Adverse Effects of Testosterone Therapy in Adult Men: A Systematic Review and Meta-Analysis

Fernández-Balsells, Mercè; Murad, M. Hassan; Lane, Melanie A.; Lampropulos, Juliana F.; Albuquerque, Felipe N.; Mullan, Rebecca J.; Agrwal, Neera; Elamin, Mohamed B.; Gallegos‐Orozco, Juan F.; Wang, Amy T.; Erwin, Patricia J.; Bhasin, Shalender; Montori, Víctor M.

doi:10.1210/jc.2009-2575

Cited by 634 publications

(507 citation statements)

References 70 publications

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“…The reduction in HDL levels may be explained by a reported testosteroneinduced decrease in lipoprotein lipase activity in humans (Rebuffe-Scrive et al 1991), but the mechanism underlying testosterone-induced decrease in HDL levels has not been clarified. Our data were consistent with a meta-analysis (Whitsel et al 2001) and a recent systematic review (Fernandez-Balsells et al 2010) that reported a significant small decrease in HDL cholesterol levels in men treated with testosterone; however, a meta-analysis found no change in HDL cholesterol levels in response to testosterone treatment (Isidori et al 2005). A low HDL is linked to an increased morbidity and mortality of cardiovascular disease, and in a recent study on old men with limitations in mobility, cardiovascular and respiratory events were significantly increased during testosterone therapy compared to placebo (Basaria et al 2010).…”

Section: Discussionsupporting

confidence: 92%

Testosterone therapy increased muscle mass and lipid oxidation in aging men

Frederiksen

Højlund

Hougaard

et al. 2011

AGE

115

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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, placebocontrolled 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.

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Section: Discussionsupporting

confidence: 92%

Testosterone therapy increased muscle mass and lipid oxidation in aging men

Frederiksen

Højlund

Hougaard

et al. 2011

AGE

115

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“…102 It has been also reported that testosterone accelerates vascular remodeling 119 and stimulates renal prohypertensive processes, including the renin-angiotensin-aldosterone system. 120 Recent metaanalyses have revealed that CVD events were not different between testosterone and placebo groups, 86,121 indicating the complexity of testosterone therapy, as was shown for estrogen therapy in women.…”

Section: Possible Harmful Effects Of Testosterone On Blood Vesselsmentioning

confidence: 97%

Hormonal effects on blood vessels

Akishita

2012

Hypertens Res

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The incidence of cardiovascular disease (CVD) is lower in younger women than in men of the same age, but it increases after menopause, implicating the atheroprotective action of endogenous estrogen. Although observational studies have suggested the efficacy of estrogen therapy in postmenopausal women, placebo-controlled, randomized trials, such as the Women's Health Initiative, have not confirmed effects of estrogen therapy on CVD. Conversely, basic, experimental research has progressed and provided mechanistic insight into estrogen's action on blood vessels. By contrast, the vascular effects of androgens remain poorly understood and have been controversial for a long time. In recent years, an increasing body of evidence has suggested that androgens may exert protective effects against the development of atherosclerosis, at least in elderly men. Epidemiological studies have shown that the incidence of and mortality due to CVD were increased in elderly men with low testosterone levels, although the efficacy of androgen therapy remains unknown. Furthermore, recent experimental studies have demonstrated the direct action of androgens on the vasculature. In this review, we illustrate the effects of sex steroids on the cardiovascular system, focusing on the action of testosterone on the blood vessels.

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“…The testosterone-treated men were at a higher risk of developing erythrocytosis than the placebo/nonintervention group. The adverse effects of testosterone therapy include an increase in hemoglobin and hematocrit (5). A meta-analysis of 51 studies revealed that TRT is associated with an average 0.8 g/dl increase in Hb and a 3.2 % increase in Ht, but there was no signifi cant effect on mortality, prostate size or cardiovascular outcomes (5).…”

Section: Discussionmentioning

confidence: 99%

Testosterone replacement therapy (TRT) and its effect on bone marrow. How serious is it and is there a true polyglobulia?

Levcikova¹,

Breza²,

Luha³

et al. 2017

BLL

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INTRODUCTION: TRT in men with testosterone defi ciency syndrome (TDS) had multiple positive effects and restore a quality of life of affected men. Polyglobulia is the most common dose-limiting adverse effect of TRT, but the mechanisms of TRT-mediated erythropoesis remain unclear. In this study, we evaluated long term haematological side effects of TRT: polyglobulia, elevated hemoglobin (Hb) and haematocrit (Ht). METHODS: In a cross-sectional descriptive study, the authors treated 69 men with TDS and the average age 59 years and the follow-up period 81.32 months. The men were treated with three-month i.m. injections of 1000 mg testosterone undecanoate. The elevated values were: Hb above 176 g/l, Ht above 0.52 and erythrocytes (Ery) above 6.0 mil/mcl. RESULTS: 21 out of 69 patients (30.43 %) had an increased Hb, Ht or Ery during treatment. The interesting fact was that only fi ve men (7.24 %) had increased the number of Ery (true polyglobulia). No men with elevated level of Hb, Ht or Ery had other side effects (like thrombosis). CONCLUSION: It is still not clear, why in some men on TRT the feedback does not work and bone marrow production of red blood cells continues even if the upper limit is reached. Authors expect that only 7% of men had true polyglobulia, other men had elevated Hb or Ht. Based on our own experience we recommend a regular check of men on TRT on order to avoid possible serious side-effects (Tab. 1, Fig. 2

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Adverse Effects of Testosterone Therapy in Adult Men: A Systematic Review and Meta-Analysis

Cited by 634 publications

References 70 publications

Testosterone therapy increased muscle mass and lipid oxidation in aging men

Testosterone therapy increased muscle mass and lipid oxidation in aging men

Hormonal effects on blood vessels

Testosterone replacement therapy (TRT) and its effect on bone marrow. How serious is it and is there a true polyglobulia?

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