In the most comprehensive review of available evidence to date, researchers have shown that testosterone replacement therapy appears safe for use in the short-to-medium term to treat a condition caused by deficiency of the male sex hormone.
But current guidelines are unclear on whether the treatment is associated with any increased cardiovascular risk. The US Food & Drugs Agency (FDA) has a safety warning about testosterone and heart disease, but the European Medicines Agency (EMA) has concluded that there is not enough information to say that testosterone causes heart problems.
The lack of agreement about testosterone’s safety makes doctors and patients uncertain about the risks. But findings presented today at the at the ENDO 2022 congress in the United States and published in the journal The Lancet Healthy Longevity, suggest that men given testosterone to treat hypogonadism are at no greater risk of heart attack, stroke and other cardiovascular events, or death, in the short-to-medium term than men who do not receive testosterone treatment.
In a meta-analysis, researchers looked at 17 trials involving nearly 3,500 participants, around half of which received testosterone, while half received a placebo. They found no significant increase in cardiovascular events between the testosterone and placebo groups (7.5% vs 7.2%, respectively), or mortality rate (0.4% vs 0.8%, respectively).
They found that testosterone significantly reduced some key markers of cardiovascular health, including serum total cholesterol, high-density lipoprotein (HDL), and triglycerides compared with placebo. However, there were no significant differences in serum low-density lipoprotein (LDL), blood pressure, incidence of diabetes and prostate adverse outcomes between the testosterone and placebo groups.
Dr Channa Jayasena, from Imperial College London, senior author on the paper, said: “Most men who need testosterone treatment are 50 years or older, an age at which risk factors for heart problems become more common. The majority of current guidelines say that previous studies have contradictory results about the heart safety of testosterone treatment. It is therefore likely that some men with symptomatic low testosterone are being deprived treatment due to these concerns.
“Our study is likely to supersede the previous evidence and suggests that, within the first year of treatment at least, testosterone treatment is not associated with heart problems. While our study does not look at the longer-term safety of the treatment, these findings will enable doctors to be more confident prescribing testosterone to men who need it.”
‘Adverse cardiovascular events and mortality in men during testosterone treatment: an individual patient and aggregate data meta-analysis’ by Jemma Hudson et al. is published in The Lancet Healthy Longevity. DOI: 10.1016/S2666-7568(22)00096-4
This article is based on press materials from The Lancet.