Testosterone therapy increased risk for acute MI in some men
The risk for acute MI within 90 days of testosterone therapy prescription is elevated in older men and younger men with a prior history of CVD, according to new study data.
These data, along with results from other recent studies, led the FDA to announce a reassessment of the risk for stroke, MI and death in men who use FDA-approved testosterone products.
For the current study, researchers reviewed records of 55,593 men prescribed testosterone therapy and 167,279 men prescribed a phosphodiesterase type 5 inhibitor such as sildenafil (Viagra, Pfizer) or tadalafil (Cialis, Lilly). The primary outcome was incidence of acute MI. The researchers compared the incidence rate of MI in the 90 days after initial prescription of testosterone therapy with the incidence rate of MI in the year prior to initial prescription.
For all men prescribed testosterone, the post/pre-prescription rate ratio was 1.36 (95% CI, 1.03-1.81). For men aged 65 years and older, the post/pre-prescription rate ratio for those prescribed testosterone was 2.19 (95% CI, 1.27-3.77) compared with 1.15 (95% CI, 0.83-1.59) for those prescribed phosphodiesterase type 5 inhibitors.
The rate ratio for prescription of testosterone increased with age, rising from 0.95 (95% CI, 0.54-1.67) in men younger than 55 years to 3.43 (95% CI, 1.54-7.56) in men aged 75 years and older (P=.03). The researchers found no similar trend for men prescribed phosphodiesterase type 5 inhibitors (P=.18).
Men younger than 65 years with a history of CVD had post/pre-prescription rate ratio for testosterone of 2.9 (95% CI, 1.49-5.62), according to the researchers. The rate ratio for phosphodiesterase type 5 inhibitors was 1.4 (95% CI, 0.91-2.14).
The researchers found no excess risk for acute MI after testosterone prescription in men younger than 65 years without a history of CVD.
“Given the rapidly increasing use of [testosterone therapy], the current results, along with other recent findings, emphasize the urgency of the previous call for clinical trials adequately powered to assess the range of benefits and risks suggested for such therapy,” the researchers wrote. “Until that time, clinicians might well be advised to include serious cardiovascular events in their discussions with patients of potential risks, particularly for men with existing cardiovascular disease.”
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.