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1.
Respir Investig ; 62(2): 284-290, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38277865

RESUMEN

BACKGROUND: CONVERT, a randomized, active-controlled, global, Phase 3 trial demonstrated that patients with treatment-refractory Mycobacterium avium complex (MAC) pulmonary disease were more likely to achieve culture conversion with amikacin liposome inhalation suspension (ALIS) plus guideline-based therapy (GBT) versus those continuing on GBT alone. This subgroup analysis reports the efficacy and safety of ALIS in Japanese patients enrolled in CONVERT. METHODS: Japanese patients aged ≥20 years with treatment-refractory MAC pulmonary disease from Japanese sites were included. Patients were randomized to receive once-daily 590 mg ALIS + GBT or GBT alone; patients converting by Month 6 remained in the study to complete 12-month treatment followed by a 12-month off-treatment period. Nonconverters exited the study at Month 8. The primary endpoint was the proportion of patients achieving culture conversion by Month 6. RESULTS: Of the 59 Japanese patients screened, 48 were randomized to receive ALIS + GBT (n = 34) or GBT alone (n = 14), and 41/48 (85.4 %) were women. The mean (standard deviation) age of patients was 64.5 (8.6) years, and 83.3 % of patients had bronchiectasis at baseline. By Month 6, sputum culture conversion was cumulatively achieved in 9/34 (26.5 %) patients receiving ALIS + GBT versus none receiving GBT alone. Treatment-emergent adverse events were reported in 94.1 % and 100.0 % of patients receiving ALIS + GBT and GBT alone, respectively. No deaths were reported. CONCLUSIONS: The efficacy observed in the Japanese subpopulation was largely consistent with that in the overall CONVERT study population, with more patients achieving culture conversion with ALIS + GBT versus GBT alone. Safety profiles were similar between the overall population and the Japanese subpopulation. CLINICAL TRIAL REGISTRATION: NCT02344004.


Asunto(s)
Enfermedades Pulmonares , Infección por Mycobacterium avium-intracellulare , Femenino , Humanos , Masculino , Amicacina/efectos adversos , Antibacterianos/efectos adversos , Japón , Liposomas/uso terapéutico , Enfermedades Pulmonares/inducido químicamente , Complejo Mycobacterium avium , Infección por Mycobacterium avium-intracellulare/tratamiento farmacológico , Persona de Mediana Edad , Anciano
2.
J Urol ; 189(4): 1396-401, 2013 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-23159276

RESUMEN

PURPOSE: Awakening from sleep to urinate is the hallmark of nocturia, a condition that impacts several facets of health related quality of life and for which current therapy is suboptimal. Given the paucity of prospective data on antimuscarinics for the management of nocturia, we investigated the efficacy and safety of flexible dose fesoterodine for the treatment of nocturnal urgency in subjects with nocturia and overactive bladder. MATERIALS AND METHODS: Subjects with 2 to 8 nocturnal urgency episodes per 24 hours began a 2-week, single-blind, placebo run-in followed by 1:1 randomization to 12 weeks of double-blind treatment with fesoterodine (4 mg daily for 4 weeks with an optional increase to 8 mg) or placebo using predefined criteria for nocturnal urgency episodes, nocturnal urine volume voided and total 24-hour urine volume voided. The primary end point was change from baseline to week 12 in the mean number of micturition related nocturnal urgency episodes per 24 hours. RESULTS: Overall 963 subjects were randomized from 2,990 screened, and 82% of subjects treated with fesoterodine and 84% of those treated with placebo completed the study. Significant improvements in the primary end point (-1.28 vs -1.07), in nocturnal micturitions per 24 hours (-1.02 vs -0.85) and in nocturnal frequency urgency sum (-4.01 vs -3.42) were observed with fesoterodine vs placebo (all p ≤0.01). Health related quality of life measures (overactive bladder questionnaire Symptom Bother -20.1 vs -16.5, sleep 22.3 vs 19.9 and other domains; all p <0.05) were improved with fesoterodine. CONCLUSIONS: To our knowledge this is the first prospective study to assess antimuscarinic efficacy for reducing nocturnal urgency. Flexible dose fesoterodine significantly reduced nocturnal urgency episodes vs placebo in subjects with overactive bladder.


Asunto(s)
Compuestos de Bencidrilo/administración & dosificación , Nocturia/tratamiento farmacológico , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Adulto , Compuestos de Bencidrilo/efectos adversos , Método Doble Ciego , Femenino , Humanos , Masculino , Estudios Prospectivos
3.
Neurourol Urodyn ; 31(4): 455-9, 2012 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-22275170

RESUMEN

AIMS: Urgency is a key symptom in the diagnosis of overactive bladder (OAB), yet its definition and measurement are subject to continuing debate whether urinary urgency is a pathologic sensation or an intensification of normal desire to pass urine. The objective of this research was to explore the concept of urgency among participants with OAB symptoms and to evaluate the content validity of the urinary sensation scale (USS). METHODS: Two qualitative studies were conducted among participants with OAB symptoms. For both studies, participants were interviewed on the USS to ascertain their ability to complete and interpret each response. Study 2 included open-ended questions to explore the concept of urgency with participants asked to describe "normal urge" and "urgency." RESULTS: Thirty-one men and women (Study 1, n = 12; Study 2, n = 19) participated. Nearly all participants (n = 29) thought the word descriptions for the 1-5 scale were easy to comprehend and were able to differentiate among ratings by degree of severity. Study 2 noted little difference between continent (n = 9) and incontinent (n = 10) participant descriptions of "urge or desire to urinate" and "typical sensation." The majority of the continent (n = 6) and incontinent (n = 7) participants stated they have both "regular" sensations to urinate and "urgent" sensations to urinate. CONCLUSIONS: This qualitative research provides evidence that men and women with OAB symptoms can distinguish between "normal" urge (desire) to urinate and "urgency" suggesting that urinary urgency is a continuum, rather than an all-or-none phenomenon. The USS demonstrated content validity and was acceptable to patients.


Asunto(s)
Calidad de Vida , Índice de Severidad de la Enfermedad , Vejiga Urinaria Hiperactiva/diagnóstico , Incontinencia Urinaria de Urgencia/diagnóstico , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Micción/fisiología
4.
ERJ Open Res ; 8(3)2022 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-35821755

RESUMEN

Marraset al. report a low number needed to treat and high number needed to harm supporting addition of amikacin liposome inhalation suspension to guideline-based treatments in patients with treatment-refractory Mycobacterium avium complex lung disease https://bit.ly/3tPFW7D.

5.
Br J Clin Pharmacol ; 72(2): 263-9, 2011 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-21545485

RESUMEN

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: Available data suggest that fesoterodine dosage should not exceed 4 mg once daily when taken concomitantly with potent CYP3A4 inhibitors, such as ketoconazole. Currently, no information is available on whether dose adjustment is necessary when fesoterodine is administered with a moderate CYP3A4 inhibitor. WHAT THIS STUDY ADDS: This study shows that adjustment of fesoterodine dose is not warranted when co-administered with a moderate CYP3A4 inhibitor. AIMS: To assess the effects of fluconazole, a moderate CYP3A4 inhibitor, on the pharmacokinetics (PK) and safety/tolerability of fesoterodine. METHODS: In this open-label, randomized, two-way crossover study, 28 healthy subjects (18-55 years) received single doses of fesoterodine 8 mg alone or with fluconazole 200 mg. PK endpoints, including the area under the plasma concentration-time curve from 0 to infinity (AUC(0,∞)), maximum plasma concentration (C(max) ), time to C(max) (t(max) ), and half-life (t(1/2) ), were assessed for 5-hydroxymethyl tolterodine (5-HMT), the active moiety of fesoterodine. RESULTS: Concomitant administration of fesoterodine with fluconazole increased AUC(0,∞) and C(max) of 5-HMT by approximately 27% and 19%, respectively, with corresponding 90% confidence intervals of (18%, 36%) and (11%, 28%). There was no apparent effect of fluconazole on 5-HMT t(max) or t(½) . Fesoterodine was generally well tolerated regardless of fluconazole co-administration, with no reports of death, serious adverse events (AEs) or severe AEs. Following co-administration of fesoterodine with fluconazole, 13 subjects (48%) experienced a total of 40 AEs; following administration of fesoterodine alone, six subjects (22%) experienced a total of 19 AEs. The majority of AEs were of mild intensity. There were no clinically significant changes in laboratory or physical examination parameters. CONCLUSION: Fesoterodine 8 mg single dose was well tolerated when administered alone or with fluconazole. Based on the observed increase in 5-HMT exposures being within the inherent variability of 5-HMT pharmacokinetics, adjustment of fesoterodine dose is not warranted when co-administered with a moderate CYP3A4 inhibitor provided they are not also inhibitors of transporters.


Asunto(s)
Antifúngicos/farmacología , Compuestos de Bencidrilo/farmacocinética , Inhibidores del Citocromo P-450 CYP3A , Fluconazol/farmacología , Antagonistas Muscarínicos/farmacocinética , Adolescente , Adulto , Análisis de Varianza , Área Bajo la Curva , Estudios Cruzados , Citocromo P-450 CYP3A/metabolismo , Método Doble Ciego , Interacciones Farmacológicas , Femenino , Semivida , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven
6.
J Cyst Fibros ; 20(6): 1010-1017, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-34144923

RESUMEN

BACKGROUND: . In CLEAR-108-a phase 3, randomised, open-label study-once-daily amikacin liposome inhalation suspension (ALIS) was noninferior to twice-daily tobramycin inhalation solution (TIS) in improving lung function in patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa infection after 3 treatment cycles (28 days on/28 days off). The CLEAR-110 extension study (ClinicalTrials.gov: NCT01316276; EudraCT: 2011-000443-24) assessed long-term safety, tolerability, and efficacy of ALIS in eligible patients who completed CLEAR-108. METHODS: . Patients received once-daily ALIS 590 mg for 12 treatment cycles (96 weeks). Patients were grouped by prior treatment: the "prior-ALIS" cohort received ALIS in CLEAR-108, and the "ALIS-naive" cohort received TIS in CLEAR-108. RESULTS: . Overall, 206 patients (prior-ALIS, n=92; ALIS-naive, n=114) entered CLEAR-110 and received ≥1 dose of ALIS. Most patients (88.8%) experienced ≥1 treatment-emergent adverse event (TEAE) through day 672 (end of year 2). Most TEAEs (72.3%) were mild or moderate in severity. Severe TEAEs were reported in 31 patients (15.0%). Two life-threatening TEAEs (haemoptysis; intestinal obstruction) and 1 death (cardiac failure) were reported. Twenty-one patients (10.2%) discontinued treatment due to a TEAE (mostly infective pulmonary exacerbation of CF). Mean change from baseline in forced expiratory volume in 1 second percent predicted at day 672 was -3.1% (prior-ALIS, -4.0%; ALIS-naive, -2.3%). Mean change from baseline in sputum density of P. aeruginosa at day 672 was 0.02 (prior-ALIS, -0.16; ALIS-naive, 0.19) log CFU/g. CONCLUSIONS: . Long-term treatment with ALIS was well tolerated with a favourable adverse event profile and demonstrated continued antibacterial activity in CF patients with chronic P. aeruginosa infection.


Asunto(s)
Amicacina/administración & dosificación , Antibacterianos/administración & dosificación , Fibrosis Quística/tratamiento farmacológico , Fibrosis Quística/microbiología , Infecciones por Pseudomonas/tratamiento farmacológico , Administración por Inhalación , Adolescente , Adulto , Niño , Enfermedad Crónica , Femenino , Volumen Espiratorio Forzado , Humanos , Liposomas , Masculino , Persona de Mediana Edad , Suspensiones
7.
BJU Int ; 105(9): 1283-90, 2010 May.
Artículo en Inglés | MEDLINE | ID: mdl-19912189

RESUMEN

OBJECTIVE: To identify predictors of self-reported discontinuation of overactive bladder (OAB) medication using a three-phase survey. PATIENTS AND METHODS: In January 2005, a phase 1 survey was sent to 260 000 households in the USA to assess the prevalence of OAB symptom bother, treatment patterns and healthcare consulting behaviour. In July 2005, a detailed phase 2 follow-up survey was sent to 6577 phase 1 respondents who had used one or more OAB medications within the 12 months before phase 1; the phase 2 survey included questions about respondents' sociodemographic characteristics, general health status, OAB symptom bother, healthcare consulting behaviour, beliefs about OAB and treatment options, and medication usage. Six months later, a phase 3 survey was sent to 3387 phase-2 respondents who were persistent with OAB medication or had discontinued within <18 months of phase 2; the phase 3 survey measured the same variables as phase 2. Only phase 3 respondents who were persistent with OAB medication at phase 2 were included in the analyses reported here. Assessed were the proportions of respondents who were still persistent with OAB medication at phase 3 and who discontinued OAB medication between phases 2 and 3. The variables measured during the phase 2 survey were screened as potential predictors of discontinuation at phase 3 using univariate analysis and then assessed using multivariate logistic regression. RESULTS: Among 2838 respondents at phase 3 (84% response rate), 1194 had recently discontinued and 1644 were persistent with medication at phase 2. Among phase-3 respondents who were persistent at phase 2, 1040 (66%) continued to be persistent at phase 3, 280 (18%) had discontinued between phases 2 and 3, and 261 (17%) had switched medication between phases 2 and 3; 63 respondents had missing prescription information at phase 3. Predictors of discontinuing at phase 3 included smoking (odds ratio 1.80; 95% confidence interval 1.15-2.83; P = 0.010), not knowing whether treating bladder problems requires multiple daily doses of medication (1.71, 1.10-2.67; P = 0.018), believing (2.11, 1.34-3.33; P = 0.001) or not knowing (1.76, 1.23-2.52; P = 0.002) whether adverse effects of OAB medications are often severe, and being bothered 'quite a bit or more' by a sudden urge to urinate (1.54, 1.05-2.26; P = 0.028). Respondents taking two or more medications were less likely to discontinue (odds ratio 0.45-0.58; P < 0.05). CONCLUSION: Persistence with OAB medications might be improved by addressing predictors of discontinuation in the management of OAB, by proactively informing patients about the severity of antimuscarinic adverse effects, and dosing regimens. Bother associated with the key OAB symptom, urgency, is a predictor of discontinuation of treatment.


Asunto(s)
Actitud Frente a la Salud , Cumplimiento de la Medicación/psicología , Antagonistas Muscarínicos/uso terapéutico , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Adolescente , Adulto , Anciano , Métodos Epidemiológicos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Antagonistas Muscarínicos/efectos adversos , Estados Unidos/epidemiología , Vejiga Urinaria Hiperactiva/epidemiología , Vejiga Urinaria Hiperactiva/psicología , Adulto Joven
8.
BJU Int ; 105(9): 1276-82, 2010 May.
Artículo en Inglés | MEDLINE | ID: mdl-19912188

RESUMEN

OBJECTIVE: To evaluate patient-reported reasons for discontinuing antimuscarinic prescription medications for overactive bladder (OAB). PATIENTS AND METHODS: A phase 1 screening survey was sent to a representative sample of 260 000 households in the USA to identify patients using antimuscarinic agents for OAB. A detailed phase-2 follow-up survey was sent to 6577 respondents with one or more antimuscarinic prescriptions for OAB in the 12 months before the phase 1 survey. The follow-up survey included questions about demographics, clinical characteristics, antimuscarinic use, beliefs about OAB, treatment expectations, OAB symptom bother, and pre-coded reasons for discontinuation. Patients who reported discontinuing one or more OAB medication during the 12 months before phase 2 were grouped by reason, using latent class analysis (LCA); the Lo-Mendell-Rubin likelihood statistical test was used to determine the number of classes. Conditional probabilities of reasons for discontinuation were calculated for each class. Multivariable logistic regression was used to assess the influence of demographic and clinical characteristics on class assignment. RESULTS: In all, 162 906 (63%) and 5392 (82%) useable responses were returned in phases 1 and 2, respectively; the demographics were similar in respondents and nonrespondents in both phases. In all, 1322 phase 2 respondents (24.5%) reported discontinuing one or more antimuscarinic drugs during the 12 months before phase 2. LCA identified two classes (Lo-Mendell-Rubin statistic, P = 0.01) based on reasons for discontinuation. Most respondents (89%) reported discontinuing OAB medication primarily due to unmet treatment expectations and/or tolerability; many respondents in this class switched to a new antimuscarinic agent. A smaller group (11%) indicated a general aversion to taking medication. Age, sex, race, income, and history of incontinence were not predictive of class assignment. CONCLUSIONS: Expectations about treatment efficacy and side-effects are the most important considerations in discontinuing OAB medications for most patients. Interventions to promote realistic expectations about treatment efficacy and side-effects might enhance adherence.


Asunto(s)
Cumplimiento de la Medicación/psicología , Antagonistas Muscarínicos/uso terapéutico , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Métodos Epidemiológicos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Antagonistas Muscarínicos/efectos adversos , Estados Unidos/epidemiología , Vejiga Urinaria Hiperactiva/epidemiología , Vejiga Urinaria Hiperactiva/psicología , Adulto Joven
9.
J Urol ; 181(6): 2591-8, 2009 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-19375096

RESUMEN

PURPOSE: We measured patient reported bother due to overactive bladder syndrome, patterns of physician consultation and prescription medication use for overactive bladder symptoms in adults in the United States. MATERIALS AND METHODS: A survey sample was derived from a consumer panel of 600,000 American households developed to match the United States Census of 260,000 adults. The survey included the Overactive Bladder-Validated 8 awareness tool, which includes 8 questions that measure the degree of bother due to specific bladder symptoms. A score of 8 or greater denotes probable overactive bladder. Additional questions probed treatment patterns, health care consultation, overactive bladder diagnosis, treatment type and prescription treatment used. A nonrespondent telephone survey in 1,004 participants was done to evaluate differences between mail survey respondents and nonrespondents. RESULTS: The response rate was 63% (162,906 respondents). Women represented 55.1% of the sample and 21.8% of respondents were 65 years old or older. Symptom bother, as determined by an Overactive Bladder-Validated 8 score of 8 or greater, was reported by 26.6% of the total sample, including 23.7% of men and 28.9% of women. The percent of men and women reporting bother increased with age. Of respondents with probable overactive bladder only 45.7% had discussed the symptoms with a medical provider, 22.5% had previously used prescription medication for overactive bladder, 13.5% had used overactive bladder medication in the last 12 months and 8.1% were currently on treatment. CONCLUSIONS: A substantial proportion of adults in the United States reported some degree of bother due to overactive bladder symptoms. The degree of bother was associated with age and gender. Overall less than half of patients with probable overactive bladder discussed the symptoms with a health care provider. A small proportion was prescribed medication and an even smaller proportion was currently on treatment.


Asunto(s)
Aceptación de la Atención de Salud/estadística & datos numéricos , Vejiga Urinaria Hiperactiva , Adolescente , Adulto , Distribución por Edad , Anciano , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Distribución por Sexo , Encuestas y Cuestionarios , Estados Unidos , Vejiga Urinaria Hiperactiva/diagnóstico , Vejiga Urinaria Hiperactiva/epidemiología , Vejiga Urinaria Hiperactiva/terapia , Adulto Joven
10.
Am J Health Syst Pharm ; 63(23): 2357-64, 2006 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-17106009

RESUMEN

PURPOSE: The frequency, relative risk, resource utilization, and costs related to comorbidities associated with overactive bladder (OAB) were studied. METHODS: A retrospective analysis of patients with OAB who initiated treatment with tolterodine extended release (ER), oxybutynin ER, or oxybutynin immediate release (IR) between January 2001 and December 2002 was conducted to evaluate the frequency, relative risk, resource utilization, and costs related to three specific comorbidities associated with OAB: urinary tract infections (UTIs), depression, and fracture. Two patient cohorts (tolterodine ER versus oxybutynin ER and tolterodine ER versus oxybutynin IR) were matched on a 1:1 basis according to their propensity to receive a prescription for tolterodine ER. RESULTS: The frequency and relative risk of UTIs were significantly lower in the tolterodine ER group than in the oxybutynin ER and oxybutynin IR groups. The relative risk of depression was also lower in the tolterodine ER group than the oxybutynin ER and oxybutynin IR groups; however, the differences were only significant in the tolterodine ER versus oxybutynin IR comparison. The utilization of UTI- and depression-related services and the number of antiinfective and antidepressant prescriptions were significantly lower in the tolterodine ER group than in the oxybutynin ER group. UTI- and depression-related costs were generally lower in the tolterodine ER group than in the oxybutynin ER or oxybutynin IR group. CONCLUSION: Treatment of OAB patients with tolterodine ER was associated with reduced frequency, relative risk, medical and pharmacy resource utilization, and incurred costs related to selected OAB-associated comorbidities compared with treatment with oxybutynin ER or oxybutynin IR.


Asunto(s)
Compuestos de Bencidrilo/uso terapéutico , Cresoles/uso terapéutico , Ácidos Mandélicos/uso terapéutico , Antagonistas Muscarínicos/uso terapéutico , Fenilpropanolamina/uso terapéutico , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Vejiga Urinaria Hiperactiva/epidemiología , Compuestos de Bencidrilo/economía , Comorbilidad , Cresoles/economía , Preparaciones de Acción Retardada , Depresión/economía , Depresión/epidemiología , Femenino , Fracturas Óseas/epidemiología , Humanos , Masculino , Ácidos Mandélicos/economía , Persona de Mediana Edad , Antagonistas Muscarínicos/economía , Fenilpropanolamina/economía , Estudios Retrospectivos , Riesgo , Tartrato de Tolterodina , Estados Unidos/epidemiología , Vejiga Urinaria Hiperactiva/economía , Infecciones Urinarias/economía , Infecciones Urinarias/epidemiología
11.
J Manag Care Spec Pharm ; 22(12): 1417-1425, 2016 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-27882838

RESUMEN

BACKGROUND: Smoking is the leading preventable cause of death, and tobacco control professionals continue to make progress in cessation efforts. Pharmacists can assist smokers seeking to quit by offering counseling on smoking cessation pharmacotherapies. Pragmatic randomized trials are useful for investigating practical questions about an intervention's risks, benefits, and costs in routine clinical practice. OBJECTIVE: To evaluate an enhanced pharmacy care (EPC) program involving personalized pharmacist-provided telephone counseling for supporting prescription smoking cessation medications compared with usual care (UC). METHODS: Cigarette smokers filling a newly prescribed smoking cessation pharmacotherapy and with pharmacy benefits managed by Express Scripts were recruited. Qualified subjects were randomized 1:1 to EPC and UC. Subjects in EPC received 3 telephone-counseling sessions from specialist pharmacists during the early course of the study, while subjects in UC did not receive any counseling sessions. Study outcomes were collected through telephone contact and using the Express Scripts prescription database. The primary outcome assessed the 1-week point prevalence (PP) of smoking abstinence at the end of the trial (week 12). Secondary outcomes included 4-week PP at week 12 and adherence, evaluated by proportion of days covered (PDC), to prescribed smoking cessation pharmacotherapies. RESULTS: There were 1,017 randomized subjects. Among them, 1,002 subjects were included in the analysis, and 513 were randomized into EPC and 489 into UC. Baseline demographics, smoking history, and prescribed smoking cessation pharmacotherapies were comparable. Varenicline and nicotine replacement therapy (NRT) were most frequently prescribed for smoking cessation. In EPC, 46.0% received all 3 counseling sessions; 29.4% received 2 sessions; and 14.6% received 1 session. Overall, 353 subjects in EPC and 383 subjects in UC completed the week 12 assessment. In the analysis for 1-week PP of smoking abstinence at week 12, the percentage of abstainers in EPC was numerically higher than in UC (42.3% vs. 38.2%) with OR = 1.24, 95% CI = 0.96-1.61. It was not statistically significant. Adherence to prescription smoking cessation medication was significantly higher in EPC versus UC (49.7% vs. 45.6%; P = 0.033). CONCLUSIONS: This study evaluated whether a telephone-based pharmacy care program, provided by pharmacists and designed to support attempted quitters, improved quitting and increased adherence over usual care. The findings suggest that an enhanced program may benefit smokers by increasing prescription smoking cessation medication adherence. Future research should explore this program's effect on smokers who are compliant, based on insights on quitting provided by the post hoc analyses and limitations of the current study design. DISCLOSURES: This study was sponsored by Pfizer. Gong, Baker, Zou, Bruno, Jumadilova, and Lawrence are employees and stockholders of Pfizer. Wilson and Ewel are employees of United BioSource Corporation, which received funding from Pfizer for conducting this study and for the development of this manuscript. Study concept and design were contributed by Gong, Bruno, and Ewel, with assistance from Jumadilova, Lawrence, and Zou. Gong, Jumadilova, Lawrence, and Ewel collected the data. Data interpretation was performed by Baker, Zou, and Wilson, assisted by Gong, Lawrence, and Ewel. The manuscript was written by Baker, Ewel, and Gong, with assistance from the other authors, and revised by Baker, Wilson, Zou, and Gong, with assistance from Bruno and Jumadilova.


Asunto(s)
Consejo/métodos , Servicios Farmacéuticos , Farmacéuticos , Cese del Hábito de Fumar/métodos , Fumar/terapia , Teléfono , Adulto , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Agonistas Nicotínicos/efectos adversos , Agonistas Nicotínicos/uso terapéutico , Atención al Paciente/métodos , Rol Profesional , Estudios Prospectivos , Fumar/psicología , Cese del Hábito de Fumar/psicología , Teléfono/estadística & datos numéricos , Vareniclina/efectos adversos , Vareniclina/uso terapéutico
12.
Am J Manag Care ; 11(4 Suppl): S112-20, 2005 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-16161384

RESUMEN

OBJECTIVES: To provide a descriptive overview of the elderly, nursing home patient population with urinary incontinence (UI). METHODS: This study was a descriptive, cross-sectional database analysis (2002-2003) examining UI prevalence, demographic and clinical characteristics of UI patients, and UI pharmacotherapy prevalence in the nursing home setting. RESULTS: Of the 29 645 eligible subjects, 8995 experienced some level of UI at the time the minimum data set (MDS) was completed (30%). Compared with continent residents, a greater percentage of incontinent residents were older, white women and had a longer length of stay. Incontinent residents also had more indicators of frailty than those who were continent; they were more impaired on activities of daily living and cognitive performance scale scores, were hospitalized more frequently, and had more urinary tract infections, pressure ulcers, and depression. More incontinent residents were using pads/briefs and had bladder retraining and scheduled toileting. Only 8.7% of those residents rated as having the most severe level of incontinence (MDS level 4) were being treated with pharmacotherapy. Of the 8995 residents with a UI rating of 1 to 4, only 8% (n = 731) had pharmacotherapy. CONCLUSION: There is a high prevalence of UI among nursing home residents and having this condition is negatively correlated with measures of resident health status and healthcare utilization. A variety of interventions are used in this setting to treat UI, and use of pharmacologic therapy appears to be quite low. Appropriate use of interventional strategies that may include drug treatment for UI in the nursing home may reduce the substantial personal and cost burdens associated with this condition. However, clinicians may need population-specific scientific evidence in determining which nursing home patients will benefit most from pharmacotherapy.


Asunto(s)
Pacientes Internos , Instituciones de Cuidados Especializados de Enfermería , Incontinencia Urinaria/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Estudios Transversales , Humanos , Estados Unidos
13.
Am J Manag Care ; 11(4 Suppl): S150-7, 2005 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-16161388

RESUMEN

OBJECTIVE: The objective of this study was to compare 1-year total healthcare costs for patients with overactive bladder (OAB) initiating treatment with extended-release formulations of tolterodine and oxybutynin: tolterodine tartrate extended-release capsules (tolterodine ER) versus extended-release oxybutynin chloride (oxybutynin ER). METHODS: A model was developed from the payer perspective using data from the PharMetrics Patient-Centric database. Monthly discontinuation rates were derived from a cohort of newly treated patients with OAB (tolterodine ER, n = 15 394 or oxybutynin ER, n = 7934). All were assumed to be receiving therapy for at least 1 month. Medical management costs were based on reimbursement for all services for a matched cohort of patients taking tolterodine ER and oxybutynin ER. Medical management costs for those discontinuing therapy were based on patients receiving OAB care without pharmacotherapy (n = 29 992). Drug costs were from AnalySource (December 2004). RESULTS: After the 11-month follow-up period, 21% of patients taking tolterodine ER and 15% of patients taking oxybutynin ER remained on original therapy. One-year average total costs per patient for those started on tolterodine ER were dollar 8876 and dollar 9080 for oxybutynin ER, a difference of dollar 204 per year. Sensitivity analyses indicated results were robust to changes in drug cost and probability of discontinuation. When discontinuation rates were held equal, cost differences continued to favor tolterodine ER (21%, dollar 272/yr; 15%, dollar 233/yr). CONCLUSION: Those taking tolterodine ER had lower monthly drug and medical management costs. This resulted in a total average annual cost savings of dollar 204 per patient for those started on tolterodine ER. At the end of 1 year, patients with OAB were more likely to remain on original drug treatment taking tolterodine ER versus oxybutynin ER.


Asunto(s)
Compuestos de Bencidrilo/economía , Cresoles/economía , Ácidos Mandélicos/economía , Antagonistas Muscarínicos/economía , Fenilpropanolamina/economía , Incontinencia Urinaria/tratamiento farmacológico , Anciano , Compuestos de Bencidrilo/administración & dosificación , Compuestos de Bencidrilo/uso terapéutico , Estudios de Cohortes , Cresoles/administración & dosificación , Cresoles/uso terapéutico , Preparaciones de Acción Retardada , Costos de la Atención en Salud , Humanos , Ácidos Mandélicos/administración & dosificación , Ácidos Mandélicos/uso terapéutico , Modelos Teóricos , Antagonistas Muscarínicos/administración & dosificación , Antagonistas Muscarínicos/uso terapéutico , Fenilpropanolamina/administración & dosificación , Fenilpropanolamina/uso terapéutico , Tartrato de Tolterodina , Estados Unidos , Incontinencia Urinaria/economía
14.
Am J Manag Care ; 11(4 Suppl): S121-9, 2005 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-16161385

RESUMEN

STATEMENT OF PROBLEM AND RATIONALE: The management of chronic conditions, such as overactive bladder (OAB), is often limited by lack of patient adherence to medication. This article compares persistence rates among Medicaid patients who were prescribed 1 of 3 drugs for treatment of OAB: 2 long-acting agents with once-daily dosing, tolterodine tartrate extended-release capsules (tolterodine ER) and oxybutynin chloride extended release (oxybutynin ER), and oxybutynin immediate release (oxybutynin IR), requiring 3 tablets daily. METHODOLOGY: The study population was comprised of continuously enrolled Medicaid managed care patients filling prescriptions for tolterodine ER, oxybutynin ER, or oxybutynin IR between January 1, 2000, and December 31, 2003. Patients taking any OAB drug in the first 6 months of their observed period of enrollment were excluded to capture new users only. Using survival analyses adjusted for age, sex, and race, the rates of persistence by drug were analyzed. Possession time, the degree to which patients keep medication available even though they may not be taking it daily as prescribed, was also measured. RESULTS: Of 1637 patients (75% women, 45% African American, 26% younger than 18 years of age), 182 were started on tolterodine ER, 215 on oxybutynin ER, and 1240 on oxybutynin IR. Only 32% of those taking oxybutynin IR and 44% of those taking either long-acting agent remained adherent past 30 days. Of those remaining after 30 days, the risk of nonadherence was higher for oxybutynin ER than for tolterodine ER (hazard ratio = 1.47; 95% confidence interval, 1.01-2.14). CONCLUSION: Persistence rates are better for patients taking drugs with once-daily dosing, but there is a need for a better understanding of non-persistent patients.


Asunto(s)
Compuestos de Bencidrilo/uso terapéutico , Cresoles/uso terapéutico , Ácidos Mandélicos/uso terapéutico , Medicaid , Antagonistas Muscarínicos/uso terapéutico , Cooperación del Paciente , Fenilpropanolamina/uso terapéutico , Incontinencia Urinaria/tratamiento farmacológico , Adolescente , Adulto , Preparaciones de Acción Retardada , Femenino , Humanos , Masculino , Ácidos Mandélicos/administración & dosificación , Persona de Mediana Edad , Tartrato de Tolterodina , Estados Unidos
15.
Am J Manag Care ; 11(4 Suppl): S140-9, 2005 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-16161387

RESUMEN

OBJECTIVE: To examine levels of persistence and compliance as well as the economic impact of extended-release tolterodine (tolterodine ER) versus immediate- and extended-release oxybutynin (oxybutynin IR or oxybutynin ER) among commercially-insured patients with overactive bladder (OAB). METHODS: Patients with OAB who initiated tolterodine ER, oxybutynin IR, or oxybutynin ER between January 2001 and December 2002 were identified from the PharMetrics Patient-Centric database; the first medication used in this timeframe was used for treatment group assignment (ie, patients were only in 1 group). Exploratory assessment of persistency and compliance was conducted among all treated patients: subjects were matched 1:1 based on the estimated propensity score for tolterodine ER in remaining analyses. Measures included patient characteristics as well as levels of medication, outpatient and inpatient resource utilization, and costs. Primary comparisons were made descriptively; costs were evaluated using generalized linear models with a gamma distribution and log-link function. RESULTS: Compliance did not differ between tolterodine ER (77.4%) and oxybutynin ER (74.3%), but was lower for oxybutynin IR (60.9%). Mean (+/- standard deviation) duration of therapy was higher for tolterodine ER (139 +/- 132 days) versus oxybutynin ER (115 +/- 122) and oxybutynin IR (60 +/- 85). Totals of 7257 and 5936 matched pairs were available for tolterodine ER versus oxybutynin ER and oxybutynin IR comparisons, respectively. The mean age was 54 years in all groups; the majority was women. Utilization of outpatient and inpatient medical services was consistently lower among tolterodine ER patients in both comparisons. Total costs were slightly lower for tolterodine ER versus oxybutynin ER (dollar 8303 +/- dollar 18 802 vs dollar 8862 +/- dollar 18 684) and oxybutynin IR (dollar 9975 +/- dollar 24860 vs dollar 10521 +/- dollar 22 602); differences were significant after multivariate adjustment. CONCLUSIONS: Use of tolterodine ER results in comparable compliance to oxybutynin ER and longer duration of use relative to either form of oxybutynin. In addition, tolterodine ER may be cost-effective relative to oxybutynin IR or oxybutynin ER among commercially-insured persons with OAB.


Asunto(s)
Compuestos de Bencidrilo/economía , Cresoles/economía , Cobertura del Seguro , Ácidos Mandélicos/economía , Antagonistas Muscarínicos/economía , Fenilpropanolamina/economía , Incontinencia Urinaria/tratamiento farmacológico , Anciano , Compuestos de Bencidrilo/administración & dosificación , Compuestos de Bencidrilo/uso terapéutico , Cresoles/administración & dosificación , Cresoles/uso terapéutico , Preparaciones de Acción Retardada , Femenino , Humanos , Masculino , Ácidos Mandélicos/administración & dosificación , Ácidos Mandélicos/uso terapéutico , Antagonistas Muscarínicos/administración & dosificación , Antagonistas Muscarínicos/uso terapéutico , Fenilpropanolamina/administración & dosificación , Fenilpropanolamina/uso terapéutico , Tartrato de Tolterodina , Estados Unidos , Incontinencia Urinaria/economía
16.
Am J Manag Care ; 11(4 Suppl): S130-9, 2005 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-16161386

RESUMEN

OBJECTIVES: To compare posttreatment medical costs for patients with overactive bladder (OAB) initiating treatment with oxybutynin chloride immediate release (oxybutynin IR), oxybutynin chloride extended release (oxybutynin ER), or tolterodine extended-release tartrate capsules (tolterodine ER). METHODS: Data were drawn from administrative claims of enrollees aged 18 years and older of a large US health plan. OAB patients were identified if at least 1 claim with an International Statistical Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code for OAB appeared in medical claims from January 1, 2001, to December 31, 2002. The index prescription was assigned as the first filled prescription of oxybutynin IR (n = 3052), oxybutynin ER (n = 4503), or tolterodine ER (n = 7027) during the subject identification period. Medical costs over the year after initiation were calculated as a function of the health plan and member liability. Independent variables were treatment cohort, sex, age group, geographic region, baseline costs, specific OAB diagnosis codes, and comorbid illnesses. To compare medical costs across treatment cohorts, multivariate regressions correcting for potential selection bias were used. RESULTS: Multivariate analysis results revealed that costs for patients taking oxybutynin IR were 48% higher than costs for patients taking tolterodine ER (P = .026), and costs for patients taking oxybutynin ER were 191% higher than costs for patients taking tolterodine ER (P <.0001). Adjusted medical costs were dollar 7486 for patients taking oxybutynin IR and dollar 14 766 for patients taking oxybutynin ER compared with dollar 5074 for patients taking tolterodine ER. CONCLUSION: Differences in medical costs that remained after adjusting for patient characteristics suggest that treatment with tolterodine ER may be associated with lower medical care utilization after initiation of therapy for OAB.


Asunto(s)
Compuestos de Bencidrilo/uso terapéutico , Cresoles/uso terapéutico , Costos de la Atención en Salud , Ácidos Mandélicos/uso terapéutico , Antagonistas Muscarínicos/uso terapéutico , Fenilpropanolamina/uso terapéutico , Sesgo de Selección , Incontinencia Urinaria/tratamiento farmacológico , Adolescente , Adulto , Anciano , Estudios de Cohortes , Preparaciones de Acción Retardada , Femenino , Humanos , Masculino , Ácidos Mandélicos/administración & dosificación , Persona de Mediana Edad , Estudios Retrospectivos , Tartrato de Tolterodina , Estados Unidos , Incontinencia Urinaria/economía
17.
Expert Rev Clin Pharmacol ; 5(2): 149-56, 2012 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-22390557

RESUMEN

Although the overwhelming majority of study volunteers want to receive information on the results of their participation in clinical trials, research suggests that most study volunteers never do. CISCRP - an independent nonprofit organization - in collaboration with Pfizer, conducted a study evaluating the feasibility and impact of a new process to inform study volunteers of the results of their clinical trials. Two process components were evaluated via surveys, focus groups, and interviews with volunteers and investigative site staff: a series of ongoing post-trial communications to set expectations for when trial results would be received; and routine development and delivery of the lay language trial results summary. The results of this assessment show that study volunteers and investigative site staff are extremely receptive to receiving clinical trial results and that the process of preparing and disseminating clinical trial results is feasible and generally easy to execute. The results also indicate that study volunteer comprehension of basic facts about their clinical trial pre- and post-test increased by as much as 65.6 percentage points, and suggest that this communication initiative may positively impact volunteer recruitment, retention and long-term trust in the clinical research enterprise.


Asunto(s)
Ensayos Clínicos como Asunto/psicología , Comunicación , Conocimientos, Actitudes y Práctica en Salud , Participación del Paciente/psicología , Investigadores/psicología , Sujetos de Investigación/psicología , Actitud del Personal de Salud , Humanos , Factores de Tiempo
18.
Curr Med Res Opin ; 25(9): 2159-65, 2009 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-19601704

RESUMEN

OBJECTIVE: To assess the effects of tolterodine extended release (ER) on patient-reported outcomes (PROs) in sexually active women with overactive bladder (OAB) and urgency urinary incontinence (UUI). RESEARCH DESIGN AND METHODS: This multicenter, double-blind, placebo controlled trial included 411 women aged > or =18 years reporting OAB symptoms for > or =3 months; > or =8 micturitions per 24 hours (including > or =0.6 UUI episodes and > or =3 OAB micturitions) in 5-day bladder diaries at baseline, and being in a sexually active relationship for > or =6 months. Subjects randomized to placebo or tolterodine ER completed validated OAB- or incontinence-specific questionnaires, including the Patient Perception of Bladder Condition (PPBC), Overactive Bladder Questionnaire (OAB-q), Urgency Perception Scale (UPS), and the Incontinence Impact Questionnaire (IIQ) at baseline and week 12, as well as the Perception of Treatment Benefit and Treatment Satisfaction questions at week 12. This study is registered with ClinicalTrials.Gov (identifier: NCT00143481). RESULTS: The mean age of enrolled women was approximately 48 years. Compared with placebo, the tolterodine ER group reported significant baseline to week 12 improvements in PPBC responses (p = 0.0048); OAB-q Symptom Bother, total Health-Related Quality of Life (HRQL), and HRQL domain scores (all p < 0.05); IIQ Emotional Health domain scores (p < 0.05); proportions of subjects reporting treatment benefit (79 vs. 54%; p < 0.0001) and satisfaction (78 vs. 59%; p < 0.0001). Improvements on the UPS were not significantly different. CONCLUSIONS: Tolterodine ER treatment was associated with improvements in multiple OAB- and incontinence-specific PROs in a sexually active, relatively young, and racially diverse population of women. The findings provide clinicians with new insights into the impact of OAB and its treatment on HRQL in this population, which has been underrepresented in previous OAB studies. Study limitations include a potential underestimation of the impact of OAB symptoms resulting from the exclusion of women who may not be sexually active because of their urinary symptoms.


Asunto(s)
Compuestos de Bencidrilo/administración & dosificación , Cresoles/administración & dosificación , Fenilpropanolamina/administración & dosificación , Conducta Sexual , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Incontinencia Urinaria de Urgencia/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Compuestos de Bencidrilo/farmacología , Cresoles/farmacología , Preparaciones de Acción Retardada , Método Doble Ciego , Femenino , Humanos , Persona de Mediana Edad , Antagonistas Muscarínicos/administración & dosificación , Antagonistas Muscarínicos/farmacología , Satisfacción del Paciente , Fenilpropanolamina/farmacología , Placebos , Conducta Sexual/efectos de los fármacos , Tartrato de Tolterodina , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/complicaciones , Incontinencia Urinaria de Urgencia/complicaciones , Adulto Joven
19.
Int Urogynecol J Pelvic Floor Dysfunct ; 19(11): 1551-7, 2008 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-18685795

RESUMEN

We evaluated overactive bladder (OAB) symptoms and sexual and emotional health in sexually active women with OAB/urgency urinary incontinence (UUI) treated with tolterodine extended release (ER). Sexually active women with OAB symptoms were randomized to placebo or tolterodine ER. Five-day bladder diaries, Sexual Quality of Life Questionnaire-Female (SQOL-F), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), and Hospital Anxiety and Depression Scale (HAD) were completed at baseline and week 12. Tolterodine ER (n = 201; mean +/- SD age, 49 +/- 12 years) reduced UUI episodes (P = 0.0029), total (P = 0.0006) and OAB (P < 0.0001) micturitions, and pad use per 24 h (P = 0.0024), and was associated with improvements in SQOL-F (P = 0.004), PISQ total (P = 0.009), and HAD Anxiety (P = 0.03) scores versus placebo (n = 210; mean +/- SD age, 47 +/- 12 years). OAB symptoms improved with tolterodine ER as did the scores of sexual health and anxiety measures in sexually active women with OAB.


Asunto(s)
Compuestos de Bencidrilo/uso terapéutico , Cresoles/uso terapéutico , Emociones/fisiología , Antagonistas Muscarínicos/uso terapéutico , Fenilpropanolamina/uso terapéutico , Calidad de Vida/psicología , Sexualidad/fisiología , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Encuestas y Cuestionarios , Tartrato de Tolterodina , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/fisiopatología , Vejiga Urinaria Hiperactiva/psicología , Adulto Joven
20.
Neurourol Urodyn ; 26(2): 196-203, 2007.
Artículo en Inglés | MEDLINE | ID: mdl-17016794

RESUMEN

AIMS: Although the majority of patients with overactive bladder (OAB) are continent, most patient-reported outcome measures for OAB were designed for patients with urinary incontinence. The overactive bladder questionnaire (OAB-q) was developed to assess symptom bother and HRQL among both continent and incontinent OAB patients; however, the responsiveness of the OAB-q among continent patients has not been evaluated. The purpose of this analysis was to assess the responsiveness of the OAB-q among OAB patient subgroups with a focus on continent patients. METHODS: Post-hoc analyses were conducted from two 12-week trials of tolterodine for the treatment of OAB. Patients completed the OAB-q and daily bladder diaries (assessing frequency, urgency, and incontinence episodes) at baseline, 4 weeks, and 12 weeks. Three patient subgroups were identified on the basis of continence status at all three timepoints: (1) continent; (2) incontinent; and (3) incontinent at baseline and continent by Week 12 (ITC). General linear models were used to compare changes from baseline, and Spearman correlations assessed the association between OAB-q changes and bladder diary changes. Effect sizes were computed separately for each group. RESULTS: A total of 262 continent, 552 incontinent, and 397 ITC patients were included in this analysis. Continent patients tended to be younger than incontinent patients, and patients were predominantly female, although continent patients had the highest percentage of male patients in both studies. Compared with continent patients, patients who were incontinent at baseline tended to have greater symptom bother and lower HRQL at baseline. All OAB-q change scores were consistently greatest for the ITC group (12.1-33.9), and greater for continent patients (10.8-28.6) than for incontinent patients (7.6-20.1). All three groups of patients experienced reductions in frequency and urgency episodes, and these changes were significantly correlated with changes in the OAB-q scales. Among all three groups, effect sizes were in the moderate-to-large range for all OAB-q subscales except Social Interaction. CONCLUSIONS: The OAB-q is highly responsive to change between continent and incontinent patients with OAB, and is a valid tool for measuring treatment outcomes among continent OAB patients.


Asunto(s)
Encuestas y Cuestionarios , Vejiga Urinaria Hiperactiva/psicología , Adaptación Psicológica , Anciano , Compuestos de Bencidrilo/uso terapéutico , Cresoles/uso terapéutico , Femenino , Humanos , Masculino , Registros Médicos , Persona de Mediana Edad , Agonistas Muscarínicos/uso terapéutico , Fenilpropanolamina/uso terapéutico , Caracteres Sexuales , Tartrato de Tolterodina , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/complicaciones , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Incontinencia Urinaria/tratamiento farmacológico , Incontinencia Urinaria/etiología , Incontinencia Urinaria/psicología , Micción/fisiología
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