Effects of Testosterone Treatment in Older Men.

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Abstract

Serum testosterone concentrations decrease as men age, but benefits of raising testosterone levels in older men have not been established.

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Adverse events associated with testosterone administration.

Shehzad Basaria, Andrea D. Coviello, Thomas Travison … (2010)

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. 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. 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. 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. (ClinicalTrials.gov number, NCT00240981.) 2010 Massachusetts Medical Society

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Two-stage residual inclusion estimation: addressing endogeneity in health econometric modeling.

Joseph V Terza, Anirban Basu, Paul Rathouz (2008)

The paper focuses on two estimation methods that have been widely used to address endogeneity in empirical research in health economics and health services research-two-stage predictor substitution (2SPS) and two-stage residual inclusion (2SRI). 2SPS is the rote extension (to nonlinear models) of the popular linear two-stage least squares estimator. The 2SRI estimator is similar except that in the second-stage regression, the endogenous variables are not replaced by first-stage predictors. Instead, first-stage residuals are included as additional regressors. In a generic parametric framework, we show that 2SRI is consistent and 2SPS is not. Results from a simulation study and an illustrative example also recommend against 2SPS and favor 2SRI. Our findings are important given that there are many prominent examples of the application of inconsistent 2SPS in the recent literature. This study can be used as a guide by future researchers in health economics who are confronted with endogeneity in their empirical work.

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Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.

Rebecca Vigen (2013)

Rates of testosterone therapy are increasing and the effects of testosterone therapy on cardiovascular outcomes and mortality are unknown. A recent randomized clinical trial of testosterone therapy in men with a high prevalence of cardiovascular diseases was stopped prematurely due to adverse cardiovascular events raising concerns about testosterone therapy safety. To assess the association between testosterone therapy and all-cause mortality, myocardial infarction (MI), or stroke among male veterans and to determine whether this association is modified by underlying coronary artery disease. A retrospective national cohort study of men with low testosterone levels (<300 ng/dL) who underwent coronary angiography in the Veterans Affairs (VA) system between 2005 and 2011. Primary outcome was a composite of all-cause mortality, MI, and ischemic stroke. Of the 8709 men with a total testosterone level lower than 300 ng/dL, 1223 patients started testosterone therapy after a median of 531 days following coronary angiography. Of the 1710 outcome events, 748 men died, 443 had MIs, and 519 had strokes. Of 7486 patients not receiving testosterone therapy, 681 died, 420 had MIs, and 486 had strokes. Among 1223 patients receiving testosterone therapy, 67 died, 23 had MIs, and 33 had strokes. At 3 years after coronary angiography, the Kaplan-Meier estimated cumulative percentages with events were 19.9%in the no testosterone therapy group vs 25.7%in the testosterone therapy group,with an absolute risk difference of 5.8%(95%CI, -1.4%to 13.1%) [corrected].The Kaplan-Meier estimated cumulative percentages with events among the no testosterone therapy group vs testosterone therapy group at 1 year after coronary angiography were 10.1% vs 11.3%; at 2 years, 15.4% vs 18.5%; and at 3 years, 19.9% vs 25.7 [corrected].There was no significant difference in the effect size of testosterone therapy among those with and without coronary artery disease (test for interaction, P = .41). Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level, the use of testosterone therapy was associated with increased risk of adverse outcomes. These findings may inform the discussion about the potential risks of testosterone therapy.

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Author and article information

Journal

Journal ID (iso-abbrev): N. Engl. J. Med.

Title: The New England journal of medicine

ISSN (Electronic): 1533-4406

ISSN (Print): 0028-4793

Publication date (Electronic): Feb 18 2016

Volume: 374

Issue: 7

Affiliations

[1 ] From the Division of Endocrinology, Diabetes, and Metabolism (P.J.S.), the Department of Biostatistics and Epidemiology (A.J.S.-S., J.T.F., X.H., B.Z., J.R.L., S.S.E.), the Center for Clinical Epidemiology and Biostatistics (D. Cifelli, D.D., L.F.), and the Division of Cardiovascular Disease, Section of Vascular Medicine, Department of Medicine (E.R.M.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston (S. Bhasin, T.W.S., S. Basaria), and New England Research Institutes, Watertown (R.C.R.) - both in Massachusetts; the Departments of Medicine and Molecular and Cellular Biology, Division of Diabetes, Endocrinology, and Metabolism, Baylor College of Medicine and Baylor St. Luke's Medical Center, Houston (G.R.C.); Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs (VA) Puget Sound Health Care System, and the Division of Gerontology and Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine - both in Seattle (A.M.M.); the Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh (J.A.C.); the Division of Geriatric Medicine, Yale School of Medicine, New Haven, CT (T.M.G.); the Department of Internal Medicine and Division of Epidemiology, Department of Family Medicine and Public Health, University of California, San Diego, School of Medicine, La Jolla (E.B.-C.), the Division of Endocrinology, Harbor-UCLA Medical Center (R.S.S., C.W.), and Los Angeles Biomedical Research Institute (R.S.S., C.W.), Torrance, and the Department of Urology, Moores Comprehensive Cancer Center, University of California, San Diego (J.K.P.) - all in California; the Department of Medicine, Division of Epidemiology and Community Health, University of Minnesota (K.E.E., S.J.D.), and Minneapolis VA Health Care System (K.E.E.) - both in Minneapolis; the D

Article

DOI: 10.1056/NEJMoa1506119

PubMed ID: 26886521

SO-VID: 01a27458-788c-4361-ad36-f930be2545b2

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