Adverse Events Associated with Testosterone Administration
By S. Basaria, A. Coviello, T. Travison, T. Storer, W. Farwell, A. Jette, Richard V. Eder, S. Tennstedt, J. Ulloor, Anqi Zhang and 17 more. New England Journal of Medicine, 2010
1,293 citations recorded by the source corpus.
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.
Subfields: Endocrinology, Diabetes and Metabolism, Rehabilitation, Sociology and Political Science
View Paper: https://www.semanticscholar.org/paper/1aaf9dede2c577b09828809ddffd8e23e2f27dd6
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Citations in the corpus
- Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men (2014, methodology): “[4] This was followed by a meta-analysis of a number of a number of very small trials in predominantly older men which also suggested excess cardiovascular risk.”
- Frailty syndrome: an overview (2014, positive): “Such hormonal therapy as testosterone, while it improves muscle strength, has significant systemic side effects.(90) Estrogen-replacement therapy in postmenopausal women also has an unfavorable safety profile.”
- Evaluation and Management of Testosterone Deficiency: AUA Guideline (2018, result): “Evidence Level: Grade B) Current evidence consistently shows that untreated low testosterone levels are associated with an increased risk of MACE; however, studies that measure cardiovascular benefit or harm in men on testosterone therapy have returned inconsistent and controversial results.(23,40,4”
- A SIMPLE FRAILTY QUESTIONNAIRE (FRAIL) PREDICTS OUTCOMES IN MIDDLE AGED AFRICAN AMERICANS (2012, neutral): “Testosterone may also decrease frailty (6, 29).”