Daniel Arumi

Cost-effectiveness analysis of antimuscarinics in the treatment of patients with overactive bladder in Spain: A decision-tree model

BackgroundFesoterodine, a new once daily antimuscarinic, has proven to be an effective, safe, and well-tolerated treatment in patients with overactive bladder (OAB). To date, no analysis has evaluated the economic costs and benefits associated with fesoterodine, compared to antimuscarinics in Spain. The purpose of this analysis was to assess the economic value of OAB treatment with fesoterodine relative to extended release tolterodine and solifenacin, from the societal perspective.MethodsThe economic model was based on data from two 12-week, randomized, double-blind, and multicenter trials comparing fesoterodine and tolterodine extended released (ER). Treatment response rates for solifenacin were extracted from the published literature. Discontinuation and efficacy were based on the results of a 12-week multinational randomized clinical trial extrapolated to 52 weeks. Changes in health related quality of life were assessed with the Kings Health Questionnaire, which was transformed into preference-based utility values. Medical costs included (expressed in € 2010) were antimuscarinics, physician visits, laboratory tests, incontinence pads and the costs of OAB-related comorbidities, fractures, skin infections, urinary tract infections, depression, and nursing home admissions associated with incontinence. Time lost from work was also considered. Univariate sensitivity analyses were also performed.ResultsAt week 12, continents accounted for 50.6%, 40.6% and 47.2% of patients in the fesoterodine, tolterodine, and solifenacin groups, respectively. By week 52, the projected proportions of patients remaining on therapy were 33.1%, 26.5% and 30.8%, respectively. The projected quality- adjusted life years (QALY) gain (compared to baseline) over the 52-week simulation period were 0.01014, 0.00846 and 0.00957, respectively. The overall treatment cost was estimated at €1,937, €2,089 and €1,960 for fesoterodine, tolterodine and solifenacin, respectively. Therefore, treatment with fesoterodine resulted in similar overall costs and greater QALY gain than treatment with either tolterodine or solifenacin. Sensitivity analysis showed that these results were robust to all changes performed.ConclusionsThe results of this economic analysis suggest that fesoterodine is a cost-effective alternative to tolterodine and solifenacin for the treatment of patients with OAB in Spain. Fesoterodine provides additional health benefits while maintain a similar level of costs being a cost-effective treatment strategy from a societal perspective.

Quality of life in patients with overactive bladder: validation and psychometric properties of the Spanish Overactive Bladder Questionnaire-short Form.

BACKGROUND Overactive bladder (OAB) is characterized by the symptoms of urinary urgency or urge incontinence, which appear without a local pathological or metabolic explanation. OAB is defined by symptoms and the evaluation of treatment effectiveness should be based upon patient perceptions. The Overactive Bladder Questionnaire-Short Form (OAB-q SF) is a brief, self-administered patient-reported outcomes tool with two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. OBJECTIVE This study aimed to adapt the OAB-q SF into Spanish and to estimate its psychometric properties in patients with symptomatic overactive bladder. METHODS The Spanish version of the OAB-q SF was administered on two occasions, 3 months apart, to a set of patients of both sexes, over 18 years of age, diagnosed with OAB, scoring ≥8 on the OAB-V8 scale (a self-reported 8-item OAB screening and awareness tool), and able to understand patient-reported-outcome instruments written in Spanish. Patients were recruited consecutively at urology clinics. Feasibility, internal consistency (Cronbachs alpha), test-retest reliability, structure of instrument, criteria and construct validity and responsiveness were examined using classic test theory statistics. RESULTS Data from 246 OAB patients (mean age 57.7 years, 76% women, 99% Caucasian, 37% workers and 36% with a primary education) were evaluated. Floor and ceiling effects ranged between 0.8% and 33%, and missing items were below 2%. Cronbachs alphas attained 0.811 and 0.922 for symptom-bother and HR-QOL domains, respectively. These two subscales matched the original structure and explained variances above 50%, which correlated moderately with EQ-5D (EuroQol) [r = -0.28 and r = +0.31, respectively (p < 0.001 in both cases)]. A significant change in OAB-q SF mean domain scores (-23.8; 95% CI -26.3, -21.3; and +17.7; 95% CI 15.4, 20.6; p < 0.001 in both cases; [effect sizes: 1.32 and 0.98]) was observed after 3 months of medical treatment. CONCLUSION The Spanish version of the OAB-q SF demonstrated sufficiently strong psychometric properties of reliability, validity and responsiveness to be used in the measurement of OAB symptom severity and HR-QOL.

Dose and aging effect on patients reported treatment benefit switching from the first overactive bladder therapy with tolterodine ER to fesoterodine: post-hoc analysis from an observational and retrospective study.

BackgroundPrevious randomized studies have demonstrated that fesoterodine significantly improves the Overactive Bladder (OAB) symptoms and their assessment by patients compared with tolterodine extended-release (ER). This study aimed to assess the effect of aging and dose escalation on patient-reported treatment benefit, after changing their first Overactive Bladder (OAB) therapy with tolterodine-ER to fesoterodine in daily clinical practice.MethodsA post-hoc analysis of data from a retrospective, cross-sectional and observational study was performed in a cohort of 748 OAB adults patients (OAB-V8 score ≥8), who switched to fesoterodine from their first tolterodine-ER-based therapy within the 3–4 months before study visit. Effect of fesoterodine doses (4 mg vs. 8 mg) and patient age (<65 yr vs. ≥65 yr) were assessed. Patient reported treatment benefit [Treatment Benefit Scale (TBS)] and physician assessment of improvement with change [Clinical Global Impression of Improvement subscale (CGI-I)] were recorded. Treatment satisfaction, degree of worry, bother and interference with daily living activities due to urinary symptoms were also assessed.ResultsImprovements were not affected by age. Fesoterodine 8 mg vs. 4 mg provides significant improvements in terms of treatment benefit [TBS 97.1% vs. 88.4%, p < 0.001; CGI-I 95.8% vs. 90.8% p < 0.05)], degree of worry, bother and interference with daily-living activities related to OAB symptoms (p <0.05).ConclusionsA change from tolterodine ER therapy to fesoterodine with dose escalation to 8 mg in symptomatic OAB patients, seems to be associated with greater improvement in terms of both patient-reported-treatment benefit and clinical global impression of change. Improvement was not affected by age.

Assessment of reasons for overactive bladder treatment change

Abstract Objectives Although efficacious, some patients do not respond optimally to overactive bladder (OAB) treatment. The objective of this study was to identify the reasons why some patients do not respond and to look for reasons for changes in treatment and patient satisfaction with the new treatment. Materials and methods Epidemiological, cross-sectional, non-interventional study to determine the reasons for OAB treatment switching and satisfaction with such OAB treatment switch. OAB patients (OAB-V8≥8), 18 years or more, who had modified their treatment during the previous 3–4 months, were recruited. Demographic data, symptoms, previous, current and concomitant treatments, reasons for treatment switch, clinical global impression (CGI) on disease severity and symptom improvement, Morinsky Green questionnaire, satisfaction with treatment, treatment preference and treatment benefit scale (TBS) were compared. Results Out of 3,365 successive patients, 2,038 (61%) were eligible (61.1±11.2 years; 77% women). The physician decided to switch in 69% of the cases and 31% of patients asked for a change in treatment. Reasons for switching were lack of clinical benefit (60%), side effects (24%), patients’ request (8%), non-compliance (6%) and other (2%). 52% of patients complied with new treatment. According to the CGI, 65.4% showed improvement with respect to their previous treatment. 60% were quite/very satisfied with current treatment, 91% preferred it to their previous treatment and 93% reported that their symptoms had improved. Conclusions The lack of clinical benefit is the main reason for changing OAB treatment. Most of the patients that switched prefer their new treatment.

Validación psicométrica de las escalas OAB-V8 y OAB-V3 para la detección de pacientes con probable vejiga hiperactiva en la población española

BACKGROUND AND OBJECTIVE To perform the psychometric validation in the Spanish population of the Overactive Bladder Awareness Tool (OAB-V8) scale and its abbreviated version OAB-V3 for screening patients with probable overactive bladder (OAB). PATIENTS AND METHODS A cross-sectional study was conducted in a population aged over 18 years, which was representative of the prevalence of OAB in Spain using an online methodology (Internet survey). Psychometric properties included feasibility, reliability, and validity. Subjects were classified according to the likelihood of OAB, using an automated algorithm validated previously. ROC curve analysis was performed, and the sensitivity, specificity, and positive and negative predictive values were also assessed. RESULTS A total of 2,035 subjects with a mean+SD age of 52.7+12.1 years were included (50.8%) men. In total 13.7% were classified as «Probable», 27.9% «Possible», and 58.3% «No» OAB. The internal consistency of both OAB-V8 and OAB-V3 scales was high (0.894 and 0.851, respectively). The item-total correlation coefficients were high; 0.87-0.88 and 0.71-0.83, respectively. Intraclass correlation coefficient for OAB-V8 was 0.826 (confidence interval 95% 0.695-0.901) and it was 0.828 (confidence interval 0.623-0.922) for OAB-V3. The optimum cut-off value of OAB-V8 for detecting probable OAB was≥8 points (AUC=0.895, sensitivity 0.875, specificity 0.735), while for the OAB-V3 it was ≥ 3 (AUC=0.910, sensitivity 0.828, specificity 0.825). CONCLUSION Both OAB-V8 and OAB-V3 scales were considered useful online self-administered screening tools, which were also feasible, reliable and valid for the detection of patients with probable OAB in the general population in Spain.

Efficacy and safety of fesoterodine 8 mg in subjects with overactive bladder after a suboptimal response to tolterodine ER

To assess fesoterodine 8 mg efficacy over time and vs. placebo in subjects with overactive bladder (OAB) who responded suboptimally to tolterodine extended release (ER) 4 mg.

Quality of Life in Patients with Overactive Bladder

AbstractBackground: Overactive bladder (OAB) is characterized by the symptoms of urinary urgency or urge incontinence, which appear without a local patho logical or metabolic explanation. OAB is defined by symptoms and the evaluation of treatment effectiveness should be based upon patient perceptions. The Overactive Bladder Questionnaire-Short Form (OAB-q SF) is a brief, self-administered patient-reported outcomes tool with two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. Objective: This study aimed to adapt the OAB-q SF into Spanish and to estimate its psychometric properties in patients with symptomatic overactive bladder. Methods: The Spanish version of the OAB-q SF was administered on two occasions, 3 months apart, to a set of patients of both sexes, over 18 years of age, diagnosed with OAB, scoring ≥8 on the OAB-V8 scale (a self-reported 8-item OAB screening and awareness tool), and able to understand patient-reported-outcome instruments written in Spanish. Patients were recruited consecutively at urology clinics. Feasibility, internal consistency (Cronbach’s alpha), test-retest reliability, structure of instrument, criteria and construct validity and responsiveness were examined using classic test theory statistics. Results: Data from 246 OAB patients (mean age 57.7 years, 76% women, 99% Caucasian, 37% workers and 36% with a primary education) were evaluated. Floor and ceiling effects ranged between 0.8% and 33%, and missing items were below 2%. Cronbach’ alphas attained 0.811 and 0.922 for symptom-botherz and HR-QOL domains, respectively. These two subscales matched the original structure and explained variances above 50%, which correlated moderately with EQ-5D (EuroQol) [r=−0.28 and r=+0.31, respectively (p< 0.001 in both cases)]. A significant change in OAB−q SF mean domain scores (−23.8; 95% CI −26.3, −21.3; and +17.7; 95% CI 15.4, 20.6; p<0.001 in both cases; [effect sizes: 1.32 and 0.98]) was observed after 3 months of medical treatment. Conclusion: The Spanish version of the OAB-q SF demonstrated sufficiently strong psychometric properties of reliability, validity and responsiveness to be used in the measurement of O AB symptom severity and HR-QOL.

Fesoterodine clinical efficacy and safety for the treatment of overactive bladder in relation to patient profiles: a systematic review

Abstract Objective: To summarize published evidence on the pharmacology, efficacy, and safety of fesoterodine for the treatment of overactive bladder (OAB) symptoms in relation to patient clinical and demographic profiles. Methods: A systematic review of published articles on fesoterodine was conducted via a PubMed search. Articles were identified using the search term fesoterodine, with limits of human species and abstract available. Review and meta-analysis articles, validation studies, articles focused on treatment compliance/adherence, meeting abstracts, and articles not focused on oral fesoterodine administration in human subjects were excluded. Data from retained articles were summarized descriptively. Results: Of 137 articles identified, 61 (15 articles on the pharmacology and 46 articles on the efficacy and/or safety of fesoterodine) met inclusion criteria. Superiority trials demonstrated the additional efficacy of fesoterodine 8 mg versus fesoterodine 4 mg and tolterodine extended release 4 mg in treating OAB. Prospective trials in specific patient populations indicated beneficial effects of fesoterodine in elderly patients, vulnerable elderly patients, patients dissatisfied with or with a suboptimal response to previous antimuscarinic therapy, patients with urge urinary incontinence (UUI) or nocturnal urgency, and men with persistent LUTS during alpha-blocker treatment. With two effective doses, the fesoterodine dose can be adjusted to achieve optimal efficacy and tolerability in individual patients. The most common adverse events during fesoterodine treatment are dry mouth and constipation. Conclusions: Extensive evidence demonstrates the efficacy and safety of fesoterodine in relieving OAB symptoms, including urgency, urinary frequency, UUI, and nocturnal urgency, in patients with various clinical and demographic profiles. Trial results provide valuable information on fesoterodine treatment in specific patient populations, including both elderly and vulnerable elderly patients. Potential limitations of this review are that only English language articles in PubMed were searched and included.

Flexible dosing with fesoterodine 4 and 8 mg: a systematic review of data from clinical trials

To systematically review dose‐escalation data from flexible‐dose studies of fesoterodine and summarise factors associated with dose‐escalation decisions.

La severidad de la vejiga hiperactiva modifica la carga asistencial y la productividad laboral

OBJECTIVE To explore the relationship between the severity of urinary urge incontinence (UUI) on healthcare resources utilization (HRU) and loss of labor productivity of subjects with overactive bladder (OAB) in the general population in Spain. METHODS Secondary analysis of a cross-sectional web-based study conducted in the general population >18 years, through a battery of HRU questions asked using an online method. Probable OAB subjects were identified using a previously validated algorithm and a score >8 in the OAB-V8 questionnaire. HRU questions included an assessment of concomitant medication used as a consequence of OAB/UUI, pad utilization, and medical office visits. Patients were grouped according to the number of UUI episodes into 0, 1, 2-3 or 4+ episodes. RESULTS Of a total of 2,035 subjects participating from the general population, 396 patients [52.5% women, mean age: 55.3 (11.1) years, OAB-V8 mean score: 14.5 (7.9)] were analyzed; 203 (51.3%) with 0 episodes, 119 (30.1%) with 1, 52 (13.1%) with 2 or 3, and 22 (5.6%) with 4 or more episodes. A linear and significant adjusted association was observed between the number of UUI episodes and HRU; the higher the number of daily episodes the higher the HRU. Subjects with more episodes had medical visits more frequently at the primary care (P = .001) and specialist (P = .009) level as well. Consumption of day (P < .001) and night (P < .001) urinary absorbents, anxiolytic medicines (P = .021) and antibiotics (P = .05) was higher in patients with more UUI episodes. CONCLUSION The severity of OAB in terms of frequency of daily urge incontinence episodes was significantly and linearly associated with higher healthcare resources utilization and a decrease in labor productivity in subjects with probable OAB in Spain.