Efficacy and Safety of Mirabegron in Males with Overactive Bladder and Lower Urinary Tract Symptoms: Analysis from an Integrated Database
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
Background and objective: Several phase 2-4 studies have investigated mirabegron for treating patients with overactive bladder (OAB). The objective of this study was to evaluate the efficacy and safety of mirabegron in adult male OAB patients with or without benign prostate enlargement (BPE) receiving medications for lower urinary tract symptoms (LUTS) management. Methods: A post hoc analysis of 13 phase 2-4 studies using mirabegron (2- or 4-wk single-blind placebo run-in followed by 12-wk double-blind treatment period) was conducted. The studies had four treatment arms-(1) mirabegron beginning with 25 mg and then escalated to 50 mg (25/50 mg), (2) mirabegron 50 mg, (3) mirabegron 25/50 mg + tamsulosin hydrochloride (HCl) 0.4 mg, and (4) mirabegron 50 mg + tamsulosin HCl 0.2 mg, and three cohorts-cohort 1, OAB males overall; cohort 2, OAB males with concomitant BPE taking alpha blockers; and cohort 3, OAB males with concomitant BPE taking other LUTS medications (not alpha blockers). The primary efficacy endpoints were change from baseline to 12 wk in the mean daily number of micturitions and mean daily number of incontinence episodes. The secondary endpoints included safety, tolerability, and measures of OAB derived from the daily micturition diary, and patient-reported outcomes of voiding and storage. Key findings and limitations: These results showed improvement in the primary and most secondary endpoints. Participants taking alpha blockers and mirabegron had increased volume voided per micturition. Safety results were consistent with the known profile of mirabegron. Outcomes should be interpreted with caution, as there were few participants taking other LUTS medications. Conclusions and clinical implications: Results showed that mirabegron is effective and safe in male OAB patients, with or without BPE or receiving medications for LUTS management. Patient summary: We conducted a combined analysis of 13 studies of mirabegron in males with overactive bladder with or without benign prostate enlargement. The analyzed patients included those taking mirabegron and mirabegron combined with other medications for lower urinary tract symptoms. Our results showed that mirabegron was safe and effective in reducing the symptoms of overactive bladder.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 it