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Effects of Transdermal Testosterone Tretment on Inflammatory Markers in Elderly Males
Affiliation:1. Department of Clinical and Experimental Medicine, Section of Geriatrics, University of Parma, Italy;2. Geriatric Rehabilitation Department, University Hospital of Parma, Parma, Italy;3. Division of Endocrinology, Diabetes, and Metabolism, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania;4. Department of Psychiatry, VU University Medical Center/GGZ inGeest, Amsterdam, the Netherlands;5. National Institute on Aging, National Institutes of Health, Baltimore, Maryland.;1. Departments of Endocrinology, Instituto Português de Oncologia de Lisboa;2. Departments of Nuclear Medicine Department, Instituto Português de Oncologia de Lisboa;3. Departments of University Clinic of Endocrinology, Faculdade de Ciências Médicas, Universidade Nova de Lisboa.;1. department of Endocrinology, Diabetes, and Metabolism; Cleveland Clinic Foundation, Cleveland, Ohio;2. Department of Otolaryngology; Cleveland Clinic Foundation, Cleveland, Ohio;3. Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center, Department of Neurosurgery and the Neurological Institute;;1. College of Physicians and Surgeons, Columbia University, New York, New York;2. Department of Internal Medicine and Medical Disciplines, “Sapienza” University of Rome, Italy;1. Division of Endocrinology, Diabetes, and Metabolism, Santa Croce and Carle, Cuneo, Italy;2. Department of Radiology, Santa Croce and Carle, Cuneo, Italy,;3. Endocrinology Service, Galeazzi Institute IRCCS, Milan, Italy,;4. Division of Nephrology, Santa Croce and Carle, Cuneo, Italy.
Abstract:ObjectiveDuring the male aging process, testosterone (T) levels progressively fall and inflammatory biomarkers increase. Although a relationship between these 2 phenomena has been tested in previous clinical trials, there is inconclusive evidence about the potential anti-inflammatory action of T.MethodsA total of 108 healthy males > 65 years with serum T concentration < 475 ng/dL were recruited by direct mailings to alumni of the University of Pennsylvania and Temple University and randomized to 60-cm2 T or a placebo patch for 36 months. Ninety-six subjects completed the trial. Information and stored serum specimens from this trial were used to test the hypothesis of the inhibitory effect of T on inflammation. We evaluated 70 males (42 in the T group) who had banked specimens from multiple time points available for assays of T, C-reactive protein (CRP), tumor necrosis factor (TNF)-α, soluble TNF-α receptor-1 (TNFR1), interleukin-6 (IL-6), and soluble IL-6 receptors (sIL6r and sgp130).ResultsThe mean age ± SD at baseline was 71.8 ± 4.9 years. Testosterone replacement therapy for 36 months did not induce significant decreases in inflammatory markers. A trend toward a significant increase was observed in the placebo group for TNF-α (P = .03) and sgp130 (P = .01). Significant differences in estimated means of TNFR1 (but not other inflammatory markers), with lower levels in the T group, were observed at the 36-month time point. In T-treated subjects we found an almost significant treatment × time interaction term TNFR1 (P = .02) independent of total body fat content as assessed by dual energy X-ray absorptiometry (DXA). No serious adverse effect was observed.ConclusionsTransdermal T treatment of older males for 36 months is not associated with significant changes in inflammatory markers. (Endocr Pract. 2014;20:1170-1177)
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