January 14, 2015 — Pharmacotherapy has published a study linking the first-time use of testosterone replacement therapy with a 41% increased risk of heart attack compared to non-users.
Even higher risks were observed for first-time users who also had a medical history of coronary artery disease — they were 78% more likely to have a heart attack.
The conclusions of the study were based on observational data on nearly 1 million men between the ages of 45 and 80 years old. No increased risk of heart attack (myocardial infarction) was seen in current or past users of testosterone.
The researchers, from the University of British Columbia, concluded:
“In this large observational study, an association between MI and past or current TRT use was not found. However, a statistically significant association was observed between first-time TRT exposure and MI, although the absolute risk was low.”
This is not the first time testosterone therapy has been linked to cardiovascular disease. The FDA launched a Safety Investigation last year after two concerning studies were published.
One study found a 30% increased risk of heart attack, stroke, and death among older men in poor health who used testosterones compared to those who did not. The other study found that the risk of heart attack double for men over 65 on tesotsterone.
AbbVie, Inc. and several other manufacturers are now facing nearly 300 lawsuits in federal court, mostly involving AndroGel. Men involved in the litigation accuse drug-makers of aggressively marketing testosterone for “Low T” rather than hypogonadism.
Lawsuits claim the “Low T” ad campaign suggested testosterone therapy might be appropriate for every middle-aged man with fatigue, sexual dysfunction, muscle loss, and other normal age-related ailments.