Re: Effects of Testosterone Treatment in Older Men

Re: Effects of Testosterone Treatment in Older Men

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Male and Female Sexual Function and Dysfunction; Andrology 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 University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania N Engl J Med 2016; 374: 611e624. doi: 10.1056/NEJMoa1506119

Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26886521 Editorial Comment: This article is significant in that the data continue to support use of testosterone replacement therapy (TRT) to treat sexual dysfunction in men with late onset hypogonadism (LOH), refuting attempts to vilify TRT and LOH.1 The mild depression scores of 6.6 noted at the study outset using the Patient Health Questionnaire-9 scale improved to the near normal range (less than 5) by study month 6. Importantly prostate cancer developed in only 1 patient in the TRT group. TRT does not appear to worsen urinary symptoms, supporting a recently reported metaanalysis.2 No increase in major adverse cardiac events was observed in the TRT group during the study. One can conclude that TRT is not causative of major adverse cardiac events, in contradistinction to previous reports.3,4 This understated but provocative study strongly supports use of TRT for men with hypogonadism and LOH. The lack of adverse events is equally reassuring. Data such as these should allay concerns and provide a strong rationale to judiciously use TRT in men with LOH. Allen D. Seftel, MD 1. Nguyen CP, Hirsch MS, Moeny D et al: Testosterone and “age-related hypogonadism”dFDA concerns. N Engl J Med 2015; 373: 689. 2. Kathrins M, Doersch K, Nimeh T et al: The relationship between testosterone-replacement therapy and lower urinary tract symptoms: a systematic review. Urology 2016; 88: 22. 3. Vigen R, O’Donnell CI, Baron AE et al: Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA 2013; 310: 1829. 4. Finkle WD, Greenland S, Ridgeway GK et al: Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One 2014; 9: e85805.

Suggested Reading Seftel A: How best to measure and test for androgen deficiency. J Urol 2016; Epub ahead of print. Le M, Flores D, May D et al: Current practices of measuring and reference range reporting of free and total testosterone in the United States. J Urol 2015; Epub ahead of print. Li H, Benoit K, Wang W et al: Association between use of exogenous testosterone therapy and risk of venous thrombotic events among exogenous testosterone treated and untreated men with hypogonadism. J Urol 2015; Epub ahead of print.

0022-5347/16/1962-0001/0 THE JOURNAL OF UROLOGY® Ó 2016 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION

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http://dx.doi.org/10.1016/j.juro.2016.05.062 Vol. 196, 1-3, August 2016 Printed in U.S.A.

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MALE AND FEMALE SEXUAL FUNCTION AND DYSFUNCTION; ANDROLOGY

Re: Effects of Testosterone Replacement Therapy on Lower Urinary Tract Symptoms: A Systematic Review and Meta-Analysis T. P. Kohn, D. A. Mata, R. Ramasamy and L. I. Lipshultz Scott Department of Urology, Baylor College of Medicine, Houston, Texas, Department of Pathology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, and Department of Urology, University of Miami Miller School of Medicine, Miami, Florida Eur Urol 2016; Epub ahead of print. doi: 10.1016/j.eururo.2016.01.043

Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26874809 Editorial Comment: This is another recent report delineating the lack of negative impact of testosterone replacement therapy (TRT) on lower urinary tract symptoms (LUTS).1,2 In this analysis of 14 clinical trials testosterone replacement therapy did not worsen lower urinary tract symptoms in men being treated for late onset hypogonadism. The data are congruent with previous reports and do not show any worsening of LUTS when using TRT. The issue remains that the data to date have not included many patients with LUTS/AUA score above 19 as these men have been routinely excluded from TRT trials. This patient group with AUA scores above 19 would be worthwhile to study. Allen D. Seftel, MD 1. Seftel AD, Kathrins M and Niederberger C: Critical update of the 2010 Endocrine Society Clinical Practice Guidelines for Male Hypogonadism: a systematic analysis. Mayo Clin Proc 2015; 90: 1104. 2. Kathrins M, Doersch K, Nimeh T et al: The relationship between testosterone-replacement therapy and lower urinary tract symptoms: a systematic review. Urology 2016; 88: 22.

Re: Effect of Lifestyle Intervention on the Hormonal Profile of Frail, Obese Older Men R. Armamento-Villareal, L. E. Aguirre, C. Qualls and D. T. Villareal Department of Medicine, Baylor College of Medicine, Houston, Texas J Nutr Health Aging 2016; 20: 334e340. doi: 10.1007/s12603-016-0698-x

Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26892583 Editorial Comment: This was a randomized, controlled, 1-year trial of lifestyle intervention in 40 frail, obese men 65 years or older. After 12 months of intervention diet alone resulted in a mean  SD weight loss of 10.1  1.9 kg in the diet group and 9.1  0.9 kg in the diet-exercise group. Intervention resulted in a significant decrease in total estradiol compared to baseline among subjects in the diet and diet-exercise groups. Total testosterone (T) significantly increased (p <0.05) in response to diet (mean  SD 71.0  21.0 ng/dl) and diet-exercise (49.9  15.5 pg/ml), resulting in mean  SD values of 287.0  28.1 ng/dl in the diet group and 317.6  33.1 ng/dl in the diet-exercise group. Thus, diet and exercise augment total T levels. Therefore, diet and diet-exercise appear to help decrease estradiol and increase total T in men older than 65 years. Allen D. Seftel, MD

Re: A Pilot Study Using a Web Survey to Identify Characteristics that Influence Hypogonadal Men to Initiate Testosterone Replacement Therapy R. C. Rosen, A. D. Seftel, D. D. Ruff and D. Muram New England Research Institutes, Inc., Watertown, Massachusetts, Cooper University Hospital, Camden, New Jersey, and Eli Lilly and Company, Indianapolis, Indiana Am J Mens Health 2016; Epub ahead of print. pii: 1557988315625773

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MALE AND FEMALE SEXUAL FUNCTION AND DYSFUNCTION; ANDROLOGY

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Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26819183 Editorial Comment: Men with hypogonadism (HG) who choose testosterone replacement therapy (TRT) may have distinct characteristics that provide insight as to why they may/may not initiate therapy. The aim of the current study was to identify trends in patient characteristics and attitudes in men diagnosed with HG who initiated TRT (TRT+) compared to men who were diagnosed with HG but did not initiate TRT (TRT-). The market research based online survey conducted between 2012 and 2013 included patients from a Federated Sample, a commercially available panel of patients with diverse medical conditions. College educated, heterosexual married men with comorbid erectile dysfunction living in suburban and urban areas were more likely to initiate treatment. The most bothersome symptoms reported were lack of energy, decreased strength and endurance, and deterioration in work performance. Lack of energy prompted men to seek help. Patients in the TRT+ group were more knowledgeable regarding HG compared to TRT- respondents, and most men obtained their information from a health care professional. These data are interesting and shed light on the patient rationale for seeking TRT. Allen D. Seftel, MD

Suggested Reading Seftel A: How best to measure and test for androgen deficiency. J Urol 2016; Epub ahead of print. Le M, Flores D, May D et al: Current practices of measuring and reference range reporting of free and total testosterone in the United States. J Urol 2015; Epub ahead of print. Li H, Benoit K, Wang W et al: Association between use of exogenous testosterone therapy and risk of venous thrombotic events among exogenous testosterone treated and untreated men with hypogonadism. J Urol 2015; Epub ahead of print.

Re: Six Months of Daily Treatment with Vardenafil Improves Parameters of Endothelial Inflammation and of Hypogonadism in Male Patients with Type 2 Diabetes and Erectile Dysfunction: A Randomized, Double-Blind, Prospective Trial D. Santi, A. R. Granata, A. Guidi, E. Pignatti, T. Trenti, L. Roli, R. Bozic, S. Zaza, C. Pacchioni, S. Romano, J. R. Nofer, V. Rochira, C. Carani and M. Simoni Unit of Endocrinology and Metabolism, Department of Biomedical, Metabolic and Neural Sciences, and Center for Genomic Research, University of Modena and Reggio Emilia, and Department of Medicine, Division of Endocrinology, Metabolism and Geriatrics, Department of Laboratory Medicine and Pathological Anatomy, and Diabetic Service, Azienda USL of Modena, Modena, and PerkinElmer and SHIMADZU Italia, Milan, Italy, and Center for Laboratory Medicine, University Hospital Mu¨nster, Mu¨nster, Germany Eur J Endocrinol 2016; 174: 513e522. doi: 10.1530/EJE-15-1100

Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26792933 Editorial Comment: In this prospective, investigator initiated, randomized, placebo controlled, double-blind, clinical trial 54 male patients affected by type 2 diabetes mellitus diagnosed within the last 5 years and erectile dysfunction (ED) were enrolled, regardless of testosterone levels. Of the patients 26 and 28 were assigned to the treatment and placebo groups, respectively. The study consisted of an enrollment phase, a treatment phase (consisting of 10 mg vardenafil or placebo twice daily for 24 weeks) and a followup phase (24 weeks). Erectile function improved during treatment as measured by the International Index of Erectile Function 15. At the end of treatment flow mediated dilatation (FMD) and serum interleukin 6 had significantly improved (p ¼ 0.040 and p ¼ 0.019, respectively). FMD correlated with serum testosterone levels. Testosterone increased significantly with vardenafil treatment and returned to the eugonadal range only in hypogonadal men without changes in gonadotropins. The improvement in FMD and the decrease in serum interleukin 6 are noteworthy and suggest that vardenafil may have an important role in men with type 2 diabetes mellitus and ED beyond the improvement in ED. Allen D. Seftel, MD

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