis. Expert Opin Drug Saf 13:1327–1351CrossRefPubMed
35.
Corona G, Rastrelli G, Balercia G, Sforza A, Forti G, Maggi M (2012) Testosterone and cardiovascular risk in patients with erectile dysfunction. J Endocrinol Invest 35:809–816PubMed
36.
Francomano D, Bruzziches R, Barbaro G, Lenzi A, Aversa A (2014) Effects of testosterone undecanoate replacement and withdrawal on cardio-metabolic, hormonal and body composition outcomes in severely obese hypogonadal men: a pilot study. J Endocrinol Invest 37:401–411CrossRefPubMed
37.
Corona G, Vignozzi L, Rastrelli G, Lotti F, Cipriani S, Maggi M (2014) Benign prostatic hyperplasia: a new metabolic disease of the aging male and its correlation with sexual dysfunctions. Int J Endocrinol 2014:329456CrossRefPubMedPubMedCentral
38.
Vignozzi L, Rastrelli G, Corona G, Gacci M, Forti G, Maggi M (2014) Benign prostatic hyperplasia: a new metabolic disease? J Endocrinol Invest 37:313–322CrossRefPubMed
39.
Pan JG, Liu M, Zhou X (2014) Relationship between lower urinary tract symptoms and metabolic syndrome in a Chinese male population. J Endocrinol Invest 37:339–344CrossRefPubMed
40.
Robinette CL (1988) Sex-hormone-induced inflammation and fibromuscular proliferation in the rat lateral prostate. Prostate 12:271–286CrossRefPubMed
41.
Desai KV, Michalowska AM, Kondaiah P, Ward JM, Shih JH, Green JE (2004) Gene expression profiling identifies a unique androgen-mediated inflammatory/immune signature and a PTEN (phosphatase and tensin homolog deleted on chromosome 10)-mediated apoptotic response specific to the rat ventral prostate. Mol Endocrinol 18:2895–2907CrossRefPubMed
42.
Quintar AA, Roth FD, De Paul AL, Aoki A, Maldonado CA (2006) Toll-like receptor 4 in rat prostate: odulation by testosterone and acute bacterial infection in epithelial and stromal cells. Biol Reproduct 75:664–672CrossRef
43.
Meng J, Mostaghel EA, Vakar-Lopez F, Montgomery B, True L, Nelson PS (2011) Testosterone regulates tight junction proteins and influences prostatic autoimmune responses. Horm Cancer 2:145–156CrossRefPubMedPubMedCentral
44.
Vignozzi L, Morelli A, Sarchielli E, Comeglio P, Filippi S, Cellai I, Maneschi E, Serni S, Gacci M, Carini M, Piccinni MP, Saad F, Adorini L, Vannelli GB, Maggi M (2012) Testosterone protects from metabolic syndrome-associated prostate inflammation: an experimental study in rabbit. J Endocrinol 212:71–84CrossRefPubMed
45.
Fijak M, Schneider E, Klug J, Bhushan S, Hackstein H, Schuler G, Wygrecka M, Gromoll J, Meinhardt A (2011) Testosterone replacement effectively inhibits the development of experimental autoimmune orchitis in rats: evidence for a direct role of testosterone on regulatory T cell expansion. J Immunol 186:5162–5172CrossRefPubMed
46.
Bebo BF Jr, Schuster JC, Vandenbark AA, Offner H (1999) Androgens alter the cytokine profile and reduce encephalitogenicity of myelin-reactive T cells. J Immunol 162:35–40PubMed
47.
Liva SM, Voskhul RR (2001) Testosterone acts directly on CD4+ T lymphocytes to increase IL-10 production. J Immunol 167:2060–2067CrossRefPubMed
48.
Vignozzi L, Cellai I, Santi R, Lombardelli L, Morelli A, Comeglio P, Filippi S, Logiodice F, Carini M, Nesi G, Gacci M, Piccinni MP, Adorini L, Maggi M (2012) Antiinflammatory effect of androgen receptor activation in human benign prostatic hyperplasia cells. J Endocrinol 214:31–43CrossRefPubMed
49.
Isidori AM, Balercia G, Calogero AE, Corona G, Ferlin A, Francavilla S, Santi D, Maggi M (2015) Outcomes of androgen replacement therapy in adult male hypogonadism: recommendations from the Italian society of endocrinology. J Endocrinol Invest 38:103–112CrossRefPubMedPubMedCentral
50.
Corona G, Isidori AM, Buvat J, Aversa A, Rastrelli G, Hackett G, Rochira V, Sforza A, Lenzi A, Mannucci E, Maggi M (2014) Testosterone supplementation and sexual function: a meta-analysis study. J Sex Med 11:1577–1592CrossRefPubMed
51.
Isidori AM, Giannetta E, Gianfrilli D, Greco EA, Bonifacio V, Aversa A, Isidori A, Fabbri A, Lenzi A (2005) Effects of testosterone on sexual function in men: results of a meta-analysis. Clin Endocrinol (Oxf) 63:381–394CrossRef
52.
Spitzer M, Bhasin S, Travison TG, Davda MN, Stroh H, Basaria S (2013) Sildenafil increases serum testosterone levels by a direct action on the testes. Andrology 1:913–918CrossRefPubMed
53.
Pofi R, Gianfrilli D, Badagliacca R, Di Dato C, Venneri MA, Giannetta E (2016) Everything you ever wanted to know about phosphodiesterase 5 inhibitors and the heart (but never dared ask): How do they work? J Endocrinol Invest 39:131–142CrossRefPubMed
54.
De Araujo AC, Da Silva FG, Salvi F, Awad MC, Da Silva EA, Damião R (2009) the management of erectile dysfunction with placebo only: Does it work? J Sex Med 6:3440–3448CrossRefPubMed
55.
Zitzmann M, Mattern A, Hanisch J, Gooren L, Jones H, Maggi M (2013) IPASS: a study on the tolerability and effectiveness of injectable testosterone undecanoate for the treatment of male hypogonadism in a worldwide sample of 1,438 men. J Sex Med 10:579–588CrossRefPubMed
56.
Corona G, Giagulli VA, Maseroli E, Vignozzi L, Aversa A, Zitzmann M, Saad F, Mannucci E, Maggi M (2015) Testosterone supplementation and body composition: results from a meta-analysis study. Eur J Endocrinol
57.
Isidori AM, Giannetta E, Greco EA, Gianfrilli D, Bonifacio V, Isidori A, Lenzi A, Fabbri A (2005) Effects of testosterone on body composition, bone metabolism and serum lipid profile in middle-aged men: a meta-analysis. Clin Endocrinol (Oxf) 63:280–293CrossRef
58.
Corona G, Monami M, Rastrelli G, Aversa A, Tishova Y, Saad F, Lenzi A, Forti G, Mannucci E, Maggi M (2011) Testosterone and metabolic syndrome: a meta-analysis study. J Sex Med 8:272–283CrossRefPubMed
59.
Corona G, Monami M, Rastrelli G, Aversa A, Sforza A, Lenzi A, Forti G, Mannucci E, Maggi M (2011) Type 2 diabetes mellitus and testosterone: a meta-analysis study. Int J Androl 34:528–540CrossRefPubMed
Metadata
Title
Predictors and clinical consequences of starting androgen therapy in men with low testosterone: results from the SIAMO-NOI registry
Authors
G. Rastrelli
L. Giovannini
A. E. Calogero
D. Gianfrilli
E. Serra
A. Pizzocaro
V. A. Giagulli
G. Motta
G. Vancieri
A. Sperandio
S. Andò
R. Selice
G. Luca
F. Cocchiara
D. Canale
M. Maggi
Publication date
01-06-2016
Publisher
Springer International Publishing
Published in
Journal of Endocrinological Investigation / Issue 6/2016
Electronic ISSN: 1720-8386
DOI
https://doi.org/10.1007/s40618-016-0461-5

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