Testosterone replacement in aging men: an evidence-based patient-centric perspective.
Ontology highlight
ABSTRACT:
SUBMITTER: Bhasin S
PROVIDER: S-EPMC7880314 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
Publications
Testosterone replacement in aging men: an evidence-based patient-centric perspective.
The Journal of clinical investigation 20210201 4
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Project description:The T Trials were a coordinated set of seven double-blind, placebo-controlled trials to assess efficacy and safety of testosterone versus placebo gel treatment for one year in 788 older men 65 years or older with hypogonadism who had self-reported and objective impairment of sexual and physical function and/or vitality and an average of two morning serum testosterone concentrations < 275 ng/dL. Testosterone dose was adjusted to the mid-normal range for young men. Compared to placebo, testosterone treatment moderately improved sexual function, hemoglobin concentration and corrected anemia, and slightly improved walking distance, vitality, mood and depressive symptoms and bone density and strength, but did not improve cognitive function. Testosterone treatment slightly increased non-calcified and total plaque volume; while concerning, the clinical significance of this finding is not clear. Testosterone treatment also increased PSA levels and referral for urological evaluation, and caused erythrocytosis in some men. The T Trials provided definitive evidence for short-term clinically meaningful, albeit modest benefits and risks of testosterone treatment in older men with unequivocal age-related hypogonadism. Larger and longer-term placebo-controlled clinical trials are needed to assess the long-term benefits and risks of testosterone treatment on clinical outcomes such as frailty, depression, fractures, prostate cancer and cardiovascular events.
| S-EPMC7009797 | biostudies-literature
Project description:ObjectiveThe aim of the study was to examine whether receipt of testosterone replacement therapy was associated with reduced 30-day rehospitalization after postacute care among older men with testosterone deficiency.Design, patients, and methodsWe conducted a retrospective cohort study using a 5% national sample of Medicare beneficiaries. We identified 1290 nonsurgical inpatient postacute care discharges between January 1, 2007, and October 31, 2014, for male patients, 66 yrs or older, with a previous diagnosis of testosterone deficiency. Multivariable logistic regression was used to calculate odds ratios and 95% confidence intervals for 30-day postacute care rehospitalization related to receipt of testosterone replacement therapy.ResultsIn older men with testosterone deficiency, receipt of testosterone replacement therapy was not associated with rehospitalization (odds ratio = 0.87, 95% confidence interval, 0.59-1.29) in the 30 days after postacute care discharge. These findings persisted after adjustment for quintile of propensity scores (odds ratio = 0.90, 95% confidence interval = 0.62-1.30).ConclusionTestosterone replacement therapy was not associated with reduced rehospitalization after postacute care discharge in older men with testosterone deficiency. Further research in this population should examine the effects of testosterone replacement therapy on functional recovery and community independence.
| S-EPMC6522284 | biostudies-literature
Project description:The aim of this review was to summarize current knowledge on the correlation between depressive symptoms with a syndrome called partial androgen deficiency of the aging male (PADAM) and on the potential benefits of testosterone (T) treatment on mood. Despite, the causative nature of the relationship between low T levels and depression is uncertain, many hypogonadal men suffer from depression and vice versa several depressed patients are affected by hypogonadism. Supplementation with testosterone failed to show sound evidence of effectiveness in the treatment of depression. Nevertheless, testosterone supplementation has proved to be effective on some domains significant for the quality of life of aged patients with PADAM (sexual function and cognitive functions, muscular strengths).
| S-EPMC3376477 | biostudies-literature
Project description:The indication for testosterone therapy in aging hypogonadal men without hypothalamic, pituitary, or testicular disease remains to be elucidated. The aim of this study was to investigate the effect of testosterone therapy on insulin sensitivity, substrate metabolism, body composition, and lipids in aging men with low normal bioavailable testosterone levels using a predefined cutoff level for bioavailable testosterone. A randomized, double-blinded, placebo-controlled study of testosterone treatment (gel) was done on 38 men, aged 60-78 years, with bioavailable testosterone <7.3 nmol/l and a waist circumference >94 cm. Insulin-stimulated glucose disposal (Rd) and substrate oxidation were assessed by euglycemic hyperinsulinemic clamps combined with indirect calorimetry. Lean body mass (LBM) and total fat mass (TFM) were measured by dual x-ray absorptiometry, and serum total testosterone was measured by tandem mass spectrometry. Bioavailable testosterone was calculated. Coefficients (b) represent the placebo-controlled mean effect of intervention. LBM (b?=?1.9 kg, p?=?0.003) increased while HDL-cholesterol (b?=?-0.12 mmol/l, p?=?0.043) and TFM decreased (b?=?-1.2 kg, p?=?0.038) in the testosterone group compared to placebo. Basal lipid oxidation (b?=?5.65 mg/min/m(2), p?=?0.045) increased and basal glucose oxidation (b?=?-9.71 mg/min/m(2), p?=?0.046) decreased in response to testosterone therapy even when corrected for changes in LBM. No significant changes in insulin-stimulated Rd was observed (b?=?-0.01mg/min/m(2), p?=?0.92). Testosterone therapy increased muscle mass and lipid oxidation in aging men with low normal bioavailable testosterone levels; however, our data did not support an effect of testosterone on whole-body insulin sensitivity using the euglycemic hyperinsulinemic clamp technique.
| S-EPMC3260358 | biostudies-literature
Project description: Not available
| S-EPMC6816466 | biostudies-literature
Project description:With increasing age and the additional impact from the bowel cancer and the chemotherapy and/ or radiotherapy it has been described that testosterone (a male hormone produced naturally in the body) levels are reduced. Testosterone has an impact on numerous body functions including the muscle mass and quality. Previous studies have identified that muscle mass is reduced as a result of ageing but also because of the deleterious effect of cancer and chemotherapy and/or radiotherapy. There is growing evidence from published studies that patients with better muscle mass and quality, do better after surgery. Mr Jenkins and his team are therefore looking at ways, the investigators can try and prevent or reduce this muscle loss and therefore improve patient outcomes.
The aim of this study is to assess whether using testosterone replacement therapy in the form of a topically applied gel daily for a total of 12 weeks, is feasible and acceptable by the patients who are diagnosed with colorectal cancer and are waiting to undergo surgery. The investigators will also collect information related to the testosterone replacement therapy such as questionnaires on the quality of life, fatigue and muscle mass, and blood biomarker changes in the blood.
| 2729656 | ecrin-mdr-crc
Project description:ImportanceThe effect of testosterone replacement therapy (TRT) on the risk of prostate cancer and other adverse prostate events is unknown.ObjectiveTo compare the effect of TRT vs placebo on the incidences of high-grade prostate cancers (Gleason score ≥4 + 3), any prostate cancer, acute urinary retention, invasive prostate procedures, and pharmacologic treatment for lower urinary tract symptoms in men with hypogonadism.Design, setting, and participantsThis placebo-controlled, double-blind randomized clinical trial enrolled 5246 men (aged 45-80 years) from 316 US trial sites who had 2 testosterone concentrations less than 300 ng/dL, hypogonadal symptoms, and cardiovascular disease (CVD) or increased CVD risk. Men with prostate-specific antigen (PSA) concentrations greater than 3.0 ng/mL and International Prostate Symptom Score (IPSS) greater than 19 were excluded. Enrollment took place between May 23, 2018, and February 1, 2022, and end-of-study visits were conducted between May 31, 2022, and January 19, 2023.InterventionParticipants were randomized, with stratification for prior CVD, to topical 1.62% testosterone gel or placebo.Main outcomes and measuresThe primary prostate safety end point was the incidence of adjudicated high-grade prostate cancer. Secondary end points included incidence of any adjudicated prostate cancer, acute urinary retention, invasive prostate surgical procedure, prostate biopsy, and new pharmacologic treatment. Intervention effect was analyzed using a discrete-time proportional hazards model.ResultsA total of 5204 men (mean [SD] age, 63.3 [7.9] years) were analyzed. At baseline, the mean (SD) PSA concentration was 0.92 (0.67) ng/mL, and the mean (SD) IPSS was 7.1 (5.6). The mean (SD) treatment duration as 21.8 (14.2) months in the TRT group and 21.6 (14.0) months in the placebo group. During 14 304 person-years of follow-up, the incidence of high-grade prostate cancer (5 of 2596 [0.19%] in the TRT group vs 3 of 2602 [0.12%] in the placebo group; hazard ratio, 1.62; 95% CI, 0.39-6.77; P = .51) did not differ significantly between groups; the incidences of any prostate cancer, acute urinary retention, invasive surgical procedures, prostate biopsy, and new pharmacologic treatment also did not differ significantly. Change in IPSS did not differ between groups. The PSA concentrations increased more in testosterone-treated than placebo-treated men.Conclusions and relevanceIn a population of middle-aged and older men with hypogonadism, carefully evaluated to exclude those at high risk of prostate cancer, the incidences of high-grade or any prostate cancer and other prostate events were low and did not differ significantly between testosterone- and placebo-treated men. The study's findings may facilitate a more informed appraisal of the potential risks of TRT.Trial registrationClinicalTrials.gov Identifier: NCT03518034.
| S-EPMC10753401 | biostudies-literature
Project description:Symptomatic androgen deficiency is common in patients taking opioid analgesics, as these drugs potently suppress the hypothalamic-pituitary-gonadal axis. However, the efficacy of testosterone replacement in this setting remains unclear. The objective of this trial was to evaluate the efficacy of testosterone replacement on pain perception and other androgen-dependent outcomes in men with opioid-induced androgen deficiency. We conducted a randomized, double-blind, parallel placebo-controlled trial at an outpatient academic research center. Participants were men aged 18 to 64 years on opioid analgesics for chronic noncancer pain, and total testosterone levels were <350 ng/dL. Participants were randomly assigned to 14 weeks of daily transdermal gel that contained 5 g of testosterone or placebo. Primary outcomes were changes in self-reported clinical pain and objectively assessed pain sensitivity. Sexual function, quality of life, and body composition were also assessed. The mean age was 49 years. The median total and free testosterone levels at baseline were 243 ng/dL and 47 pg/mL and 251 ng/dL and 43 pg/mL in the testosterone and placebo arm, respectively. Of the 84 randomized participants, 65 had follow-up data on efficacy outcomes. Compared with men assigned to the placebo arm, those assigned to testosterone replacement experienced greater improvements in pressure and mechanical hyperalgesia, sexual desire, and role limitation due to emotional problems. Testosterone administration was also associated with an improvement in body composition. There were no between-group differences in changes in self-reported pain. In conclusion, in men with opioid-induced androgen deficiency, testosterone administration improved pain sensitivity, sexual desire, body composition, and aspects of quality of life.
| S-EPMC6036339 | biostudies-literature
Project description:Literature proves anti-mullerian hormone (AMH) and total testosterone (TT) as two important reproductive hormones in male development, however evidence regarding age variations of these hormones is lacking.To estimate the normal serum AMH values and to assess the age-specific TT levels in men aged 30-70, we conducted the present population-based study.A total of 831 healthy eligible men, aged 30-70 years, were recruited from Tehran Lipid and Glucose study cohort. Centiles for AMH were estimated according to the exponential normal 3-parameter model. The parametric method of Royston available in general software was applied for the first time to estimate the age-specific AMH and TT percentiles of 5th, 10th, 25th, 50th, 75th, 90th and 95th.Mean AMH level was 6.93, ranging from 0.1 to 40.1 ng/ml. Serum AMH concentrations followed a steady reduction with increasing age. Mean TT level was 4.8, ranging from 0.44 to 11.4 ng/ml.A measurable serum concentrations of AMH in healthy males throughout lifespan with variations, based on age, confirming a slight age-related AMH decline. Fractional polynomial (FP) regression models revealed that the mean and standard deviation (SD) of the TT were not associated with age, so the percentiles estimated were not age-specific.We presented a nomogram of age-specific AMH values in a healthy cohort of Iranian men. This finding might have clinical importance in dealing hormonal disorders in men.
| S-EPMC5513413 | biostudies-other
Project description:ImportanceTestosterone deficiency causes mild anemia. Whether testosterone replacement therapy (TRT) can correct anemia or prevent the development of anemia in men with hypogonadism remains incompletely understood.ObjectiveTo assess the efficacy of TRT in correcting anemia in men with hypogonadism and anemia, and reducing the risk of developing anemia in those without anemia.Design, setting, and participantsThis randomized, placebo-controlled trial included men with hypogonadism at 316 US sites enrolled between May 2018 and February 2022. This study was nested within the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) Study, which evaluated the effect of TRT on major adverse cardiovascular events in middle-aged and older men with hypogonadism. Eligible participants were aged 45 to 80 years, with 2 testosterone concentration results below 300 ng/dL, hypogonadal symptoms, and cardiovascular disease (CVD) or increased CVD risk. The last study visit took place in January 2023. Data were analyzed between March and August 2023.InterventionParticipants were randomized with stratification for preexisting CVD to 1.62% testosterone gel or placebo gel daily for the study duration.Main outcomes and measuresProportion of participants with anemia (hemoglobin below 12.7 g/dL) whose anemia remitted (hemoglobin 12.7 g/dL or above) over the study duration. Secondary end points included incidence of anemia among men who were not anemic. Binary end points were analyzed using repeated-measures log-binomial regression.ResultsA total of 5204 men were included, 815 with anemia (mean [SD] age, 64.8 [7.7] years; 247 Black [30.3%], 544 White [66.7%], 24 other [2.9%]) and 4379 without anemia (mean [SD] age, 63.0 [7.9] years; 629 Black [14.4%], 3603 White [82.3%], 147 other [3.4%]). Anemia corrected in a significantly greater proportion of testosterone-treated than placebo-treated men at 6 months (143 of 349 [41.0%] vs 103 of 375 [27.5%]), 12 months (152 of 338 [45.0%] vs 122 of 360 [33.9%]), 24 months (124 of 290 [42.8%] vs 95 of 307 [30.9%]), 36 months (94 of 216 [43.5%] vs 76 of 229 [33.2%]), and 48 months (41 of 92 [44.6%] vs 38 of 97 [39.2%]) (P = .002). Among participants without anemia, a significantly smaller proportion of testosterone-treated men developed anemia than placebo-treated men. Changes in hemoglobin were associated with changes in energy level.Conclusions and relevanceIn middle-aged and older men with hypogonadism and anemia, TRT was more efficacious than placebo in correcting anemia. Among men who were not anemic, a smaller proportion of testosterone-treated men developed anemia than placebo-treated men.Trial registrationClinicalTrials.gov Identifier: NCT03518034.
| S-EPMC10611996 | biostudies-literature