Abstract

You have accessJournal of UrologyCME1 May 2022MP35-01 PREVALENCE OF SECONDARY ERYTHROCYTOSIS IN MEN RECEIVING TESTOSTERONE THERAPY: A MATCHED COHORT ANALYSIS OF INJECTIONS, INTRANASAL GEL, AND PELLETS Rohit Reddy, Parris Diaz, Ruben Blachman-Braun, Isaac J. Zucker, Alexandra Dullea, Eliyahu Kresch, Daniel Gonzalez, and Ranjith Ramasamy Rohit ReddyRohit Reddy More articles by this author , Parris DiazParris Diaz More articles by this author , Ruben Blachman-BraunRuben Blachman-Braun More articles by this author , Isaac J. ZuckerIsaac J. Zucker More articles by this author , Alexandra DulleaAlexandra Dullea More articles by this author , Eliyahu KreschEliyahu Kresch More articles by this author , Daniel GonzalezDaniel Gonzalez More articles by this author , and Ranjith RamasamyRanjith Ramasamy More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002589.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In the last 80 years, varying formulations of testosterone have emerged and differing impacts on classic adverse events of polycythemia and suppression of the HPG axis are unclear. We predicted that responsive TRT causes consistent secondary hormonal changes irrespective of formulation. Based on the results of two simultaneous open label randomized clinical trials, we evaluated changes in T, hematocrit (HCt), PSA, and estradiol (E). METHODS: Hypogonadal men (2 serum T <300 ng/dL by MS) were randomized into open label RCTs. Eligible subjects received: 800 mg subcutaneous T pellets, 11 mg TID intranasal T, or 200 mg×2 weeks TC for 16 weeks. Serum T, HCt, PSA, E, and OSA prevalence via STOP-BANG were collected at baseline and follow-up. Data from 75 men presented as a post-hoc analysis was reported as the mean percent change (SD). Student T-tests were used to determine change in adverse effects parameters between each formulation. RESULTS: Median age was 45 years old. Baseline T, HCt, PSA, and E were 223.5 ng/dL, 43.9%, 0.70 ng/mL, and 23.2 ng/mL respectively. Prevalence of OSA was 16% in TC, 12% in intranasal T, and 12% in T pellets. Follow-up values in all three formulations showed increases in T and E, with the largest increases seen in TC (+157%, +23.0%) followed by intranasal T (+114%, +14.5%) and pellets (+79%, +1.4%) (p=0.01). Of note, nasal T showed a decrease in HCt (45.2 to 44.4) while both longer acting formulations showed increases in HCt. Participants positively screened for existing OSA showed no significant differences in HCt before and after four months of treatment (p=0.994 and 0.289). Mean PSA in all three treatment groups was unchanged (0.70 ng/mL). CONCLUSIONS: Prevalence of OSA among men with testosterone deficiency was 13%. Intranasal T appears to have minimal impact on HCt compared to TC and T pellets despite significant increases in serum T and E when controlled for OSA. While the results of these single center RCTs support evidence that intranasal T avoids adverse effects due to its biomimetic short-acting properties, further investigation is required to elucidate predispositions and effects from long term TRT. Source of Funding: Support by National Institutes of Health Grant R01 DK130991 and Clinician Scientist Development Grant from the American Cancer Society to RR © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e587 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Rohit Reddy More articles by this author Parris Diaz More articles by this author Ruben Blachman-Braun More articles by this author Isaac J. Zucker More articles by this author Alexandra Dullea More articles by this author Eliyahu Kresch More articles by this author Daniel Gonzalez More articles by this author Ranjith Ramasamy More articles by this author Expand All Advertisement PDF downloadLoading ...