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)
Bibliographic record
Abstract
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 ...
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.012 | 0.001 |
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".