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Hansjuergen Woerle - One of the best experts on this subject based on the ideXlab platform.

  • empagliflozin as Add on Therapy to pioglitazone with or without metformin in patients with type 2 diabetes mellitus
    Clinical Therapeutics, 2015
    Co-Authors: Christopher S Kovacs, Hansjuergen Woerle, Veeraswamy Seshiah, Ludwig Merker, Anita Vedel Christiansen, Flavien Roux, Afshin Salsali, G Kim, Peter Stella, Uli C Broedl
    Abstract:

    Purpose To investigate the long-term efficacy and safety of empagliflozin as Add-on Therapy to pioglitazone with or without metformin in patients with type 2 diabetes mellitus. Methods Of 498 patients randomized to empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily for 24 weeks in the EMPA-REG PIO™ study, 305 (61.2%) were treated in a double-blind extension trial for ≥52 weeks (total duration ≥76 weeks). Exploratory end points at week 76 included changes from baseline in glycosylated hemoglobin (HbA1c), weight, and blood pressure assessed using ANCOVA in patients who received ≥1 dose of study drug and had a baseline HbA1c measurement in the initial study. Findings Compared with placebo, adjusted mean (95% CI) changes from baseline in HbA1c level at week 76 were -0.59% (-0.79% to -0.40%; P Implications Empagliflozin 10 mg or 25 mg as Add-on Therapy to pioglitazone with or without metformin for 76 weeks was well tolerated and led to sustained reductions in HbA1c and weight compared with placebo in patients with type 2 diabetes. ClinicalTrials.gov identifier: NCT01210001.

  • linagliptin provides effective well tolerated Add on Therapy to pre existing oral antidiabetic Therapy over 1 year in japanese patients with type 2 diabetes
    Diabetes Obesity and Metabolism, 2013
    Co-Authors: Nobuya Inagaki, Sanjay Patel, Hirotaka Watada, Yan Gong, M Murai, T Kagimura, Hansjuergen Woerle
    Abstract:

    Aims To evaluate the long-term safety and efficacy of linagliptin as Add-on Therapy to one approved oral antidiabetic drug (OAD) in Japanese patients with type 2 diabetes mellitus and insufficient glycaemic control. Methods This 52-week, multicentre, open-label, parallel-group study evaluated once-daily linagliptin 5 mg as Add-on Therapy to one OAD [biguanide, glinide, glitazone, sulphonylurea (SU) or α-glucosidase inhibitors (A-GI)] in 618 patients. After a 2-week run-in, patients on SU or A-GI were randomized to either linagliptin (once daily, 5 mg) or metformin (twice or thrice daily, up to 2250 mg/day) as Add-on Therapy. Patients receiving the other OADs received linagliptin Add-on Therapy (non-randomized). Results Adverse events were mostly mild or moderate, and rates were similar across all groups. Hypoglycaemic events were rare, except in the SU group. Overall, 26 (5.8%) hypoglycaemic events were reported in patients receiving linagliptin (non-randomized). Hypoglycaemic events were similar for linagliptin and metformin Added to A-GI (1/61 vs. 2/61, respectively) or SU (17/124 vs. 10/63, respectively). Significant reductions in glycated haemoglobin (HbA1c) levels (between −0.7 and −0.9%) occurred throughout the study period for the background Therapy groups that received linagliptin (baseline HbA1c 7.9–8.1%). The decline in HbA1c levels was indistinguishable between linagliptin and metformin groups when administered as Add-on Therapy to A-GI or SU. Conclusions once-daily linagliptin showed safety and tolerability over 1 year and provided effective Add-on Therapy leading to significant HbA1c reductions, similar to metformin, over 52 weeks in Japanese patients.

  • safety and efficacy of linagliptin as Add on Therapy to metformin in patients with type 2 diabetes a randomized double blind placebo controlled study
    Diabetes Obesity and Metabolism, 2011
    Co-Authors: Marjariitta Taskinen, Sanjay Patel, Julio Rosenstock, I Tamminen, R Kubiak, Klaus Dugi, Hansjuergen Woerle
    Abstract:

    AIM: To evaluate the efficacy and safety of the potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin administered as Add-on Therapy to metformin in patients with type 2 diabetes with inadequate glycaemic control. METHODS: This 24-week, randomized, placebo-controlled, double-blind, parallel-group study was carried out in 82 centres in 10 countries. Patients with HbA1c levels of 7.0-10.0% on metformin and a maximum of one Additional antidiabetes medication, which was discontinued at screening, continued on metformin ≥1500 mg/day for 6 weeks, including a placebo run-in period of 2 weeks, before being randomized to linagliptin 5 mg once daily (n = 524) or placebo (n = 177) Add-on. The primary outcome was the change from baseline in HbA1c after 24 weeks of treatment, evaluated with an analysis of covariance (ANCOVA). RESULTS: Mean baseline HbA1c and fasting plasma glucose (FPG) were 8.1% and 9.4 mmol/l, respectively. Linagliptin showed significant reductions vs. placebo in adjusted mean changes from baseline of HbA1c (-0.49 vs. 0.15%), FPG (-0.59 vs. 0.58 mmol/l) and 2hPPG (-2.7 vs. 1.0 mmol/l); all p < 0.0001. Hypoglycaemia was rare, occurring in three patients (0.6%) treated with linagliptin and five patients (2.8%) in the placebo group. Body weight did not change significantly from baseline in both groups (-0.5 kg placebo, -0.4 kg linagliptin). ConCLUSIonS: The Addition of linagliptin 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin resulted in a significant and clinically meaningful improvement in glycaemic control without weight gain or increased risk of hypoglycaemia.

Anthony G Marson - One of the best experts on this subject based on the ideXlab platform.

  • rufinamide Add on Therapy for drug resistant epilepsy
    Cochrane Database of Systematic Reviews, 2020
    Co-Authors: Mariangela Panebianco, Anthony G Marson, Hemanshu Prabhakar
    Abstract:

    Background Epilepsy is a central nervous system disorder (neurological disorder). Epileptic seizures are the result of excessive and abnormal cortical nerve cell electrical activity in the brain. Despite the development of more than 10 new antiepileptic drugs (AEDs) since the early 2000s, approximately a third of people with epilepsy remain resistant to pharmacoTherapy, often requiring treatment with a combination of AEDs. In this review, we summarised the current evidence regarding rufinamide, a novel anticonvulsant medication, which, as a triazole derivative, is structurally unrelated to any other currently used anticonvulsant medication when used as an Add-on treatment for drug-resistant epilepsy. In January 2009, rufinamide was approved by the US Food and Drug Administration for the treatment of children four years of age and older with Lennox-Gastaut syndrome. It is also approved as an Add-on treatment for adults and adolescents with focal seizures. This is an updated version of the original Cochrane Review published in 2018. Objectives To evaluate the efficacy and tolerability of rufinamide when used as an Add-on treatment for people with drug-resistant epilepsy. Search methods We imposed no language restrictions. We contacted the manufacturers of rufinamide and authors in the field to identify any relevant unpublished studies. Selection criteria Randomised, double-blind, placebo-controlled, Add-on trials of rufinamide, recruiting people (of any age or gender) with drug-resistant epilepsy. Data collection and analysis Two review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: 50% or greater reduction in seizure frequency (primary outcome); seizure freedom; treatment withdrawal; and adverse effects (secondary outcomes). Primary analyses were intention-to-treat (ITT) and we presented summary risk ratios (RRs) with 95% confidence intervals (CIs). We evaluated dose response in regression models. We carried out a risk of bias assessment for each included study using the Cochrane 'Risk of bias' tool and assessed the overall certainty of evidence using the GRADE approach. Main results The review included six trials, representing 1759 participants. Four trials (1563 participants) included people with uncontrolled focal seizures. Two trials (196 participants) included individuals with established Lennox-Gastaut syndrome. Overall, the age of adults ranged from 18 to 80 years and the age of children ranged from 4 to 16 years. Baseline phases ranged from 28 to 56 days and double-blind phases from 84 to 96 days. Five of the six included trials described adequate methods of concealment of randomisation, and only three described adequate blinding. All analyses were by ITT. Overall, five studies were at low risk of bias and one had unclear risk of bias due to lack of reported information around study design. All trials were sponsored by the manufacturer of rufinamide and therefore were at high risk of funding bias. The overall RR for 50% or greater reduction in seizure frequency was 1.79 (95% CI 1.44 to 2.22; 6 randomised controlled trials (RCTs), 1759 participants; moderate-certainty evidence), indicating that rufinamide (plus conventional AED) was significantly more effective than placebo (plus conventional AED) in reducing seizure frequency by at least 50% when Added to conventionally used AEDs in people with drug-resistant focal epilepsy. Data from only one study (73 participants) reported seizure freedom: RR 1.32 (95% CI 0.36 to 4.86; 1 RCT, 73 participants; moderate-certainty evidence). The overall RR for treatment withdrawal (for any reason and due to AED) was 1.83 (95% CI 1.45 to 2.31; 6 RCTs, 1759 participants; moderate-certainty evidence), showing that rufinamide was significantly more likely to be withdrawn than placebo. Most adverse effects were significantly more likely to occur in the rufinamide-treated group. Adverse events significantly associated with rufinamide were headache, dizziness, somnolence, vomiting, nausea, fatigue, and diplopia. The RRs for these adverse effects were as follows: headache 1.36 (95% Cl 1.08 to 1.69; 3 RCTs, 1228 participants; high-certainty evidence); dizziness 2.52 (95% Cl 1.90 to 3.34; 3 RCTs, 1295 participants; moderate-certainty evidence); somnolence 1.94 (95% Cl 1.44 to 2.61; 6 RCTs, 1759 participants; moderate-certainty evidence); vomiting 2.95 (95% Cl 1.80 to 4.82; 4 RCTs, 777 participants; low-certainty evidence); nausea 1.87 (95% Cl 1.33 to 2.64; 3 RCTs, 1295 participants; moderate-certainty evidence); fatigue 1.46 (95% Cl 1.08 to 1.97; 3 RCTs, 1295 participants; moderate-certainty evidence); and diplopia 4.60 (95% Cl 2.53 to 8.38; 3 RCTs, 1295 participants; low-certainty evidence). There was no important heterogeneity between studies for any outcomes. Overall, we assessed the evidence as moderate to low certainty due to wide CIs and potential risk of bias from some studies contributing to the analysis. Authors' conclusions For people with drug-resistant focal epilepsy, rufinamide when used as an Add-on treatment was effective in reducing seizure frequency. However, the trials reviewed were of relatively short duration and provided no evidence for long-term use of rufinamide. In the short term, rufinamide as an Add-on was associated with several adverse events. This review focused on the use of rufinamide in drug-resistant focal epilepsy, and the results cannot be generalised to Add-on treatment for generalised epilepsies. Likewise, no inference can be made about the effects of rufinamide when used as monoTherapy.

  • clobazam Add on Therapy for drug resistant epilepsy
    Cochrane Database of Systematic Reviews, 2019
    Co-Authors: Rebecca Bresnahan, Anthony G Marson, Kirsty J Martinmcgill, John Williamson, Benedict D Michael
    Abstract:

    Background Epilepsy affects approximately 1% of the population, with up to 30% of patients continuing to have seizures, despite antiepileptic drug treatment. Clobazam is a 1,5-benzodiazepine and is commonly used as an Add-on treatment for drug-resistant epilepsy. This review is an updated version of the original Cochrane Review, first published in 2008, and examines the most current literature regarding clobazam as an Add-on for drug-resistant epilepsy. Objectives To assess the efficacy, effectiveness and tolerability of clobazam as an Add-on Therapy for drug-resistant generalised-onset and focal-onset seizures, with or without secondary generalisation, in adults and children. Search methods For the latest update, we searched the following databases on 9 October 2018: Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL), Medline (Ovid) 1946 to 8 October, 2018, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP). For some previous updates we also searched SCOPUS, DARE, and BIOSIS Previews, but these are no longer needed. (SCOPUS was searched as a substitute for EMBASE, but randomised and quasi-randomised controlled trials in EMBASE are now included in CENTRAL; DARE ceased operation at the end of March 2015; BIOSIS Previews yielded no relevant items that were not found in the other databases). Selection criteria Randomised trials of Add-on clobazam, with adequate methods of allocation concealment, recruiting patients with drug-resistant focal or generalised-onset seizures, with a minimum treatment period of eight weeks. Data collection and analysis Two review authors independently selected trials for inclusion and extracted relevant data. The following outcomes were assessed: 50% or greater reduction in seizures, seizure freedom, treatment withdrawal and adverse events. Main results Four double-blind, placebo-controlled, cross-over studies, representing 197 participants, were included in the review. All four studies were assessed as having unclear risk of bias due to the unavailability of methodological details. The studies demonstrated significant methodological heterogeneity and differences in outcome measures were noted. Consequently, it was not possible to summarise the data in a meta-analysis. Instead, findings were summarised in a narrative data synthesis, only two of the studies reported 50% or greater seizure reduction. They respectively reported that 57.7% and 52.4% of participants receiving Add-on clobazam experienced a 50% or greater reduction in seizure frequency, although publication bias needs to be considered (2 RCTs, n = 47, very low-quality evidence). Seizure freedom was reported by three of the included studies. Collectively, 27 out of 175 patients were seizure-free during treatment with clobazam (3 RCTs, n = 175, very low-quality evidence). Two studies specifically stated that seizure freedom was not observed in any of the participants receiving Add-on placebo. Treatment withdrawal was reported by all four studies. There was a slightly higher incidence of treatment withdrawal associated with receiving clobazam, although the overall incidence was still fairly low (4 RCTs, n = 197, very low-quality evidence). Adverse events were only described in two of the studies, reportedly 36% and 85% of participants experienced one or more adverse events whilst receiving clobazam. The most commonly reported adverse event was drowsiness. Authors' conclusions Clobazam as an Add-on treatment may reduce seizure frequency and may be most effective in focal-onset seizures. It is important to recognise that this finding has been derived from very low-quality evidence and from studies judged to have an unclear risk of bias. It remains unclear which population demographic will best benefit from clobazam and over what time-frame. A large-scale, randomised controlled trial, conducted over a greater period of time, incorporating subgroups with differing seizure types, is required to effectively inform clinical practice.

  • Brivaracetam Add-on Therapy for drug-resistant epilepsy.
    The Cochrane database of systematic reviews, 2019
    Co-Authors: Rebecca Bresnahan, Mariangela Panebianco, Anthony G Marson
    Abstract:

    BACKGROUND Epilepsy is one of the most common neurological disorders. It is estimated that up to 30% of patients with epilepsy continue to have epileptic seizures despite treatment with an antiepileptic drug. These patients are classified as drug-resistant and require treatment with a combination of multiple antiepileptic drugs. Brivaracetam is a third-generation antiepileptic drug that is a high-affinity ligand for synaptic vesicle protein 2A. This review investigates the use of brivaracetam as Add-on Therapy for epilepsy. OBJECTIVES To evaluate the efficacy and tolerability of brivaracetam when used as Add-on treatment for people with drug-resistant epilepsy. SEARCH METHODS We searched the following databases on 9 October 2018: the Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL); Medline (Ovid) 1946 to 8 October 2018; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Originally we also searched SCOPUS as a substitute for Embase, but this is no longer necessary, because randomised and quasi-randomised controlled trials in Embase are now included in CENTRAL. SELECTIon CRITERIA We sought randomised controlled trials with parallel-group design, recruiting people of any age with drug-resistant epilepsy. We accepted studies with any level of blinding (double-blind, single-blind, or unblind). DATA COLLECTIon AND ANALYSIS In accordance with standard methodological procedures expected by the Cochrane Collaboration, two review authors independently assessed trials for inclusion before evaluating trial quality and extracting relevant data. The primary outcome to be assessed was 50% or greater reduction in seizure frequency. Secondary outcomes were: seizure freedom, treatment withdrawal for any reason, treatment withdrawal due to adverse events, the proportion of participants who experienced any adverse events, and drug interactions. We used an intention-to-treat (ITT) population for all primary analyses, and we presented results as risk ratios (RRs) with 95% confidence intervals (CIs). MAIN RESULTS The review included six trials representing 2411 participants. only one study included participants with both focal and generalised onset seizures; the other five trials included participants with focal onset seizures only. All six studies included adult participants between 16 and 80 years old, and treatment periods ranged from 7 to 16 weeks. We judged two studies to have low risk of bias and four to have unclear risk of bias. one study failed to provide details on the method used for allocation concealment, and one did not report all outcomes prespecified in the trial protocol. one study did not describe how blinding was maintained, and another noted discrepancies in reporting.Participants receiving brivaracetam Add-on were significantly more likely to experience a 50% or greater reduction in seizure frequency than those receiving placebo (RR 1.81, 95% CI 1.53 to 2.14; 6 studies; moderate-quality evidence). Participants receiving brivaracetam were also significantly more likely to attain seizure freedom (RR 5.89, 95% CI 2.30 to 15.13; 6 studies; moderate-quality evidence). The incidence of treatment withdrawal for any reason (RR 1.27, 95% CI 0.94 to 1.74; 6 studies; low-quality evidence), as well as the risk of participants experiencing one or more adverse events (RR 1.08, 95% CI 1.00 to 1.17; 5 studies; moderate-quality evidence), was not significantly different following treatment with brivaracetam compared to placebo. However, participants receiving brivaracetam did appear to be significantly more likely to withdraw from treatment specifically because of adverse events compared with those receiving placebo (RR 1.54, 95% CI 1.02 to 2.33; 6 studies; low-quality evidence). AUTHORS' ConCLUSIonS Brivaracetam, when used as Add-on Therapy for patients with drug-resistant epilepsy, is effective in reducing seizure frequency and can aid patients in achieving seizure freedom. However, Add-on brivaracetam is associated with a greater proportion of treatment withdrawals due to adverse events compared with placebo. It is important to note that only one of the eligible studies included participants with generalised epilepsy. None of the studies included participants under the age of 16, and all studies were of short duration. Consequently, these findings are mainly applicable to adult patients with drug-resistant focal epilepsy. Future research should thus focus on investigating the tolerability and efficacy of brivaracetam during longer-term follow-up, and should also assess the efficacy and tolerability of Add-on brivaracetam in managing other types of seizures and its use in other age groups.

  • rufinamide Add on Therapy for refractory epilepsy
    Cochrane Database of Systematic Reviews, 2015
    Co-Authors: Mariangela Panebianco, Hemanshu Prabhakar, Anthony G Marson
    Abstract:

    Background Epilepsy is a central nervous system disorder (neurological disorder). Epileptic seizures are the result of excessive and abnormal cortical nerve cell electrical activity in the brain. Despite the development of more than 10 new antiepileptic drugs (AEDs) since the early 2000s, approximately a third of people with epilepsy remain resistant to pharmacoTherapy, often requiring treatment with a combination of AEDs. In this review, we summarised the current evidence regarding rufinamide, a novel anticonvulsant medication, which, as a triazole derivative, is structurally unrelated to any other currently used anticonvulsant medication, when used as an Add‐on treatment for refractory epilepsy. In January 2009, rufinamide was approved by the US Food and Drug Administration for treatment of children four years of age and older with Lennox‐Gastaut syndrome. It is also approved as an Add‐on treatment for adults and adolescents with focal seizures.

  • lacosamide Add on Therapy for partial epilepsy
    Cochrane Database of Systematic Reviews, 2015
    Co-Authors: Jennifer Weston, Arif Shukralla, Andrew Mckay, Anthony G Marson
    Abstract:

    Background Around half of people with epilepsy will not achieve seizure freedom on their first antiepileptic drug; many will require Add-on treatment with another drug. Sometimes multiple treatment combinations are tried to achieve maximum seizure control, although around a third of people do not achieve complete seizure control. Lacosamide is an antiepileptic drug that has been licensed as an Add-on treatment for partial epilepsy. Objectives To evaluate the efficacy and tolerability of lacosamide when used as an Add-on treatment for patients with drug-resistant partial epilepsy. Search methods We searched the Cochrane Epilepsy Group's Specialized Register (21 May 2015), the Cochrane Central Register of Controlled Trials (CENTRAL , The Cochrane Library Issue 4, April 2015), MEDLINE (Ovid, 1946 to 21 May 2015), Scopus (1823 to 13 November 2014), ClinicalTrials.gov (21 May 2015) and the WHO International Clinical Trials Registry Platform (ICTRP, 21 May 2015). We imposed no language restrictions. We contacted UCB (sponsors of lacosamide) and experts in the field. Selection criteria Randomised controlled trials of Add-on lacosamide in people with drug-resistant partial epilepsy. Data collection and analysis Two review authors independently assessed trials for inclusion and extracted the relevant data. We assessed the following outcomes: (1) 50% or greater reduction in seizure frequency; (2) seizure freedom; (3) treatment withdrawal for any reason; and (4) adverse events. Primary analyses were intention-to-treat. Summary risk ratios were estimated for each outcome. Main results We included three trials in our review (1311 participants), which were classified as having low risk of bias. All trials were placebo-controlled and assessed doses ranging from 200 mg to 600 mg per day. Trial duration ranged from 24 to 26 weeks. All trials used adequate methods of randomisation and were double-blind. Overall the quality of the evidence was rated as moderate to high. The overall risk ratio for a 50% or greater reduction in seizure frequency for all doses of lacosamide compared with placebo was 1.70 (95% confidence interval (CI) 1.38 to 2.10); for seizure freedom for all doses of lacosamide compared with placebo was 2.50 (95% CI 0.85 to 7.34); and for treatment withdrawal for all doses of lacosamide compared with placebo was 1.88 (95% CI 1.40 to 2.52). Adverse effects significantly associated with lacosamide were abnormal co-ordination (risk ratio (RR) 6.12, 99% CI 1.35 to 27.77), diplopia (RR 5.29, 99% CI 1.97 to 14.23), dizziness (RR 3.53, 99% CI 2.20 to 5.68), nausea (RR 2.37, 99% CI 1.23 to 4.58) and vomiting (RR 3.49, 99% CI 1.43 to 8.54). Adverse effects that were not statistically significant were headache (RR 1.34, 99% CI 0.83 to 2.18), fatigue (RR 2.11, 99% CI 0.92 to 4.85), nystagmus (RR 1.47, 99% CI 0.61 to 3.52) and somnolence (RR 1.44, 99% CI 0.67 to 3.09). Authors' conclusions This review has shown lacosamide to be effective and fairly well tolerated in the short term when used as Add-on treatment for drug-resistant partial epilepsy in adults. Higher doses of lacosamide may be more associated with adverse effects and withdrawal of the drug than lower doses. Additional evidence on children is needed, and longer-term efficacy is unknown.

Masaki Yoshida - One of the best experts on this subject based on the ideXlab platform.

  • long term safety and efficacy of antimuscarinic Add on Therapy in patients with overactive blAdder who had a suboptimal response to mirabegron monoTherapy a multicenter randomized study in japan milai ii study
    International Journal of Urology, 2018
    Co-Authors: Osamu Yamaguchi, Momokazu Gotoh, Hidehiro Kakizaki, Yukio Homma, Yasuhiko Igawa, Masayuki Takeda, Osamu Nishizawa, Masaki Yoshida, Osamu Yokoyama, Narihito Seki
    Abstract:

    Objectives To evaluate the long-term safety (primary objective) and efficacy (secondary objective) of antimuscarinic Add-on Therapy in patients receiving mirabegron. Methods During a 2-week screening period, patients (aged ≥20 years, mirabegron treatment for ≥6 weeks, residual overactive blAdder symptoms) received mirabegron 50 mg once daily. These patients were subsequently randomized to 52 weeks' treatment with mirabegron 50 mg/day plus an antimuscarinic (solifenacin 5 mg, propiverine 20 mg, imidafenacin 0.2 mg, or tolterodine 4 mg) with the potential to double the antimuscarinic dose (except for tolterodine) at week 8. Safety assessments included treatment-emergent adverse events, vital signs, 12-lead electrocardiograms, post-void residual volume, and laboratory evaluations. Efficacy was assessed using changes from baseline in overactive blAdder symptom score total score; overactive blAdder questionnaire short form score; micturitions, urgency episodes, urinary incontinence episodes, and urgency urinary incontinence episodes/24 h; mean volume voided per micturition; and number of night-time micturitions. Results Overall, 80.2% of patients (88.1% women, mean age 65 years) experienced at least one treatment-emergent adverse event, with similar rates for all treatments. The adverse events most commonly reported were dry mouth, nasopharyngitis, and constipation. No marked change was observed in systolic or diastolic blood pressure for any treatment, although pulse rate increased slightly in the mirabegron and propiverine, and mirabegron and tolterodine groups. For all treatments, significant improvements were observed in all efficacy parameters, including overactive blAdder symptom score total and questionnaire short form scores. Conclusions Antimuscarinic Add-on Therapy is well tolerated and effective after initial treatment with mirabegron in patients with overactive blAdder symptoms.

  • safety and efficacy of mirabegron as Add on Therapy in patients with overactive blAdder treated with solifenacin a post marketing open label study in japan milai study
    BJUI, 2015
    Co-Authors: Osamu Yamaguchi, Momokazu Gotoh, Hidehiro Kakizaki, Yukio Homma, Yasuhiko Igawa, Masayuki Takeda, Osamu Nishizawa, Masaki Yoshida, Osamu Yokoyama, Narihito Seki
    Abstract:

    Objective To examine the safety and efficacy of mirabegron as ‘Add-on’ Therapy to solifenacin in patients with overactive blAdder (OAB). Patients and Methods This multicentre, open-label, phase IV study enrolled patients aged ≥20 years with OAB, as determined by an OAB symptom score (OABSS) total of ≥3 points and an OABSS Question 3 score of ≥2 points, who were being treated with solifenacin at a stable dose of 2.5 or 5 mg once daily for at least 4 weeks. Study duration was 18 weeks, comprising a 2-week screening period and a 16-week treatment period. Patients meeting eligibility criteria continued to receive solifenacin (2.5 or 5 mg once daily) and Additional mirabegron (25 mg once daily) for 16 weeks. After 8 weeks of treatment, the mirabegron dose could be increased to 50 mg if the patient's symptom improvement was not sufficient, if he/she was agreeable to the dose increase, and the investigator judged that there were no safety concerns. Safety assessments included adverse events (AEs), laboratory tests, vital signs, 12-lead electrocardiogram, QT corrected for heart rate using Fridericia's correction (QTcF) interval and post-void residual (PVR) volume. Efficacy endpoints were changes from baseline in OABSS total score, OAB questionnaire short form (OAB-q SF) score (symptom bother and total health-related quality of life [HRQL] score), mean number of micturitions/24 h, mean number of urgency episodes/24 h, mean number of urinary incontinence (UI) episodes/24 h, mean number of urgency UI episodes/24 h, mean volume voided/micturition, and mean number of nocturia episodes/night. Patients were instructed to complete the OABSS sheets at weeks −2, 0, 8 and 16 (or at discontinuation), OAB-q SF sheets at weeks 0, 8 and 16 (or at discontinuation) and patient voiding diaries at weeks 0, 4, 8, 12 and 16 (or at discontinuation). Results Overall incidence of drug-related treatment-emergent AEs (TEAEs) was 23.3%. Almost all TEAEs were mild or moderate. The most common TEAE was constipation, with similar incidence in the groups receiving a dose increase to that observed in the groups maintained on the original dose. Changes in PVR volume, QTcF interval, pulse rate and blood pressure were not considered to be clinically significant and there were no reports of urinary retention. Significant improvement was seen for changes in efficacy endpoints from baseline to end of treatment (EOT) in all groups (patients receiving solifenacin 2.5 or 5 mg + mirabegron 25 or 50 mg). Conclusions Add-on Therapy with mirabegron 25 mg once daily for 16 weeks, with an optional dose increase to 50 mg at week 8, was well tolerated in patients with OAB treated with solifenacin 2.5 mg or 5 mg once daily. There were significant improvements from baseline to EOT in OAB symptoms with combination Therapy with mirabegron and solifenacin. Add-on Therapy with mirabegron and an antimuscarinic agent, such as solifenacin, may provide an attractive therapeutic option.

  • solifenacin as Add on Therapy for overactive blAdder symptoms in men treated for lower urinary tract symptoms assist randomized controlled study
    Urology, 2011
    Co-Authors: Osamu Yamaguchi, Momokazu Gotoh, Hidehiro Kakizaki, Yukio Homma, Masayuki Takeda, Osamu Nishizawa, Osamu Yokoyama, Narihito Seki, Masaki Yoshida
    Abstract:

    Objectives To assess the efficacy and safety of solifenacin Add-on Therapy to tamsulosin in lower urinary tract symptoms (LUTS) men with residual overactive blAdder (OAB) symptoms despite tamsulosin monoTherapy. Methods In this randomized, multicenter, double-blind study, male LUTS patients aged ≥50 years with urgency episodes/24 hours ≥2 and micturitions/24 hours ≥8 were randomized to 3 groups: 12-weeks tamsulosin plus placebo (TAM + PBO), tamsulosin plus solifenacin 2.5 mg (TAM + SOL), and tamsulosin plus solifenacin 5 mg (TAM + SOL). Changes from baseline to end of treatment in the number of urgency episodes/24 hours (primary endpoint), micturitions, nocturia, urgency incontinence episodes, International Prostate Symptom Scores (IPSS), and Overactive BlAdder Symptom Score (OABSS) were compared between the TAM + SOL groups and TAM + PBO. Safety was assessed on adverse events, postvoid residual volume, and maximal urinary flow rate (Qmax.). Results Six-hundred thirty-eight men were randomized. Urgency was reduced by 2.2 and 2.4 episodes in the TAM + SOL 2.5 and 5 mg groups, respectively. The TAM + SOL 5 mg group showed significant improvement compared with TAM + PBO (−2.4 vs −1.9, P = .049). The number of micturitions in both TAM + SOL groups were significantly reduced compared with TAM + PBO (both P Conclusions In male LUTS patients with residual OAB symptoms despite tamsulosin monoTherapy, TAM + SOL showed efficacy on urgency, which represents OAB symptoms and was well tolerated.

  • solifenacin as Add on Therapy for overactive blAdder symptoms in men treated for lower urinary tract symptoms assist randomized controlled study
    Urology, 2011
    Co-Authors: Osamu Yamaguchi, Momokazu Gotoh, Hidehiro Kakizaki, Yukio Homma, Masayuki Takeda, Osamu Nishizawa, Osamu Yokoyama, Narihito Seki, Masaki Yoshida
    Abstract:

    Objectives To assess the efficacy and safety of solifenacin Add-on Therapy to tamsulosin in lower urinary tract symptoms (LUTS) men with residual overactive blAdder (OAB) symptoms despite tamsulosin monoTherapy. Methods In this randomized, multicenter, double-blind study, male LUTS patients aged ≥50 years with urgency episodes/24 hours ≥2 and micturitions/24 hours ≥8 were randomized to 3 groups: 12-weeks tamsulosin plus placebo (TAM + PBO), tamsulosin plus solifenacin 2.5 mg (TAM + SOL), and tamsulosin plus solifenacin 5 mg (TAM + SOL). Changes from baseline to end of treatment in the number of urgency episodes/24 hours (primary endpoint), micturitions, nocturia, urgency incontinence episodes, International Prostate Symptom Scores (IPSS), and Overactive BlAdder Symptom Score (OABSS) were compared between the TAM + SOL groups and TAM + PBO. Safety was assessed on adverse events, postvoid residual volume, and maximal urinary flow rate (Qmax.). Results Six-hundred thirty-eight men were randomized. Urgency was reduced by 2.2 and 2.4 episodes in the TAM + SOL 2.5 and 5 mg groups, respectively. The TAM + SOL 5 mg group showed significant improvement compared with TAM + PBO (−2.4 vs −1.9, P = .049). The number of micturitions in both TAM + SOL groups were significantly reduced compared with TAM + PBO (both P <.001). IPSS storage symptom score and OABSS significantly improved in both TAM + SOL groups compared with TAM + PBO. Changes in IPSS voiding symptom score and Qmax. were similar in all groups. Four patients (1.9%) in the TAM + SOL 5 mg group had urinary retention, but all recovered after catheterization. Conclusions In male LUTS patients with residual OAB symptoms despite tamsulosin monoTherapy, TAM + SOL showed efficacy on urgency, which represents OAB symptoms and was well tolerated.

Momokazu Gotoh - One of the best experts on this subject based on the ideXlab platform.

  • Comparison in the efficacy of fesoterodine or mirabegron Add-on Therapy to silodosin for patients with benign prostatic hyperplasia complicated by overactive blAdder: A randomized, prospective trial using urodynamic studies.
    Neurourology and Urodynamics, 2019
    Co-Authors: Yoshihisa Matsukawa, Shun Takai, Tsuyoshi Majima, Yasuhito Funahashi, Naoto Sassa, Masashi Kato, Tokunori Yamamoto, Momokazu Gotoh
    Abstract:

    Aims 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. Methods 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. Results 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. Conclusion 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.

  • long term safety and efficacy of antimuscarinic Add on Therapy in patients with overactive blAdder who had a suboptimal response to mirabegron monoTherapy a multicenter randomized study in japan milai ii study
    International Journal of Urology, 2018
    Co-Authors: Osamu Yamaguchi, Momokazu Gotoh, Hidehiro Kakizaki, Yukio Homma, Yasuhiko Igawa, Masayuki Takeda, Osamu Nishizawa, Masaki Yoshida, Osamu Yokoyama, Narihito Seki
    Abstract:

    Objectives To evaluate the long-term safety (primary objective) and efficacy (secondary objective) of antimuscarinic Add-on Therapy in patients receiving mirabegron. Methods During a 2-week screening period, patients (aged ≥20 years, mirabegron treatment for ≥6 weeks, residual overactive blAdder symptoms) received mirabegron 50 mg once daily. These patients were subsequently randomized to 52 weeks' treatment with mirabegron 50 mg/day plus an antimuscarinic (solifenacin 5 mg, propiverine 20 mg, imidafenacin 0.2 mg, or tolterodine 4 mg) with the potential to double the antimuscarinic dose (except for tolterodine) at week 8. Safety assessments included treatment-emergent adverse events, vital signs, 12-lead electrocardiograms, post-void residual volume, and laboratory evaluations. Efficacy was assessed using changes from baseline in overactive blAdder symptom score total score; overactive blAdder questionnaire short form score; micturitions, urgency episodes, urinary incontinence episodes, and urgency urinary incontinence episodes/24 h; mean volume voided per micturition; and number of night-time micturitions. Results Overall, 80.2% of patients (88.1% women, mean age 65 years) experienced at least one treatment-emergent adverse event, with similar rates for all treatments. The adverse events most commonly reported were dry mouth, nasopharyngitis, and constipation. No marked change was observed in systolic or diastolic blood pressure for any treatment, although pulse rate increased slightly in the mirabegron and propiverine, and mirabegron and tolterodine groups. For all treatments, significant improvements were observed in all efficacy parameters, including overactive blAdder symptom score total and questionnaire short form scores. Conclusions Antimuscarinic Add-on Therapy is well tolerated and effective after initial treatment with mirabegron in patients with overactive blAdder symptoms.

  • safety and efficacy of mirabegron as Add on Therapy in patients with overactive blAdder treated with solifenacin a post marketing open label study in japan milai study
    BJUI, 2015
    Co-Authors: Osamu Yamaguchi, Momokazu Gotoh, Hidehiro Kakizaki, Yukio Homma, Yasuhiko Igawa, Masayuki Takeda, Osamu Nishizawa, Masaki Yoshida, Osamu Yokoyama, Narihito Seki
    Abstract:

    Objective To examine the safety and efficacy of mirabegron as ‘Add-on’ Therapy to solifenacin in patients with overactive blAdder (OAB). Patients and Methods This multicentre, open-label, phase IV study enrolled patients aged ≥20 years with OAB, as determined by an OAB symptom score (OABSS) total of ≥3 points and an OABSS Question 3 score of ≥2 points, who were being treated with solifenacin at a stable dose of 2.5 or 5 mg once daily for at least 4 weeks. Study duration was 18 weeks, comprising a 2-week screening period and a 16-week treatment period. Patients meeting eligibility criteria continued to receive solifenacin (2.5 or 5 mg once daily) and Additional mirabegron (25 mg once daily) for 16 weeks. After 8 weeks of treatment, the mirabegron dose could be increased to 50 mg if the patient's symptom improvement was not sufficient, if he/she was agreeable to the dose increase, and the investigator judged that there were no safety concerns. Safety assessments included adverse events (AEs), laboratory tests, vital signs, 12-lead electrocardiogram, QT corrected for heart rate using Fridericia's correction (QTcF) interval and post-void residual (PVR) volume. Efficacy endpoints were changes from baseline in OABSS total score, OAB questionnaire short form (OAB-q SF) score (symptom bother and total health-related quality of life [HRQL] score), mean number of micturitions/24 h, mean number of urgency episodes/24 h, mean number of urinary incontinence (UI) episodes/24 h, mean number of urgency UI episodes/24 h, mean volume voided/micturition, and mean number of nocturia episodes/night. Patients were instructed to complete the OABSS sheets at weeks −2, 0, 8 and 16 (or at discontinuation), OAB-q SF sheets at weeks 0, 8 and 16 (or at discontinuation) and patient voiding diaries at weeks 0, 4, 8, 12 and 16 (or at discontinuation). Results Overall incidence of drug-related treatment-emergent AEs (TEAEs) was 23.3%. Almost all TEAEs were mild or moderate. The most common TEAE was constipation, with similar incidence in the groups receiving a dose increase to that observed in the groups maintained on the original dose. Changes in PVR volume, QTcF interval, pulse rate and blood pressure were not considered to be clinically significant and there were no reports of urinary retention. Significant improvement was seen for changes in efficacy endpoints from baseline to end of treatment (EOT) in all groups (patients receiving solifenacin 2.5 or 5 mg + mirabegron 25 or 50 mg). Conclusions Add-on Therapy with mirabegron 25 mg once daily for 16 weeks, with an optional dose increase to 50 mg at week 8, was well tolerated in patients with OAB treated with solifenacin 2.5 mg or 5 mg once daily. There were significant improvements from baseline to EOT in OAB symptoms with combination Therapy with mirabegron and solifenacin. Add-on Therapy with mirabegron and an antimuscarinic agent, such as solifenacin, may provide an attractive therapeutic option.

  • solifenacin as Add on Therapy for overactive blAdder symptoms in men treated for lower urinary tract symptoms assist randomized controlled study
    Urology, 2011
    Co-Authors: Osamu Yamaguchi, Momokazu Gotoh, Hidehiro Kakizaki, Yukio Homma, Masayuki Takeda, Osamu Nishizawa, Osamu Yokoyama, Narihito Seki, Masaki Yoshida
    Abstract:

    Objectives To assess the efficacy and safety of solifenacin Add-on Therapy to tamsulosin in lower urinary tract symptoms (LUTS) men with residual overactive blAdder (OAB) symptoms despite tamsulosin monoTherapy. Methods In this randomized, multicenter, double-blind study, male LUTS patients aged ≥50 years with urgency episodes/24 hours ≥2 and micturitions/24 hours ≥8 were randomized to 3 groups: 12-weeks tamsulosin plus placebo (TAM + PBO), tamsulosin plus solifenacin 2.5 mg (TAM + SOL), and tamsulosin plus solifenacin 5 mg (TAM + SOL). Changes from baseline to end of treatment in the number of urgency episodes/24 hours (primary endpoint), micturitions, nocturia, urgency incontinence episodes, International Prostate Symptom Scores (IPSS), and Overactive BlAdder Symptom Score (OABSS) were compared between the TAM + SOL groups and TAM + PBO. Safety was assessed on adverse events, postvoid residual volume, and maximal urinary flow rate (Qmax.). Results Six-hundred thirty-eight men were randomized. Urgency was reduced by 2.2 and 2.4 episodes in the TAM + SOL 2.5 and 5 mg groups, respectively. The TAM + SOL 5 mg group showed significant improvement compared with TAM + PBO (−2.4 vs −1.9, P = .049). The number of micturitions in both TAM + SOL groups were significantly reduced compared with TAM + PBO (both P Conclusions In male LUTS patients with residual OAB symptoms despite tamsulosin monoTherapy, TAM + SOL showed efficacy on urgency, which represents OAB symptoms and was well tolerated.

  • solifenacin as Add on Therapy for overactive blAdder symptoms in men treated for lower urinary tract symptoms assist randomized controlled study
    Urology, 2011
    Co-Authors: Osamu Yamaguchi, Momokazu Gotoh, Hidehiro Kakizaki, Yukio Homma, Masayuki Takeda, Osamu Nishizawa, Osamu Yokoyama, Narihito Seki, Masaki Yoshida
    Abstract:

    Objectives To assess the efficacy and safety of solifenacin Add-on Therapy to tamsulosin in lower urinary tract symptoms (LUTS) men with residual overactive blAdder (OAB) symptoms despite tamsulosin monoTherapy. Methods In this randomized, multicenter, double-blind study, male LUTS patients aged ≥50 years with urgency episodes/24 hours ≥2 and micturitions/24 hours ≥8 were randomized to 3 groups: 12-weeks tamsulosin plus placebo (TAM + PBO), tamsulosin plus solifenacin 2.5 mg (TAM + SOL), and tamsulosin plus solifenacin 5 mg (TAM + SOL). Changes from baseline to end of treatment in the number of urgency episodes/24 hours (primary endpoint), micturitions, nocturia, urgency incontinence episodes, International Prostate Symptom Scores (IPSS), and Overactive BlAdder Symptom Score (OABSS) were compared between the TAM + SOL groups and TAM + PBO. Safety was assessed on adverse events, postvoid residual volume, and maximal urinary flow rate (Qmax.). Results Six-hundred thirty-eight men were randomized. Urgency was reduced by 2.2 and 2.4 episodes in the TAM + SOL 2.5 and 5 mg groups, respectively. The TAM + SOL 5 mg group showed significant improvement compared with TAM + PBO (−2.4 vs −1.9, P = .049). The number of micturitions in both TAM + SOL groups were significantly reduced compared with TAM + PBO (both P <.001). IPSS storage symptom score and OABSS significantly improved in both TAM + SOL groups compared with TAM + PBO. Changes in IPSS voiding symptom score and Qmax. were similar in all groups. Four patients (1.9%) in the TAM + SOL 5 mg group had urinary retention, but all recovered after catheterization. Conclusions In male LUTS patients with residual OAB symptoms despite tamsulosin monoTherapy, TAM + SOL showed efficacy on urgency, which represents OAB symptoms and was well tolerated.

Osamu Yamaguchi - One of the best experts on this subject based on the ideXlab platform.

  • long term safety and efficacy of antimuscarinic Add on Therapy in patients with overactive blAdder who had a suboptimal response to mirabegron monoTherapy a multicenter randomized study in japan milai ii study
    International Journal of Urology, 2018
    Co-Authors: Osamu Yamaguchi, Momokazu Gotoh, Hidehiro Kakizaki, Yukio Homma, Yasuhiko Igawa, Masayuki Takeda, Osamu Nishizawa, Masaki Yoshida, Osamu Yokoyama, Narihito Seki
    Abstract:

    Objectives To evaluate the long-term safety (primary objective) and efficacy (secondary objective) of antimuscarinic Add-on Therapy in patients receiving mirabegron. Methods During a 2-week screening period, patients (aged ≥20 years, mirabegron treatment for ≥6 weeks, residual overactive blAdder symptoms) received mirabegron 50 mg once daily. These patients were subsequently randomized to 52 weeks' treatment with mirabegron 50 mg/day plus an antimuscarinic (solifenacin 5 mg, propiverine 20 mg, imidafenacin 0.2 mg, or tolterodine 4 mg) with the potential to double the antimuscarinic dose (except for tolterodine) at week 8. Safety assessments included treatment-emergent adverse events, vital signs, 12-lead electrocardiograms, post-void residual volume, and laboratory evaluations. Efficacy was assessed using changes from baseline in overactive blAdder symptom score total score; overactive blAdder questionnaire short form score; micturitions, urgency episodes, urinary incontinence episodes, and urgency urinary incontinence episodes/24 h; mean volume voided per micturition; and number of night-time micturitions. Results Overall, 80.2% of patients (88.1% women, mean age 65 years) experienced at least one treatment-emergent adverse event, with similar rates for all treatments. The adverse events most commonly reported were dry mouth, nasopharyngitis, and constipation. No marked change was observed in systolic or diastolic blood pressure for any treatment, although pulse rate increased slightly in the mirabegron and propiverine, and mirabegron and tolterodine groups. For all treatments, significant improvements were observed in all efficacy parameters, including overactive blAdder symptom score total and questionnaire short form scores. Conclusions Antimuscarinic Add-on Therapy is well tolerated and effective after initial treatment with mirabegron in patients with overactive blAdder symptoms.

  • safety and efficacy of mirabegron as Add on Therapy in patients with overactive blAdder treated with solifenacin a post marketing open label study in japan milai study
    BJUI, 2015
    Co-Authors: Osamu Yamaguchi, Momokazu Gotoh, Hidehiro Kakizaki, Yukio Homma, Yasuhiko Igawa, Masayuki Takeda, Osamu Nishizawa, Masaki Yoshida, Osamu Yokoyama, Narihito Seki
    Abstract:

    Objective To examine the safety and efficacy of mirabegron as ‘Add-on’ Therapy to solifenacin in patients with overactive blAdder (OAB). Patients and Methods This multicentre, open-label, phase IV study enrolled patients aged ≥20 years with OAB, as determined by an OAB symptom score (OABSS) total of ≥3 points and an OABSS Question 3 score of ≥2 points, who were being treated with solifenacin at a stable dose of 2.5 or 5 mg once daily for at least 4 weeks. Study duration was 18 weeks, comprising a 2-week screening period and a 16-week treatment period. Patients meeting eligibility criteria continued to receive solifenacin (2.5 or 5 mg once daily) and Additional mirabegron (25 mg once daily) for 16 weeks. After 8 weeks of treatment, the mirabegron dose could be increased to 50 mg if the patient's symptom improvement was not sufficient, if he/she was agreeable to the dose increase, and the investigator judged that there were no safety concerns. Safety assessments included adverse events (AEs), laboratory tests, vital signs, 12-lead electrocardiogram, QT corrected for heart rate using Fridericia's correction (QTcF) interval and post-void residual (PVR) volume. Efficacy endpoints were changes from baseline in OABSS total score, OAB questionnaire short form (OAB-q SF) score (symptom bother and total health-related quality of life [HRQL] score), mean number of micturitions/24 h, mean number of urgency episodes/24 h, mean number of urinary incontinence (UI) episodes/24 h, mean number of urgency UI episodes/24 h, mean volume voided/micturition, and mean number of nocturia episodes/night. Patients were instructed to complete the OABSS sheets at weeks −2, 0, 8 and 16 (or at discontinuation), OAB-q SF sheets at weeks 0, 8 and 16 (or at discontinuation) and patient voiding diaries at weeks 0, 4, 8, 12 and 16 (or at discontinuation). Results Overall incidence of drug-related treatment-emergent AEs (TEAEs) was 23.3%. Almost all TEAEs were mild or moderate. The most common TEAE was constipation, with similar incidence in the groups receiving a dose increase to that observed in the groups maintained on the original dose. Changes in PVR volume, QTcF interval, pulse rate and blood pressure were not considered to be clinically significant and there were no reports of urinary retention. Significant improvement was seen for changes in efficacy endpoints from baseline to end of treatment (EOT) in all groups (patients receiving solifenacin 2.5 or 5 mg + mirabegron 25 or 50 mg). Conclusions Add-on Therapy with mirabegron 25 mg once daily for 16 weeks, with an optional dose increase to 50 mg at week 8, was well tolerated in patients with OAB treated with solifenacin 2.5 mg or 5 mg once daily. There were significant improvements from baseline to EOT in OAB symptoms with combination Therapy with mirabegron and solifenacin. Add-on Therapy with mirabegron and an antimuscarinic agent, such as solifenacin, may provide an attractive therapeutic option.

  • solifenacin as Add on Therapy for overactive blAdder symptoms in men treated for lower urinary tract symptoms assist randomized controlled study
    Urology, 2011
    Co-Authors: Osamu Yamaguchi, Momokazu Gotoh, Hidehiro Kakizaki, Yukio Homma, Masayuki Takeda, Osamu Nishizawa, Osamu Yokoyama, Narihito Seki, Masaki Yoshida
    Abstract:

    Objectives To assess the efficacy and safety of solifenacin Add-on Therapy to tamsulosin in lower urinary tract symptoms (LUTS) men with residual overactive blAdder (OAB) symptoms despite tamsulosin monoTherapy. Methods In this randomized, multicenter, double-blind study, male LUTS patients aged ≥50 years with urgency episodes/24 hours ≥2 and micturitions/24 hours ≥8 were randomized to 3 groups: 12-weeks tamsulosin plus placebo (TAM + PBO), tamsulosin plus solifenacin 2.5 mg (TAM + SOL), and tamsulosin plus solifenacin 5 mg (TAM + SOL). Changes from baseline to end of treatment in the number of urgency episodes/24 hours (primary endpoint), micturitions, nocturia, urgency incontinence episodes, International Prostate Symptom Scores (IPSS), and Overactive BlAdder Symptom Score (OABSS) were compared between the TAM + SOL groups and TAM + PBO. Safety was assessed on adverse events, postvoid residual volume, and maximal urinary flow rate (Qmax.). Results Six-hundred thirty-eight men were randomized. Urgency was reduced by 2.2 and 2.4 episodes in the TAM + SOL 2.5 and 5 mg groups, respectively. The TAM + SOL 5 mg group showed significant improvement compared with TAM + PBO (−2.4 vs −1.9, P = .049). The number of micturitions in both TAM + SOL groups were significantly reduced compared with TAM + PBO (both P Conclusions In male LUTS patients with residual OAB symptoms despite tamsulosin monoTherapy, TAM + SOL showed efficacy on urgency, which represents OAB symptoms and was well tolerated.

  • solifenacin as Add on Therapy for overactive blAdder symptoms in men treated for lower urinary tract symptoms assist randomized controlled study
    Urology, 2011
    Co-Authors: Osamu Yamaguchi, Momokazu Gotoh, Hidehiro Kakizaki, Yukio Homma, Masayuki Takeda, Osamu Nishizawa, Osamu Yokoyama, Narihito Seki, Masaki Yoshida
    Abstract:

    Objectives To assess the efficacy and safety of solifenacin Add-on Therapy to tamsulosin in lower urinary tract symptoms (LUTS) men with residual overactive blAdder (OAB) symptoms despite tamsulosin monoTherapy. Methods In this randomized, multicenter, double-blind study, male LUTS patients aged ≥50 years with urgency episodes/24 hours ≥2 and micturitions/24 hours ≥8 were randomized to 3 groups: 12-weeks tamsulosin plus placebo (TAM + PBO), tamsulosin plus solifenacin 2.5 mg (TAM + SOL), and tamsulosin plus solifenacin 5 mg (TAM + SOL). Changes from baseline to end of treatment in the number of urgency episodes/24 hours (primary endpoint), micturitions, nocturia, urgency incontinence episodes, International Prostate Symptom Scores (IPSS), and Overactive BlAdder Symptom Score (OABSS) were compared between the TAM + SOL groups and TAM + PBO. Safety was assessed on adverse events, postvoid residual volume, and maximal urinary flow rate (Qmax.). Results Six-hundred thirty-eight men were randomized. Urgency was reduced by 2.2 and 2.4 episodes in the TAM + SOL 2.5 and 5 mg groups, respectively. The TAM + SOL 5 mg group showed significant improvement compared with TAM + PBO (−2.4 vs −1.9, P = .049). The number of micturitions in both TAM + SOL groups were significantly reduced compared with TAM + PBO (both P <.001). IPSS storage symptom score and OABSS significantly improved in both TAM + SOL groups compared with TAM + PBO. Changes in IPSS voiding symptom score and Qmax. were similar in all groups. Four patients (1.9%) in the TAM + SOL 5 mg group had urinary retention, but all recovered after catheterization. Conclusions In male LUTS patients with residual OAB symptoms despite tamsulosin monoTherapy, TAM + SOL showed efficacy on urgency, which represents OAB symptoms and was well tolerated.