madman
Super Moderator
Introduction: Xyosted® is a subcutaneous testosterone enanthate-autoinjector (SCTE-AI) which was approved by the Food and Drug Administration in 2018 for patient-administered weekly testosterone replacement therapy (TRT).
Objective: This is the largest non-industry sponsored post-market study to evaluate the safety and efficacy profile of SCTE-AI in outpatient urology clinics.
Methods: From January to October 2019, 110 hypogonadal men were treated with SCTE-AI at a two-institutions. Patients were assessed in a pre-therapy visit prior to receiving SCTE-AI and re-assessed at 6-weeks after treatment initiation. Patients with a history of prostate cancer were excluded. Trough serum total testosterone (TT), estradiol, prostate-specific antigen (PSA), and hematocrit (HCT) levels were collected at clinic visits. Therapeutic phlebotomy was recommended for HCT>54%, and treatment was discontinued for significant increases in PSA and for significant treatment-related adverse events. Values from each visit were compared with univariate analysis.
Results: 110 patients completed the 6 weeks of observation with a mean age of 40.3 ± 10.5. TT significantly rose from 246.6 ± 113.3 ng/dL pretherapy to 538.4 ± 209.3 ng/dL at 6 weeks, p<0.001. Post-therapy, 101/110 (91.8%) of patients had TT>300 ng/dL (Table). No patients had HCT > 54%. 74 patients (70.5%) had PSA increase with only 3 (2.9%) experiencing an increase >1.0. There was a significant increase in mean PSA from 1.07 ± 0.8 pretherapy to 1.18 ± 0.9 at 6 weeks, p= 0.01. One patient had immediate treatment cessation following the discovery of prostate cancer.
Conclusions: This is the largest non-industry sponsored safety and efficacy profile of SCTE-AI application in urology clinics. After 6 weeks of observation, TT levels increased significantly. SCTE-AI is a safe and effective alternative method for TRT.
Table: Total Testosterone (TT) ranges before and after 6 weeks of SCTE-AI therapy
Objective: This is the largest non-industry sponsored post-market study to evaluate the safety and efficacy profile of SCTE-AI in outpatient urology clinics.
Methods: From January to October 2019, 110 hypogonadal men were treated with SCTE-AI at a two-institutions. Patients were assessed in a pre-therapy visit prior to receiving SCTE-AI and re-assessed at 6-weeks after treatment initiation. Patients with a history of prostate cancer were excluded. Trough serum total testosterone (TT), estradiol, prostate-specific antigen (PSA), and hematocrit (HCT) levels were collected at clinic visits. Therapeutic phlebotomy was recommended for HCT>54%, and treatment was discontinued for significant increases in PSA and for significant treatment-related adverse events. Values from each visit were compared with univariate analysis.
Results: 110 patients completed the 6 weeks of observation with a mean age of 40.3 ± 10.5. TT significantly rose from 246.6 ± 113.3 ng/dL pretherapy to 538.4 ± 209.3 ng/dL at 6 weeks, p<0.001. Post-therapy, 101/110 (91.8%) of patients had TT>300 ng/dL (Table). No patients had HCT > 54%. 74 patients (70.5%) had PSA increase with only 3 (2.9%) experiencing an increase >1.0. There was a significant increase in mean PSA from 1.07 ± 0.8 pretherapy to 1.18 ± 0.9 at 6 weeks, p= 0.01. One patient had immediate treatment cessation following the discovery of prostate cancer.
Conclusions: This is the largest non-industry sponsored safety and efficacy profile of SCTE-AI application in urology clinics. After 6 weeks of observation, TT levels increased significantly. SCTE-AI is a safe and effective alternative method for TRT.
Table: Total Testosterone (TT) ranges before and after 6 weeks of SCTE-AI therapy
Pre-Therapy | 6 weeks | |||
TT (ng/dL) | n | % | n | % |
0-300 | 96 | 87.3% | 9 | 8.2% |
300-1000 | 14 | 12.7% | 97 | 88.2% |
>1000 | 0 | 0.0% | 4 | 3.6% |
