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
Bibliographic record
Abstract
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 ...
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.015 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.012 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.019 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".