Adverse events associated with testosterone administration

Shehzad Basaria, Andrea D. Coviello, Thomas G. Travison, Thomas W. Storer, Wildon R. Farwell, Alan M. Jette, Richard Eder, Sharon Tennstedt, Jagadish Ulloor, Anqi Zhang, Karen Choong, Kishore M. Lakshman, Norman A. Mazer, Renee Miciek, Joanne Krasnoff, Ayan Elmi, Philip E. Knapp, Brad Brooks, Erica Appleman, Sheetal AggarwalGeeta Bhasin, Leif Hede-Brierley, Ashmeet Bhatia, Lauren Collins, Nathan K LeBrasseur, Louis D. Fiore, Shalender Bhasin

Research output: Contribution to journalArticle

924 Citations (Scopus)

Abstract

BACKGROUND: Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied. METHODS: Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group. RESULTS: A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load. CONCLUSIONS: In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.

Original languageEnglish (US)
Pages (from-to)109-122
Number of pages14
JournalNew England Journal of Medicine
Volume363
Issue number2
DOIs
StatePublished - Jul 8 2010
Externally publishedYes

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Testosterone
Mobility Limitation
Placebos
Gels
Medical Dictionaries
Clinical Trials Data Monitoring Committees
Independent Living
Safety
Muscle Strength
Respiratory Rate
Hyperlipidemias
Serum
Population
Leg
Chronic Disease
Thorax
Obesity
Hypertension
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Basaria, S., Coviello, A. D., Travison, T. G., Storer, T. W., Farwell, W. R., Jette, A. M., ... Bhasin, S. (2010). Adverse events associated with testosterone administration. New England Journal of Medicine, 363(2), 109-122. https://doi.org/10.1056/NEJMoa1000485

Adverse events associated with testosterone administration. / Basaria, Shehzad; Coviello, Andrea D.; Travison, Thomas G.; Storer, Thomas W.; Farwell, Wildon R.; Jette, Alan M.; Eder, Richard; Tennstedt, Sharon; Ulloor, Jagadish; Zhang, Anqi; Choong, Karen; Lakshman, Kishore M.; Mazer, Norman A.; Miciek, Renee; Krasnoff, Joanne; Elmi, Ayan; Knapp, Philip E.; Brooks, Brad; Appleman, Erica; Aggarwal, Sheetal; Bhasin, Geeta; Hede-Brierley, Leif; Bhatia, Ashmeet; Collins, Lauren; LeBrasseur, Nathan K; Fiore, Louis D.; Bhasin, Shalender.

In: New England Journal of Medicine, Vol. 363, No. 2, 08.07.2010, p. 109-122.

Research output: Contribution to journalArticle

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, NK, Fiore, LD & Bhasin, S 2010, 'Adverse events associated with testosterone administration', New England Journal of Medicine, vol. 363, no. 2, pp. 109-122. https://doi.org/10.1056/NEJMoa1000485
Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM et al. Adverse events associated with testosterone administration. New England Journal of Medicine. 2010 Jul 8;363(2):109-122. https://doi.org/10.1056/NEJMoa1000485
Basaria, Shehzad ; Coviello, Andrea D. ; Travison, Thomas G. ; Storer, Thomas W. ; Farwell, Wildon R. ; Jette, Alan M. ; Eder, Richard ; Tennstedt, Sharon ; Ulloor, Jagadish ; Zhang, Anqi ; Choong, Karen ; Lakshman, Kishore M. ; Mazer, Norman A. ; Miciek, Renee ; Krasnoff, Joanne ; Elmi, Ayan ; Knapp, Philip E. ; Brooks, Brad ; Appleman, Erica ; Aggarwal, Sheetal ; Bhasin, Geeta ; Hede-Brierley, Leif ; Bhatia, Ashmeet ; Collins, Lauren ; LeBrasseur, Nathan K ; Fiore, Louis D. ; Bhasin, Shalender. / Adverse events associated with testosterone administration. In: New England Journal of Medicine. 2010 ; Vol. 363, No. 2. pp. 109-122.
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AU - Travison, Thomas G.

AU - Storer, Thomas W.

AU - Farwell, Wildon R.

AU - Jette, Alan M.

AU - Eder, Richard

AU - Tennstedt, Sharon

AU - Ulloor, Jagadish

AU - Zhang, Anqi

AU - Choong, Karen

AU - Lakshman, Kishore M.

AU - Mazer, Norman A.

AU - Miciek, Renee

AU - Krasnoff, Joanne

AU - Elmi, Ayan

AU - Knapp, Philip E.

AU - Brooks, Brad

AU - Appleman, Erica

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AU - Bhasin, Geeta

AU - Hede-Brierley, Leif

AU - Bhatia, Ashmeet

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N2 - BACKGROUND: Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied. METHODS: Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group. RESULTS: A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load. CONCLUSIONS: In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.

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