TIE appears to be frequent and does not only present within the first year of therapy, indicating that baseline BMI and baseline HCT measurement should be considered in risk stratification of TIE development.
Key Findings
Results
Hematocrit values increased significantly from baseline to last follow-up in all patients receiving testosterone replacement therapy.
In all patients (n=92), HCT increased by +0.04 (95% CI [0.027, 0.050], p<0.0001) compared to baseline.
In the testosterone undecanoate group (n=71), HCT increased by +0.06 (95% CI [0.031, 0.057], p<0.0001) compared to baseline.
Median age of the 247 included patients was 47.0 years (IQR 32-60) with a median follow-up of 2.9 years (IQR 1.0-5.5).
TRT formulations used were testosterone undecanoate (n=194), testosterone enanthate (n=18), and testosterone gel (n=35).
Results
A majority of patients on testosterone replacement therapy reached hematocrit values above the threshold of 0.46.
57% of patients reached an HCT value >0.46.
23% of patients reached an HCT value >0.50.
5% of patients reached an HCT value >0.54.
46% of patients who reached an HCT value >0.46 had their highest HCT measurement within the first year of TRT application.
Results
BMI was significantly associated with the development of testosterone-induced erythrocytosis.
Logistic regression analysis indicated that BMI was significantly associated with the development of HCT ≥0.50 (p=0.013).
BMI was also significantly associated with the development of HCT ≥0.46 (p=0.008).
The direction of the BMI association is not explicitly stated in the abstract but was identified as a predictive factor in risk stratification.
Results
Baseline hematocrit was significantly associated with the likelihood of developing testosterone-induced erythrocytosis.
There was a significant association between baseline HCT measurement and the outcome of HCT ≥0.46 (p=0.025).
Patients with high starting HCT values were more likely to develop TIE.
Baseline HCT was identified as a factor that should be considered in risk stratification for TIE development.
Methods
The most common indication for testosterone replacement therapy in this cohort was central hypogonadism.
Central hypogonadism accounted for 51% of TRT indications.
Primary hypogonadism was the second most common indication at 26%.
The study was a retrospective single-center observational study including 247 patients.
Conclusions
Testosterone-induced erythrocytosis does not occur exclusively within the first year of therapy, suggesting the need for ongoing monitoring.
Only 46% of patients who reached HCT >0.46 had their highest HCT measurement within the first year of TRT.
The authors recommend close follow-up of laboratory values within the first year followed by annual controls.
TIE was described as 'frequent' based on the prevalence data observed in this cohort.
Neidhart A, von Wyl V, Käslin B, Henzen C, Fischli S. (2025). Prevalence and predictive factors of testosterone-induced erythrocytosis: a retrospective single center study.. Frontiers in endocrinology. https://doi.org/10.3389/fendo.2024.1496906