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      A case series of the safety and efficacy of testosterone replacement therapy in renal failure and kidney transplant patients

      research-article
      ,
      Translational Andrology and Urology
      AME Publishing Company
      Renal failure, testosterone (T), dialysis

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          Abstract

          Background

          Hypogonadism is common in patients with renal dysfunction and does not always correct following transplantation. Recent studies show increased mortality for dialysis and transplant patients with low testosterone (T). These patients are often not treated due to concerns over efficacy and complications (both real and imagined). There is surprisingly scant literature supporting the use of T therapy in these patients. We wished to examine the results of T therapy in our patients with renal failure or following transplant.

          Methods

          We identified 15 men in our Men’s Health Registry treated with T who either were on dialysis or had a functioning transplant at time of therapy. Demographic, laboratory and clinical outcome data were collected from the electronic medical record.

          Results

          There were 3 men on dialysis and 12 with a functioning transplant. Mean age was 53.7 years (range, 39–71 years) and mean total serum T was 207.9 ng/mL (range, 45–330 ng/mL). All had bothersome symptoms including fatigue (15/15) and erectile dysfunction (ED) (14/15). Mean hematocrit was 35.8% and 9/15 were anemic. Therapy included patches in 1, topical gels in 6 and testopel pellets in 8. With a mean follow-up of 22.7 months (range, 11–58 months), mean T post therapy was 528 (range, 226–869). Mean hematocrit improved to 42.6% and 7/9 anemic patients improved out of the anemic range. There were no cardiovascular or infectious complications.

          Conclusions

          Symptomatic hypogonadism is common in dialysis and transplant patients and T replacement therapy can be safely given with improvement in T values and symptoms in most patients. Anemia is usually improved. Testopel pellets can be used in immunosuppressed transplant recipients without infectious complications.

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          Most cited references33

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          Low serum testosterone and mortality in older men.

          Declining testosterone levels in elderly men are thought to underlie many of the symptoms and diseases of aging; however, studies demonstrating associations of low testosterone with clinical outcomes are few. The objective of the study was to examine the association of endogenous testosterone levels with mortality in older community-dwelling men. This was a prospective, population-based study of 794 men, aged 50-91 (median 73.6) yr who had serum testosterone measurements at baseline (1984-1987) and were followed for mortality through July 2004. All-cause mortality by serum testosterone level was measured. During an average 11.8-yr follow-up, 538 deaths occurred. Men whose total testosterone levels were in the lowest quartile (<241 ng/dl) were 40% [hazards ratio (HR) 1.40; 95% confidence interval (CI) 1.14-1.71] more likely to die than those with higher levels, independent of age, adiposity, and lifestyle. Additional adjustment for health status markers, lipids, lipoproteins, blood pressure, glycemia, adipocytokines, and estradiol levels had minimal effect on results. The low testosterone-mortality association was also independent of the metabolic syndrome, diabetes, and prevalent cardiovascular disease but was attenuated by adjustment for IL-6 and C-reactive protein. In cause-specific analyses, low testosterone predicted increased risk of cardiovascular (HR 1.38; 95% CI 1.02-1.85) and respiratory disease (HR 2.29; 95% CI 1.25-4.20) mortality but was not significantly related to cancer death (HR 1.34; 95% CI 0.89-2.00). Results were similar for bioavailable testosterone. Testosterone insufficiency in older men is associated with increased risk of death over the following 20 yr, independent of multiple risk factors and several preexisting health conditions.
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            Cardiac diseases in maintenance hemodialysis patients: results of the HEMO Study.

            Cardiac disease is a common cause of death in chronic hemodialysis patients. A subanalysis of the data on cardiac diseases in the Hemodialysis (HEMO) Study was performed. The specific objectives were: (1) to analyze the prevalence of cardiac disease at baseline; (2) to characterize the incidence of various types of cardiac events during follow-up; (3) to examine the association of cardiac events during follow-up with baseline cardiac diseases; and (4) to examine the effect of dose and flux interventions on various types of cardiac events. The HEMO Study is a randomized multi-center trial on 1846 chronic hemodialysis patients at 15 clinical centers comprising 72 dialysis units. The scheduled maximum follow-up duration was 0.9 to 6.6 years, with the mean actual follow-up of 2.84 years. The interventions were standard-dose versus high-dose and low-flux versus high-flux hemodialysis in a 2 x 2 factorial design. At baseline, 80% of patients had cardiac diseases, including ischemic heart disease (IHD) (39%), congestive heart failure (40%), arrhythmia (31%), and other heart diseases (63%). There were a total of 1685 cardiac hospitalizations, with angina and acute myocardial infarction accounting for 42.7% of these hospitalizations. There were 343 cardiac deaths during follow-up, accounting for 39.4% of all deaths. IHD was implicated in 61.5% of the cardiac deaths. Any cardiac disease at baseline was highly predictive of cardiac death during follow-up [relative risk (RR) 2.57; 95% CI 1.73-3.83]. There were no significant effects of dose or flux assignments on the primary outcome of all-cause mortality or the main secondary cardiac composite outcome of first cardiac hospitalization or all-cause mortality. Assignment to high-flux dialysis was, however, associated with decreased cardiac mortality and the composite outcome of first cardiac hospitalization or death from cardiac causes. The HEMO Study identified IHD to be a major cause of cardiac hospitalizations and cardiac deaths. Future strategies for the prevention of cardiac diseases in the maintenance hemodialysis population should focus on this entity. Although high-flux dialysis did not reduce all-cause mortality, it might improve cardiac outcomes. This hypothesis needs to be further examined.
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              Relative contributions of testosterone and estrogen in regulating bone resorption and formation in normal elderly men.

              Young adult males who cannot produce or respond to estrogen (E) are osteopenic, suggesting that E may regulate bone turnover in men, as well as in women. Both bioavailable E and testosterone (T) decrease substantially in aging men, but it is unclear which deficiency is the more important factor contributing to the increased bone resorption and impaired bone formation that leads to their bone loss. Thus, we addressed this issue directly by eliminating endogenous T and E production in 59 elderly men (mean age 68 years), studying them first under conditions of physiologic T and E replacement and then assessing the impact on bone turnover of withdrawing both T and E, withdrawing only T, or only E, or continuing both. Bone resorption markers increased significantly in the absence of both hormones and were unchanged in men receiving both hormones. By two-factor ANOVA, E played the major role in preventing the increase in the bone resorption markers, whereas T had no significant effect. By contrast, serum osteocalcin, a bone formation marker, decreased in the absence of both hormones, and both E and T maintained osteocalcin levels. We conclude that in aging men, E is the dominant sex steroid regulating bone resorption, whereas both E and T are important in maintaining bone formation.
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                Author and article information

                Journal
                Transl Androl Urol
                Transl Androl Urol
                TAU
                Translational Andrology and Urology
                AME Publishing Company
                2223-4691
                December 2016
                December 2016
                : 5
                : 6
                : 814-818
                Affiliations
                [1]Department of Urology, Glickman Urological and Kidney Institute, The Cleveland Clinic, Cleveland, OH, USA
                Author notes

                Contributions: (I) Conception and design: All authors; (II) Administrative support: All authors; (III) Provision of study materials or patients: All authors; (IV) Collection and assembly of data: All authors; (V) Data analysis and interpretation: All authors; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

                Correspondence to: Daniel A. Shoskes, M.D. Glickman Urological and Kidney Institute, The Cleveland Clinic, 9500 Euclid Avenue, Desk Q10-1, Cleveland, OH 44195, USA. Email: dshoskes@ 123456gmail.com .
                Article
                tau-05-06-814
                10.21037/tau.2016.07.09
                5182221
                1f9be72c-9c9a-4862-bbf1-916b821ad231
                2016 Translational Andrology and Urology. All rights reserved.
                History
                : 02 June 2016
                : 15 June 2016
                Categories
                Original Article

                renal failure,testosterone (t),dialysis
                renal failure, testosterone (t), dialysis

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