Testosterone replacement therapy among elderly males: the Testim Registry in the US (TRiUS)

Rajib K Bhattacharya,1 Mohit Khera,2 Gary Blick,3 Harvey Kushner,4 Martin M Miner51Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA; 2Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA; 3Circle Medical LLC, Norwalk, CT, USA; 4Biometric...

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Autores principales: Bhattacharya RK, Khera M, Blick G, Kushner H, Miner MM
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Publicado: Dove Medical Press 2012
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spelling oai:doaj.org-article:20c1f78cdb1247c296ed946d8ae564b02021-12-02T00:51:18ZTestosterone replacement therapy among elderly males: the Testim Registry in the US (TRiUS)1178-1998https://doaj.org/article/20c1f78cdb1247c296ed946d8ae564b02012-08-01T00:00:00Zhttps://www.dovepress.com/testosterone-replacement-therapy-among-elderly-males-the-testim-regist-peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998Rajib K Bhattacharya,1 Mohit Khera,2 Gary Blick,3 Harvey Kushner,4 Martin M Miner51Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA; 2Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA; 3Circle Medical LLC, Norwalk, CT, USA; 4Biometrics, Auxilium Pharmaceuticals, Malvern, PA, USA; 5Men's Health Center, Miriam Hospital, Providence, RI, USABackground: Testosterone levels naturally decline with age in men, often resulting in testosterone deficiency (hypogonadism). However, few studies have examined hypogonadal characteristics and treatment in older (≥65 years) men.Objective: To compare data at baseline and after 12 months of testosterone replacement therapy (TRT) in hypogonadal men ≥65 vs <65 years old. Data for participants 65–74 vs ≥75 years old were also compared.Methods: Data were from TRiUS (Testim Registry in the United States), which enrolled 849 hypogonadal men treated with Testim® 1% (50–100 mg testosterone gel/day) for the first time. Anthropometric, laboratory, and clinical measures were taken at baseline and 12 months, including primary outcomes of total testosterone (TT), free testosterone (FT), and prostate-specific antigen (PSA) levels. Comparisons of parameters were made using Fisher's exact test or analysis of variance. Nonparametric Spearman's ρ and first-order partial correlation coefficients adjusted for the effect of age were used to examine bivariate correlations among parameters.Results: Of the registry participants at baseline with available age information, 16% (133/845) were ≥65 years old. They were similar to men <65 years old in the duration of hypogonadism prior to enrollment (~1 year), TT and FT levels at baseline, TT and FT levels at 12-month follow-up, and in reported compliance with treatment. Older patients were more likely to receive lower doses of TRT. PSA levels did not statistically differ between groups after 12 months of TRT (2.18 ± 2.18 ng/mL for ≥65 vs 1.14 ± 0.84 ng/mL for <65 years old, P = 0.1). Baseline values for the >75-year-old subcohort were not significantly different from subcohorts aged 65–74 years and <65 years.Conclusion: Hypogonadal men ≥65 years old showed significant benefit from TRT over 12 months, similar to that found for hypogonadal men <65 years old. TRT was well tolerated in older patients, successfully increased testosterone level regardless of age, and did not significantly increase PSA levels in older men.Keywords: male hypogonadism, elderly, testosterone replacement therapy, testosterone gel, TRiUS registry, TestimBhattacharya RKKhera MBlick GKushner HMiner MMDove Medical Pressarticlemale hypogonadismelderly65 yearstestosterone replacement therapytestosterone gelTRiUS registryTestimGeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 7, Pp 321-330 (2012)
institution DOAJ
collection DOAJ
language EN
topic male hypogonadism
elderly
65 years
testosterone replacement therapy
testosterone gel
TRiUS registry
Testim
Geriatrics
RC952-954.6
spellingShingle male hypogonadism
elderly
65 years
testosterone replacement therapy
testosterone gel
TRiUS registry
Testim
Geriatrics
RC952-954.6
Bhattacharya RK
Khera M
Blick G
Kushner H
Miner MM
Testosterone replacement therapy among elderly males: the Testim Registry in the US (TRiUS)
description Rajib K Bhattacharya,1 Mohit Khera,2 Gary Blick,3 Harvey Kushner,4 Martin M Miner51Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA; 2Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA; 3Circle Medical LLC, Norwalk, CT, USA; 4Biometrics, Auxilium Pharmaceuticals, Malvern, PA, USA; 5Men's Health Center, Miriam Hospital, Providence, RI, USABackground: Testosterone levels naturally decline with age in men, often resulting in testosterone deficiency (hypogonadism). However, few studies have examined hypogonadal characteristics and treatment in older (≥65 years) men.Objective: To compare data at baseline and after 12 months of testosterone replacement therapy (TRT) in hypogonadal men ≥65 vs <65 years old. Data for participants 65–74 vs ≥75 years old were also compared.Methods: Data were from TRiUS (Testim Registry in the United States), which enrolled 849 hypogonadal men treated with Testim® 1% (50–100 mg testosterone gel/day) for the first time. Anthropometric, laboratory, and clinical measures were taken at baseline and 12 months, including primary outcomes of total testosterone (TT), free testosterone (FT), and prostate-specific antigen (PSA) levels. Comparisons of parameters were made using Fisher's exact test or analysis of variance. Nonparametric Spearman's ρ and first-order partial correlation coefficients adjusted for the effect of age were used to examine bivariate correlations among parameters.Results: Of the registry participants at baseline with available age information, 16% (133/845) were ≥65 years old. They were similar to men <65 years old in the duration of hypogonadism prior to enrollment (~1 year), TT and FT levels at baseline, TT and FT levels at 12-month follow-up, and in reported compliance with treatment. Older patients were more likely to receive lower doses of TRT. PSA levels did not statistically differ between groups after 12 months of TRT (2.18 ± 2.18 ng/mL for ≥65 vs 1.14 ± 0.84 ng/mL for <65 years old, P = 0.1). Baseline values for the >75-year-old subcohort were not significantly different from subcohorts aged 65–74 years and <65 years.Conclusion: Hypogonadal men ≥65 years old showed significant benefit from TRT over 12 months, similar to that found for hypogonadal men <65 years old. TRT was well tolerated in older patients, successfully increased testosterone level regardless of age, and did not significantly increase PSA levels in older men.Keywords: male hypogonadism, elderly, testosterone replacement therapy, testosterone gel, TRiUS registry, Testim
format article
author Bhattacharya RK
Khera M
Blick G
Kushner H
Miner MM
author_facet Bhattacharya RK
Khera M
Blick G
Kushner H
Miner MM
author_sort Bhattacharya RK
title Testosterone replacement therapy among elderly males: the Testim Registry in the US (TRiUS)
title_short Testosterone replacement therapy among elderly males: the Testim Registry in the US (TRiUS)
title_full Testosterone replacement therapy among elderly males: the Testim Registry in the US (TRiUS)
title_fullStr Testosterone replacement therapy among elderly males: the Testim Registry in the US (TRiUS)
title_full_unstemmed Testosterone replacement therapy among elderly males: the Testim Registry in the US (TRiUS)
title_sort testosterone replacement therapy among elderly males: the testim registry in the us (trius)
publisher Dove Medical Press
publishDate 2012
url https://doaj.org/article/20c1f78cdb1247c296ed946d8ae564b0
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