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1.
Lupus Sci Med ; 7(1)2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33051264

RESUMO

OBJECTIVE: Long-term extension (LTE) studies of belimumab in SLE do not include a comparator arm, preventing comparisons between belimumab plus standard therapy and standard therapy alone for organ damage accrual. Propensity score matching can be used to match belimumab-treated patients from LTE studies with standard therapy-treated patients from observational cohort studies. This analysis was designed to compare organ damage progression between treatment groups (belimumab plus standard therapy vs standard therapy alone) in patients with SLE with ≥5 years of follow-up, reproducing our previous study with more generalisable data. METHODS: This exploratory post hoc analysis used a heterogeneous population of US and non-US patients receiving monthly intravenous belimumab from pooled BLISS LTE trials (BEL112234/NCT00712933) and standard therapy-treated patients from the Toronto Lupus Cohort. Sixteen clinical variables were selected to calculate the propensity score. RESULTS: The 592 LTE and 381 Toronto Lupus Cohort patients were highly dissimilar across the 16 variables; an adequately balanced sample of 181 LTE and 181 matched Toronto Lupus Cohort patients (mean bias=3.7%) was created using propensity score matching. Belimumab treatment was associated with a smaller increase in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) over 5 years than standard therapy alone (mean treatment difference=-0.453 (95% CI -0.646 to -0.260); p<0.001). Patients treated with belimumab were 60% less likely to progress to a higher SDI score over any given year of follow-up, compared with standard therapy alone (HR (95% CI) 0.397 (0.275 to 0.572); p<0.001). CONCLUSION: Using propensity score matching, this highly heterogeneous sample was sufficiently matched to the Toronto Lupus Cohort, suggesting that patients treated with intravenous belimumab may have reduced organ damage progression versus standard therapy alone. This analysis of a large and diverse pooled SLE population was consistent with our previously published US-focused study.

2.
Ann Rheum Dis ; 78(3): 372-379, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30610066

RESUMO

OBJECTIVES: The study (206347) compared organ damage progression in patients with systemic lupus erythematosus (SLE) who received belimumab in the BLISS long-term extension (LTE) study with propensity score (PS)-matched patients treated with standard of care (SoC) from the Toronto Lupus Cohort (TLC). METHODS: A systematic literature review identified 17 known predictors of organ damage to calculate a PS for each patient. Patients from the BLISS LTE and the TLC were PS matched posthoc 1:1 based on their PS (±calliper). The primary endpoint was difference in change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score from baseline to 5 years. RESULTS: For the 5- year analysis, of 567 (BLISS LTE n=195; TLC n=372) patients, 99 from each cohort were 1:1 PS matched. Change in SDI score at Year 5 was significantly lower for patients treated with belimumab compared with SoC (-0.434; 95% CI -0.667 to -0.201; p<0.001). For the time to organ damage progression analysis (≥1 year follow-up), the sample included 965 (BLISS LTE n=259; TLC n=706) patients, of whom 179 from each cohort were PS-matched. Patients receiving belimumab were 61% less likely to progress to a higher SDI score over any given year compared with patients treated with SoC (HR 0.391; 95% CI 0.253 to 0.605; p<0.001). Among the SDI score increases, the proportion of increases ≥2 was greater in the SoC group compared with the belimumab group. CONCLUSIONS: PS-matched patients receiving belimumab had significantly less organ damage progression compared with patients receiving SoC.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Imunossupressores/uso terapêutico , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Lúpus Eritematoso Sistêmico/patologia , Adulto , Progressão da Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Índice de Gravidade de Doença , Padrão de Cuidado , Resultado do Tratamento
3.
Arthritis Care Res (Hoboken) ; 71(6): 829-838, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30320964

RESUMO

OBJECTIVE: To report long-term health-related quality of life (HRQoL) and fatigue outcomes in patients with systemic lupus erythematosus (SLE) receiving belimumab. METHODS: Patients with SLE who completed the Study of Belimumab in Subjects with SLE 76-week trial (BLISS-76) were enrolled in this continuation study (BEL112233 [ClinicalTrials.gov identifier: NCT00724867]). The belimumab groups continued to receive the same dose (1 mg/kg or 10 mg/kg) intravenously. After March 2011, all patients received belimumab 10 mg/kg every 28 days plus standard therapy. The placebo group switched to belimumab 10 mg/kg. HRQoL and fatigue assessments included the Short Form 36 (SF-36) health survey and the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale. Post hoc subgroup analyses (BEL206350) assessed clinical characteristics associated with improved HRQoL and fatigue. RESULTS: Of the 268 patients enrolled, 140 completed the study. Patients receiving long-term belimumab treatment reported continued improvements in HRQoL and fatigue. At study year 6, the mean ± SD SF-36 physical component summary (PCS) score and the mental component summary (MCS) score increased from 37.0 ± 9.9 at baseline to 41.7 ± 10.0 (mean ± SD change 4.8 ± 9.4) and from 44.3 ± 11.3 to 47.0 ± 11.6 (mean ± SD change 2.7 ± 11.3) for the PCS and MCS, respectively, exceeding the minimum clinically important difference (MCID) for improvement (2.5 units). The mean ± SD FACIT-Fatigue score exceeded the MCID of 4 at study years 1-5; at study year 6, the mean ± SD change was 3.7 ± 11.8. Statistically significant associations were observed between parent trial treatment groups and change from baseline in PCS, MCS, and FACIT-Fatigue scores (P < 0.01). CONCLUSION: Long-term control of SLE disease activity with belimumab plus standard therapy translates into meaningful improvements in patient-reported fatigue and HRQoL.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Fadiga/tratamento farmacológico , Imunossupressores/uso terapêutico , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Qualidade de Vida , Adulto , Anticorpos Monoclonais Humanizados/efeitos adversos , Fadiga/diagnóstico , Fadiga/imunologia , Fadiga/psicologia , Feminino , Humanos , Imunossupressores/efeitos adversos , Lúpus Eritematoso Sistêmico/diagnóstico , Lúpus Eritematoso Sistêmico/imunologia , Lúpus Eritematoso Sistêmico/psicologia , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
4.
J Comp Eff Res ; 7(6): 581-593, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29692179

RESUMO

AIM: To compare the efficacy of intravenous (IV) and subcutaneous (SC) belimumab plus standard therapy in patients with active, autoantibody-positive systemic lupus erythematosus and high disease activity (HDA). PATIENTS & METHODS: An indirect treatment comparison using patient-level data of patients with HDA from three belimumab IV Phase III randomized controlled trials (BLISS-52 [BEL110751]; BLISS-76 [BEL110752]; Northeast Asia study [BEL113750]) and one belimumab SC randomized controlled trial (BLISS-SC [BEL112341]). RESULTS: Similar efficacy results were identified between the belimumab formulations and greater improvements in efficacy endpoints were observed for both formulations compared with placebo. CONCLUSION: This indirect treatment comparison provides further evidence of the efficacy of belimumab IV and SC in patients with systemic lupus erythematosus and HDA, compared with standard therapy.


Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Imunossupressores/administração & dosagem , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Adulto , Ásia , Feminino , Humanos , Infusões Intravenosas , Infusões Subcutâneas , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
6.
Patient ; 11(1): 119-129, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-28956281

RESUMO

OBJECTIVE: This study assessed patient experiences of using an autoinjector device to self-administer subcutaneous belimumab for the treatment of systemic lupus erythematosus (SLE). Satisfaction, ease and convenience of use, and confidence with the device were assessed, in addition to overall experience with belimumab. METHODS: This cross-sectional study was conducted among patients who completed a phase IIb open-label, multi-dose usability, tolerability, and safety study of subcutaneous belimumab (NCT02124798), in which patients receiving intravenous belimumab or subcutaneous belimumab using a prefilled syringe were switched to eight weekly self-administered doses of subcutaneous belimumab using the autoinjector. This follow-up study comprised an online/paper questionnaire and qualitative telephone interviews. RESULTS: In total, 43 patients receiving belimumab completed the questionnaire, 21 of whom also completed a follow-up telephone interview. Qualitative interviews indicated that 17 of 21 (81%) patients had a positive experience using the autoinjector; all patients considered the autoinjector to be convenient. Of the 42 patients who switched from intravenous belimumab to the autoinjector, 32 (76%) expressed a preference for the autoinjector over intravenous administration; reasons included convenience, time saved, cost, and reduced injection pain. The most commonly reported disadvantage of the autoinjector was injection discomfort (n = 5 [24%]; qualitative interview). Compared with intravenous administration, the autoinjector improved ability to work (17 of 29 [59%] of those employed) and carry out daily activities (40%). CONCLUSION: Patients with SLE reported high levels of satisfaction with the belimumab autoinjector and preferred the autoinjector to intravenous administration, citing advantages such as time saved, cost, and improved ability to work and carry out daily activities.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Imunossupressores/uso terapêutico , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Preferência do Paciente , Atividades Cotidianas , Administração Intravenosa , Adulto , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Estudos Transversais , Feminino , Humanos , Imunossupressores/administração & dosagem , Imunossupressores/efeitos adversos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Autoadministração , Autoeficácia , Fatores Socioeconômicos
7.
Clin Ther ; 39(9): 1811-1826, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28803702

RESUMO

PURPOSE: This two-part study comprised two descriptive, cross-sectional surveys to evaluate treatment satisfaction among patients with systemic lupus erythematosus (SLE) and their physicians from US clinical practices. The Lupus Plus Project (LPP; part one) involved belimumab-containing regimens; the Disease Specific Program (DSP; part two) included all treatments and was designed to build on the body of evidence from part one. METHODS: The LPP recruited patients receiving belimumab, and comprised 2 paper questionnaires: a patient self-completion questionnaire (PSC) and a patient record form (PRF) completed by the physician. The DSP enrolled patients with SLE receiving any treatment and comprised four parts: a PSC, a PRF completed by the physician after patient consultation, face-to-face physician interviews, and a workload form completed by the physicians to indicate their total SLE patient workload. The key objective of this study was to assess physician and patient satisfaction with current treatment. FINDINGS: From the PSCs, data regarding patient-reported satisfaction with current treatment were available for 263 patients who were receiving belimumab combination therapy (LPP) and 250 patients who were receiving non-belimumab treatment (DSP). The majority of patients (belimumab, 86.3% [227/263]; non-belimumab, 78.4% [196/250]) responded positively (at least "somewhat satisfied") when asked about current treatment satisfaction, as did physicians (belimumab, 82.9% [311/375]; non-belimumab, 74.3% [326/439]). In multivariate analysis, factors most strongly associated with patient-reported satisfaction for patients receiving belimumab were patient-reported improvements in leisure activities since taking belimumab (odds ratio [OR] = 4.66), physician-reported improvements in fatigue (OR = 3.72), patient-reported improvements in general symptoms (OR = 3.02), and pain/achiness (OR = 2.71). Physician satisfaction was associated with clinical outcome such as improvements in pain/achiness (OR = 6.16), fatigue (OR = 3.76), and patient-reported satisfaction with treatment frequency (OR = 3.91). In patients receiving other SLE treatments, dosing frequency of current treatment (OR = 3.64) and a reduction in fatigue severity (OR = 3.61) were most strongly associated with patient-reported satisfaction; physician satisfaction was most strongly associated with a reduction in fatigue (OR = 6.22) and current remission status (OR = 6.05). IMPLICATIONS: When considering SLE treatment satisfaction patients tend to consider impact on daily functioning, whereas physicians take into account a wider range of clinical outcomes; however, both strongly consider improvements in fatigue. These surveys provide insights into treatment satisfaction among prescribers and patients with SLE. GSK-ClinicalStudyRegister.com identifiers: GSK study 202146 [HO 15-15509] and 205086 [HO 15-16709].


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Imunossupressores/uso terapêutico , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Satisfação do Paciente , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Fadiga/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Dor/tratamento farmacológico , Satisfação Pessoal , Médicos , Inquéritos e Questionários , Resultado do Tratamento , Estados Unidos , Adulto Jovem
8.
J Rheumatol ; 43(10): 1897-1903, 2016 10.
Artigo em Inglês | MEDLINE | ID: mdl-27036386

RESUMO

OBJECTIVE: Implications of inadequate gout control were assessed through health-related quality of life (HRQOL) and work productivity of patients with gout adequately controlled while taking conventional urate-lowering therapy (ULT) for ≥ 3 months vs those whose gout was inadequately controlled. METHODS: Retrospective data were drawn from the Adelphi Disease Specific Programme (DSP), a cross-sectional survey of patients with gout in France, Germany, the United Kingdom, and the United States. Patients completed these questionnaires: EQ-5D (3L), Patient Reported Outcomes Measurement Information System (PROMIS) Health Assessment Questionnaire (HAQ), and Work Productivity and Activity Impairment. Inadequate control was defined as the most recent serum uric acid (SUA) level > 6 mg/dl (> 360 µmol/l) or ≥ 2 flares in the last 12 months; adequate control as SUA level ≤ 6 mg/dl (≤ 360 µmol/l) and 0 flares. Appropriate statistical tests were used to assess differences between groups. RESULTS: There were 836 (69%) inadequately and 368 (31%) adequately controlled gout cases. Mean age was 61 and 63 years and duration of current ULT was 32 and 57 months, respectively. Patients experiencing inadequate control reported significantly worse functioning and HRQOL, as measured by the EQ-5D (0.790 vs 0.877; difference: -0.087; p < 0.001) and PROMIS HAQ (13.21 vs 6.91; difference: 6.30; p < 0.001) scales. Productivity was also more impaired (work time missed: 4.5% vs 1.3%; impairment while working: 19.1% vs 5.2%; overall work impairment: 20.4% vs 5.6%; activity impairment: 20.3% vs 5.3%; all p < 0.001). CONCLUSION: Less than one-third of patients had gout that was adequately controlled. Those experiencing inadequately controlled gout reported significantly worse functioning, quality of life, and work productivity. Gout treatment strategies to improve disease control may lead to improvements in HRQOL and productivity.


Assuntos
Eficiência , Supressores da Gota/uso terapêutico , Gota/tratamento farmacológico , Qualidade de Vida , Ácido Úrico/sangue , Idoso , Estudos Transversais , Emprego , Feminino , França , Alemanha , Gota/sangue , Gota/diagnóstico , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Índice de Gravidade de Doença , Inquéritos e Questionários , Resultado do Tratamento , Reino Unido , Estados Unidos
9.
Patient ; 7(4): 413-26, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24890711

RESUMO

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. COPD is characterized by poor treatment adherence, and patient medication preferences may contribute to adherence. METHODS: A discrete choice experiment with an internet panel drawn from the USA was used to evaluate preference and willingness to pay (WTP) of COPD patients for long-acting maintenance medications. Key attributes derived from earlier qualitative research (brief literature review and focus groups) with COPD patients on maintenance therapy included symptom relief, speed of feeling medication start to work, inhaler ease of use, rescue medication use, side effects, and monthly out-of-pocket co-pay. Patients were presented with hypothetical medications with different profiles and asked which they preferred. Utilities and marginal WTP in monthly co-pay dollars were estimated for all patients and by severity. RESULTS: Utilities for 515 participants were in the expected direction and highest for the most favorable attribute levels. Each attribute evaluated was important, and participants were willing to pay a premium to obtain each benefit. On average, WTP was as high as $US64 for complete symptom relief, $US59 for no side effects, $US32 to rarely use rescue medication, $US16 for a quick and easy to use inhaler, and $US13 for feeling medication work quickly (within 5 min; average WTP $US18/month for patients with severe/very severe COPD). CONCLUSION: As expected, efficacy and safety were most valued by patients; however, this study showed that other COPD medication attributes, such as rescue medication, ease of use, and feeling medication work quickly, are also important in patient preferences.


Assuntos
Broncodilatadores/economia , Broncodilatadores/uso terapêutico , Aceitação pelo Paciente de Cuidados de Saúde , Preferência do Paciente , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Broncodilatadores/efeitos adversos , Feminino , Humanos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Pesquisa Qualitativa , Fatores Sexuais , Fatores Socioeconômicos , Inquéritos e Questionários
10.
J Med Econ ; 14(6): 769-76, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21942463

RESUMO

OBJECTIVE: To compare the effectiveness of budesonide/formoterol fumarate dihydrate (BFC) and fluticasone propionate/salmeterol (FSC), two combination inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) products approved for the treatment of chronic obstructive pulmonary disease (COPD) in the US with respect to cost, therapy adherence, and related healthcare utilization. The effectiveness of these two treatments has not previously been compared in a US COPD population. METHODS: A retrospective cohort study assessed COPD-related outcomes using administrative claims data among ICS/LABA-naïve patients. Patients initiating BFC were propensity matched to FSC patients. Cost and effectiveness were measured as total healthcare expenditures, exacerbation events (hospitalizations, emergency department visits, or outpatient visits associated with oral corticosteroid or antibiotic prescription fills), and treatment medication adherence. Differences in COPD symptom control were assessed via proxy measure through claims for rescue medications and outpatient encounters. RESULTS: Of the 6770 patients (3385 BFC and 3385 FSC), fewer BFC patients had claims for short-acting beta agonists (SABA) (34.7% vs 39.5%; p<0.001) and ipratropium (7.8% vs 9.8%, p<0.005) than FSC patients, but no substantial differences were seen in other clinical outcomes including tiotropium or nebulized SABA claims, COPD-related outpatient visits, or exacerbation events. There were no significant differences in total COPD-related medical costs in the 6-month period after initiation of combination therapy. LIMITATIONS: This was a retrospective observational study using claims data and accuracy of COPD diagnoses could not be verified, nor was information available on severity of disease. The results and conclusions of this study are limited to the population observed and the operational definitions of the study variables. CONCLUSIONS: For most outcomes of interest, BFC and FSC showed comparable real-world effectiveness.


Assuntos
Albuterol/análogos & derivados , Androstadienos/uso terapêutico , Broncodilatadores/uso terapêutico , Budesonida/uso terapêutico , Etanolaminas/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Idoso , Albuterol/economia , Albuterol/uso terapêutico , Androstadienos/economia , Broncodilatadores/administração & dosagem , Broncodilatadores/economia , Budesonida/administração & dosagem , Budesonida/economia , Comorbidade , Custos e Análise de Custo , Combinação de Medicamentos , Quimioterapia Combinada , Etanolaminas/administração & dosagem , Etanolaminas/economia , Feminino , Combinação Fluticasona-Salmeterol , Fumarato de Formoterol , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Masculino , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Doença Pulmonar Obstrutiva Crônica/economia , Estudos Retrospectivos
11.
J Allergy Clin Immunol ; 128(5): 983-8, 2011 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-21906790

RESUMO

BACKGROUND: The Test for Respiratory and Asthma Control in Kids (TRACK) is the first validated questionnaire to assess respiratory and asthma control exclusively in young children. OBJECTIVE: We sought to determine the minimally important difference (MID) for interpreting meaningful changes in individual patients' TRACK scores. METHODS: In this prospective, nonrandomized, longitudinal study conducted at 20 US pediatric sites, TRACK was administered at 2 separate clinic visits (4-6 weeks apart) to caregivers of children aged less than 5 years with symptoms consistent with asthma. Anchor-based methods were used to determine the MID from mean score differences between patients based on multiple criteria measures: physician guidelines-based respiratory control rating, physician-recommended changes to therapy, episodes of symptoms lasting more than 24 hours in the past 3 months, oral corticosteroid use for respiratory tract illnesses in the past year, physician-assessed change in control status at follow-up, and caregiver-reported change in respiratory status. The MID also was determined from distribution-based methods. RESULTS: TRACK scores were assessed at baseline (426 caregivers) and follow-up (396 caregivers). Mean differences in TRACK scores between patients differing on criteria measures ranged from 3.4 to 16.4 points (mean, 11.1 points). Distribution-based techniques confirmed these findings. Based on logistic regression analyses, scoring 10 or more points less than 80 on TRACK was associated with an approximately 2-fold increased odds of having uncontrolled asthma or respiratory symptoms. CONCLUSION: Changes in TRACK scores of 10 or more points represent clinically meaningful changes in respiratory control status in individual young children with respiratory symptoms consistent with asthma and should alert health care providers to re-evaluate asthma management.


Assuntos
Asma/diagnóstico , Inquéritos e Questionários , Cuidadores , Pré-Escolar , Feminino , Humanos , Lactente , Estudos Longitudinais , Masculino
12.
Pediatrics ; 127(3): e737-47, 2011 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-21339276

RESUMO

OBJECTIVE: The 5-item, caregiver-completed Test for Respiratory and Asthma Control in Kids (TRACK) was developed and validated primarily in asthma-specialist practices to monitor respiratory control in preschool-aged children. This longitudinal study in children treated by pediatricians evaluated the responsiveness of TRACK to changes in respiratory- and asthma-control status over time and further assessed TRACK's reliability and validity. PATIENTS AND METHODS: Caregivers of children younger than 5 years with symptoms consistent with asthma within the past year (N = 438) completed TRACK at 2 clinic visits separated by 4 to 6 weeks. Physicians were blinded to caregiver assessment, completed a guidelines-based respiratory-control survey at both visits, and were asked whether the visit resulted in a change in therapy. Responsiveness of TRACK to change in respiratory-control status over time was evaluated; reliability and discriminant validity were assessed. RESULTS: Mean changes in TRACK scores from the initial to follow-up visits differed in the expected direction in subsets of children whose clinical status improved, remained unchanged, or worsened based on physicians' and caregivers' assessments (P < .001). Mean TRACK scores also differed significantly (P < .001) across patient subsets, with lower scores (indicating poorer control) in children classified as very poorly controlled, in those who required a step-up in therapy, and in those who had 4 or more episodes or attacks of wheezing, coughing, or shortness of breath per week in the past 3 months. CONCLUSIONS: The present study extends the validity and reliability of TRACK by demonstrating its responsiveness to change in respiratory-control status over time in preschool-aged children with symptoms consistent with asthma.


Assuntos
Asma/prevenção & controle , Cuidadores , Inquéritos e Questionários , Adolescente , Adulto , Asma/epidemiologia , Pré-Escolar , Estudos Transversais , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Morbidade/tendências , Estudos Prospectivos , Qualidade de Vida , Curva ROC , Estados Unidos/epidemiologia , Adulto Jovem
13.
Clin Ther ; 32(7): 1320-8, 2010 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-20678680

RESUMO

BACKGROUND: According to evidence-based guidelines, the combination of inhaled corticosteroids and inhaled long-acting beta(2)-agonists in a single inhaler is recommended for patients with chronic obstructive pulmonary disease (COPD) who are experiencing exacerbations. The relative effectiveness of combination products such as budesonide/formoterol (BUD/FM) and fluticasone propionate/salmeterol (FP/SM) has not been well documented. OBJECTIVE: This study was conducted to investigate the different outcomes associated with the use of either BUD/FM or FP/SM in a single inhaler in patients with COPD. Outcomes included rates of exacerbations, emergency department (ED) visits and hospitalizations for COPD, medication utilization, and treatment adherence. METHODS: A 1-year, population-based, matched cohort study was conducted using administrative health care databases from the Canadian province of Quebec. Patients treated with BUD/FM were matched (1:1) to patients treated with FP/SM based on the following criteria: age group, sex, calendar year of treatment initiation, the number of COPD exacerbations in the year before treatment initiation, and use of inhaled short acting beta(2)-agonists (SABAs) and ipratropium bromide in the 3 months before treatment initiation. COPD exacerbations were defined as a claim for a short-course (< or =14 days) prescription of oral corticosteroids, or an ED visit or a hospitalization for COPD. Events occurring within 15 days were counted as a single exacerbation. Between-group comparisons of the number of exacerbations, ED visits, and hospitalizations for COPD, as well as claims for oral corticosteroids, were performed using Poisson regression models. Between-group comparisons of the mean number of doses of SABAs and ipratropium bromide per day were performed using linear regression models. Treatment adherence was also assessed. RESULTS: Of the 2262 patients in the matched cohort, 78.1% were aged > or =65 years and 52.1% were men. COPD exacerbations, claims for oral corticosteroids, use of SABAs, and patient adherence to treatment did not differ significantly between the BUD/FM and FP/SM groups. However, the BUD/FM group was significantly less likely to have an ED visit (adjusted relative risk [RR] = 0.75; 95% CI, 0.58 to 0.97) or hospitalization (adjusted RR = 0.61; 95% CI, 0.47 to 0.81) for COPD and had fewer claims for prescriptions for tiotropium (adjusted RR = 0.71; 95% CI, 0.57 to 0.89). The BUD/FM group also used fewer doses of ipratroprium bromide than the FP/SM group (adjusted mean difference, -0.2 dose; 95% CI, -0.3 to -0.1). CONCLUSIONS: These COPD patients treated with BUD/FM were less likely to have ED visits and hospitalizations for COPD and used fewer doses of anticholinergic medication than patients treated with FP/SM in the year after treatment initiation. However, due to the observational nature of the study design, we cannot conclude with certainty that the medication was the only factor responsible for the observed differences.


Assuntos
Broncodilatadores/uso terapêutico , Adesão à Medicação , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Adulto , Idoso , Idoso de 80 Anos ou mais , Albuterol/administração & dosagem , Albuterol/análogos & derivados , Albuterol/farmacologia , Albuterol/uso terapêutico , Androstadienos/administração & dosagem , Androstadienos/farmacologia , Androstadienos/uso terapêutico , Broncodilatadores/administração & dosagem , Broncodilatadores/farmacologia , Budesonida/administração & dosagem , Budesonida/farmacologia , Budesonida/uso terapêutico , Estudos de Coortes , Bases de Dados Factuais , Combinação de Medicamentos , Serviço Hospitalar de Emergência/estatística & dados numéricos , Etanolaminas/administração & dosagem , Etanolaminas/farmacologia , Etanolaminas/uso terapêutico , Feminino , Fluticasona , Fumarato de Formoterol , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Quebeque , Estudos Retrospectivos , Xinafoato de Salmeterol
14.
Ann Allergy Asthma Immunol ; 103(2): 114-20, 2009 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-19739423

RESUMO

BACKGROUND: The burden of pediatric asthma on parents' health care costs is not well described. OBJECTIVE: To evaluate direct and indirect health care costs of employees with children with asthma (asthma cohort) compared with employees with children without asthma (control cohort). METHODS: Retrospective analysis of 2001-2007 employer data including employee medical and pharmacy claims, payroll, work absence, demographics, and dependent medical and pharmacy claims. Asthma diagnosis or pharmacy claims for asthma controller medications were used to identify employees with dependents younger than 12 years for the asthma cohort. Controls were identified based on dependent age and lack of an asthma diagnosis or pharmacy claim for a controller medication. All costs were calculated using 2-part regression models that controlled for demographics, job information, Charlson Comorbidity Index, and region. Costs were calculated for employee health care, prescriptions, sick leave, short- and long-term disability, and workers' compensation and dependent health care and prescriptions. Costs were compared for employees with children aged 0 through 3 years, 4 through 7 years, 8 through 11 years, and younger than 12 years. RESULTS: Data were available for 11,794 asthma cohort employees and 64,812 controls. Statistically significant annual cost differences were identified for employee health care ($154, P < .001), prescriptions ($95, P < .001), sick leave (-$41, P < .001), short-term disability (-$41, P = .008), dependent health care ($862, P < .001), and prescriptions ($534, P < .001). CONCLUSIONS: Pediatric asthma is associated with significant additional health care and prescription costs for both employees and dependents.


Assuntos
Asma/economia , Custos de Saúde para o Empregador/estatística & dados numéricos , Corticosteroides/administração & dosagem , Corticosteroides/uso terapêutico , Antagonistas Adrenérgicos beta/uso terapêutico , Adulto , Fatores Etários , Asma/tratamento farmacológico , Criança , Pré-Escolar , Grupos de Populações Continentais/estatística & dados numéricos , Bases de Dados Factuais , Assistência à Saúde/economia , Feminino , Humanos , Lactente , Benefícios do Seguro/economia , Masculino , Medicamentos sob Prescrição/economia , Estudos Retrospectivos , Licença Médica/economia , Estados Unidos , Indenização aos Trabalhadores/economia
15.
P T ; 34(2): 80-5, 2009 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-19561841

RESUMO

With nearly 23 million people affected by asthma each year, optimizing care among patients with persistent disease is a constant challenge for health care providers. The Asthma Utilization Rx Analyzer (AURA) tool enables health plan managers to evaluate quality and resource utilization for its members with asthma by analyzing medical and pharmacy claims. Customizable quality measures allow users of the tool to generate results from specific plans in order to optimize asthma disease management.

16.
J Allergy Clin Immunol ; 123(4): 833-9.e9, 2009 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-19348922

RESUMO

BACKGROUND: A validated questionnaire is needed to monitor respiratory control in preschool-aged children. OBJECTIVE: We sought to develop and validate a caregiver-completed questionnaire that measures respiratory control in young children. METHODS: A 33-item questionnaire that included asthma impairment and risk items was administered to 486 caregivers of children aged younger than 5 years with a current, recent, or past history of respiratory symptoms. Stepwise regression was used to select a subset of items with the greatest discriminant validity in relation to guidelines-defined asthma control in a random two-thirds development sample. Reliability, validity, and ability to screen for respiratory control problems were tested in development and validation samples (remaining one-third sample). RESULTS: The content of the 5 items selected, the Test for Respiratory and Asthma Control in Kids (TRACK), included frequency of respiratory symptoms (wheeze, cough, shortness of breath), activity limitation, and nighttime awakenings in the past 4 weeks; rescue medication use in the past 3 months; and oral corticosteroid use in the previous year. Reliability was greater than 0.70 in both samples. ANOVA showed that mean scores differed significantly (P < .001) in the expected direction across both samples for 3 levels of guidelines-based respiratory control, physician-recommended change in therapy, and symptom status. In the development and validation samples, screening analyses revealed areas under the receiver operating characteristic curve of 0.88 and 0.82, respectively; control status was correctly classified in 81% and 78% of cases. CONCLUSION: TRACK is a valid, easy-to-administer, caregiver-completed questionnaire of respiratory control in preschool-aged children with symptoms consistent with asthma.


Assuntos
Asma/terapia , Cuidadores , Respiração , Inquéritos e Questionários , Adolescente , Adulto , Pré-Escolar , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Curva ROC
17.
Drugs ; 69(5): 549-65, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19368417

RESUMO

BACKGROUND: Combination therapy with a long-acting bronchodilator and an inhaled corticosteroid (ICS) is recommended in patients with chronic obstructive pulmonary disease (COPD) who have frequent exacerbations. The efficacy and tolerability of the combination of budesonide/formoterol have been demonstrated in patients with COPD when administered via the dry powder inhaler (DPI) in a 1-year study and when administered via the hydrofluoroalkane (HFA) pressurized metered-dose inhaler (pMDI) in a 6-month study. OBJECTIVE: This study assessed the long-term efficacy and tolerability of budesonide/formoterol HFA pMDI in patients with moderate to very severe COPD. METHODS: This was a 12-month, randomized, double-blind, double-dummy, parallel-group, active- and placebo-controlled, multicentre study (NCT00206167) of 1, 964 patients aged >or =40 years with moderate to very severe COPD conducted from 2005 to 2007 at 237 sites in the US, Europe and Mexico. After 2 weeks of treatment based on previous therapy (ICSs, short-acting bronchodilators allowed), patients received one of the following treatments twice daily: budesonide/formoterol pMDI 160/4.5 microg x two inhalations (320/9 microg); budesonide/formoterol pMDI 80/4.5 microg x two inhalations (160/9 microg); formoterol DPI 4.5 microg x two inhalations (9 microg); or placebo. MAIN OUTCOME MEASURES: The co-primary efficacy variables were pre-dose forced expiratory volume in 1 second (FEV1) and 1-hour post-dose FEV1. . RESULTS: Budesonide/formoterol 320/9 microg demonstrated greater improvements in pre-dose FEV1 versus formoterol (p = 0.008), and both budesonide/formoterol doses demonstrated greater improvements in 1-hour post-dose FEV1 versus placebo (p < 0.001). The rate of COPD exacerbations was lower in both budesonide/formoterol groups compared with formoterol and placebo (p

Assuntos
Broncodilatadores/administração & dosagem , Budesonida/administração & dosagem , Etanolaminas/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Adulto , Propelentes de Aerossol/química , Idoso , Idoso de 80 Anos ou mais , Broncodilatadores/efeitos adversos , Broncodilatadores/uso terapêutico , Budesonida/efeitos adversos , Budesonida/uso terapêutico , Método Duplo-Cego , Combinação de Medicamentos , Etanolaminas/efeitos adversos , Etanolaminas/uso terapêutico , Feminino , Seguimentos , Volume Expiratório Forçado , Fumarato de Formoterol , Humanos , Hidrocarbonetos Fluorados/química , Masculino , Inaladores Dosimetrados , Pessoa de Meia-Idade , Índice de Gravidade de Doença
18.
Drugs ; 68(14): 1975-2000, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18778120

RESUMO

BACKGROUND: The combination of an inhaled corticosteroid (ICS) and a long-acting bronchodilator is recommended in the treatment of patients with chronic obstructive pulmonary disease (COPD) who have frequent exacerbations. Budesonide/formoterol dry powder inhaler (DPI) has demonstrated efficacy and tolerability in patients with COPD. OBJECTIVE: To evaluate the efficacy and tolerability of budesonide/formoterol administered via one hydrofluoroalkane pressurized metered-dose inhaler (pMDI) in patients with COPD. METHODS: This was a 6-month, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicentre study (NCT00206154) of 1704 patients aged > or =40 years with moderate to very severe COPD conducted in 194 centres in the US, Czech Republic, the Netherlands, Poland and South Africa. After 2 weeks of treatment based on previous therapy (ICSs and short-acting bronchodilators allowed during the run-in period), patients received one of the following treatments administered twice daily: budesonide/formoterol pMDI 160/4.5 microg x two inhalations (320/9 microg); budesonide/formoterol pMDI 80/4.5 microg x two inhalations (160/9 microg); budesonide pMDI 160 microg x two inhalations (320 microg) plus formoterol DPI 4.5 microg x two inhalations (9 microg); budesonide pMDI 160 microg x two inhalations (320 microg); formoterol DPI 4.5 microg x two inhalations (9 microg); or placebo. MAIN OUTCOME MEASURES: The co-primary efficacy variables were pre-dose forced expiratory volume in 1 second (FEV(1)) and 1-hour post-dose FEV(1). RESULTS: Budesonide/formoterol 320/9 microg demonstrated significantly greater improvements in pre-dose FEV(1) versus formoterol (p = 0.026; pre-specified primary comparator) and 1-hour post-dose FEV(1) versus budesonide (p < 0.001; pre-specified primary comparator); budesonide/formoterol 160/9 microg demonstrated significantly greater improvements versus budesonide (p < 0.001) for 1-hour post-dose FEV(1) but not versus formoterol for pre-dose FEV(1). Dyspnoea (measured using the Breathlessness Diary) and health-related quality-of-life (HR-QOL) scores (based on the St George's Respiratory Questionnaire total score) were significantly improved with both dosage strengths of budesonide/formoterol compared with budesonide, formoterol and placebo (p < or = 0.044 for all). Although not powered a priori for comparisons, the number of exacerbations per patient-treatment year requiring treatment with oral corticosteroids and/or hospitalization was numerically (20-25%) lower with the budesonide-containing treatments (0.710-0.884) versus formoterol (1.098) and placebo (1.110). This result was driven by the exacerbations requiring treatment with oral corticosteroids (79-120 events). The number of exacerbations resulting in hospitalization was very low across treatment groups (11-22); the number per patient-treatment year was significantly different for budesonide/formoterol 320/9 microg (0.158) versus other treatment groups (0.081-0.108) except budesonide/formoterol 160/9 microg (0.139), and for budesonide/formoterol 160/9 microg versus formoterol (0.081) [p < or = 0.05]. All treatments were generally well tolerated. The incidence of individual non-fatal serious adverse events was similar across all treatment groups, except COPD, which was highest in the budesonide/formoterol 320/9 microg group (6.1%) and lowest in the budesonide (3.6%) and formoterol (3.9%) groups, with a range of 4.3-4.6% in the budesonide/formoterol 160/9 microg, budesonide plus formoterol and placebo groups. Budesonide/formoterol had a safety profile comparable with that of the monocomponents and placebo. There was no increase in the incidence of pneumonia in the active treatment groups relative to placebo. CONCLUSIONS: Budesonide/formoterol pMDI 320/9 microg demonstrated significantly greater efficacy for pulmonary function on both co-primary endpoints versus the pre-specified comparators (formoterol DPI 9 microg for pre-dose FEV(1) and budesonide pMDI 320 microg for 1-hour post-dose FEV(1)). Budesonide/formoterol pMDI 160/9 microg demonstrated significantly greater efficacy for 1-hour post-dose FEV(1) versus budesonide pMDI 320 microg. Dyspnoea scores and HR-QOL were significantly improved with both budesonide/formoterol pMDI dosage strengths versus both monocomponents and placebo. Both budesonide/formoterol pMDI dosage strengths were well tolerated relative to the monocomponents and placebo.


Assuntos
Anti-Inflamatórios/efeitos adversos , Anti-Inflamatórios/uso terapêutico , Broncodilatadores/efeitos adversos , Broncodilatadores/uso terapêutico , Budesonida/efeitos adversos , Budesonida/uso terapêutico , Etanolaminas/efeitos adversos , Etanolaminas/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Adulto , Propelentes de Aerossol , Idoso , Idoso de 80 Anos ou mais , Anti-Inflamatórios/administração & dosagem , Broncodilatadores/administração & dosagem , Budesonida/administração & dosagem , Método Duplo-Cego , Combinação de Medicamentos , Dispneia/induzido quimicamente , Etanolaminas/administração & dosagem , Feminino , Volume Expiratório Forçado , Fumarato de Formoterol , Humanos , Masculino , Inaladores Dosimetrados , Pessoa de Meia-Idade , Qualidade de Vida , Testes de Função Respiratória
19.
Qual Life Res ; 17(8): 1117-20, 2008 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-18777201

RESUMO

OBJECTIVES: This study examined the measurement equivalence of the original paper-based vertical format of the EQ-5D visual analog scale (EQ VAS) with a touch-screen computer-based horizontal format. METHODS: A total of 314 subjects were administered two modes of the EQ VAS in a randomized crossover design. One mode was the original paper-based 20 cm vertical EQ VAS; the other mode was touch-screen-based. Measurement equivalence was assessed by testing the 95% confidence interval of the mean differences from an equivalence threshold of -3 to +3 points on the VAS and evaluating the intraclass correlation coefficient (ICC). RESULTS: The adjusted mean (SE) EQ VAS score was 80.96 (0.87) on the paper and 79.59 (0.85) on the touch-screen. The mean (CI) difference between scores on the two formats was 1.37 with a confidence interval of 0.175-2.559, wholly contained within the equivalence interval. The ICC was 0.75, indicating acceptable agreement between the two modes. Almost a third (30.1%) of the respondents reported identical scores on both formats. CONCLUSION: These results provide evidence for the measurement equivalence of this EQ VAS touch-screen administration mode with the original paper mode.


Assuntos
Medição da Dor/instrumentação , Papel , Qualidade de Vida/psicologia , Interface Usuário-Computador , Adulto , Análise de Variância , Intervalos de Confiança , Estudos Cross-Over , Feminino , Humanos , Masculino , Psicometria , Estatística como Assunto
20.
Am J Health Syst Pharm ; 64(10): 1054-61, 2007 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-17494905

RESUMO

PURPOSE: To evaluate the effectiveness of budesonide inhalation suspension relative to other common asthma therapies in a high-risk population, a study was conducted to compare the risk of having a repeat asthma-related hospitalization or emergency department (ED) visit in a Medicaid population of children; the relationship between asthma medication adherence level and repeat asthma hospitalizations or ED visits was also evaluated. METHODS: Children eight years of age or younger, with a hospitalization or ED visit for asthma between January 1999 and June 2001 (index event), were identified in a Florida Medicaid database. Claims data for each child were examined 12 months before and after the index event. Cox proportional hazards regression was used to model the risk of subsequent asthma exacerbation according to the asthma medication received during the first 30 days after the index event. Logistic regression was used to model the relationship between medication adherence as measured by the medication possession ratio (MPR) and the likelihood of a subsequent asthma exacerbation. RESULTS: There were 10,976 children in the study. Patients who had a claim for budesonide inhalation suspension had a lower risk of a subsequent hospitalization or ED visit (hazard ratio, 0.55; 95% confidence interval, 0.41-0.76; p < 0.001) than patients who did not have budesonide inhalation suspension claims. Other controller medications were not associated with a reduction in the risk of subsequent asthma exacerbations. Adherence to medication was poor (a median MPR of 0.08 for budesonide inhalation suspension and a median MPR of 0.16 for any asthma controller medication). The odds of a repeat hospitalization or ED visit were significantly lower for children who were adherent to their asthma controller medication. CONCLUSION: Children with asthma and insured by Medicaid were at a high risk of repeat exacerbations leading to increased hospitalizations and ED visits. Treatment with budesonide inhalation suspension in the first 30 days after a hospitalization or ED visit for asthma was associated with a significant reduction in the risk of repeat asthma-related hospitalizations or ED visits during the following year. Children who were adherent to their asthma controller medication had significantly lower odds of having a subsequent asthma exacerbation.


Assuntos
Asma/tratamento farmacológico , Budesonida/uso terapêutico , Administração por Inalação , Broncodilatadores/administração & dosagem , Broncodilatadores/uso terapêutico , Budesonida/administração & dosagem , Criança , Pré-Escolar , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Medicaid , Cooperação do Paciente , Recidiva , Índice de Gravidade de Doença
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