MP79-02 PHARMACOKINETICS AND SAFETY OUTCOMES OF COMPOUNDED VERSUS BRANDED TESTOSTERONE PELLETS IN MEN WITH TESTOSTERONE DEFICIENCY: A SINGLE-CENTER, OPEN-LABEL, RANDOMIZED TRIAL
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Résumé
You have accessJournal of UrologyCME1 Apr 2023MP79-02 PHARMACOKINETICS AND SAFETY OUTCOMES OF COMPOUNDED VERSUS BRANDED TESTOSTERONE PELLETS IN MEN WITH TESTOSTERONE DEFICIENCY: A SINGLE-CENTER, OPEN-LABEL, RANDOMIZED TRIAL Nicholas Deebel, Eliyahu Kresch, Thiago Fernandes Negris Lima, Manuel Molina, Rohit Reddy, Mehul Patel, Justin Loloi, Chase Carto, Daniel Gonzalez, Jesse Ory, Halifax Canada, and Ranjith Ramasamy Nicholas DeebelNicholas Deebel More articles by this author , Eliyahu KreschEliyahu Kresch More articles by this author , Thiago Fernandes Negris LimaThiago Fernandes Negris Lima More articles by this author , Manuel MolinaManuel Molina More articles by this author , Rohit ReddyRohit Reddy More articles by this author , Mehul PatelMehul Patel More articles by this author , Justin LoloiJustin Loloi More articles by this author , Chase CartoChase Carto More articles by this author , Daniel GonzalezDaniel Gonzalez More articles by this author , Jesse OryJesse Ory More articles by this author , Halifax CanadaHalifax Canada More articles by this author , and Ranjith RamasamyRanjith Ramasamy More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003356.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Testosterone deficiency (TD) is a prevalent condition, especially in men ≥45 years old. Treatment of TD with testosterone therapy (TTh) carries numerous metabolic benefits. Subcutaneous Testopel® pellets are FDA approved for the treatment of TD however can impose a significant financial burden to the patient. The objective was to evaluate the safety profile of compounded subcutaneous testosterone pellets and compare the pharmacokinetics between compounded and FDA approved testosterone pellets (Testopel®) for TTh. METHODS: This was a prospective, randomized, non-inferiority clinical trial. We enrolled 75 men diagnosed with TD and randomized them 1:1 ratio to Testopel® and a 100mg compounded pellet group from Empower Pharmaceuticals, an FDA-registered-facility. The patients were implanted with their respective treatment: Testopel® (10 pellets of 75mg) or compounded testosterone pellets (8 pellets of 100mg). Patients were monitored for adverse events with morning laboratory assessment (serum Testosterone, estradiol, 17-hydroxyprogesterone (17-OHP), hematocrit & prostate specific antigen) at 2, 4 and 6 months. RESULTS: After randomization, 34 participants enrolled in the Testopel® 75mg arm and 42 participants in E100 arm. Serum T levels were similar between the groups at 2, 4 and 6 months, with most men (82%) dropping below 300 ng/dL by the end of the trial. The only adverse event was pellet extrusion (n=1). Most dropouts were related to persistent TD symptoms and serum T < 300ng/dL, with similar rates between the two groups in the study. The mean E levels for Testopel® and E100 at 2 months were 29.1 (IQR: 21.3-35.4) and 42.7±17.3 (IQR: 42.1-48.4) pg/mL respectively (p=0.0006). However, levels were not statistically different at the 4 (p=0.53) and 6-month (p=0.17) time points. Other lab values were similar (Figure 1). CONCLUSIONS: Compounded testosterone pellets are clinically efficacious and safe in the treatment of TD. Compounded pellets may represent an economic alternative to Testopel®. This pilot study may provide the practicing urologist with the support to offer compounded testosterone pellets as TTh. Source of Funding: Investigator-initiated grant by Empower Pharmaceuticals SupportNIH Grant R01 DK130991 and Clinician Scientist Development Grant from the ACS to RR © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1141 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Nicholas Deebel More articles by this author Eliyahu Kresch More articles by this author Thiago Fernandes Negris Lima More articles by this author Manuel Molina More articles by this author Rohit Reddy More articles by this author Mehul Patel More articles by this author Justin Loloi More articles by this author Chase Carto More articles by this author Daniel Gonzalez More articles by this author Jesse Ory More articles by this author Halifax Canada More articles by this author Ranjith Ramasamy More articles by this author Expand All Advertisement PDF downloadLoading ...
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,003 | 0,003 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,002 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,002 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,013 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».