madman
Super Moderator
Introduction & Objectives: Xyosted is the first Food and Drug Administration (FDA)-approved testosterone enanthate product aimed to provide a weekly, self-administered injector for subcutaneous delivery of testosterone. This is the first non-industry sponsored post-market study to evaluate the implementation of Xyosted in a urology clinic.
Materials & Methods: From January to October 2019, 19 hypogonadal men were treated with Xyosted at a single institution. Patients were assessed in a pre-therapy visit prior to receiving Xyosted and re-assessed at 6- and 12-week (wk) after treatment initiation. Patients with a history of prostate cancer were excluded. Blood pressure (BP), AUA Symptom Score (AUASS), International Index of Erectile Function (IIEF-5) questionnaires, trough serum total testosterone (TT), trough free testosterone (FT), 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 (TAE). Values from each visit were compared with univariate analysis.
Results: 18/19 patients completed 12wk of observation with a mean age of 52.5 ± 10.1. 13 patients were previously on testosterone replacement therapy (68%). TT and FT significantly rose by the 12wk follow-up compared to pre-therapy (Table). 10 patients had dose titration at 6 wk (10 increased, 0 decreased) and 2 at 12 wk (2 increased, 0 decreased). 4 patients (21%) had HCT > 54% and were referred for therapeutic phlebotomy. 6 patients (32%) had PSA increase. There was no significant difference in PSA mean (1.12 ± 1.0 pretherapy to 1.2 ± 0.9 at 6wk and 1.2 ± 0.6 at 12 wk, p= 0.991). No patients required treatment cessation. Systolic BP was not significantly increased with treatment (130.5 ± 18.1 pretherapy to 129.4 ± 11.0 at 6 wk and 123.8 ± 17.5 at 12 wk, p=0.548). No patients reported injection-related complications and no significant TAE’s were reported. 89% (16/18) of patients continue to use Xyosted.
Conclusions: This is the first non-industry sponsored post-market study of Xyosted after FDA approval in 2018. After 12wk of observation, TT and FT levels significantly rose without significant adverse effects. Xyosted is a safe alternative for the subcutaneous administration of testosterone.
Materials & Methods: From January to October 2019, 19 hypogonadal men were treated with Xyosted at a single institution. Patients were assessed in a pre-therapy visit prior to receiving Xyosted and re-assessed at 6- and 12-week (wk) after treatment initiation. Patients with a history of prostate cancer were excluded. Blood pressure (BP), AUA Symptom Score (AUASS), International Index of Erectile Function (IIEF-5) questionnaires, trough serum total testosterone (TT), trough free testosterone (FT), 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 (TAE). Values from each visit were compared with univariate analysis.
Results: 18/19 patients completed 12wk of observation with a mean age of 52.5 ± 10.1. 13 patients were previously on testosterone replacement therapy (68%). TT and FT significantly rose by the 12wk follow-up compared to pre-therapy (Table). 10 patients had dose titration at 6 wk (10 increased, 0 decreased) and 2 at 12 wk (2 increased, 0 decreased). 4 patients (21%) had HCT > 54% and were referred for therapeutic phlebotomy. 6 patients (32%) had PSA increase. There was no significant difference in PSA mean (1.12 ± 1.0 pretherapy to 1.2 ± 0.9 at 6wk and 1.2 ± 0.6 at 12 wk, p= 0.991). No patients required treatment cessation. Systolic BP was not significantly increased with treatment (130.5 ± 18.1 pretherapy to 129.4 ± 11.0 at 6 wk and 123.8 ± 17.5 at 12 wk, p=0.548). No patients reported injection-related complications and no significant TAE’s were reported. 89% (16/18) of patients continue to use Xyosted.
Conclusions: This is the first non-industry sponsored post-market study of Xyosted after FDA approval in 2018. After 12wk of observation, TT and FT levels significantly rose without significant adverse effects. Xyosted is a safe alternative for the subcutaneous administration of testosterone.
