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

Abstract

Background

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 hypogonad-ism 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

Acknowledgements

Funding to support this study and the preparation of this manuscript was provided by Auxilium Pharmaceuticals. An Auxilium employee co-authored this paper and was involved in the study design, analysis and interpretation of data, writing of the report, and final approval to submit. The authors thank Lynanne McGuire, PhD, of MedVal Scientific Information Services, LLC, for providing medical writing and editorial assistance. This manuscript was prepared according to the International Society for Medical Publication Professionals’ “Good publication practice for communicating company-sponsored medical research: the GPP2 Guidelines.”

Disclosure

RKB – Advisor/consultant: Auxilium. Speaker: Abbott, Bristol-Myers Squibb, Novartis, Sanofi-Aventis. MK – Research funding: Allergan. Advisor/consultant: Meda. Speaker: Auxilium, Slate. GB – Research funding: Auxilium, Boehringer Ingelheim, Gilead, Pfizer, Sangamo, ViiV. Advisor/consultant: Auxilium, Bristol-Myers Squibb, Merck, Tibotec, ViiV. Speaker: Abbott, Auxilium, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Tibotec, ViiV. HK – Employee: Auxilium. MMM – Board membership: Sexual Medicine Society of North America. Research funding: Auxilium, GlaxoSmithKline. Advisor/consultant: Abbott, Auxilium, Endo. All authors contributed equally and were involved in study design, data acquisition, or data analysis/interpretation and in drafting and/or critically revising the manuscript. All authors reviewed the final manuscript and gave approval for submission.