Androgen Society Position Paper on Cardiovascular Risk With Testosterone Therapy.

Area of Science:

• Endocrinology
• Cardiovascular Medicine
• Pharmacology

Background:

• Previous observational studies (2013-2014) suggested increased cardiovascular risks with testosterone therapy (TTh).
• These studies led to a cardiovascular warning on TTh labels by the FDA in 2015.
• The FDA mandated the TRAVERSE trial to assess TTh cardiovascular safety.

Purpose of the Study:

• To evaluate the cardiovascular safety of testosterone therapy (TTh).
• To determine if TTh increases the risk of major adverse cardiovascular events (MACE) in men at high cardiovascular risk.

Main Methods:

• The TRAVERSE trial randomized 5246 men at high risk for MACE to receive daily testosterone gel or placebo.
• Participants were followed for a mean of 33 months.
• Outcomes assessed included MACE (myocardial infarction, stroke, CV death) and venothrombotic events.

Main Results:

• Testosterone therapy (TTh) was not associated with an increased risk of MACE compared to placebo.
• No increased risk of venothrombotic events was observed with TTh.
• These findings are consistent with a large body of existing literature, including meta-analyses.

Conclusions:

• Testosterone therapy (TTh) is not associated with an increased risk of major adverse cardiovascular events (MACE).
• The TRAVERSE study provides definitive evidence of TTh cardiovascular safety.
• The Androgen Society concludes that TTh is safe regarding heart attack, stroke, and cardiovascular death risk.