Efficacy and Safety of Mirabegron versus Placebo Add-On Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Randomized, Phase 4 Study (PLUS)

Kaplan, Steven A.; Herschorn, Sender; McVary, Kevin T.; Chapple, Christopher R.; Foley, Steve; Santos, Juliana dos; Kristy, Rita M.; Choudhury, Nurul; Hairston, John; Schermer, Carol R.

doi:10.1097/ju.0000000000000738

Cited by 42 publications

(59 citation statements)

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“…The mirabegron surveillance program in Japan has substantially contributed to the quantity of data available that demonstrate the efficacy and safety of mirabegron in the clinical setting. [17][18][19] Although clinical trials have been conducted that have analyzed the efficacy and safety of mirabegron add-on therapy for treating OAB symptoms in men concurrently receiving tamsulosin for LUTS, 14,15 supports the results of previous investigations where urinary retention was reported with an incidence of 0.24% (two patients) in a pooled analysis that investigated the efficacy and safety of mirabegron in male patients with OAB symptoms. 16 Furthermore, no cases of urinary retention were noted in the MATCH study in which men with OAB received either add-on mirabegron or placebo in conjunction with an α 1 -blocker, tamsulosin, for the treatment of LUTS.…”

Section: Discussionsupporting

confidence: 60%

“…The MATCH and PLUS studies both showed that add-on mirabegron treatment was more effective than add-on placebo in men with residual OAB symptoms who were receiving tamsulosin for lower urinary tract symptoms (LUTS). 14,15 An integrated analysis of five phase 3 trials found that similar improvements in urgency, frequency, and incontinence were observed with mirabegron and the antimuscarinic solifenacin in a population of male patients with OAB symptoms. 16 In the same analysis, approximately 37% of the population had a history of LUTS associated with BPH or benign prostatic enlargement and 22% were receiving treatment with an α 1 -blocker.…”

Section: Introductionmentioning

confidence: 91%

“…Slightly higher ADR incidences were observed for the patients with BPH compared with the patients without BPH ( 38.581 ± 16.1597 [15] Concomitant drugs during the observation period, n (%) Figure 1).…”

Section: Safetymentioning

confidence: 98%

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Safety and effectiveness of mirabegron in male patients with overactive bladder with or without benign prostatic hyperplasia: A Japanese post‐marketing study

Takahashi

Kato

Tabuchi

et al. 2020

LUTS

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Objectives: The aim of this post hoc analysis from the Japanese mirabegron surveillance program was to investigate the safety and effectiveness of mirabegron in male patients with overactive bladder (OAB) symptoms with/without concomitant benign prostatic hyperplasia (BPH). Methods: This 12-week study included patients who were starting mirabegron treatment for the OAB symptoms of urinary urgency, daytime frequency, and urgency urinary incontinence. Patients were stratified according to BPH diagnosis, and patients with BPH were stratified into those who did/did not receive BPH-specific treatment. Assessments included adverse drug reactions (ADRs), residual urine volume evaluations, and total Overactive Bladder Symptom Score (OABSS) and International Prostate Symptom Score-Quality of Life (IPSS-QoL) measurements. Results: Of 4540 male patients, 3176 (70.0%) had been diagnosed with BPH. Mean age was slightly higher in patients with BPH (74.7 ± 8.41 years) versus patients without BPH (71.0 ± 12.13 years). Overall, 66/1364 (4.84%), 170/2588 (6.57%), and 35/569 (6.15%) patients without BPH, with BPH + treatment, and with BPH + no treatment, respectively, experienced ≥1 ADR. No patients without BPH and 21/3176 (0.66%) patients with BPH experienced a urinary retention ADR. No significant changes from baseline to week 12 in residual volume were noted. Mirabegron was judged to be an effective treatment for 990/1296 (76.4%) patients without BPH, 1935/2491 (77.7%) patients with BPH + treatment, and 421/538 (78.3%) patients with BPH + no treatment. Significant decreases in total OABSS and IPSS-QoL were observed for all groups. Conclusions: Mirabegron was a well-tolerated and effective treatment for patients with OAB symptoms with or without BPH in this post-marketing study.

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Section: Discussionsupporting

confidence: 60%

Section: Introductionmentioning

confidence: 91%

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Safety and effectiveness of mirabegron in male patients with overactive bladder with or without benign prostatic hyperplasia: A Japanese post‐marketing study

Takahashi

Kato

Tabuchi

et al. 2020

LUTS

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“…The methodology has been reported previously. 20 Briefly, PLUS was a Phase 4, randomized, double-blind, multi-center trial (ClinicalTrials.gov: NCT02757768) that enrolled men (≥40 years) with OAB symptoms (≥8 micturitions/day and ≥2 urgency episodes/day) who had received BPH treatment with tamsulosin (0.4 mg daily) for ≥2 months. A diagnosis of BPH was made according to the judgment of the investigator prior to study initiation.…”

Section: Methodsmentioning

confidence: 99%

“…The primary analysis showed that tamsulosin plus mirabegron (TAM + MIRA) administration resulted in statistically significant improvements in the number of micturitions/day, mean volume voided/micturition, urgency episodes/day, and Total Urgency and Frequency Score compared with tamsulosin plus placebo (TAM + PL). 20 Although the safety of mirabegron and tamsulosin as monotherapies has been comprehensively analyzed, there are a lack of clinical data on the use of the agents in combination. Therefore, the aim of the present analysis was to provide an in-depth overview of the safety results from PLUS.…”

mentioning

confidence: 99%

Mirabegron Vs Placebo Add-on Therapy in Men With Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Safety Analysis From the Randomized, Phase 4 PLUS Study

Herschorn

McVary

Santos

et al. 2021

Urology

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OBJECTIVE To analyze the safety of mirabegron add-on therapy in men with overactive bladder symptoms concurrently receiving tamsulosin for lower urinary tract symptoms associated with benign prostatic hyperplasia. METHODS The Phase 4 PLUS study comprised a 4-week run-in period (tamsulosin [0.4 mg]) and a 12-week randomized treatment period (add-on treatment: mirabegron [25 mg] or placebo). Doses were increased to mirabegron 50 mg or matched placebo after 4 weeks. Safety assessments: treatmentemergent adverse events (TEAEs), vital signs, 12-lead electrocardiograms, and changes in postvoid residual volume and maximum urinary flow (Q max). RESULTS The safety analysis set included 352 tamsulosin plus mirabegron (TAM + MIRA) and 354 tamsulosin plus placebo (TAM + PL) patients. The frequency of overall TEAEs was higher with TAM + PL, although a higher incidence of drug-related TEAEs was observed with TAM + MIRA. Most TEAEs were mild or moderate in severity. Drug-related serious TEAEs were reported for 3 patients (2 TAM + MIRA patients: acute myocardial infarction with cerebral infarction and angina pectoris, 1 TAM + PL patient: lacunar stroke). Hypertension, headache, and nasopharyngitis were the most common TEAEs. Special interest TEAEs were infrequently reported. The most common was urinary retention and 2 TAM + MIRA patients required catheterization (neither led to discontinuation). No major changes in blood pressure or pulse rate were noted and similar electrocardiogram parameters were observed for both groups. Changes in mean postvoid residual volume and Q max were not clinically meaningful. CONCLUSION No unexpected safety concerns were noted in men receiving tamsulosin for lower urinary tract symptoms associated with benign prostatic hyperplasia who subsequently received mirabegron add-on therapy. UROLOGY 00: 1−8, 2020.

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Treatment of overactive bladder in men: Is it really different?

Shapiro

Brucker

2022

Neurourology and Urodynamics

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Introduction Overactive bladder (OAB) in men is a topic that is gaining increasing attention as there is a wider understanding that OAB is not a female condition. There are several treatments; however, data in male populations are lacking compared to female cohorts. The high likelihood of concomitant benign prostatic hyperplasia (BPH) and benign prostatic obstruction (BPO) adds to the complexity of the treatment algorithm. The overlap in urinary storage symptoms also makes the interpretation of the literature challenging. Methods Articles that evaluated men with OAB and men with OAB and BPH/BPO were evaluated and assessed. Results Behavioral interventions can offer a significant benefit to male patients with OAB. Medical therapies that have been studied in men with OAB include anticholinergics, beta‐3 agonists, and phosphodiesterase‐5 inhibits. These agents can be offered in addition to alpha‐blockers for men with coexisting BPH/BPO. The literature on Onabotulinumtoxin‐A and neuromodulation modulation in the male population is growing and shows promising results. Conclusion Male OAB is complex; however, there is a growing body of literature to help guide treatments. Many treatments are available and they have shown considerable success.

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Efficacy and Safety of Mirabegron versus Placebo Add-On Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Randomized, Phase 4 Study (PLUS)

Cited by 42 publications

References 0 publications

Safety and effectiveness of mirabegron in male patients with overactive bladder with or without benign prostatic hyperplasia: A Japanese post‐marketing study

Safety and effectiveness of mirabegron in male patients with overactive bladder with or without benign prostatic hyperplasia: A Japanese post‐marketing study

Mirabegron Vs Placebo Add-on Therapy in Men With Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Safety Analysis From the Randomized, Phase 4 PLUS Study

Treatment of overactive bladder in men: Is it really different?

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