LBA-03 EFFICACY AND SAFETY OF MIRABEGRON VS. PLACEBO ADD-ON THERAPY IN MEN WITH OVERACTIVE BLADDER SYMPTOMS RECEIVING TAMSULOSIN FOR UNDERLYING BENIGN PROSTATIC HYPERPLASIA (PLUS)
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Résumé
You have accessJournal of UrologySunday Next Frontier (LBA)1 Apr 2019LBA-03 EFFICACY AND SAFETY OF MIRABEGRON VS. PLACEBO ADD-ON THERAPY IN MEN WITH OVERACTIVE BLADDER SYMPTOMS RECEIVING TAMSULOSIN FOR UNDERLYING BENIGN PROSTATIC HYPERPLASIA (PLUS) Steven Kaplan*, Sender Herschorn, Kevin McVary, David Staskin, Christopher Chapple, Steve Foley, Javier Cambronero Santos, Rita M. Kristy, Nurul Choudhury, John Hairston, and Carol Schermer Steven Kaplan*Steven Kaplan* More articles by this author , Sender HerschornSender Herschorn More articles by this author , Kevin McVaryKevin McVary More articles by this author , David StaskinDavid Staskin More articles by this author , Christopher ChappleChristopher Chapple More articles by this author , Steve FoleySteve Foley More articles by this author , Javier Cambronero SantosJavier Cambronero Santos More articles by this author , Rita M. KristyRita M. Kristy More articles by this author , Nurul ChoudhuryNurul Choudhury More articles by this author , John HairstonJohn Hairston More articles by this author , and Carol SchermerCarol Schermer More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000557495.41260.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: In men, overactive bladder (OAB) symptoms commonly overlap with those of benign prostatic hyperplasia (BPH), but limited data are available on the use of OAB medications in these patients. The objective was to study the efficacy and safety of mirabegron (MIRA) vs. placebo (PL) for treating OAB symptoms in men concurrently receiving tamsulosin (TAM) for lower urinary tract symptoms (LUTS) due to underlying BPH. METHODS: This 12-wk, phase IV, randomized, double-blind, multi-center (North America/Europe) study enrolled men aged ≥40 yr who had received TAM for ≥2 mo. After a 4-wk TAM run-in period, patients were randomized to either MIRA 25 mg or PL. At 4 wk, all patients were titrated to MIRA 50 mg or PL equivalent for 8 more wk. Primary endpoint was change from Baseline (BL) to wk 12/end of treatment (EoT) in mean number of micturitions/24 h. Changes from BL in mean volume voided (MVV)/micturition, urgency episodes/day, total urgency and frequency score (TUFS), and International Prostate Symptom Score (IPSS) total score were analyzed. Safety assessments included treatment-emergent adverse events (TEAEs) and changes in post-void residual (PVR) volume and maximum urinary flow (Qmax). RESULTS: Of 676 men, mean age was 64.9 yr (380 [56.2%] were ≥65 yr). The adjusted mean change from BL to EoT in micturitions/24 h for TAM+MIRA was statistically superior to TAM+PL (Table). Statistically superior results were also obtained for TAM+MIRA in MVV/micturition, urgency episodes/day, and TUFS (no significant difference was seen in IPSS total score). TEAE rates were higher with TAM+PL, although drug-related TEAE rates were higher with TAM+MIRA. Serious TEAE rates were similar in both groups. One (0.3%) TAM+PL and six (1.7%) TAM+MIRA patients experienced urinary retention (two TAM+MIRA patients required catheterization). Changes in mean PVR volume and Qmax were not clinically meaningful. CONCLUSIONS: Among men receiving TAM for LUTS due to BPH, the addition of MIRA was superior to PL in mean number of micturitions/24 h in patients with OAB symptoms. Similar findings were observed for MVV/micturition, urgency episodes/day, and TUFS. There were no unexpected safety concerns. These results underscore the potential utility of MIRA add-on therapy in men with BPH. Source of Funding: This study was funded by Astellas Pharma Global Development, Inc. New York City, NY; Toronto, Canada; Maywood, IL; Brighton, MA; Sheffield, United Kingdom; Reading, United Kingdom; Madrid, Spain; Northbrook, IL; Chertsey, United Kingdom; Northbrook, IL© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e992-e993 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Steven Kaplan* More articles by this author Sender Herschorn More articles by this author Kevin McVary More articles by this author David Staskin More articles by this author Christopher Chapple More articles by this author Steve Foley More articles by this author Javier Cambronero Santos More articles by this author Rita M. Kristy More articles by this author Nurul Choudhury More articles by this author John Hairston More articles by this author Carol Schermer 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 | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,012 | 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 ».