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1.
Neurourol Urodyn ; 38(3): 996-1004, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30801826

RESUMO

AIMS: To present the development of the International Consultation on Incontinence Questionnaire-underactive bladder (ICIQ-UAB) as the first patient reported outcome measure for the assessment of the symptoms and impact on the health-related quality of life of UAB developed in-line with the Food and Drug Administration Guidance for Industry. METHODS: Draft items were developed following 44 semi-structured concept elicitation interviews in the UK and refined using 36 cognitive interviews. A pilot study was designed to assess the draft ICIQ-UAB's initial psychometric properties with 54 patients recruited from European hospitals. Further concept elicitation interviews were also carried out with 11 patients in the US and 10 patients in Japan. All participants had a prior urodynamic diagnosis of detrusor underactivity. RESULTS: The cognitive interviews confirmed the initial items to be understood and interpreted as intended. Pilot testing showed that both internal consistency (Cronbach's α ≥ 0.85) and test-retest reliability (stable patients; intraclass correlation coefficient ≥ 0.88) were high. The interviews in the US and Japan elicited symptoms and impacts that support previous findings in the UK and provided further insight into the experiences of patients in those countries. The developmental ICIQ-UAB was refined using the evidence from all substudies. CONCLUSIONS: The validity and reliability of the ICIQ-UAB were supported in a pilot study setting and the wider cultural applicability by the additional interviews in the US and Japan. Following further validation in future clinical trials, the developmental ICIQ-UAB is envisaged as an important tool for the monitoring of future UAB treatment strategies.

2.
BMJ Open ; 8(11): e021889, 2018 11 21.
Artigo em Inglês | MEDLINE | ID: mdl-30467131

RESUMO

PURPOSE: To evaluate persistence and adherence of oral pharmacotherapy used in the treatment of overactive bladder (OAB) in a real-world setting. MATERIALS AND METHODS: Systematic literature searches of six electronic publication databases were performed to identify observational studies of patients with OAB treated with antimuscarinics and/or mirabegron. Studies obtaining persistence and adherence data from sources other than electronic prescription claims were excluded. Reference lists of identified studies and relevant systematic reviews were assessed to identify additional relevant studies. RESULTS: The search identified 3897 studies, of which 30 were included. Overall, persistence ranged from 5% to 47%. In studies reporting data for antimuscarinics and mirabegron (n=3), 1-year persistence was 12%-25% and 32%-38%, respectively. Median time to discontinuation was <5 months for antimuscarinics (except one study (6.5 months)) and 5.6-7.4 months for mirabegron. The proportion of patients adherent at 1 year varied between 15% and 44%. In studies reporting adherence for antimuscarinics and mirabegron, adherence was higher with mirabegron (mean medication possession ratio (MPR): 0.59 vs 0.41-0.53; mean proportion of days covered: 0.66 vs 0.55; and median MPR: 0.65 vs 0.19-0.49). Reported determinants of persistence and adherence included female (sex), older age group, use of extended-release formulation and treatment experience. CONCLUSION: Most patients with OAB discontinued oral OAB pharmacotherapy and were non-adherent 1 year after treatment initiation. In general, mirabegron was associated with greater persistence and adherence compared with antimuscarinics. Combined with existing clinical trial evidence, this real-world review merits consideration of mirabegron for first-line pharmacological treatment among patients with OAB. PROSPERO REGISTRATION NUMBER: CRD42017059894.


Assuntos
Acetanilidas/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 3/uso terapêutico , Adesão à Medicação , Antagonistas Muscarínicos/uso terapêutico , Tiazóis/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Humanos
3.
BMC Urol ; 18(1): 76, 2018 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-30180826

RESUMO

BACKGROUND: Persistence on-treatment with antimuscarinics in patients with overactive bladder (OAB) is reported to be sub-optimal. This retrospective, longitudinal, observational cohort study assessed treatment persistence with ß3-adrenoceptor agonists (i.e. mirabegron) and antimuscarinics, both classes of OAB pharmacotherapy, in patients with OAB in Spain. METHODS: Adults who received mirabegron or an antimuscarinic in routine clinical practice (1 June-31 October 2014), were identified from anonymised prescription data within the Spanish Cegedim Electronic Medical Records database. The primary endpoint, treatment persistence (time to treatment discontinuation [TTD] and the proportion of patients remaining on-treatment after 12 months), was unadjusted for potential confounders. Multivariate Cox regression models of persistence, adjusted for baseline characteristics, were used to compare differences in treatment groups. Adjusted subgroup analyses (target OAB drug, age, treatment status and sex) and sensitivity analyses (extending the time used to define treatment discontinuation from 30 days [base-case] to 45, 60 or 90 days without prescription renewal) were also performed. RESULTS: Overall, 1798 patients received mirabegron (N = 1169) or an antimuscarinic (N = 629); the mean age was 66.42 years. Median TTD was longer for mirabegron versus antimuscarinics (90 vs 56 days) and a higher proportion of patients who received mirabegron were persistent after 12 months (20.2% vs 10.2%); multivariate analyses indicated significantly greater persistence with mirabegron versus antimuscarinics (hazard ratio [HR]: 1.52; 95% confidence interval [CI]: 1.37-1.70; p < 0.001). Significant differences were also observed in subgroup analyses of mirabegron versus individual antimuscarinics (median TTD: 90 vs [range] 28-60 days; HR range: 1.21-2.17; p ≤ 0.013) and in all other subgroups assessed (p < 0.001). Sensitivity analysis showed that the median TTD for mirabegron increased by up to 31 days, and was significantly longer versus antimuscarinics across all adjusted periods (HR range: 1.43-1.53; all p < 0.001). CONCLUSIONS: Patients with OAB in Spain who received mirabegron experienced longer persistence on-treatment than those who received antimuscarinics and the proportion of patients persistent on-treatment at 12 months with mirabegron was two-times higher versus antimuscarinics. These data may provide strategic insights for clinicians and policy makers involved in the management of OAB.


Assuntos
Acetanilidas/uso terapêutico , Adesão à Medicação , Antagonistas Muscarínicos/uso terapêutico , Tiazóis/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Agentes Urológicos/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Modelos Lineares , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Espanha
4.
J Mark Access Health Policy ; 6(1): 1438721, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29686801

RESUMO

Objective: To evaluate the cost-effectiveness of solifenacin 5 mg/day versus other oral antimuscarinic agents used for overactive bladder (OAB) from a UK National Health Service (NHS) perspective. Study design: In a Markov model, hypothetical patients received solifenacin 5 mg/day or a comparator antimuscarinic, after which they could switch to an alternative antimuscarinic. The model estimated incremental cost-effectiveness ratios (ICER), expressed as cost per quality-adjusted life year (QALY) over a 5-year period. Results: Solifenacin 5 mg/day was the dominant treatment strategy (i.e., less costly and more effective) versus tolterodine extended-release (ER) 4 mg/day, fesoterodine 4 and 8 mg/day, oxybutynin ER 10 mg/day and solifenacin 10 mg/day, and was cost-effective (i.e., ICERs below the £30,000 per QALY threshold generally applied in the NHS) versus oxybutynin immediate release (IR) 10 mg/day, tolterodine IR 4 mg/day and trospium chloride 60 mg/day. The probability of solifenacin 5 mg/day being dominant/cost-effective at a willingness-to-pay threshold of £30,000 per QALY was 57-98%. Conclusions: Solifenacin 5 mg/day appears to be a cost-effective strategy for the treatment of OAB over a 5-year timeframe compared with other oral antimuscarinic agents in the UK. These findings are important for decision-makers considering the economic implications of selecting treatments for OAB.

5.
Eur Urol ; 74(3): 324-333, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29699858

RESUMO

BACKGROUND: Mirabegron is an established treatment alternative to antimuscarinic therapy for patients with overactive bladder (OAB), as shown by efficacy and tolerability data from phase III trials. OBJECTIVE: To assess efficacy and tolerability of mirabegron 50mg versus antimuscarinic monotherapies and combination therapies. DESIGN, SETTING, AND PARTICIPANTS: Systematic literature review and network meta-analysis of randomised controlled trials (2000-2017) assessing eligible treatments for OAB. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Efficacy assessments included micturition frequency, urgency urinary incontinence, dry rate, and 50% reduction in incontinence. Tolerability assessments included dry mouth, constipation, blurred vision, and hypertension. RESULTS AND LIMITATIONS: A total of 64 studies (n=46 666) were included in the network meta-analysis. Mirabegron 50mg was significantly more efficacious than placebo for all efficacy endpoints. Comparable overall efficacy was observed for mirabegron 50mg versus most active treatments, but solifenacin 10mg monotherapy and solifenacin 5mg plus mirabegron 25 or 50mg in combination were more efficacious for some/all outcomes. Mirabegron 50mg was significantly better tolerated regarding dry mouth, constipation, and urinary retention than 21/22, 9/20, and 7/10 active comparators, respectively; similar overall tolerability was observed between mirabegron 50mg and all treatments (including placebo) for the remaining endpoints. Limitations of the study included between-trial variations in the definition of certain endpoints and heterogeneity of the available data (eg, number of studies and patients assessed) for comparator treatments across different endpoints. CONCLUSIONS: The relief of key OAB symptoms produced by mirabegron 50mg is significantly better than placebo, and similar to a range of common antimuscarinics, with the benefit of significantly fewer bothersome anticholinergic side effects such as dry mouth. Combination treatment of solifenacin 5mg plus mirabegron 25 or 50mg appears to provide an efficacy benefit compared with mirabegron 50mg, with the expected side effects of individual antimuscarinics. PATIENT SUMMARY: This study assessed the efficacy and tolerability of different drug treatments for OAB. Mirabegron 50mg was as effective as antimuscarinic therapy, with fewer common, bothersome side effects such as dry mouth, constipation, and urinary retention. Combination treatment of solifenacin 5mg plus mirabegron 25 or 50mg was more effective than mirabegron 50mg alone, but with more anticholinergic side effects.


Assuntos
Acetanilidas/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 3/uso terapêutico , Antagonistas Muscarínicos/uso terapêutico , Tiazóis/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Bexiga Urinária/efeitos dos fármacos , Urodinâmica/efeitos dos fármacos , Agentes Urológicos/uso terapêutico , Acetanilidas/efeitos adversos , Agonistas de Receptores Adrenérgicos beta 3/efeitos adversos , Quimioterapia Combinada , Humanos , Antagonistas Muscarínicos/efeitos adversos , Recuperação de Função Fisiológica , Tiazóis/efeitos adversos , Resultado do Tratamento , Bexiga Urinária/fisiopatologia , Bexiga Urinária Hiperativa/diagnóstico , Bexiga Urinária Hiperativa/fisiopatologia , Agentes Urológicos/efeitos adversos
6.
Neurourol Urodyn ; 37(5): 1701-1710, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29360189

RESUMO

AIMS: To develop a comprehensive patient-reported bladder assessment tool (BAT) for assessing overactive bladder (OAB) symptoms, bother, impacts, and satisfaction with treatment. METHODS: Subjects were consented and eligibility was confirmed by a recruiting physician; subjects were then scheduled for in-person interviews. For concept elicitation and cognitive interviews, 30 and 20 subjects, respectively, were targeted for recruitment from US sites. All interviews were conducted face-to-face, audio-recorded, transcribed verbatim, anonymized, and analyzed using a qualitative data analysis software program. A draft BAT was created based on the results of the concept elicitation interviews and further revised based on cognitive interviews as well as feedback from an advisory board of clinical and patient-reported outcome (PRO) experts. RESULTS: Nocturia, daytime frequency, and urgency were reported by all subjects (n = 30, 100.0%), and incontinence was reported by most subjects (n = 25, 83.3%). The most frequently reported impacts were waking up to urinate (n = 30, 100.0%), embarrassment/shame (n = 24, 80.0%), stress/anxiety (n = 23, 76.7%), and lack of control (n = 23, 76.7%). Following analysis, item generation, cognitive interviews, and advisory board feedback, the resulting BAT contains four hypothesized domains (symptom frequency, symptom bother, impacts, and satisfaction with treatment) and 17 items with a 7-day recall period. CONCLUSIONS: The BAT has been developed in multiple stages with input from both OAB patients and clinical experts following the recommended processes included in the FDA PRO Guidance for Industry. Once fully validated, we believe it will offer a superior alternative to use of the bladder diary and other PROs for monitoring OAB patients in clinical trials and clinical practice.


Assuntos
Noctúria/diagnóstico , Bexiga Urinária Hiperativa/diagnóstico , Incontinência Urinária/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Noctúria/tratamento farmacológico , Satisfação do Paciente , Exame Físico , Qualidade de Vida , Inquéritos e Questionários , Resultado do Tratamento , Bexiga Urinária Hiperativa/tratamento farmacológico , Incontinência Urinária/tratamento farmacológico , Micção
8.
Neurourol Urodyn ; 37(1): 394-406, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-28704584

RESUMO

AIMS: To evaluate patient-reported outcomes (PROs) of combinations of solifenacin and mirabegron compared with solifenacin and mirabegron monotherapy and with placebo in patients with overactive bladder (OAB) from the SYNERGY trial. METHODS: Following a 4-week placebo run-in, period patients (≥18 years) with OAB were randomized 2:2:1:1:1:1 to receive solifenacin 5 mg + mirabegron 25 mg (combination 5 + 25 mg), solifenacin 5 mg + mirabegron 50 mg, (combination 5 + 50 mg), solifenacin 5 mg, mirabegron 25 mg, mirabegron 50 mg or placebo for 12 weeks, followed by a 2-week washout period. At each visit, PROs related to quality of life, symptom bother, and treatment satisfaction were assessed, including OAB-q Symptom Bother score, health-related quality of life (HRQOL) Total score, treatment satisfaction-visual analogue scale (TS-VAS), and patient perception of bladder condition (PPBC) questionnaires. RESULTS: Overall, 3527 patients were randomized into the study, with 3494 receiving double-blind treatment. At end of treatment (EoT), both combination groups showed greater improvements in OAB-q Symptom Bother score compared with the monotherapy groups (nominal P < 0.001). Statistically significant improvements in HRQOL Total scores were observed in the combination groups versus monotherapy groups (P ≤ 0.002). For both combination groups, the OAB-q Symptom Bother score responder rates at EoT were statistically significantly higher versus mirabegron monotherapy (P < 0.05). The mean adjusted changes from baseline to EoT for PPBC were greater in the combination groups compared with monotherapy groups. CONCLUSIONS: PROs showed that combination therapy provided clear improvements and an additive effect for many HRQOL parameters, including OAB-q Symptom Bother score, HRQOL Total score, and PPBC.


Assuntos
Acetanilidas/uso terapêutico , Succinato de Solifenacina/uso terapêutico , Tiazóis/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Agentes Urológicos/uso terapêutico , Método Duplo-Cego , Quimioterapia Combinada , Humanos , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Resultado do Tratamento , Escala Visual Analógica
9.
Neurourol Urodyn ; 37(3): 986-996, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29140559

RESUMO

AIMS: To compare efficacy and tolerability of solifenacin 5 mg/day versus other oral antimuscarinic agents for the treatment of overactive bladder (OAB). METHODS: Literature searches of MEDLINE, Embase, and the Cochrane Library were undertaken to identify randomized controlled trials in OAB (2000-2015) for antimuscarinic agents. A network meta-analysis (NMA) was performed to estimate efficacy and tolerability outcomes for solifenacin 5 mg/day relative to other antimuscarinics. RESULTS: The NMA included 53 eligible trials (published, n = 48; unpublished on search date, n = 5). Solifenacin 5 mg/day was significantly more effective than tolterodine 4 mg/day for reducing incontinence and urgency urinary incontinence (UUI) episodes, but significantly less effective than solifenacin 10 mg/day for micturition; no other statistically significant differences were noted for efficacy. Solifenacin 5 mg/day had a statistically significant lower risk of dry mouth compared with darifenacin 15 mg/day, fesoterodine 8 mg/day, oxybutynin extended-release 10 mg/day, oxybutynin immediate-release (IR) 9-15 mg/day, tolterodine IR 4 mg/day, propiverine 20 mg/day, and solifenacin 10 mg/day. There were no significant differences between solifenacin 5 mg/day and other antimuscarinics for risk of blurred vision, or for 11 of 17 active comparators for risk of constipation. CONCLUSIONS: This NMA suggests that the efficacy of solifenacin 5 mg/day is at least similar to other common antimuscarinics across the spectrum of OAB symptoms analyzed, and is more effective than tolterodine 4 mg/day in reducing incontinence and UUI episodes. Solifenacin 5 mg/day has a lower risk of dry mouth compared with several agents.


Assuntos
Antagonistas Muscarínicos/uso terapêutico , Succinato de Solifenacina/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Compostos Benzidrílicos/efeitos adversos , Compostos Benzidrílicos/uso terapêutico , Benzilatos/efeitos adversos , Benzilatos/uso terapêutico , Humanos , Ácidos Mandélicos/efeitos adversos , Ácidos Mandélicos/uso terapêutico , Antagonistas Muscarínicos/efeitos adversos , Meta-Análise em Rede , Succinato de Solifenacina/efeitos adversos , Tartarato de Tolterodina/efeitos adversos , Tartarato de Tolterodina/uso terapêutico , Resultado do Tratamento
11.
Transpl Infect Dis ; 19(5)2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28599091

RESUMO

BACKGROUND: We investigated the impact of early- (E-CMV) and late onset (L-CMV) cytomegalovirus disease on the probability of graft rejection, graft failure, mortality, and healthcare resource use, following solid organ transplantation (SOT) in France. METHODS: A retrospective analysis of data from the French 'Programme de Médicalisation des Systèmes d'Information' database (2007-2011) was conducted to identify SOT recipients who developed CMV disease in an inpatient setting. Recipients were stratified by time to CMV disease onset: E-CMV (≤3 months), L-CMV-3M (>3-24 months), and L-CMV-6M (>6-24 months). Data were analyzed by comparing recipients with CMV disease or without (controls) in a 1:2 ratio, matched according to age, gender, target organ, and previous/simultaneous occurrence of graft rejection. Graft failure, graft rejection, all-cause in-hospital mortality, and resource utilization (including hospitalization costs) were assessed over 12 months following CMV disease diagnosis. RESULTS: Among 20 473 SOT recipients, 2430 (11.86%) were reported to have CMV disease within 24 months after transplantation. CMV disease was significantly associated with an increased risk of graft rejection and mortality, as indicated by logistic regression analysis. Odd ratios (ORs) for the risk of graft rejection were E-CMV=1.43, L-CMV-3M=1.50, and L-CMV-6M=1.61 (all P<.05), while ORs for mortality were E-CMV=2.85, L-CMV-3M=4.22, and L-CMV-6M=4.77 (all P<.0001). Only L-CMV was significantly correlated with a higher risk of graft failure: E-CMV=1.18 (P=.1906), L-CMV-3M=1.77 (P=.0013), and L-CMV-6M=3.12 (P<.0001). Hospitalization costs increased by €7078 (range €6270-€22 111), €6523 (range €5328-€10 295), and €6311 (range €5295-€9184) in recipients with E-CMV, L-CMV-3M, and L-CMV-6-M, respectively. CONCLUSION: This study, based on French national data, demonstrates the considerable burden of CMV disease in SOT recipients and highlights the importance of developing new strategies to prevent and manage CMV disease and improve clinical outcomes for SOT patients.


Assuntos
Infecções por Citomegalovirus/epidemiologia , Infecções por Citomegalovirus/etiologia , Transplante de Órgãos/efeitos adversos , Transplantados , Estudos de Casos e Controles , Estudos de Coortes , França , Rejeição de Enxerto , Humanos , Incidência , Pacientes Internados , Razão de Chances , Transplante de Órgãos/mortalidade , Fatores de Risco , Análise de Sobrevida
12.
Patient ; 10(6): 677-686, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28646416

RESUMO

OBJECTIVES: The aim of this study was to compare outcomes using two preference-based measures of health status (EQ-5D-5L and OAB-5D) in patients with overactive bladder (OAB) treated with solifenacin plus mirabegron or solifenacin monotherapy in the BESIDE trial. METHODS: Patients with OAB who remained incontinent after 4 weeks' treatment with solifenacin 5 mg were randomized 1:1:1 to combination treatment (solifenacin 5 mg plus mirabegron [25 mg for the first 4 weeks/50 mg for the last 8 weeks]), solifenacin 5 mg, or solifenacin 10 mg. EQ-5D-5L and OAB-q were administered at baseline, weeks 4, 8, 12, and end of treatment (EoT). OAB-5D scores were derived from OAB-q results. Responder analysis was carried out using several definitions of minimally important difference. RESULTS: A total of 2054 patients received one or more doses of study treatment (combination, n = 694; solifenacin 5 mg, n = 684; solifenacin 10 mg, n = 676). EQ-5D-5L Index mean score changes (from baseline to EoT) were greater with combination (0.059) than with solifenacin 5 mg (0.040) and 10 mg (0.044) monotherapy, but the differences were not statistically significant. A significantly greater improvement was observed for combination on OAB-5D (0.107 vs 0.085 for 5 mg, and 0.087 for 10 mg; p ≤ 0.01). The dimensions most improved overall were anxiety/depression, pain/discomfort, and usual activities on EQ-5D-5L, and urge, urine loss, and coping on OAB-5D. The proportion of responders was significantly greater with combination compared with monotherapy using OAB-5D only. CONCLUSIONS: Improvements were observed in all study arms on both the EQ-5D-5L and OAB-5D, although only the OAB-5D showed a statistically significant benefit for combination versus solifenacin monotherapy. Combining generic and condition-specific preference-based health status measures allowed for assessment of dimensions that were particularly relevant to this patient population, while permitting comparison with outcomes from other studies, treatments, and populations via EQ-5D.


Assuntos
Acetanilidas/uso terapêutico , Medidas de Resultados Relatados pelo Paciente , Succinato de Solifenacina/uso terapêutico , Tiazóis/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Agentes Urológicos/uso terapêutico , Acetanilidas/administração & dosagem , Adulto , Idoso , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Nível de Saúde , Humanos , Masculino , Saúde Mental , Pessoa de Meia-Idade , Qualidade de Vida , Succinato de Solifenacina/administração & dosagem , Inquéritos e Questionários/normas , Tiazóis/administração & dosagem , Bexiga Urinária Hiperativa/psicologia , Agentes Urológicos/administração & dosagem
13.
Can Urol Assoc J ; 11(3-4): 123-130, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28515812

RESUMO

INTRODUCTION: This analysis compared the cost-effectiveness of once-daily regimens of mirabegron 50 mg and generic tolterodine ER 4 mg in a hypothetical cohort of previously treated patients with overactive bladder (OAB) in Canada. METHODS: A Markov model was developed to represent different health states according to OAB symptoms (frequency, incontinence), presence/absence of adverse events (AEs; dry mouth, constipation, blurred vision), and treatment status (on-treatment, discontinue treatment, restart previous treatment). The time horizon used was one year, with monthly transitions between health states. The model was populated using data from a phase 3, placebo-controlled trial of mirabegron that included tolterodine as an active comparator (SCORPIO), as well as other published literature and expert opinion. Cost-effectiveness was calculated from Canadian public payer (based on Quebec list prices) and societal perspectives. RESULTS: The incremental one-year cost per patient for mirabegron over tolterodine was $182 CAD and $157 CAD from the payer and societal perspectives, respectively. The incremental quality-adjusted life year (QALY) gain for mirabegron was 0.0066 when using EQ-5D health-state utilities. Mirabegron was cost-effective compared with tolterodine, from both payer and societal perspectives, and remained cost-effective vs. tolterodine across the majority of sensitivity analyses. The model was based on limited clinical trial evidence supplemented with expert opinion and assumptions; a select number of OAB symptoms, AEs, and direct and indirect medical costs associated with OAB; and a timeframe of only one year. CONCLUSIONS: From the payer and societal perspectives, the health economic model indicates that in Canada, mirabegron is a cost-effective treatment strategy compared with tolterodine, leading to improved health outcomes (QALYs) at an acceptable incremental cost.

14.
BMC Urol ; 17(1): 36, 2017 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-28532455

RESUMO

BACKGROUND: To assess treatment persistence and adherence in men ≥45 years of age with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), using prescription records from the Netherlands IMS Lifelink™ LRx database. METHODS: In this retrospective, observational cohort study, we identified men who received combination therapy with an α-blocker plus an antimuscarinic (e.g. solifenacin or tolterodine) between 1 November 2013 and 31 October 2014. Treatment could be received as a fixed-dose combination (FDC) tablet or as two drugs administered together (concomitant therapy), if both combination drugs were prescribed within 30 days. The primary objective was to assess treatment persistence, defined as the time from initiation of combination therapy until first discontinuation of the FDC or at least one of the drugs given concomitantly (i.e. ≥30 days without prescription renewal). Subgroup and sensitivity analyses were conducted to assess persistence by antimuscarinic agent, and with different gap lengths used to define discontinuation (45, 60 and 90 days), respectively. RESULTS: A total of 1891 men received an α-blocker plus an antimuscarinic (FDC, N = 665; concomitant therapy, N = 1226). Median time to discontinuation was significantly longer with FDC versus concomitant therapy (414 vs. 112 days; adjusted hazard ratio [HR] 2.04, 95% confidence interval 1.77, 2.35; p < 0.0001). Persistence at 12 months (51.3% vs. 29.9%) was also significantly greater with FDC compared with concomitant therapy. Assessment of antimuscarinic subgroups showed that median time to discontinuation was longest with solifenacin combinations (214 days) compared with other antimuscarinic combinations (range, 47-164 days; adjusted HR range, 1.27-1.77, p = 0.037). No observable impact on treatment persistence was found by adjusting the gaps used to define discontinuation. DISCUSSION: This study of real-world evidence of men with LUTS/BPH treated with α-blocker plus antimuscarinic combination therapy in the Netherlands showed that treatment persistence was significantly greater in those who received a FDC tablet compared with combination therapy given concomitantly. The study also shows that treatment persistence was extended in men who received combination therapy containing solifenacin compared with other antimuscarinics. CONCLUSIONS: Overall, these findings may be useful for prescribers, as improved persistence on-treatment may translate into improved outcomes for men with LUTS/BPH. Further study is warranted to establish the key drivers of persistence in men receiving combination therapy for LUTS/BPH.


Assuntos
Antagonistas Adrenérgicos alfa/administração & dosagem , Sintomas do Trato Urinário Inferior/tratamento farmacológico , Adesão à Medicação/estatística & dados numéricos , Antagonistas Muscarínicos/administração & dosagem , Hiperplasia Prostática/tratamento farmacológico , Succinato de Solifenacina/administração & dosagem , Tartarato de Tolterodina/administração & dosagem , Idoso , Estudos de Coortes , Quimioterapia Combinada , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Masculino , Pessoa de Meia-Idade , Países Baixos , Hiperplasia Prostática/complicações , Estudos Retrospectivos
15.
Eur Urol ; 72(3): 402-407, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28400168

RESUMO

BACKGROUND: Underactive bladder (UAB) is considered the symptom complex associated with the urodynamic diagnosis of detrusor underactivity. OBJECTIVE: The aim of this research was to investigate the patient reported experience of the symptoms, signs, and impact of UAB. This research is also part of the initial qualitative phase for the development of a new patient reported outcome measure for the assessment of UAB. DESIGN, SETTING, AND PARTICIPANTS: Qualitative methods were used to understand the experience of UAB from a patient perspective, in a purposive sample of male (n=29) and female (n=15) patients aged 27-88 yr (mean: 64 yr), diagnosed with a primary diagnosis of detrusor underactivity, with or without coexisting urological conditions. Semistructured interviews were conducted in Bristol, UK. RESULTS: Male and female patients reported a variety of lower urinary tract symptoms and associated impact on quality of life. Storage symptoms of nocturia, increased daytime frequency, and urgency, and the voiding symptoms of slow stream, hesitancy, and straining were reported by over half of the patients. A sensation of incomplete emptying and postmicturition dribble were also frequently described. Most had a post void residual >30ml (n=34, 77%, median: 199ml) with many reporting urinary tract infections, a history of self-catheterisation, and some experiencing occasional acute retention episodes. These symptoms and signs can have a broad impact on quality of life including having to plan their daily activities around the location of toilets, disruption to sleep, social life, and associated effect on family and friends. CONCLUSIONS: Knowledge of the lived experience of UAB obtained in the current study will be used for the development of a new patient reported outcome measure and help inform the current working definition of UAB. PATIENT SUMMARY: The symptoms, signs, and impact on quality of life of underactive bladder are described by patients with the condition.


Assuntos
Efeitos Psicossociais da Doença , Sintomas do Trato Urinário Inferior/fisiopatologia , Sintomas do Trato Urinário Inferior/psicologia , Qualidade de Vida , Doenças da Bexiga Urinária/fisiopatologia , Doenças da Bexiga Urinária/psicologia , Bexiga Urinária/fisiopatologia , Atividades Cotidianas , Adulto , Idoso , Idoso de 80 Anos ou mais , Inglaterra , Feminino , Humanos , Relações Interpessoais , Entrevistas como Assunto , Sintomas do Trato Urinário Inferior/diagnóstico , Masculino , Pessoa de Meia-Idade , Noctúria/diagnóstico , Noctúria/fisiopatologia , Noctúria/psicologia , Medidas de Resultados Relatados pelo Paciente , Pesquisa Qualitativa , Comportamento Social , Doenças da Bexiga Urinária/diagnóstico , Incontinência Urinária/diagnóstico , Incontinência Urinária/fisiopatologia , Incontinência Urinária/psicologia , Retenção Urinária/diagnóstico , Retenção Urinária/fisiopatologia , Retenção Urinária/psicologia , Infecções Urinárias/diagnóstico , Infecções Urinárias/fisiopatologia , Infecções Urinárias/psicologia , Urodinâmica
16.
J Med Econ ; 20(6): 614-622, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28286993

RESUMO

BACKGROUND: The ß3-adrenoceptor agonist, mirabegron, and antimuscarinic agents provide similar efficacy for the treatment of overactive bladder (OAB), but mirabegron appears to be associated with better persistence, perhaps due to an absence of anticholinergic side-effects. This study estimated the expected costs associated with the management of OAB in Canada from a societal perspective by utilizing real-world evidence. METHODS: An economic model with monthly cycles and a 1-year time horizon was developed to depict a treatment pathway for a hypothetical cohort of 100 patients with OAB. At model entry, patients receive mirabegron or an antimuscarinic. Patients who do not persist may switch treatment, undergo a minimally invasive procedure, or remain symptomatic (uncontrolled). The model includes direct costs (e.g. physician visits) and indirect costs (e.g. lost productivity). A one-way univariate sensitivity analysis assessed a ±20% variation in each of the key model inputs. RESULTS: At 1 year, a greater proportion of patients persisted on treatment with mirabegron compared with antimuscarinics (33% vs 15-23%), and a smaller proportion switched treatment (17% vs 20-22%). The number of healthcare visits (292 vs 299-304), pads used (74,098 vs 77,878-81,669), and work hours lost (4,497 vs 5,372-6,249) were all lower for mirabegron vs antimuscarinics. The estimated total annual cost of treatment per patient with mirabegron was $2,127.46 Canadian dollars (CAD) ($5.82 CAD/day) compared with $2,150.20-$2,496.69 CAD ($5.89-$6.84 CAD/day) for antimuscarinics. The one-way sensitivity analysis indicated the results are robust. CONCLUSIONS: Improved persistence observed in routine clinical practice with mirabegron appears to translate into benefits of reduced healthcare resource use, and lower direct and indirect costs of treatment compared with antimuscarinics. Overall, these data suggest that mirabegron may offer clinical and economic benefits for the management of patients with OAB in Canada.


Assuntos
Acetanilidas/uso terapêutico , Antagonistas Muscarínicos/uso terapêutico , Tiazóis/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Agentes Urológicos/uso terapêutico , Acetanilidas/administração & dosagem , Acetanilidas/economia , Canadá , Humanos , Adesão à Medicação/estatística & dados numéricos , Modelos Econométricos , Antagonistas Muscarínicos/administração & dosagem , Antagonistas Muscarínicos/economia , Tiazóis/administração & dosagem , Tiazóis/economia , Agentes Urológicos/administração & dosagem
17.
Eur Urol ; 72(3): 389-399, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28196724

RESUMO

BACKGROUND: Persistence with antimuscarinic therapy in overactive bladder (OAB) is poor, but may be different for mirabegron, a ß3-adrenoceptor agonist with a different adverse event profile. OBJECTIVE: To compare persistence and adherence with mirabegron versus tolterodine extended release (ER) and other antimuscarinics in routine clinical practice over a 12-mo period. DESIGN, SETTING, AND PARTICIPANTS: Retrospective, longitudinal, observational study of anonymised data from the UK Clinical Practice Research Datalink GOLD database. Eligibility: age ≥18 yr, ≥1 prescription for target OAB drug (between May 1, 2013 and June 29, 2014), and 12-mo continuous enrolment before and after the index prescription date. INTERVENTIONS: Mirabegron, darifenacin, fesoterodine, flavoxate, oxybutynin ER or immediate-release (IR), propiverine, solifenacin, tolterodine ER or IR, and trospium chloride. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was persistence (time to discontinuation). Secondary endpoints included 12-mo persistence rates and adherence (assessed using medication possession ratio, MPR). Cox proportional-hazards regression models and logistic regression models adjusted for potential confounding factors were used to compare cohorts. Analyses were repeated after 1:1 matching. RESULTS AND LIMITATIONS: The study population included 21996 eligible patients. In the unmatched analysis, the median time-to-discontinuation was significantly longer for mirabegron (169 d, interquartile range [IQR] 41-not reached) compared to tolterodine ER (56 d, IQR 28-254; adjusted hazard ratio [HR] 1.55, 95% confidence interval 1.41-1.71; p<0.0001) and other antimuscarinics (range 30-78 d; adjusted HR range 1.24-2.26, p<0.0001 for all comparisons). The 12-mo persistence rates and MPR were also significantly greater with mirabegron than with all the antimuscarinics. Limitations include the retrospective design, use of prescription records to estimate outcomes, and inability to capture reasons for discontinuation. CONCLUSIONS: Persistence and adherence were statistically significantly greater with mirabegron than with tolterodine ER and other antimuscarinics prescribed for OAB in the UK. PATIENT SUMMARY: This study assessed persistence and adherence (or compliance) with medications prescribed for OAB in a large UK population. We found that patients prescribed mirabegron remained on treatment for longer and showed greater adherence than those prescribed traditional antimuscarinics.


Assuntos
Acetanilidas/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 3/administração & dosagem , Adesão à Medicação , Antagonistas Muscarínicos/administração & dosagem , Tiazóis/administração & dosagem , Bexiga Urinária Hiperativa/tratamento farmacológico , Agentes Urológicos/administração & dosagem , Acetanilidas/efeitos adversos , Agonistas de Receptores Adrenérgicos beta 3/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Distribuição de Qui-Quadrado , Bases de Dados Factuais , Esquema de Medicação , Feminino , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Antagonistas Muscarínicos/efeitos adversos , Razão de Chances , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Tiazóis/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Reino Unido , Bexiga Urinária Hiperativa/diagnóstico , Bexiga Urinária Hiperativa/fisiopatologia , Agentes Urológicos/efeitos adversos , Adulto Jovem
18.
Pharmacoecon Open ; 1(1): 25-36, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29442303

RESUMO

PURPOSE: Our objective was to estimate the economic outcomes of using mirabegron versus antimuscarinics in the treatment of patients with overactive bladder (OAB) from a societal perspective in the UK. MATERIALS AND METHODS: A Markov model was developed using Microsoft Excel®. The time horizon and cycle length are 12 and 1 months, respectively; and the hypothetical cohort size 100 patients. Antimuscarinic comparators are fesoterodine, oxybutynin extended release (ER) and immediate release (IR), solifenacin, tolterodine ER/IR, trospium ER/IR, darifenacin and flavoxate. Model inputs included real-world treatment patterns data, healthcare resource use (e.g. clinic visits) and direct and indirect costs (e.g. drug acquisition and productivity loss). Model outputs included patient disposition, healthcare resource use, drug acquisition costs and other treatment-related costs over a 1-year time horizon. A one-way sensitivity analysis was performed to determine the key drivers of the model. RESULTS: In a hypothetical cohort of 100 patients, total annual costs per patient were lower with mirabegron than with all antimuscarinics (£1270.84 vs. 1321.71-1607.48). Healthcare resource use was lower with mirabegron than with all antimuscarinics (115 vs. 119-123 general practitioner visits; 173 vs. 178-185 specialist visits and 0.0042 vs. 0.0050-0.0060 surgical operations) and fewer work hours were lost (4017 vs. 5114-6990 [all per 100 patients]). Sensitivity analysis showed the model was sensitive to persistence and switching rates, although the impact on the overall results was minimal. CONCLUSIONS: In the UK, using mirabegron to treat OAB may improve persistence and lead to reductions in switching treatment, healthcare resource utilization, productivity costs, and overall treatment costs versus antimuscarinics.

19.
Qual Life Res ; 26(5): 1187-1195, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-27896711

RESUMO

OBJECTIVES: To assess changes in the health status of men with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) using the EQ-5D-3L and OAB-5D instruments and to evaluate the sensitivity of the instruments. METHODS: Data were available from a large randomised phase III trial of men with moderate-to-severe storage and voiding LUTS/BPH (NEPTUNE). Men received a fixed-dose combination of solifenacin 6 mg plus oral controlled absorption system (OCAS™) formulation of tamsulosin (TOCAS, 0.4 mg), TOCAS monotherapy or placebo and completed the EQ-5D-3L and OAB-5D at baseline and weeks 4, 8 and 12. Analysis of covariance was used to estimate changes in EQ-5D-3L Index, EQ-VAS and OAB-5D. Changes in dimension level were summarised using the Paretian Classification of Health Change (PCHC). RESULTS: Improved health-related quality of life from baseline was seen in all treatment arms on EQ-5D-3L and OAB-5D at week 12, although only OAB-5D showed statistically significant differences between active treatment and placebo, both on the index score and using the PCHC approach. Effect sizes in the active treatment groups were large (>0.8) on OAB-5D but small (≈0.2) on EQ-5D-3L. EQ-5D-3L showed a very high ceiling effect (45% of men reported full health at baseline) and a substantial proportion of these men reported improvements at week 12 in several dimensions of OAB-5D. CONCLUSIONS: A large ceiling effect on EQ-5D-3L substantially limited its sensitivity in this population. OAB-5D proved more sensitive to changes in health status and could be considered a complement to ED-5D-3L as a source of utilities for health economic modelling.


Assuntos
Sintomas do Trato Urinário Inferior/psicologia , Hiperplasia Prostática/complicações , Qualidade de Vida/psicologia , Idoso , Nível de Saúde , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Masculino , Pessoa de Meia-Idade , Hiperplasia Prostática/psicologia
20.
Urology ; 99: 84-91, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27616606

RESUMO

OBJECTIVE: To estimate the burden of illness associated with bladder pain in 5 European countries: France, Germany, Italy, Spain, and the United Kingdom. PATIENTS AND METHODS: Patients with a diagnosis of bladder pain (ie, unpleasant sensation, pain, pressure, or discomfort related to the urinary bladder) were identified from data collected by the cross-sectional National Health and Wellness Survey performed in 2013. Propensity score matching was used to construct a comparator group without bladder pain (1 case: 2 controls). Assessments were performed for several outcomes including health-related quality of life (HRQoL; 36-item Short-Form, version 2), work-related function (Work Productivity and Activity Impairment questionnaire), employment status, and all-cause healthcare resource use. RESULTS: We identified 275 patients with a physician diagnosis of bladder pain, 274 of whom were successfully matched to 548 controls without bladder pain. Compared with matched controls, patients with bladder pain had significantly impaired HRQoL (mental component summary: 38.5 vs 44.5; physical component summary: 38.9 vs 47.8; P <.001). Overall work productivity loss was significantly greater in patients with bladder pain compared with matched controls (41.7% vs 21.5%; P <.001). Patients with bladder pain were also significantly more likely to use all-cause healthcare resources and make more visits to healthcare providers in the previous 6 months than matched controls (P <.001 for all outcomes). CONCLUSION: Bladder pain is associated with a considerable burden in Europe in terms of impaired HRQoL and work productivity, and increased healthcare resource use.


Assuntos
Efeitos Psicossociais da Doença , Nível de Saúde , Inquéritos Epidemiológicos/métodos , Dor Pélvica/epidemiologia , Qualidade de Vida , Doenças da Bexiga Urinária/epidemiologia , Adolescente , Adulto , Idoso , Estudos Transversais , Europa (Continente)/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor Pélvica/economia , Dor Pélvica/etiologia , Estudos Retrospectivos , Inquéritos e Questionários , Bexiga Urinária , Doenças da Bexiga Urinária/complicações , Doenças da Bexiga Urinária/economia , Adulto Jovem
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