- Email: [email protected]
Re: Effects of Testosterone Treatment in Older Men
Urological Survey Geriatrics Re: Effects of Testosterone Treatment in Older Men P. J. Snyder, S. Bhasin, G. R. Cunningham, A. M. Matsumoto, A. J. Stephens-Shields, J. A. Cauley, T. M. Gill, E. Barrett-Connor, R. S. Swerdloff, C. Wang, K. E. Ensrud, C. E. Lewis, J. T. Farrar, D. Cella, R. C. Rosen, M. Pahor, J. P. Crandall, M. E. Molitch, D. Cifelli, D. Dougar, L. Fluharty, S. M. Resnick, T. W. Storer, S. Anton, S. Basaria, S. J. Diem, X. Hou, E. R. Mohler, III, J. K. Parsons, N. K. Wenger, B. Zeldow, J. R. Landis and S. S. Ellenberg; Testosterone Trials Investigators National Institutes of Health, Bethesda, Maryland N Engl J Med 2016; 374: 611e624. doi: 10.1056/NEJMoa1506119
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26886521 Editorial Comment: Serum testosterone levels tend to decrease with advancing age. Testosterone replacement therapy (TRT) had gained widespread attention in the scientific and lay press. However, the benefits of TRT have come under increased scrutiny recently, particularly for elderly men. This study was designed to examine clinical outcomes associated with TRT in 790 men 65 years or older within the framework of sexual health, physical function and vitality. Subjects were randomized to receive either testosterone topical gel or placebo gel daily for a year. The goal in the treatment group was to increase serum testosterone levels, and patients generally achieved levels considered to be in the normal range for men 19 to 40 years old. Results indicated that sexual function, including libido and erectile function, were improved significantly compared to placebo. Physical function improved when the data were pooled across the various trials for men receiving testosterone therapy compared to placebo. Use of TRT statistically improved scores for vitality but led to a general improvement in mood and decrease in depressive symptoms. The authors note that the number of subjects was insufficient to make definitive statements regarding risks of adverse events from TRT. Additional research will be needed to validate these findings and extend knowledge about potential risks in this geriatric population. Tomas L. Griebling, MD, MPH
Re: Testosterone Treatment and Sexual Function in Older Men with Low Testosterone Levels G. R. Cunningham, A. J. Stephens-Shields, R. C. Rosen, C. Wang, S. Bhasin, A. M. Matsumoto, J. K. Parsons, T. M. Gill, M. E. Molitch, J. T. Farrar, D. Cella, E. Barrett-Connor, J. A. Cauley, D. Cifelli, J. P. Crandall, K. E. Ensrud, L. Gallagher, B. Zeldow, C. E. Lewis, M. Pahor, R. S. Swerdloff, X. Hou, S. Anton, S. Basaria, S. J. Diem, V. Tabatabaie, S. S. Ellenberg and P. J. Snyder Departments of Medicine, and Molecular and Cellular Biology, and Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and Baylor St. Luke’s Medical Center, Houston, Texas, Department of Biostatistics and Epidemiology, and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia and Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania, New England Research Institutes, Inc., Watertown and Research Program in Men’s Health: Aging and Metabolism, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, Division of Endocrinology, Harbor-University of California at Los Angeles Medical Center and Los Angeles Biomedical Research Institute, Torrance, Department of Urology, Moores Comprehensive Cancer Center, University of California, San Diego and
0022-5347/17/1972-0001/0 THE JOURNAL OF UROLOGY® Ó 2017 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
AND
RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2016.11.049 Vol. 197, 1-2, February 2017 Printed in U.S.A.
www.jurology.com
j
1
GERIATRICS
2
Division of Epidemiology, Department of Family and Preventive Medicine, University of California, San Diego School of Medicine, La Jolla, California, Geriatric Research, Education and Clinical Center, Department of Veterans Affairs Puget Sound Health Care System, and Division of Gerontology and Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine, Seattle, Washington, Division of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut, and Division of Endocrinology, Metabolism and Molecular Medicine, and Department of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, Illinois J Clin Endocrinol Metab 2016; 101: 3096e3104. doi: 10.1210/jc.2016-1645
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/27355400 Editorial Comment: Testosterone replacement therapy (TRT) has been widely advocated for treatment of a number of conditions associated with hypogonadism and aging in elderly men. This study was part of a larger set of clinical trials examining TRT in men 65 years or older who had symptomatic hypogonadism. In this arm of the studies 470 men with decreased libido, low testosterone levels and a sexual partner were randomized to receive either testosterone gel or placebo gel for a year. Using validated instruments, sexual function was assessed before and after treatment, and improved overall in those on TRT compared to placebo. Of the 12 variables measured 10 (83.3%) significantly improved in the treatment group compared to the placebo group. Erectile function did not appear to be influenced by increased testosterone levels in this trial. Importantly there was no threshold testosterone level identified at which improvements were consistently noted. Subjects were evaluated for a variety of pretreatment factors, including demographic variables, functional status and comorbidities, and none was predictive of clinical changes in response to testosterone replacement. These data suggest that testosterone may influence sexual function in multiple ways in elderly men, and TRT may be useful in many older men with symptomatic hypogonadism. Tomas L. Griebling, MD, MPH
Suggested Reading Brock G, Heiselman D, Maggi M et al: Effect of testosterone solution 2% on testosterone concentration, sex drive and energy in hypogonadal men: results of a placebo controlled study. J Urol 2016; 195: 699.
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26886521 Editorial Comment: Serum testosterone levels tend to decrease with advancing age. Testosterone replacement therapy (TRT) had gained widespread attention in the scientific and lay press. However, the benefits of TRT have come under increased scrutiny recently, particularly for elderly men. This study was designed to examine clinical outcomes associated with TRT in 790 men 65 years or older within the framework of sexual health, physical function and vitality. Subjects were randomized to receive either testosterone topical gel or placebo gel daily for a year. The goal in the treatment group was to increase serum testosterone levels, and patients generally achieved levels considered to be in the normal range for men 19 to 40 years old. Results indicated that sexual function, including libido and erectile function, were improved significantly compared to placebo. Physical function improved when the data were pooled across the various trials for men receiving testosterone therapy compared to placebo. Use of TRT statistically improved scores for vitality but led to a general improvement in mood and decrease in depressive symptoms. The authors note that the number of subjects was insufficient to make definitive statements regarding risks of adverse events from TRT. Additional research will be needed to validate these findings and extend knowledge about potential risks in this geriatric population. Tomas L. Griebling, MD, MPH
Re: Testosterone Treatment and Sexual Function in Older Men with Low Testosterone Levels G. R. Cunningham, A. J. Stephens-Shields, R. C. Rosen, C. Wang, S. Bhasin, A. M. Matsumoto, J. K. Parsons, T. M. Gill, M. E. Molitch, J. T. Farrar, D. Cella, E. Barrett-Connor, J. A. Cauley, D. Cifelli, J. P. Crandall, K. E. Ensrud, L. Gallagher, B. Zeldow, C. E. Lewis, M. Pahor, R. S. Swerdloff, X. Hou, S. Anton, S. Basaria, S. J. Diem, V. Tabatabaie, S. S. Ellenberg and P. J. Snyder Departments of Medicine, and Molecular and Cellular Biology, and Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and Baylor St. Luke’s Medical Center, Houston, Texas, Department of Biostatistics and Epidemiology, and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia and Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania, New England Research Institutes, Inc., Watertown and Research Program in Men’s Health: Aging and Metabolism, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, Division of Endocrinology, Harbor-University of California at Los Angeles Medical Center and Los Angeles Biomedical Research Institute, Torrance, Department of Urology, Moores Comprehensive Cancer Center, University of California, San Diego and
0022-5347/17/1972-0001/0 THE JOURNAL OF UROLOGY® Ó 2017 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
AND
RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2016.11.049 Vol. 197, 1-2, February 2017 Printed in U.S.A.
www.jurology.com
j
1
GERIATRICS
2
Division of Epidemiology, Department of Family and Preventive Medicine, University of California, San Diego School of Medicine, La Jolla, California, Geriatric Research, Education and Clinical Center, Department of Veterans Affairs Puget Sound Health Care System, and Division of Gerontology and Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine, Seattle, Washington, Division of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut, and Division of Endocrinology, Metabolism and Molecular Medicine, and Department of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, Illinois J Clin Endocrinol Metab 2016; 101: 3096e3104. doi: 10.1210/jc.2016-1645
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/27355400 Editorial Comment: Testosterone replacement therapy (TRT) has been widely advocated for treatment of a number of conditions associated with hypogonadism and aging in elderly men. This study was part of a larger set of clinical trials examining TRT in men 65 years or older who had symptomatic hypogonadism. In this arm of the studies 470 men with decreased libido, low testosterone levels and a sexual partner were randomized to receive either testosterone gel or placebo gel for a year. Using validated instruments, sexual function was assessed before and after treatment, and improved overall in those on TRT compared to placebo. Of the 12 variables measured 10 (83.3%) significantly improved in the treatment group compared to the placebo group. Erectile function did not appear to be influenced by increased testosterone levels in this trial. Importantly there was no threshold testosterone level identified at which improvements were consistently noted. Subjects were evaluated for a variety of pretreatment factors, including demographic variables, functional status and comorbidities, and none was predictive of clinical changes in response to testosterone replacement. These data suggest that testosterone may influence sexual function in multiple ways in elderly men, and TRT may be useful in many older men with symptomatic hypogonadism. Tomas L. Griebling, MD, MPH
Suggested Reading Brock G, Heiselman D, Maggi M et al: Effect of testosterone solution 2% on testosterone concentration, sex drive and energy in hypogonadal men: results of a placebo controlled study. J Urol 2016; 195: 699.