mirabegron and Prostatic-Hyperplasia

To review the efficacy and safety of mirabegron in men with overactive bladder (OAB) and benign prostatic hyperplasia (BPH).. Numerous studies have shown mirabegron to be efficacious and safe in treating symptoms of OAB. More recent studies evaluating the use of mirabegron in men with OAB and BPH have also shown the medication to be effective with few adverse side effects when used as monotherapy or in combination therapy. Mirabegron is an effective and safe treatment for men with OAB and BPH.

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Aged; Humans; Lower Urinary Tract Symptoms; Male; Prostatic Hyperplasia; Randomized Controlled Trials as Topic; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urological Agents

We conducted a meta-analysis to assess the efficacy and safety of mirabegron on overactive bladder (OAB) induced by benign prostatic hyperplasia (BPH) in men receiving tamsulosin therapy.. We performed the analysis by using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The databases including MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were retrieved to get information regarding randomized controlled trials of mirabegron on OAB induced by BPH in men receiving tamsulosin therapy. We also searched the references of included literatures.. Three randomized controlled trials containing a total of 1317 BPH patients were included in the analysis. Co-primary efficacy end points: the mean number of micturitions per day [the mean difference (MD) = -0.27, 95% confidence interval (CI): -0.46 to -0.09, P = .004], the urgency episodes per day (the MD = -0.50, 95% CI: -0.77 to -0.22, P = .0004), the total OAB symptom score (the MD = -0.69, 95% CI: -1.00 to -0.38, P < .0001), and mean volume voided (the MD = 10.76, 95% CI: 4.87-16.64, P = .0003) indicated that mirabegron was effective in treating OAB induced by BPH in men receiving tamsulosin therapy. Safety assessments that included treatment-emergent adverse events (odds ratio = 0.88, 95% CI: 0.68-1.13, P = .31) indicated that mirabegron was well tolerated with the exception of post-void residual urine volume (MD = 12.02, 95% CI: 6.01-18.04, P < .0001).. This analysis demonstrates that mirabegron is an effective and safe treatment for OAB symptoms induced by BPH in men receiving tamsulosin therapy with a low occurrence of side effects. Besides, we should be aware that the administration of mirabegron might have the risk of increasing post-void residual urine volume.

Topics: Acetanilides; Adrenergic alpha-1 Receptor Antagonists; Adrenergic beta-3 Receptor Agonists; Humans; Male; Prostatic Hyperplasia; Randomized Controlled Trials as Topic; Tamsulosin; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive

To assess the efficacy of mirabegron in the treatment of erectile dysfunction concomitant with lower urinary tract symptoms in benign prostatic obstruction patients.. In this randomized controlled trial, 55 sexually active lower urinary tract symptoms/benign prostatic obstruction patients with concomitant erectile dysfunction were randomly allocated in two groups: the first received mirabegron 50 mg plus doxazosin 2 mg once daily (mirabegron group) and the second received tolterodine 4 mg plus doxazosin 2 mg (tolterodine group) for 12 weeks. The evaluation was based on the International Index of Erectile Function questionnaire, Erection Hardness Score questionnaire, International Prostate Symptom Score, quality of life, uroflowmetry and post-voiding residual. The therapeutic outcomes were assessed at 4 and 12 weeks compared with the baseline.. Only the mirabegron group achieved significant improvement in sexual functions after 4 and 12 weeks. By using ≥5 points difference from the baseline as a cut-off point of change, there was a significant difference in change of direction of the International Index of Erectile Function-15 total score in favor of the mirabegron group; after 12 weeks, the International Index of Erectile Function-15 total score decreased in 0%, was unchanged in 8.3% and improved in 91.7% in the mirabegron group compared with 8.7%, 65.2% and 26.1%, respectively, in the tolterodine group (P < 0.001). Regarding the urinary characteristics, both groups showed significant improvement in the International Prostate Symptom Score, quality of life, and post-voiding residual after 4 and 12 weeks, with no significant difference among them.. Mirabegron improves urinary characteristics and the associated sexual dysfunction in patients with lower urinary tract symptoms/benign prostatic obstruction.

Topics: Acetanilides; Doxazosin; Erectile Dysfunction; Humans; Lower Urinary Tract Symptoms; Male; Prostatic Hyperplasia; Quality of Life; Thiazoles; Tolterodine Tartrate; Treatment Outcome

To investigate the efficacy and safety of mirabegron versus solifenacin as add-on for persistent OAB symptoms after tamsulosin monotherapy in men with probable BPO.. This prospective randomized single-blind study was conducted on patients with persistent OAB symptoms after at least 12 weeks of tamsulosin 0.4 mg. The patients were randomized into group A in which mirabegron (50 mg once daily) was added and group B in which solifenacin (5 mg once daily) was added. Before and 12 weeks after addition of either drugs, we assessed the efficacy of the treatment using the OABSS, IPSS, Q max, MVV/mic and PVR.. Ninety two men were included in this study (46 patients in each group). All the study parameters were significantly improved after the 12-week treatment period in both groups except mean PVR which showed non-significant change in group A and a significant change in group B despite of being clinically irrelevant with only one case of acute urine retention. Overall, no significant difference has been observed between both groups after 12 weeks of treatment regarding all studied parameters except PVR. The incidence of side effects in group A was 10.9% versus 26.1% in group B. Main side effects included dry mouth in 2.2% and 8.7% and constipation in 2.2% and 6.5% in group A and B, respectively.. Our results indicate that the addition of either mirabegron or solifenacin to patients with persistent OAB symptoms after tamsulosin monotherapy has significant efficacy in controlling these symptoms. The adequate balance between efficacy and tolerability reported in this study with mirabegron may result in better QOL and overall patient satisfaction if compared with antimuscarinics.

Topics: Acetanilides; Humans; Male; Middle Aged; Prospective Studies; Prostatic Hyperplasia; Single-Blind Method; Solifenacin Succinate; Tamsulosin; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive

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.. 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: treatment-emergent adverse events (TEAEs), vital signs, 12-lead electrocardiograms, and changes in postvoid residual volume and maximum urinary flow (Q. 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. 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.

Topics: Acetanilides; Adrenergic alpha-1 Receptor Antagonists; Adrenergic beta-3 Receptor Agonists; Adult; Aged; Double-Blind Method; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Prostatic Hyperplasia; Tamsulosin; Thiazoles; Urinary Bladder, Overactive

The efficacy and safety of βeta-3 agonists (Mirabegron 50 mg) have been sparingly assessed in the published English literature. We aim to do an efficacy-safety analysis of Mirabegron-Tamsulosin combination therapy vs tamsulosin-placebo monotherapy in a select subset of medication virgin Benign Prostatic Enlargement (BPE) patients with coexisting predominant non-neurogenic overactive bladder symptoms (OABS).. After prior written informed consent and IEC, 80 patients of uncomplicated BPE with coexisting non-neurogenic OABS and IPSS of >7 without contraindications to drug therapy were computer randomised/allocated to receive either[50 mg Mirabegron plus Tamsulosin 0.4 mg (Intervention arm-I)]or [Tamsulosin 0.4 mg plus capsule lactobacillus (Comparator arm-II)] once daily for 8 weeks. Efficacy was evaluated using the OABS Score (OABSS), mean change in nocturnal frequency (NF), PVR and IPSS, while safety was assessed by recording treatment emergent adverse events (TEAE). Follow-up visits were performed at second, fourth and eighth week.. Patient data in both groups were generally comparable with the exception of NF and IPSS storage sub score (IPSS-ss). Significant improvements were visualised in the eighth week primary endpoint total OABS sub score (OABSS-ss) in the combination group (P < .001).Similar significant improvements were seen with most secondary parameters such as the mean change in NF, IPSS, IPSS-ss, OABS-ss, voided volume, Qmax, and Quality of life index (QOL) (P < .001). No significant increase in PVR was observed in the Mirabegron arm and no patient developed urinary retention. The TEAE were minor, self-limiting and managed symptomatically without drug discontinuity.. Mirabegron can be significantly efficacious and safe in ameliorating non-neurogenic OABS induced by BPE vs placebo by initiating combination therapy from the start as opposed to the usual 'add on therapy' protocol. This combination appeared to be superior in terms of overall safety, minimal side effects, better compliance and tolerability vs Tamsulosin monotherapy in select BPE patients with predominant non-neurogenic OABS.

Topics: Acetanilides; Drug Therapy, Combination; Humans; Male; Prostatic Hyperplasia; Quality of Life; Tamsulosin; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive

PLUS investigated the efficacy and safety of mirabegron add-on therapy in men with overactive bladder symptoms receiving tamsulosin for underlying lower urinary tract symptoms attributable to benign prostatic hyperplasia.. In this phase 4 study a 4-week 0.4 mg tamsulosin run-in period was followed by a 12-week, randomized, double-blind, treatment period in which patients initially received 25 mg mirabegron or placebo add-on therapy. At 4 weeks doses were titrated to 50 mg mirabegron or placebo equivalent. Efficacy end points were changes from baseline to end of treatment in mean number of micturitions per day (primary), mean volume voided per micturition, number of urgency episodes per day, total urgency and frequency score, and total International Prostate Symptom Score (secondary). Safety assessments included treatment emergent adverse events, and post-void residual volume, and maximum urinary flow measurements.. Of the 676 men most were 65 years old or older (380, 56.2%). Tamsulosin plus mirabegron was statistically superior to tamsulosin plus placebo in reducing the mean number of micturitions per day (-2.00 vs -1.62; adjusted difference -0.39; 95% CI -0.76, -0.02). Statistically superior results were noted for tamsulosin plus mirabegron in mean volume voided per micturition, urgency episodes per day, and total urgency and frequency score (not International Prostate Symptom Score). Higher overall treatment emergent adverse event rates were observed with tamsulosin plus placebo, although higher rates of drug related treatment emergent adverse events were noted with tamsulosin plus mirabegron. Urinary retention rates were higher in the tamsulosin plus mirabegron group. Post-void residual volume and maximum urinary flow results were not clinically meaningful.. The results of PLUS underscore the utility of mirabegron add-on therapy to treat men with overactive bladder symptoms receiving tamsulosin for benign prostatic hyperplasia.

Topics: Acetanilides; Adult; Aged; Aged, 80 and over; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Humans; Male; Middle Aged; Prostatic Hyperplasia; Tamsulosin; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urological Agents

To evaluate efficacy and safety of combination of tadalafil + mirabegron for overactive bladder/benign prostatic hyperplasia (OAB/BPH).. Male patients with lower urinary tract symptoms (50 to 89 years), with remaining OAB symptoms even after administering tadalafil for more than 8 weeks were randomly assigned to either tadalafil monotherapy group (5 mg/day) or tadalafil/mirabegron combination therapy group (5 mg/50 mg/day). The primary endpoint was change from baseline in total OAB symptom score (OABSS) at week 12. The secondary endpoints were changes in International Prostate Symptom Score (IPSS), NIH-chronic prostatitis symptom index (NIH-CPSI), and micturition chart parameters at weeks 4 and 12.. A total of 176 patients were randomized to either monotherapy (87 patients) or combination therapy (89 patients). The baseline characteristics of patients in the two groups were similar. The total OABSS (95% confidence interval) of combination therapy was significantly decreased by 1.78 (1.05-2.50) points compared with that of monotherapy (P < .001). Changes from baseline in OABSS nighttime voiding score, urgency score, urgency incontinence score, IPSS storage subscores, NIH-CPSI total score, and numbers of voids, nighttime-voids, and urgency episodes/day in micturition chart were significantly reduced in combination therapy (all P < .001). Patient-reported outcome was significantly more satisfactory in combination therapy than in monotherapy (P < .001). One moderate adverse event (pain in hip joint) with hardly presumed causal relationship with therapy and seven mild adverse events were noted in monotherapy and combination therapy group, respectively.. The effect of tadalafil/mirabegron combination therapy on relieving OAB symptoms appeared to be greater than that of tadalafil monotherapy and can be safely used.

Topics: Acetanilides; Aged; Aged, 80 and over; Drug Therapy, Combination; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Prostatic Hyperplasia; Tadalafil; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urinary Incontinence; Urination; Urological Agents

To compare the efficacy of fesoterodine or mirabegron add-on therapy for persistent overactive bladder (OAB) symptoms despite silodosin monotherapy in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia, in both subjective and objective aspects.. A total of 120 patients with persistent OAB symptoms despite silodosin monotherapy were randomized to receive add-on therapy with fesoterodine (4 mg/day) or mirabegron (50 mg/day) for 12 weeks. At week 12, changes from baseline in patients' subjective symptoms and voiding/storage functions, as assessed using the International Prostate Symptom Score (IPSS), OAB symptom score (OABSS), and urodynamic studies, were compared between the groups.. The final analysis included 50 and 52 patients in the fesoterodine and mirabegron groups, respectively. Although the IPSS and OABSS significantly improved in both groups, the fesoterodine (vs mirabegron) group showed significantly greater improvements in the OABSS-total (-2.8 vs -1.5, P = 0.004), IPSS-QOL (-1.5 vs -1.1, P = 0.04), and OABSS-urgency score (-1.5 vs -0.9, P = 0.008) at 12 weeks. Regarding storage functions, although both groups showed significant improvements, the fesoterodine group demonstrated greater improvements in the detrusor overactivity alleviation rate (52.6% vs 28.9%, P = 0.03). Voiding functions did not deteriorate in either group at 12 weeks; no significant inter-group differences were observed. Post-void residual urine significantly increased by 16 mL only in the fesoterodine group.. Add-on therapy of fesoterodine to silodosin was more effective than adding mirabegron to silodosin for improving OAB symptoms and storage functions, without deteriorating voiding symptoms or functions.

Topics: Acetanilides; Aged; Aged, 80 and over; Benzhydryl Compounds; Drug Therapy, Combination; Humans; Indoles; Male; Middle Aged; Prospective Studies; Prostatic Hyperplasia; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urodynamics; Urological Agents

We evaluated the efficacy and safety of add-on treatment with a β3-adrenoceptor agonist (mirabegron) for overactive bladder symptoms remaining after α1-blocker (tamsulosin) treatment in men with benign prostatic obstruction.. Patients with benign prostatic obstruction with urinary urgency at least once per week and a total OABSS of 3 or more points after 8 or more weeks of treatment with tamsulosin were enrolled in the study. They were randomly allocated to receive 0.2 mg tamsulosin daily or 0.2 mg tamsulosin and 50 mg mirabegron daily for 8 weeks. The primary end point was change in total OABSS. Safety assessments included change in post-void residual urine volume and adverse events.. From January 2012 through September 2013 a total of 94 patients were randomized. Of these patients 76 completed the protocol treatment. In the full analysis set the change in total OABSS during the treatment period was significantly greater in the combination group than in the monotherapy group (-2.21 vs -0.87, p=0.012). The changes in scores for urinary urgency, daytime frequency, International Prostate Symptom Score storage symptom subscore and quality of life index at 8 weeks were significantly greater in the combination group. The change in post-void residual urine volume was significantly greater in the combination group. Although 6 patients experienced adverse events in the combination group, urinary retention was observed in only 1 patient.. Combined tamsulosin and mirabegron treatment is effective and safe for patients with benign prostatic obstruction who have overactive bladder symptoms after tamsulosin monotherapy.

Topics: Acetanilides; Adrenergic alpha-1 Receptor Antagonists; Adrenergic beta-3 Receptor Agonists; Aged; Drug Therapy, Combination; Humans; Male; Prostatic Hyperplasia; Sulfonamides; Tamsulosin; Thiazoles; Urinary Bladder, Overactive

To investigate the safety and efficacy of mirabegron for patients with overactive bladder (OAB) that is unresponsive to antimuscarinic agents or is related to benign prostatic hyperplasia (BPH).. Fifty-two newly diagnosed OAB patients (M group) and 45 patients with OAB that was unresponsive to antimuscarinics (S group) received mirabegron 50 mg once daily and were evaluated by OAB symptom score (OABSS), IPSS-QOL index, and IPSS at the time of baseline, 4 and 8 weeks. Newly diagnosed OAB patients treated with antimuscarinic agents were compared as controls.. Mirabegron was effective for 85.2 % in M group. Significant improvements were seen in each domain of OABSS, and there was no significant difference with antimuscarinic therapy. Mirabegron was efficacious for 61.6 % of S group, and significant decreases of OABSS and IPSS-QOL index were observed. Significant improvements were also seen in voiding symptoms in men. Post-void residual urine volumes before and after treatment were 32.1 and 34.8 ml, and 26.2 and 31.3 ml in M and S group, respectively, and there was no significant difference. The incidence of adverse events was 8.4 %, although none were serious, and the patients recovered spontaneously after mirabegron was discontinued.. The present study suggests mirabegron is as effective as antimuscarinics for OAB. It improves OAB symptoms in patients with OAB for which antimuscarinic agents are insufficient. This study revealed that mirabegron improves not only OAB symptoms related to BPH, but also voiding symptoms in men. Low and mild incidences of side effects support the safe utility of mirabegron.

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Aged; Female; Humans; Male; Muscarinic Antagonists; Prostatic Hyperplasia; Quality of Life; Severity of Illness Index; Thiazoles; Ultrasonography; Urinary Bladder, Overactive; Urodynamics

Storage symptoms significantly deteriorate the quality of life in men with benign prostate enlargement (BPE). Muscarinic receptor antagonists (MRAs) and β3-adrenergic receptors agonists alone, or in combination with selective α1-alpha-antagonists, are considered the most effective medicines relieving storage symptoms. The aim of this study was to analyze the pharmacotherapy of storage symptoms in men with BPE, and their compliance with the European Association of Urology (EAU) guidelines.. The survey was conducted in 2018 by 261 urologists among 24,613 men with lower urinary tract symptoms (LUTS) and BPE treated pharmacologically. Data concerning recent severity of non-neurological LUTS, storage symptoms and pharmacotherapy were collected.. Storage symptoms were reported by 12,356 patients (50.2%) with BPE, more frequently nocturia (75.8%), than urinary urgency (57.8%) and frequency (44.3%). Patients with storage symptoms were more frequently prescribed with MRAs and mirabegron (43.1% vs. 5.0% and 2.4% vs. 0.3%, respectively; p<0.001). Of note, 54.5% of patients with storage symptoms were treated neither with MRAs, nor β3-adrenergic receptors agonists. In the subgroup with storage symptoms, the increasing severity of LUTS accounted for more frequent prescription of MRA (2.1% vs.  29.1% vs. 42.8% in patients with mild, moderate, and severe LUTS, respectively). Decision tree analysis revealed that patients with urinary urgency and urinary frequency, as well as younger ones with urinary urgency but without urinary frequency, were more frequently prescribed with MRAs.. Urinary urgency and frequency are associated with increased utilization of MRAs in men with BPE in everyday clinical practice. The attitude of Polish urologists toward management of persistent storage symptoms in BPE patients is in line with the EAU guidelines.

Topics: Acetanilides; Adrenergic alpha-Antagonists; Adrenergic beta-3 Receptor Agonists; Age Factors; Aged; Cohort Studies; Decision Trees; Guideline Adherence; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Muscarinic Antagonists; Practice Guidelines as Topic; Practice Patterns, Physicians'; Prostatic Hyperplasia; Quality of Life; Severity of Illness Index; Surveys and Questionnaires; Thiazoles

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).. 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.. 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.. Mirabegron was a well-tolerated and effective treatment for patients with OAB symptoms with or without BPH in this post-marketing study.

Topics: Acetanilides; Aged; Female; Humans; Male; Prostatic Hyperplasia; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urodynamics; Urological Agents

Topics: Acetanilides; Humans; Male; Prostatic Hyperplasia; Tamsulosin; Thiazoles; Urinary Bladder, Overactive

Intravesical prostatic protrusion (IPP) is associated with the degree of benign prostatic obstruction. We evaluated the effects of Mirabegron, a selective β3 adrenoceptor agonist, on overactive bladder (OAB) in male patients with different degrees of IPP.. About 185 male patients ≥40 years with lower urinary tract symptoms were recruited from a tertiary referral center. OAB was defined by the overactive bladder symptom score (OABSS) urgency score of ≥2 and sum score of ≥3. IPP was measured in the midsagittal section using transrectal ultrasound and patients were divided into IPP ≤5 mm and IPP >5 mm groups. Outcomes were assessed at the baseline, 4, and 12 weeks.. About 104 patients (56.2%) were diagnosed with OAB and received Mirabegron (50 mg) daily use. Both IPP groups (≤5 and >5 mm) had similar baseline OABSS and International Prostate Symptom Scores (IPSS). Four-week Mirabegron usage was associated with significant decreases in both symptom score measurements, OABSS: IPP ≤5 mm -27.4% and IPP >5 mm -19.7% (P = .419) and IPSS: -32% and -22.5% (P = .202), respectively. Urgency, urge incontinence, and nocturia sub-scores were decreased in both groups, -26.3% and -27.4% (P = .690), 53.3% and 46.2% (P = .916), and 20.8% and 15.4% (P = .958). Effects were maintained at 12 weeks. We found no significant improvement in the frequency sub-score in either group. One patient stopped medication because of intolerable hypertension. Most frequent adverse event was increased residual urine (≥50 mL higher than baseline), IPP ≤5 mm 9.2% and IPP >5 mm 5.1% (P = .707), but no case had acute urinary retention.. Mirabegron is an effective drug to treat male OAB regardless of IPP grade.

Topics: Acetanilides; Aged; Humans; Male; Middle Aged; Prostate; Prostatic Hyperplasia; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urological Agents

To compare the efficacies of mirabegron 50 mg addition after alpha-adrenoreceptor blocker in terms of reducing storage symptoms in patients with BPH.. Fifty-eight patients that had been taking alpha-adrenoreceptor blocker for more than 8 weeks, but had an OABSS of greater than 3 points, were initially enrolled. One group added any alpha-adrenoreceptor blocker with mirabegron 50 mg (n=39; the mirabegron group) and the other group received alpha-adrenoreceptor blocker only (n=19; the control group) for 8 weeks.. In the control group, mean total IPSS decreased from 15.7 to 13.1 (p=0.298) and in mirabegron group, mean total IPSS decreased from 19.4 to 16.5 (p=0.024). Mean storage symptom scores reduced in the control and mirabegron groups from 8.5 to 7.9 (p=0.584) and from 9.1 to 7.6 (p=0.015), respectively, and mean QoL scores from 3.7 to 3.1 (p=0.052) and 3.6 to 3.2 (p=0.027), respectively. Mean overall OABSS in the control and mirabegron groups reduced from 8.4 to 7.2 (p=0.173) and from 8.8 to 7.3, respectively (p=0.005); mean OABSS Q3 from 3.6 to 2.9 (p=0.073) and from 3.5 to 2.7 (p=0.002), respectively; and mean OABSS Q4 from 2.4 to 2.0 (p=0.306) and from 2.7 to 2.0 (p=0.016), respectively. The change of mean Qmax and PVR was insignificant in 2 groups.. IPSS total scores, storage symptom scores, QoL, overall OABSS, OABSS Q3 and Q4 were more improved significantly by alpha-adrenoreceptor blocker with mirabegron 50 mg in BPH patients with persistent overactive symptoms. Mirabegron 50 mg addition is considered to patients with persistent storage symptoms after alpha-adrenoreceptor blocker.

Topics: Acetanilides; Adrenergic alpha-Antagonists; Adrenergic beta-3 Receptor Agonists; Aged; Drug Therapy, Combination; Humans; Male; Middle Aged; Prospective Studies; Prostatic Hyperplasia; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive

To provide real-world data on Japanese patients with overactive bladder (OAB) initiating treatment with the β. Full medical histories, including prior/concomitant drug use, were collected before initiating mirabegron treatment. After 12 weeks mirabegron, physicians assessed ADR incidence and treatment effectiveness. Residual urine volume was assessed and patients completed the Overactive Bladder Symptom Score (OABSS) and International Prostate Symptom Score-Quality of Life (I-PSS QoL) surveys at Baseline and 12 weeks. Data were collected between April 2012 and July 2014.. Of 9795 OAB patients (46.8% male; 80.8% ≥65 years), 71.7% had coexisting disease [notably benign prostatic hyperplasia (BPH, 32.4%), hypertension (31.9%), and diabetes mellitus (9.4%)] and 53.4% reported concomitant drug use (27.8% α. In the clinical setting, mirabegron is well tolerated, with no unanticipated ADRs, and is an effective treatment for Japanese patients with OAB.

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Adult; Aged; Aged, 80 and over; Diabetes Complications; Drug Administration Schedule; Female; Humans; Hypertension; Male; Middle Aged; Product Surveillance, Postmarketing; Prostatic Hyperplasia; Quality of Life; Severity of Illness Index; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urinary Retention; Urological Agents

Topics: Acetanilides; Adrenergic alpha-1 Receptor Antagonists; Aged; Drug Therapy, Combination; Humans; Lower Urinary Tract Symptoms; Male; Prospective Studies; Prostatic Hyperplasia; Receptors, Adrenergic; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive

To evaluate the clinical response and adverse events (AEs) of solifenacin (SOL) or mirabegron (MIR) in benign prostatic hyperplasia patients with persistent overactive bladder (OAB) symptoms after dutasteride (DUT) treatment.. Fifty cases with residual OAB symptom score (OABSS) ≥ 5 and OABSS Q3 ≥ 2 after at least 6 months treatment of DUT were included in this study. Patients were administered 5 mg/d of SOL (N = 25) or 50 mg/d of MIR (N = 25), and International Prostate Symptom Score (IPSS) and OABSS were prospectively collected at 4 and 12 weeks. The safety was evaluated by changes in postvoided residual urine volume and the incidence of AEs.. After DUT administration, the mean prostate volume, IPSS, and OABSS were 39.0 mL, 17.6, and 8.1, respectively. SOL 5 mg significantly reduced the IPSS, OABSS, and OABSS Q3 at 4 and at 12 weeks (-3.1, -2.7, -1.3; P <.05); however, 4 patients could not continue the SOL treatment owing to AEs. All patients could continue the 12 weeks of MIR treatment, and MIR 50 mg reduced IPSS and OABSS at 4 weeks and reduced IPSS, OABSS, and the OABSS Q3 (-3.0, -2.5, -0.9; P <.05) at 12 weeks. Postvoided residual urine volume increased by ≥ 100 mL after treatment in 2 cases in the SOL group but not in any patient in the MIR group.. Additional SOL or MIR might result in amelioration of the persistent OAB symptom after DUT treatment in patients with an enlarged prostate.

Topics: 5-alpha Reductase Inhibitors; Acetanilides; Adrenergic beta-3 Receptor Agonists; Aged; Aged, 80 and over; Azasteroids; Dutasteride; Humans; Male; Middle Aged; Muscarinic Antagonists; Prospective Studies; Prostatic Hyperplasia; Quinuclidines; Solifenacin Succinate; Tetrahydroisoquinolines; Thiazoles; Urinary Bladder, Overactive

Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in men. Patients with BPH often present with a combination of obstructive and overactive bladder (OAB) symptoms. It is postulated that bladder outlet obstruction (BOO) from BPH results in concomitant OAB symptoms through ischemic induced variations in the response to neurotransmitters of both the detrusor and the urothelium. This altered response leads to the pathologic activation of the micturition reflex, generating sensory dysfunction and involuntary bladder contractions. Alpha-1 adrenoceptor antagonists (alpha-blockers) and 5-alpha reductase inhibitors (5-ARIs) are commonly used to treat the BOO caused by BPH. Anticholinergic agents are frequently used to treat concurrently OAB symptoms caused by the BOO. Unfortunately, anticholinergic medications demonstrate bothersome side effects and a theoretical risk of urinary retention. Basic science and clinical research has led to the development of a new class of pharmaceuticals for the treatment of overactive bladder with diminished risk of urinary retention and lacking many anticholinergic side effects. This novel compound, mirabegron (Mybertriq, Astellas Pharma US, Inc.), is a β₃-adrenoceptor agonist and represents a promising new class of oral agents designed for the treatment of OAB symptoms, with minimal effect on voiding.

Topics: 5-alpha Reductase Inhibitors; Acetanilides; Adrenergic alpha-1 Receptor Antagonists; Adrenergic beta-3 Receptor Agonists; Humans; Lower Urinary Tract Symptoms; Male; Nocturia; Prostatic Hyperplasia; Prostatism; Thiazoles; Urinary Bladder, Overactive; Urological Agents