Association of testosterone replacement therapy with atrial fibrillation and acute kidney injury.

Testosterone replacement therapy was associated with a significantly increased risk of acute kidney injury within 3 years.

• Kaplan-Meier survival analysis showed RR 1.53 (95% CI 1.07-2.18) for AKI among men on TRT
• 2134 men were included in each cohort after propensity score matching
• Cohort included men ages 45-80 years old with testosterone levels of 100-300 ng/dL
• The outcome was assessed within a 3-year follow-up period

Testosterone replacement therapy was not associated with a significantly increased risk of new-onset atrial fibrillation within 3 years.

• Kaplan-Meier survival analysis showed RR 1.48 (95% CI 0.93-2.37) for new-onset AF, which was not statistically significant
• This finding contrasts with secondary analyses of the TRAVERSE trial, which reported significantly higher rates of new-onset AF in the TRT cohort
• The study used propensity score matching with 2134 men in each cohort
• The outcome was assessed within a 3-year follow-up period

Men prescribed TRT had significantly lower baseline testosterone levels compared to men not prescribed TRT.

• Men on TRT had mean testosterone of 207 ± 66 ng/dL at the time of diagnosis
• Men not prescribed TRT had mean testosterone of 246 ± 140 ng/dL
• The difference was statistically significant (P < 0.001)
• Both groups met the hypogonadal inclusion criteria of testosterone 100-300 ng/dL

The study utilized the TriNetX Research Network to replicate the inclusion criteria of the TRAVERSE trial in a real-world retrospective setting.

• Men ages 45-80 years with testosterone 100-300 ng/dL were identified from the TriNetX global research database
• The TRT group received topical testosterone therapy prescriptions
• Propensity score matching was used to balance patient populations between groups
• The study is limited by its retrospective design and reliance on documented claims data

The authors concluded that hypogonadal men with underlying cardiovascular risk factors or pre-existing cardiovascular disease who receive TRT may be at increased risk of AKI after starting therapy.

• The study population included men with cardiovascular risk factors or pre-existing cardiovascular disease, consistent with TRAVERSE trial criteria
• The authors note that further studies are required to validate these results
• The findings partially validate the secondary findings of the TRAVERSE trial with respect to AKI but not AF