Long-term testosterone undecanoate replacement therapy: Impact of ethnicity.
PSA
ethnicity
haematocrit
hypogonadism
low-density lipoprotein
testosterone undecanoate
total cholesterol
Journal
Clinical endocrinology
ISSN: 1365-2265
Titre abrégé: Clin Endocrinol (Oxf)
Pays: England
ID NLM: 0346653
Informations de publication
Date de publication:
05 2020
05 2020
Historique:
received:
31
07
2019
revised:
07
01
2020
accepted:
08
01
2020
pubmed:
17
1
2020
medline:
19
8
2021
entrez:
17
1
2020
Statut:
ppublish
Résumé
Testosterone replacement therapy (TRT) is indicated for symptomatic male hypogonadism. However, the safety and efficacy profiles across different ethnicities for long-term TRT remain unclear. To measure the impact of ethnicity on various biochemical parameters following testosterone undecanoate (TU) replacement. A retrospective analysis of 50 male patients treated with TU from 2006 to 2017 in a large secondary care centre was performed. Changes in total testosterone, PSA, haematocrit, haemoglobin, total cholesterol and low-density lipoprotein (LDL) over eight years of treatment were analysed. Wilcoxon rank sum test was used to assess differences in these parameters between Caucasians and South Asians. Thirty-one Caucasians (age: median (IQR) 55.0 years (49.0-68.0); total duration of follow-up 6.1 years (2.9-9.3)) and 19 South Asians (age: median (IQR) 52.0 years (38.0-69.0); duration of follow-up 6.5 years (1.3-8.4)) were treated with TU during the study period. There was no significant difference in total testosterone levels between the two ethnicities. We noted a higher free and bioavailable testosterone in South Asians than Caucasians, albeit within their reference range. PSA was higher in Caucasians than South Asians at two and eight years of TU therapy. After one year of TRT, haematocrit was higher in South Asians than Caucasians at one year, whereas LDL and total cholesterol were significantly higher in Caucasians than South Asians. Caucasians have a tendency towards increased PSA, total cholesterol and LDL compared with South Asians with TU replacement therapy. There is a higher increment of haematocrit in South Asians following one year of TU replacement therapy. All biochemical changes following TRT were within the respective reference ranges suggesting no apparent risk of prostate cancer and venous thromboembolism.
Sections du résumé
BACKGROUND
Testosterone replacement therapy (TRT) is indicated for symptomatic male hypogonadism. However, the safety and efficacy profiles across different ethnicities for long-term TRT remain unclear.
OBJECTIVE
To measure the impact of ethnicity on various biochemical parameters following testosterone undecanoate (TU) replacement.
METHOD
A retrospective analysis of 50 male patients treated with TU from 2006 to 2017 in a large secondary care centre was performed. Changes in total testosterone, PSA, haematocrit, haemoglobin, total cholesterol and low-density lipoprotein (LDL) over eight years of treatment were analysed. Wilcoxon rank sum test was used to assess differences in these parameters between Caucasians and South Asians.
RESULTS
Thirty-one Caucasians (age: median (IQR) 55.0 years (49.0-68.0); total duration of follow-up 6.1 years (2.9-9.3)) and 19 South Asians (age: median (IQR) 52.0 years (38.0-69.0); duration of follow-up 6.5 years (1.3-8.4)) were treated with TU during the study period. There was no significant difference in total testosterone levels between the two ethnicities. We noted a higher free and bioavailable testosterone in South Asians than Caucasians, albeit within their reference range. PSA was higher in Caucasians than South Asians at two and eight years of TU therapy. After one year of TRT, haematocrit was higher in South Asians than Caucasians at one year, whereas LDL and total cholesterol were significantly higher in Caucasians than South Asians.
CONCLUSIONS
Caucasians have a tendency towards increased PSA, total cholesterol and LDL compared with South Asians with TU replacement therapy. There is a higher increment of haematocrit in South Asians following one year of TU replacement therapy. All biochemical changes following TRT were within the respective reference ranges suggesting no apparent risk of prostate cancer and venous thromboembolism.
Substances chimiques
Testosterone
3XMK78S47O
testosterone undecanoate
H16A5VCT9C
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
428-433Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2020 John Wiley & Sons Ltd.
Références
Wang C, Nieschlag E, Swerdloff R, et al. ISA, ISSAM, EAU, EAA and ASA recommendations: Investigation, treatment and monitoring of late-onset hypogonadism in males. Int J Impot Res. 2009;21:1-8.
Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and management of testosterone Deficiency: AUA Guideline. J Urol. 2018;200:423-432.
Araujo AB, Esche GR, Kupelian V, et al. Prevalence of symptomatic androgen deficiency in men. J Clin Endocrinol Metab. 2007;92:4241-4247.
Kumar P, Kumar N, Thakur DS, Patidar A. Male hypogonadism: symptoms and treatment. J Adv Pharm Technol Res. 2010;1:297-301.
Boyle P, Koechlin A, Bota M, et al. Endogenous and exogenous testosterone and the risk of prostate cancer and increased prostate-specific antigen (PSA) level: a meta-analysis. BJU Int. 2016;118:731-741.
Guo C, Gu W, Liu M, et al. Efficacy and safety of testosterone replacement therapy in men with hypogonadism: A meta-analysis study of placebo-controlled trials. Exp Ther Med. 2016;11:853-863.
Middleton T, Turner L, Fennell C, et al. Complications of injectable testosterone undecanoate in routine clinical practice. Eur J Endocrinol. 2015;172:511-517.
Zitzmann M. Are long-acting intramuscular testosterone injections safe? Nat Rev Urol. 2015;12:248-249.
Bayer, Nebido.Testosterone Undecanoate. Nebido monograph and executive summary; 2018. https://www.nebido.com/en/hcp/product-information/nebido-monograph/. Accessed July 30, 2018.
Conaglen HM, Paul RG, Yarndley T, Kamp JEM, Elston MS, Conaglen JV. Retrospective investigation of testosterone undecanoate depot for the long-term treatment of male hypogonadism in clinical practice. J Sex Med. 2014;11:574-582.
Minnemann T, Schubert M, Freude S, et al. Comparison of a new long-acting testosterone undecanoate formulation vs testosterone enanthate for intramuscular androgen therapy in male hypogonadism. J Endocrinol Invest. 2008;31:718-723.
Mirone V, Debruyne F, Dohle G, et al. European association of urology position statement on the role of the urologist in the management of male hypogonadism and testosterone therapy. Eur Urol. 2017;72:164-167.
Tan WS, Low WY, Ng CJ, et al. Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study. BJU Int. 2013;111:1130-1140.
Bhasin S, Brito JP, Cunningham GR, et al. Testosterone therapy in men with hypogonadism: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2018;103:1715-1744.
Vermeulen A, Verdonck L, Kaufman JM. A critical evaluation of simple methods for the estimation of free testosterone in serum. J Clin Endocrinol Metab. 1999;84:3666-3672.
Biswas M, Hampton D, Turkes A, Newcombe RGARD. Reduced total testosterone concentrations in young healthy South Asian men are partly explained by increased insulin resistance but not by altered adiposity. Clin Endocrinol (Oxf). 2010;73:457-462.
Kehinde EO, Akanji AO, Al-Hunayan A, et al. Do differences in age specific androgenic steroid hormone levels account for differing prostate cancer rates between Arabs and Caucasians? Int J Urol. 2006;13:354-361.
Heald A, Ivison F, Anderson SG, Cruickshank K, Laing I, Gibson JM. Significant ethnic variation in total and free testosterone concentration. Clin Endocrinol (Oxf). 2003;58:262-266.
Fabbri E, An Y, Gonzalez-Freire M, et al. Bioavailable testosterone linearly declines over a wide age spectrum in men and women from the Baltimore longitudinal study of aging. J Gerontol A Biol Sci Med Sci. 2016;71:1202-1209.
Coward RM, Simhan J, Carson CC. Racial differences in hypogonadal improvement and prostate-specific antigen levels in hypogonadal men treated with testosterone replacement therapy. Int Braz J Urol. 2010;36:700-709.
Moisey R, Swinburne J, Orme S. Serum testosterone and bioavailable testosterone correlate with age and body size in hypogonadal men treated with testosterone undecanoate (1000 mg IM-Nebido). Clin Endocrinol (Oxf). 2008;69:642-647.
Grober ED, Lamb DJ, Khera M, Murthy L, Lipshultz LI. Correlation between simultaneous PSA and serum testosterone concentrations among eugonadal, untreated hypogonadal and hypogonadal men receiving testosterone replacement therapy. Int J Impot Res. 2008;20:561-565.
Rhoden EL, Morgentaler A. Influence of demographic factors and biochemical characteristics on the prostate-specific antigen (PSA) response to testosterone replacement therapy. Int J Impot Res. 2006;18:201-205.
Zhang LT, Shin YS, Kim JY, Park JK. Could testosterone replacement therapy in hypogonadal men ameliorate anemia, a cardiovascular risk factor? an observational, 54-week cumulative registry study. J Urol. 2016;195:1057-1064.
Jones SD Jr, Dukovac T, Sangkum P, Yafi FA, Hellstrom WJ. Erythrocytosis and polycythemia secondary to testosterone replacement therapy in the aging male. Sex Med Rev. 2015;3:101-112.
Shin YS, You JH, Cha JS, Park JK. The relationship between serum total testosterone and free testosterone levels with serum hemoglobin and hematocrit levels: a study in 1221 men. Aging Male. 2016;19:209-214.
Lim E, Miyamura J, Chen JJ. Racial/ethnic-specific reference intervals for common laboratory tests: a comparison among asians, blacks, hispanics, and white. Hawaii J Med Public Health. 2015;74:302-310.
Yassin DJ, Doros G, Hammerer PG, Yassin AA. Long-term testosterone treatment in elderly men with hypogonadism and erectile dysfunction reduces obesity parameters and improves metabolic syndrome and health-related quality of life. J Sex Med. 2014;11:1567-1576.
Traish AM, Haider A, Doros G, Saad F. Long-term testosterone therapy in hypogonadal men ameliorates elements of the metabolic syndrome: an observational, long-term registry study. Int J Clin Prac. 2014;68:314-329.
Chillarón JJ, Fernández-Miró M, Albareda M, Fontserè S, Colom C, Vila L. Testosterone undecanoate improves lipid profile in patients with type 1 diabetes and hypogonadotrophic hypogonadism. Endocr J. 2016;63:849-855.
Krysiak R, Gilowski W, Okopien B. The effect of metformin and metformin-testosterone combination on cardiometabolic risk factors in men with late-onset hypogonadism and impaired glucose tolerance. Exp Clin Endocrinol Diabetes. 2015;123:608-613.