Update on hypogonadism and cardiovascular risk - INTERVIEW

Description

I think that the topic of cardiovascular risk related to testosterone replacement therapy is not an issue. This concern arose due to one meta-analysis by Xu, one randomized placebo-controlled trial, and two pharmaco-epidemiological studies. Creating a lot of fear in the scientific community and media. However, there are several other meta-analyses published before and after the Xu meta-analysis showing no cardiovascular risk. In 2014 we performed a large meta-analysis analysing major cardiovascular events in randomized placebo-controlled trials of testosterone therapy. Results showed no risk for major cardiovascular events, which are the events required by regulatory agencies involved in the evaluation of the cardiovascular safety of drugs.

New concerns arose in 2017 with the publication of the results from the Testosterone Trials (TTrials). While the TTrials showed no difference in cardiovascular risk between the testosterone group and the placebo group, there was an increase in coronary plaque in testosterone group. So we performed a new meta-analysis, also analyzing the data from pharmaco epidemiological studies, and again, we found no risk. A very interesting new finding was a protective effect of testosterone therapy in trials with obese men (BMI >30).

We recently published the new meta-analysis analyzing all published randomized, placebo-controlled trials, looking at the metabolic effects of testosterone therapy. We found a positive effect on body composition, with a reduction of body fat and increase in lean mass, without change in body weight. The improvement in body composition was accompanied with a reduction in fasting glucose levels and improvement in insulin sensitivity (assessed by HOMA).

We have also meta-analyzed long-term (pharmaco-epidemiological) registry studies, where we found significant reductions in body weight and BMI. The main difference between subjects enrolled in randomized control trials and subjects enrolled in registry studies is that subjects in the registry studies were more obese and had lower testosterone levels. And importantly, the registry studies are of much longer duration (up to 10 years) than the randomized control trials (the longest of which is 3 years). By performing meta-regression analysis we found a direct correlation between the duration of the studies and the amount of reduction in body weight.

My clinical experience is in line with what we observed in the meta-analyses. Especially the meta-analysis of the registry studies, which reflect real-life circumstances, confirm what I see in daily practice. Patients who are obese, patients with metabolic disease, and patients with more severe sexual dysfunction, get the best results from testosterone therapy.

There are some reports from the US showing that only 50% of patients who were prescribed testosterone were still on treatment after two years. So, we – me and my mentor, Mario Maggi, we were invited by the General Secretary of Medicine to write an editorial commentary on the topic of adherence to testosterone therapy. We pointed out the remarkably low drop-out rate of 1% in the long-term registry studies which use long-acting injections of testosterone undecanoate.

Current guidelines do not recommend widespread evaluation of testosterone levels. The European Male Aging study demonstrated that sexual symptoms are the most specific symptoms associated with low testosterone levels. So in men with sexual dysfunction, testosterone must be measured. But I think that testosterone must also be measured in men with metabolic diseases, especially obesity and type 2 diabetes, in whom low testosterone is common. Symptoms need to be confirmed with measure low testosterone levels.


 

Speakers

Prof. Dr. med. Marija Pfeifer

Prof. Dr. med. Marija Pfeifer
Medical Faculty
University of Ljubljana,
Slovenia

Giovanni Corona, MD, PhD

Endocrinology Unity Medical Department
Ospedale Maggiore Bologna, Italy

 

Prof. Dr. med. Marija Pfeifer

Ljublja, Slovenia

 

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