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The relationship of testosterone levels with CV outcomes is challenging and has shown conflicting results. Numerous studies have reported decreasing testosterone levels in men with advancing age. Moreover, in patients with established CV disease, those with high CV risk factors including diabetes, or those with significant risk factors for atherosclerotic CV disease (ASCVD), the benefits of TRT should be weighed against the risks of replacement. The goal of treatment is to improve the symptoms including the physical, sexual, and cognitive health with the aim being to keep the testosterone in the mid-normal limit of the reference range. The TRAVERSE trial, reviewed here, was performed as a response to the Food and Drug Administration’s requirement in 2015 that manufacturers of testosterone replacement therapy conduct such trials. Results from the completed ABPM studies confirmed an increase in blood pressure with use of all testosterone products, class-wide. The study design; collection, analysis, and interpretation of data; writing of the manuscript; and decision to submit for publication were performed independent of the funders.
Details of study design, interventions, participants, and outcome measures were extracted from published articles and anonymised IPD was requested from investigators of all identified trials. The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU. It follows concerns over reports about side effects of these medicines on the heart.
Although rare, there is a potential for injury to underlying structures such as nerves, blood vessels, or muscle tissue. Modern surgical protocols significantly reduce infection risk. However, when performed by an experienced surgeon, complication rates remain low and outcomes are typically highly satisfactory.
One of them involving both cross-sectional and longitudinal components reported low levels of total testosterone (TT) in up to 20% of men over 60 years, 30% over 70, and 50% over 80 years of age. According to one study, 2.4 million men aged between 40 and 69 years suffer from hypogonadism in the US with an estimated 481,000 new cases of hypogonadism reported annually in men within the same age group. He returns for follow-up after being on guideline-based medical treatment to optimize his blood pressure control and also taking a high-intensity statin and aspirin. According to one study, 2.4 million men aged between 40 and 69 years suffer from hypogonadism in the United States (US) with an estimated 481,000 new cases of hypogonadism reported annually in men within the same age group.
This IPD meta-analysis draws data from multiple, geographically diverse studies with approximately five-times more participants than the largest single participating trial. Nevertheless, we cannot exclude that a high number of unreported cardiovascular events in the non-IPD studies could ultimately change the conclusions of our analysis. Men with hypogonadism included in this IPD analysis had a higher prevalence of cardiovascular risk factors compared with the general population. Two-stage IPD meta-analysis for all-cause mortality (A) and cardiovascular or cerebrovascular events (B) For cardiovascular (or cerebrovascular) events, pre-specified subgroup analyses according to current methodological recommendations were done to assess effects of diabetes diagnosis, smoking status, testosterone, and free testosterone concentrations. For models not converging using REML, we used a random-effects model using the DerSimonian and Laird method.34 No adjustment for zero events was required due to the use of a parametric model and because both the one-stage and two-stage analysis approaches use information from across all the studies.
Many secondary outcomes (eg, blood pressure) were measured serially. We also collected data on additional outcomes including diabetes and prostate cancer (appendix p 4). At baseline, data on age, body-mass index (BMI), ethnicity, hormone concentrations, cardiovascular history, and other medical history were extracted. MC extracted details of study design, interventions, participants, and outcome measures from published articles using a bespoke data extraction form.
Marketers urge men to talk to their doctors if they have certain \"possible signs\" that mean they could need low-T treatment. However, legitimate safety concerns linger. The ongoing pharmaceutical marketing blitz promises that low-T treatment can make men feel more alert, energetic, mentally sharp, and sexually functional.
The PRAC further considered that the risks of effects on the heart and circulation, and any potential mechanisms for such effects should continue to be monitored, and information from ongoing studies should be provided as part of the next regular safety review (to which these medicines, like all medicines in the EU, are subject). However, further studies are warranted to elucidate the risks of TRT in patients with significant CV risk factors and those with prior history of CV events. The results are very reassuring in that testosterone replacement does not increase overall cardiovascular risk in this group of patients with symptomatic hypogonadism and low testosterone level. A total of 5,246 men aged years with pre-existing or high risk of cardiovascular disease, symptoms of hypogonadism, and testosterone levels Results from the TRAVERSE trial were submitted in 2023, concluding that there was no increase in the risk of adverse cardiovascular outcomes in men using testosterone for hypogonadism.

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