1372 EFFICACY OF THE β3-ADRENOCEPTOR AGONIST MIRABEGRON FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) IN PATIENTS WITH INCONTINENCE: PROSPECTIVE POOLED ANALYSIS OF 3 RANDOMIZED PHASE 3 TRIALS
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Résumé
You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence, Evaluation & Therapy (III)1 Apr 20131372 EFFICACY OF THE β3-ADRENOCEPTOR AGONIST MIRABEGRON FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) IN PATIENTS WITH INCONTINENCE: PROSPECTIVE POOLED ANALYSIS OF 3 RANDOMIZED PHASE 3 TRIALS Victor Nitti, Jack Barkin, Philip Van Kerrebroeck, Frankel Jeffrey, David Mitcheson, Mary Beth Blauwet, Emad Siddiqui, and Nancy Martin Victor NittiVictor Nitti New York, NY , Jack BarkinJack Barkin Toronto, Canada , Philip Van KerrebroeckPhilip Van Kerrebroeck Maastricht, Netherlands , Frankel JeffreyFrankel Jeffrey Burien, WA , David MitchesonDavid Mitcheson Brighton, MA , Mary Beth BlauwetMary Beth Blauwet Northbrook, IL , Emad SiddiquiEmad Siddiqui Chertsey, United Kingdom , and Nancy MartinNancy Martin Northbrook, IL View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2726AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES In 3 large, randomized, double-blind, placebo-controlled, 12-week Phase 3 trials, in patients ≥18 years with symptoms of OAB for ≥3 months, mirabegron (Mira; 50 and 100 mg once daily) resulted in statistically significant improvements vs placebo (PBO) in mean numbers of incontinence episodes and micturitions/24h from baseline (BL) to final visit (FV). We report the results of a prospective pooled analysis of the efficacy results in patients who were incontinent at BL. METHODS Patients were randomized (1:1:1:1 or 1:1:1) to PBO, Mira 50 or 100 mg, or tolterodine extended release 4 mg (active control; NCT00689104); PBO, Mira 50 or 100 mg (NCT00662909); or PBO, Mira 25 or 50 mg (NCT00912964). The pooled full analysis set (FAS) comprised all randomized patients who took ≥1 dose of double-blind study drug; had completed the 3-day micturition diary at BL and ≥1 post-BL diary. Patients who also had ≥1 incontinence episode in the 3-day micturition diary at BL comprised the FAS-I population. Analysis of covariance was performed on the pooled population (with treatment group, sex and study as fixed factors and BL as a covariate) and NCT00912964 population (with treatment group, sex and geographical region as fixed factors and BL as a covariate). RESULTS The pooled FAS-I comprised 2317 patients (65.4% of FAS). Patient demographics and BL characteristics were comparable across treatment groups. Mira 50 and 100 mg resulted in statistically significant improvements vs PBO in mean number of incontinence episodes/24h from BL to both Week 4 and FV; and mean number of urgency incontinence episodes/24h from BL to FV (Table). At FV, 37.8%, 44.1% and 46.4% of FAS-I patients in the PBO, Mira 50 and 100 mg groups, respectively, reported no episodes of incontinence and 59.6%, 69.5% and 70.5%, respectively, reported a 50% reduction from BL to FV. In NCT00912964, Mira 25 mg resulted in improvements vs PBO in all 3 outcome measures; statistically significant for change from BL to FV in mean number of incontinence episodes/24h. CONCLUSIONS This prospective pooled analysis of 3 large, randomized, Phase 3 trials, demonstrates the efficacy of mirabegron once daily at all assessed doses in incontinent OAB patients. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e561 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Victor Nitti New York, NY More articles by this author Jack Barkin Toronto, Canada More articles by this author Philip Van Kerrebroeck Maastricht, Netherlands More articles by this author Frankel Jeffrey Burien, WA More articles by this author David Mitcheson Brighton, MA More articles by this author Mary Beth Blauwet Northbrook, IL More articles by this author Emad Siddiqui Chertsey, United Kingdom More articles by this author Nancy Martin Northbrook, IL More articles by this author Expand All Advertisement 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 | 0,007 | 0,015 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,004 | 0,012 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,002 | 0,001 |
| Science ouverte | 0,000 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,019 | 0,002 |
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 ».