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(4) Studies assessing the pre-specified primary or secondary outcomes of interest. The steroid hormone testosterone is fundamental to male physical development and sexual behaviour. We searched major electronic databases (MEDLINE, Embase, Science Citation Index, and CENTRAL), clinical trial registries, and contacted clinical experts. Testosterone treatment is most often given to men aged 40–65 years.
Male hypogonadism has been increasingly diagnosed and treated in elderly males since the last decade. In addition to being responsible for primary sexual characteristics at birth and puberty (development and changes of sexual organs such as uterus, vagina, penis, and testes), testosterone is also involved in maintaining secondary sexual characteristics. However, a higher incidence of pulmonary embolism, acute kidney injury, and atrial fibrillation was noted in the testosterone group. Of note, a higher incidence of pulmonary embolism, acute kidney injury, and atrial fibrillation was noted in the testosterone group. The primary endpoint occurred in 7% of the testosterone group and in 7.3% of the placebo group.
Worldwide prescribing of testosterone for hypogonadism is increasing;2 however, conflicting messages on testosterone safety might have caused variations in treatment among patients. The secondary objective of this IPD analysis was to assess the physiological effects of testosterone treatment. To assess the effect of studies for which IPD were not available, we extracted appropriate aggregate study-level data and incorporated them alongside the IPD using two-stage IPD random-effect meta-analyses.64 Our aggregate meta-analysis suggested that outcome data were not significantly discrepant between our IPD and non-IPD studies. In view of the lack of consistent cardiovascular event classification, adjudication, or reporting within trials, we did a masked analysis of each individual adverse event by two independent clinicians to classify cardiovascular events from all IPD studies objectively. However, no overall association was observed between cardiovascular events and either free or total serum testosterone at baseline or during testosterone treatment.
Here is how to take a cautious approach to testosterone therapy. Although this new information is somewhat reassuring, men and their doctors should still weigh these issues before committing to long term testosterone therapy. Doctors also watch out for high red blood cell counts, which could increase the risk of clotting. Men can often feel a big difference when they stop therapy because their body\'s testosterone production has not yet recovered. On treatment, the body stops making testosterone.
However, its safety in patients with CV risks and previous CV events is still doubtful due to recent studies showing conflicting results for TRT in patients with adverse CV risk factors. From observational studies and meta-analyses, it is evident that patients with CV events have low testosterone, which might be an indicator of poor health in general. In summary, testosterone therapy appears generally safe from an overall cardiovascular standpoint but may come with risks that must be weighed in balance with its potential benefits on an individual patient whose hypogonadism may be affecting their overall quality of life. This study does not address testosterone’s safety in otherwise normal people who take it solely to build muscle or for other reasons—it just applies to patients with symptomatic hypogonadism and low testosterone levels. Does testosterone replacement therapy in middle-aged and older men with hypogonadism cause increased overall cardiovascular risk? We have conducted the most comprehensive study to date investigating the safety of testosterone treatment of hypogonadism.
The risk of study bias was assessed independently by MC and MA-M using the original version of the Cochrane Collaboration\'s risk of bias tool for randomised controlled trials.33 Follow-up enquiries were made with collaborators providing IPD for cases in which details required were unclear or not reported. All but two eligible studies had durations of 12 months or less; to aid data comparison between studies, secondary outcomes were assessed at 12 months or the time-point closest to 12 months. To address ongoing uncertainly about the safety of testosterone, the Testosterone Efficacy and Safety Consortium was established as a global collaboration of principal investigators of testosterone trials. Long-term safety of testosterone is not yet established; an FDA-mandated study is ongoing. We focused on trials with at least 3-month treatment duration and mean baseline total testosterone of 12 nmol/L or less (or equivalent) before treatment.

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