Testosterone treatment and cardiovascular and venous thromboembolism risk: what is 'new'?
Giovanni Corona,Mauro Dicuio,Giulia Rastrelli,Elisa Maseroli,Francesco Lotti,Angela Sforza,Mario Maggi +6 more
TL;DR: The analysis shows that available data do not support an increased CV risk related to TTh, and similar considerations can be drawn for the relationship between TTh and VTE.
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Abstract: In men, testosterone (T) production declines as a function of ageing. Late-onset hypogonadism (LOH) is the most commonly used term to indicate this age-related condition. In LOH, the relative clinical significance and the potential benefit of testosterone treatment (TTh) are still the subject of strong criticisms in the scientific community. The debate is further complicated by the recent position statement of the US Food and Drug Administration (FDA) emphasizing that, in LOH, the benefits and safety of TTh have not been fully established. Hence, the FDA required a labeling change to inform patients about a possible increased cardiovascular (CV) risk of TTh. Similar considerations were previously released by the FDA and by Health Canada concerning a TTh-related venous thromboembolism (VTE) risk. In this review, we will summarize the available evidence concerning a possible link among TTh and CV and VTE risks. For this purpose, data derived from epidemiological studies analyzing relationships between the aforementioned risks and endogenous T levels will be analyzed. In addition, evidence deriving from interventional studies including pharmacoepidemiological and placebo-controlled randomized controlled trials (RCTs) will be examined. Our analysis shows that available data do not support an increased CV risk related to TTh. Similar considerations can be drawn for the relationship between TTh and VTE. The previously reported cases of TTh-related VTE were frequently related to a previously undiagnosed thrombophilia-hypofibrinolysis status. Hence, an anamnestic screening for thrombophilia before starting TTh is recommended, just as it is for the use of oral contraceptives.
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Citations
European Academy of Andrology (EAA) guidelines on investigation, treatment and monitoring of functional hypogonadism in males: Endorsing organization: European Society of Endocrinology.
Giovanni Corona,Dimitrios G. Goulis,Ilpo Huhtaniemi,Ilpo Huhtaniemi,Michael Zitzmann,Jorma Toppari,Jorma Toppari,Gianni Forti,Dirk Vanderschueren,Frederick C. W. Wu +9 more
TL;DR: Evidence regarding functional hypog onadism, previously referred to as ‘late‐onset’ hypogonadism’, has increased substantially during the last 10 year.
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Endogenous Testosterone Levels and Cardiovascular Risk: Meta-Analysis of Observational Studies
Giovanni Corona,Giulia Rastrelli,Giuseppe Di Pasquale,Alessandra Sforza,Edoardo Mannucci,Mario Maggi +5 more
TL;DR: The present meta-analysis shows that low T in aging men is a marker of CV risk and the possible benefits of T treatment in reducing this risk should be examined in longer-term, specifically designed trials.
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Testosterone and Cardiovascular Risk: Meta-Analysis of Interventional Studies.
Giovanni Corona,Giulia Rastrelli,Giuseppe Di Pasquale,Alessandra Sforza,Edoardo Mannucci,Mario Maggi +5 more
TL;DR: Corona et al. as discussed by the authors conducted a random effect meta-analysis considering all available data from pharmaco-epidemiological studies as well as randomized placebo-controlled trials (RCTs).
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Association of Testosterone Therapy With Risk of Venous Thromboembolism Among Men With and Without Hypogonadism
Rob F. Walker,Neil A. Zakai,Richard F. MacLehose,Logan Cowan,Terrence J. Adam,Alvaro Alonso,Pamela L. Lutsey +6 more
TL;DR: Testosterone therapy was associated with an increase in short-term risk for VTE among men with and without hypogonadism, with some evidence that the association was more pronounced among younger men, and caution should be used when prescribing testosterone therapy.
Prospective evaluation of hematocrit in gender-affirming hormone treatment: results from European Network for the Investigation of Gender Incongruence.
Justine Defreyne,B. Vantomme,E. Van Caenegem,K. Wierckx,C. J. M. de Blok,Maartje Klaver,Nienke M. Nota,D. Van Dijk,Chantal M. Wiepjes,M. den Heijer,Guy T'Sjoen +10 more
TL;DR: Serum hematocrit levels can be found in the reference range of the perceived gender as from 3 months after the initiation of gender‐affirming hormonal treatment.
98
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Adverse events associated with testosterone replacement in middle-aged and older men: a meta-analysis of randomized, placebo-controlled trials
Olga M. Calof,Atam B. Singh,Martin Lee,Anne M. Kenny,Randall J. Urban,Joyce L. Tenover,Shalender Bhasin,Shalender Bhasin +7 more
TL;DR: Testosterone replacement in older men was associated with a significantly higher risk of detection of prostate events and of hematocrit >50% than was placebo; he matocrit increase was the most frequent adverse event associated with testosterone replacement.
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