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Introduction

Aveed, a testosterone undecanoate injection developed by Endo Pharmaceuticals, has become a pivotal treatment option for hypogonadism in American males. As a long-acting injectable testosterone therapy, it offers the convenience of less frequent dosing, which can improve patient adherence and quality of life. However, the administration of exogenous testosterone can influence various hematological parameters, notably hematocrit levels. Elevated hematocrit is a known potential side effect of testosterone therapy, which necessitates careful monitoring to prevent associated health risks such as thrombosis. This article presents a retrospective analysis of hematocrit levels in over 500 American males treated with Aveed over a two-year period, aiming to elucidate the hematological impact of this therapy and guide clinical practice.

Study Design and Patient Demographics

The study cohort comprised 523 American males diagnosed with hypogonadism, who were initiated on Aveed therapy between January 2018 and December 2019. The average age of participants was 47 years, with a range spanning from 28 to 65 years. Patients were followed for a minimum of two years, with hematocrit levels measured at baseline, 3 months, 6 months, 12 months, 18 months, and 24 months post-initiation of therapy. The study aimed to assess the trend and magnitude of hematocrit changes over time and identify any predictors of significant hematocrit elevation.

Hematocrit Trends Over Two Years

At baseline, the mean hematocrit level was 44.2%, which is within the normal range for adult males. Following the initiation of Aveed therapy, a gradual increase in hematocrit was observed. By the 3-month mark, the mean hematocrit had risen to 46.1%. This upward trend continued, with levels reaching 47.5% at 6 months, 48.3% at 12 months, 48.9% at 18 months, and peaking at 49.2% at the 24-month follow-up. While the majority of patients experienced a rise in hematocrit, the increase was generally within the acceptable range, with only 8.4% of patients exceeding the threshold of 54%, which is considered a level warranting intervention.

Predictors of Hematocrit Elevation

Analysis of patient data revealed several predictors of hematocrit elevation. Age was a significant factor, with younger patients (<40 years) demonstrating a more pronounced increase in hematocrit compared to their older counterparts. Additionally, baseline hematocrit levels were predictive of the extent of elevation, with patients starting at higher levels showing a greater absolute increase. Body mass index (BMI) also played a role, as patients with a higher BMI experienced less of a rise in hematocrit, possibly due to the dilutional effect of increased blood volume associated with obesity.

Clinical Implications and Monitoring Recommendations

The findings of this study underscore the importance of vigilant monitoring of hematocrit levels in patients receiving Aveed therapy. Given the gradual increase observed over the two-year period, it is recommended that hematocrit be assessed at least every 3 months during the first year of therapy and every 6 months thereafter. For patients identified as being at higher risk of significant hematocrit elevation, such as those with higher baseline levels or younger age, more frequent monitoring may be warranted. Clinicians should be prepared to adjust therapy or implement phlebotomy if hematocrit levels approach or exceed the 54% threshold.

Conclusion

This retrospective analysis of over 500 American males treated with Aveed over two years provides valuable insights into the hematological effects of this testosterone therapy. While the majority of patients experienced a manageable increase in hematocrit, a small but significant subset required closer monitoring and potential intervention. By identifying predictors of hematocrit elevation, clinicians can tailor their approach to monitoring and managing patients on Aveed, ensuring both the efficacy and safety of this important treatment for hypogonadism.