Solifenacin For Overactive Bladder Research Articles

Meta-analysis of the efficacy and safety of mirabegron and solifenacin monotherapy for overactive bladder.

We conducted a meta-analysis to evaluate the safety and efficacy of mirabegron (50 mg) and solifenacin (5 mg) monotherapy for overactive bladder (OAB) during a 12-week cycle. Randomized controlled trials (RCTs) of mirabegron and solifenacin for OAB were searched systematically by using MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of retrieved studies were also perused. Five RCTs which compared solifenacin with mirabegron were studied. Mirabegron achieved the same effect as solifenacin in treating OAB. The mean number of incontinence episodes per 24 h (P = 0.20), mean number of micturitions per 24 h (P = 0.11), mean number of urgency episodes per 24 h (P = 0.23), and mean volume voided per micturition (P = 0.05) suggested that mirabegron and solifenacin had no significant differences in terms of OAB treatment. With regard to drug-related treatment-emergent adverse events (DR-TEAEs) and dry mouth, mirabegron showed better tolerance than solifenacin. Post-voiding residual volume showed a distinct difference in the two groups. Hypertension and tachycardia did not show a significant difference between the two groups, but the pulse rate did. The therapeutic effect of mirabegron is similar to that of solifenacin, and mirabegron does not increase the risk of adverse events (AEs).

Influence of Daytime or Nighttime Dosing with Solifenacin for Overactive Bladder with Nocturia: Impact on Nocturia and Sleep Quality.

We compared changes in nocturia and sleep-related parameters between daytime and nighttime solifenacin dosing in patents with overactive bladder (OAB) and nocturia. We comparatively analyzed the data of a 12-week prospective, open-label, multicenter, randomized study. All 127 patients who presented to 5 centers in Korea for the treatment of OAB with nocturia between January 2011 and December 2013 were enrolled in this study. The patients were divided into 2 groups by medication timing: group 1, daytime (n = 62); and group 2, nighttime (n = 65). The International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), and Athens Insomnia Scale (AIS) were used to assess OAB symptoms and sleep quality. We evaluated the parameter changes before and 12 weeks after daytime or nighttime solifenacin administration. Baseline data, which included sex, age, body mass index (BMI), total AIS, IPSS, and OABSS, did not differ between the 2 groups. Total IPSS, OABSS, and total AIS significantly improved after solifenacin administration regardless of timing (P < 0.001). After solifenacin administration, the number of nocturia episodes decreased in the group 1 and 2 (P < 0.001). There were no significant intergroup differences in changes in AIS, IPSS, OABSS, and number of nocturia episodes 12 weeks after solifenacin administration. Treating OAB with solifenacin may improve nocturia and sleep quality, but advantages did not differ significantly by medication timing.

Trends in Urological Direct-to-Consumer Advertising during Prime-Time Television News Programs

IntroductionThe purpose of this study is to characterize contemporary trends in direct-to-consumer advertising of urological pharmaceutical products on American prime-time television programs. Television is the highest expenditure segment of the consumer drug marketing industry. The extent of advertising in urology and its potential impact on patients are not well understood. MethodsWe retrospectively analyzed an indexed database of prime-time news broadcasts on 5 national networks in the United States. The database was queried with the names of 77 urological pharmaceutical products to identify all commercials that aired during a 36-month period between 2010 and 2013. Noncommercial segments were excluded. Descriptive and linear regression analysis was performed. ResultsWe analyzed 4,574 broadcasts, representing 3,067.5 hours of prime-time television. A total of 2,068 commercials for 8 products and 4 urological indications were aired, including sildenafil and tadalafil for erectile dysfunction; 2 testosterone products for hypogonadism; fesoterodine, oxybutynin and solifenacin for overactive bladder; and sipuleucel-T for metastatic castration resistant prostate cancer. Commercials for male oriented indications accounted for 90% of the sample. At least 1 urological advertisement was contained in 1,744 broadcasts (38%). The introduction of television marketing for newly approved testosterone supplementation products in 2012 corresponded to strongly linear growth in overall urological advertising, reaching peak levels in 2013. ConclusionsUrological pharmaceutical products have been consistently advertised on television. Commercials have extensively targeted male oriented indications. Viewers of national news programs were exposed to urological advertising during about 40% of broadcasts with steadily increasing exposure since 2012. Providers should be aware of these trends to contextualize demand and monitor prescribing patterns.

Persistence and concomitant medication in patients with overactive bladder treated with antimuscarinic agents in primary care. An observational baseline study

ObjectiveTo assess therapeutic persistence and its relationship with concomitant medication in patients treated with fesoterodine versus tolterodine and solifenacin for overactive bladder (OAB) in standard clinical practice conditions. Material and methodsAn observational, multicentre retrospective study was performed based on medical registries of patients followed-up in primary care (PC). Three study groups were analyzed. Persistence was defined as the time (in months) without withdrawing from the initial therapy or without changing to another medication for at least 30 days after the initial prescription. The concomitant medications were antidepressants, anxiolytic/hypnotic agents, antibiotics, antiseptic agents, laxatives and skin products. We employed the SPSSWIN program version 17 (statistical significance, p<.05). ResultsWe selected 3094 patients for the study. The median age was 54.0 years and 62.2% were women. The patients treated with fesoterodine shown greater treatment persistence (12 months) when compared with those who took solifenacin and tolterodine (40.2% vs. 34.7% and 33.6%, respectively; p=.008). They also showed a lower use of concomitant medication (1.1 vs. 1.2 and 1.2 drugs, respectively; percentages: 61.6% vs. 67.1% and 70.1%, respectively; p<.03). ConclusionsThe patients undergoing OAB treatment with fesoterodine, when compared with those taking solifenacin and tolterodine, were associated with greater treatment persistence and a reduced use of concomitant medication.

Persistencia y medicación concomitante en pacientes con vejiga hiperactiva tratados con antimuscarínicos en atención primaria: estudio de base observacional

ObjectiveTo assess therapeutic persistence and its relationship with concomitant medication in patients treated with fesoterodine versus tolterodine and solifenacin for overactive bladder (OAB) in standard clinical practice conditions. Material and methodsAn observational, multicentre retrospective study was performed based on medical registries of patients followed-up in primary care (PC). Three study groups were analysed. Persistence was defined as the time (in months) without withdrawing from the initial therapy or without changing to another medication for at least 30 days after the initial prescription. The concomitant medications were antidepressants, anxiolytic/hypnotic agents, antibiotics, antiseptic agents, laxatives and skin products. We employed the SPSSWIN program version 17 (statistical significance, P<.05). ResultsWe selected 3094 patients for the study. The median age was 54.0 years and 62.2% were women. The patients treated with fesoterodine shown greater treatment persistence (12 months) when compared with those who took solifenacin and tolterodine (40.2% vs. 34.7% and 33.6%, respectively; P=.008). They also showed a lower use of concomitant medication (1.1 vs. 1.2 and 1.2 drugs, respectively; percentages: 61.6% vs. 67.1% and 70.1%, respectively; P<.03). ConclusionsThe patients undergoing OAB treatment with fesoterodine, when compared with those taking solifenacin and tolterodine, were associated with greater treatment persistence and a reduced use of concomitant medication.

Health economics perspective of fesoterodine, tolterodine or solifenacin as first-time therapy for overactive bladder syndrome in the primary care setting in Spain

BackgroundOveractive bladder (OAB) is associated with high healthcare costs, which may be partially driven by drug treatment. There is little comparative data on antimuscarinic drugs with respect to resource use and costs. This study was conducted to address this gap and the growing need for naturalistic studies comparing health economics outcomes in adult patients with OAB syndrome initiating treatment with different antimuscarinic drugs in a primary care setting in Spain.MethodsMedical records from the databases of primary healthcare centres in three locations in Spain were assessed retrospectively. Men and women ≥18 years of age who initiated treatment with fesoterodine, tolterodine or solifenacin for OAB between 2008 and 2010 were followed for 52 weeks. Healthcare resource utilization and related costs in the Spanish National Health System were compared. Comparisons among drugs were made using multivariate general linear models adjusted for location, age, sex, time since diagnosis, Charlson comorbidity index, and medication possession ratio.ResultsA total of 1,971 medical records of patients (58.3% women; mean age, 70.1 [SD:10.6] years) initiating treatment with fesoterodine (n = 302), solifenacin (n = 952) or tolterodine (n = 717) were examined. Annual mean cost per patient was €1798 (95% CI: €1745; €1848). Adjusted mean (95% bootstrap CI) healthcare costs were significantly lower in patients receiving fesoterodine (€1639 [1542; 1725]) compared with solifenacin (€1780 [€1699; €1854], P = 0.022) or tolterodine (€1893 [€1815; €1969], P = 0.001). Cost differences occurred because of significantly fewer medical visits, and less use of absorbent products and OAB-related concomitant medication in the fesoterodine group.ConclusionsCompared with solifenacin and tolterodine, fesoterodine was a cost-saving therapy for treatment of OAB in the primary care setting in Spain.

Finding unrecognized information in overactive bladder clinical trial data: A new approach to understanding placebo and treatment effects

To identify combinations of variables among overactive bladder (OAB) clinical trial subjects that allow prediction of those who are more--or less--likely to respond strongly to placebo, or to medication. Data from two Phase IIIb clinical trials of solifenacin in OAB were combined. Predictive models for placebo and treatment responses were constructed using baseline variables including individual items from the OAB questionnaire. These models were reduced to an essential subset of predictor variables. Two outcome measures are reported: urgency and incontinence. In placebo subjects, 14 selected variables permitted distinction between those who responded with significant reductions in urgency and those who did not. A subset of nine variables in treated subjects permitted distinction between those more--or less--likely to respond to medication. Data for urgency were combined from both placebo and actively treated subjects to identify those who had one of the previously identified clusters of variables. It was possible to predict, among all subjects, who would be likely to experience a strong placebo or active treatment response and who would not. This process was also applied to incontinence data. We have developed a new process to help understand placebo and treatment responses and their relationships to baseline conditions. The effectiveness of these methods was indicated using data from two solifenacin clinical trials and would benefit from future validation using other data sets. Methods used here are suitable for predicting the placebo effect in other clinical trials.

Solifenacin for overactive bladder: a systematic review and meta-analysis

This study aims to evaluate the efficacy and safety of solifenacin for treating overactive bladder. Randomized controlled trials (RCTs) were identified and extracted from MEDLINE, Embase, and CENTRAL. The quality of the included RCTs was assessed using the Jadad score, and heterogeneity was analyzed using the chi-squared test. The data of the included RCTs were collected, extracted, and assessed by our protocol. A total of nine RCTs were identified from the search strategy. Compared with the placebo and tolterodine treatments, both short-term (mostly 12-week) trials indicated that solifenacin significantly reduced urgency episodes, micturitions, and incontinence episodes per 24 h. Compared with the solifenacin (5 mg) group, the solifenacin (10 mg) group was significantly better in terms of the number of micturitions per 24 h. With regard to adverse effects, the patients treated with solifenacin had significantly higher rates of constipation and blurred vision than patients treated with tolterodine. The solifenacin therapy was not inferior to tolterodine in terms of efficacy profiles and had a similar incidence of overall adverse events compared with tolterodine treatment. Solifenacin (5 mg) is thus a recommended dose because of its reported balance between efficacy and acceptable tolerability.

UP-2.41: A comprehensive patient support programme improves persistence with solifenacin in overactive bladder (OAB)

UP-2.41: A comprehensive patient support programme improves persistence with solifenacin in overactive bladder (OAB)

Solifenacin for overactive bladder: secondary analysis of data from VENUS based on baseline continence status

VENUS evaluated the efficacy of solifenacin on urgency in patients with overactive bladder (OAB). We hypothesized that solifenacin would be comparably efficacious in continent and incontinent patients. VENUS was a 12-week, placebo-controlled trial in patients with OAB. Treatment efficacy was assessed using bladder diaries and patient-reported outcome measures. The primary endpoint was the change in daily urgency episodes. Exploratory subgroup analyses were conducted using baseline continence status. Solifenacin reduced urgency episodes versus placebo in continent (-3.4 vs. -2.3) and incontinent patients (-4.2 vs. -2.9) and incontinence episodes (-2.1 vs. -1.2) in that subgroup; 58% versus 42% of incontinent patients receiving solifenacin versus placebo were continent at study end. In both cohorts, solifenacin- versus placebo-treated patients showed greater improvements in perceptions of urgency severity, symptom bother, and health-related quality of life. This post hoc analysis demonstrates the efficacy of solifenacin regardless of baseline continence status.

Solifenacin for Overactive Bladder: Patient-Reported Outcomes from a Large Placebo-Controlled Trial

Objective: Overactive bladder (OAB) is a prevalent, chronic condition that can negatively affect health-related quality of life (HRQL). Treatment goals are to improve symptoms and HRQL. We assessed the efficacy of solifenacin in OAB patients using several patient-reported outcome (PRO) measures, with a focus on urgency severity. Results for the primary endpoint, reductions in daily urgency episodes, and other bladder-diary variables have been recently reported. Materials and Methods: In this 12-week multicenter trial, 739 patients (aged ⩾ 18 years) were randomized to flexibly dosed solifenacin (5/10 mg) or placebo. Prespecified secondary PRO measures included the Indevus Urgency Severity Scale (IUSS), Urgency Perception Scale (UPS), Patient Perception of Bladder Condition (PPBC), and Overactive Bladder Questionnaire (OAB-q). Appropriate statistical tests compared treatment-group differences in continuous and categorical data. Results: In the full analysis set, patients who received solifenacin (n = 357) versus placebo (n = 350) showed significant improvements on the IUSS and UPS; treatment-group differences were 0.4 (P < 0.0001) and 0.2 (P = 0.0018), respectively. On the PPBC, significantly more patients taking solifenacin (66%) than placebo (48%) perceived fewer bladder-related problems (P < 0.0001) by week 12. On the OAB-q, solifenacin was superior to placebo for the Symptom Bother and total HRQL scales and for 3 of the 4 HRQL domains at study end (P < 0.01). Overall, these findings were consistent with those reported previously for bladder-diary-documented urgency and other OAB symptoms. Conclusion: Flexibly dosed, once-daily solifenacin was associated with statistically significant and clinically meaningful improvements in urgency and other symptom-specific bother and HRQL compared with placebo.

Solifenacin for overactive bladder in women unsuccessfully treated with immediate release oxybutynin: A pilot study

SummaryThe aim of the study was to determine the efficacy, tolerability and cost comparison of solifenacin for women with an overactive bladder (OAB) who failed to respond to immediate release oxybutynin (IR). A standard 3-day bladder diary, cost of incontinence pads used over 4 weeks and a validated OAB quality-of-life questionnaire were collected at baseline, at 4 weeks and at 12 weeks of commencing solifenacin treatment. Nine women were enrolled into the study. Eight of the women completed the 12-week study and one woman withdrew. The mean number of day-time micturitions was 11.4 ± 2.7 at baseline and 7.3 ± 3.5 at 12 weeks of solifenacin treatment (p = 0.0002). The mean number of nocturia was 2.8 ± 1.4 at baseline and 0.9 ± 0.9 at 12 weeks of solifenacin treatment (p = 0.0004). The total number of incontinence episodes per day was 4.9 ± 4.6 at baseline and 1.9 ± 2.7 at 12 weeks of solifenacin treatment (p = 0.02). The mean micturition volumes were 160 ± 50 ml at baseline and 280 ± 50 ml at 12 weeks of solifenacin treatment (p = 0.002). The symptom severity domain of the OAB-questionnaire (OAB-q) showed a value of 60.8 ± 23.0% at baseline and 32.0 ± 25.9 % at 12 weeks of solifenacin treatment (p = 0.001). The health-related quality-of-life (HRQL) domain of the OAB-q showed a value of 45.5 ± 28.0% at baseline and 73.3 ± 24.8% at 12 weeks of solifenacin treatment (p = 0.0006). This study shows a significant improvement in bladder diary and validated quality-of-life parameters with solifenacin in women with urge incontinence who have previously failed to respond to or have been intolerant of oxybutynin IR.

Solifenacin for Overactive Bladder with Incontinence: Symptom Bother and Health-Related Quality of Life Outcomes

Approximately one-third of patients with overactive bladder (OAB) experience incontinence, a bothersome symptom with a clear negative effect on quality of life. To assess OAB patients' perceptions of improvements in symptom bother and quality of life after taking solifenacin under conditions reflecting day-to-day practice. VOLT (the VESIcare Open-Label Trial) was a prospective, open-label study in patients with OAB (defined as urgency, urge urinary incontinence, daytime frequency, or nocturia for > or =3 mo) who were treated with flexibly dosed, once-daily solifenacin for 12 weeks. This study included subjects enrolled in VOLT who, at baseline, had urge incontinence and reported incontinence as their most bothersome symptom. All patients were started on solifenacin 5 mg/day; at week 4, the dosage could be increased to 10 mg/day and at week 8 could be maintained or decreased back to 5 mg/day. Efficacy was assessed by 3 independent patient-reported outcomes: the Patient Perception of Bladder Condition (PPBC) scale, a visual analog scale (VAS) for assessing individual symptoms, and the Overactive Bladder Questionnaire (OAB-q). Of the 2205 patients in the VOLT full analysis set, 1586 (71.9%) had urge incontinence at baseline, of which 582 (36.7%) reported incontinence as their most bothersome symptom. In this cohort, mean PPBC score at baseline was 4.6 (indicating moderate-to-severe problems) and at endpoint had decreased significantly to 2.9 (very minor to some minor problems; p < 0.001). At endpoint, 80.4% of patients achieved improvement in their PPBC score. These patients reported significant improvements from baseline in urinary urgency, urge incontinence, frequency, and nocturia on the VAS (p < 0.001) and all OAB-q domains (symptom severity, coping, concern, sleep, social, health-related quality of life) at endpoint (p < 0.001). Patients reporting urge incontinence as their most bothersome OAB symptom can be expected to demonstrate significant improvements in multiple patient-related outcomes following treatment with flexibly dosed solifenacin.

Solifenacin in Overactive Bladder

look at urgency as a primary endpoint. Solifenacin The International Continence Society catsignificantly improved all symptoms of OAB and egorised the overactive bladder (OAB) as a synquality of life compared to placebo. The combined drome with urgency being the cornerstone sympdoses of solifenacin seemed to be non-inferior in tom. The new definition of OAB provided a symptoimproving nocturia or daytime frequency, but had matic clinical diagnosis for a combination of superior efficacy in reducing urgency, urgency insymptoms, allowing the initiation of treatment withcontinence and pads used and in increasing the out relying initially on a urodynamic diagnosis of volume voided per void, when compared to tolterdetrusor overactivity. odine ER (extended release). Adverse effects were