RESUMEN
OBJECTIVE: Black and Latino children experience significantly worse asthma morbidity than their white peers for multifactorial reasons. This study investigated differences in family-provider interactions for pediatric asthma, based on race/ethnicity. METHODS: This was a cross-sectional study of parent surveys of asthmatic children within the Population-Based Effectiveness in Asthma and Lung Diseases Network. Our study population comprised 647 parents with survey response data. Data on self-reported race/ethnicity of the child were collected from parents of the children with asthma. Outcomes studied were responses to the questions about family-provider interactions in the previous 12 months: (1) number of visits with asthma provider; (2) number of times provider reviewed asthma medications with patient/family; (3) review of a written asthma treatment plan with provider; and (4) preferences about making asthma decisions. RESULTS: In multivariate adjusted analyses controlling for asthma control and other co-morbidities, black children had fewer visits in the previous 12 months for asthma than white children: OR 0.63 (95% CI 0.40, 0.99). Additionally, black children were less likely to have a written asthma treatment plan given/reviewed by a provider than their white peers, OR 0.44 (95% CI 0.26, 0.75). There were no significant differences by race in preferences about asthma decision-making nor in the frequency of asthma medication review. CONCLUSION: Black children with asthma have fewer visits with their providers and are less likely to have a written asthma treatment plan than white children. Asthma providers could focus on improving these specific family-provider interactions in minority children.
Asunto(s)
Asma/etnología , Hispánicos o Latinos/estadística & datos numéricos , Visita a Consultorio Médico/estadística & datos numéricos , Médicos de Familia/estadística & datos numéricos , Grupos Raciales/estadística & datos numéricos , Antiasmáticos/uso terapéutico , Asma/tratamiento farmacológico , Niño , Preescolar , Femenino , Humanos , Masculino , Conciliación de Medicamentos , Padres , Satisfacción del Paciente , Encuestas y CuestionariosRESUMEN
OBJECTIVE: Evidence of safety issues associated with long-acting beta2-agonist (LABA) treatment has led to multiple regulatory activities by the U.S. Food and Drug Administration (FDA) on this class of medications. This study describes the impact of the regulatory activities on incident LABA-containing medication dispensing. METHODS: A monthly rolling cohort of asthma patients who were eligible to initiate a LABA-containing product was created in the Mini-Sentinel Distributed Database between January 2005 and June 2011. Cohorts of individuals who initiated LABA were examined for the changes in the proportions of single-ingredient to fixed-dose inhaled corticosteroid (ICS)-LABA initiators, appropriate initiation of LABA-containing products, and use of controller medications. The impact of the 2005 and 2010 FDA regulatory activities associated with LABA-containing products was measured using interrupted time series with segmented regression. RESULTS: LABA-containing product initiation was declining prior to the 2005 regulatory activities and continued to decline over the study period, accompanied by increased initiation of fixed dose ICS-LABA among LABA initiators. While the 2010 regulatory activities had no immediate impact on the proportion of LABA initiation in patients with prior controller medication dispensing and/or poor asthma control, there was an increasing positive trend toward LABA initiation in the appropriate patient population after the regulatory activities. CONCLUSION: The 2005 and 2010 FDA regulatory activities likely had an impact on communicating the safety concerns of LABA products. However, the impact cannot be viewed independent of scientific publications, guidelines for asthma treatment and other regulatory activities.
Asunto(s)
Agonistas de Receptores Adrenérgicos beta 2/efectos adversos , Antiasmáticos/efectos adversos , Asma/tratamiento farmacológico , Revisión de la Utilización de Medicamentos/estadística & datos numéricos , United States Food and Drug Administration/legislación & jurisprudencia , Administración por Inhalación , Adolescente , Agonistas de Receptores Adrenérgicos beta 2/administración & dosificación , Adulto , Antiasmáticos/administración & dosificación , Niño , Preescolar , Estudios de Cohortes , Combinación de Medicamentos , Prescripciones de Medicamentos/estadística & datos numéricos , Femenino , Glucocorticoides/administración & dosificación , Humanos , Lactante , Revisión de Utilización de Seguros , Masculino , Persona de Mediana Edad , Estados Unidos , Adulto JovenRESUMEN
OBJECTIVE: Nonadherence to controller and overuse of reliever asthma medications are associated with exacerbations. We aimed to determine patterns of seasonal asthma medication use and to identify time period(s) during which interventions to improve medication adherence could reduce asthma morbidity. METHODS: We conducted a retrospective cohort study of asthmatics 4-50 years of age and enrolled in three diverse health insurance plans. Seasonal patterns of medications were reported by monthly prescription fill rates per 1000 individuals with asthma from 1998 to 2013, and stratified by healthcare plan, sex, and age. RESULTS: There was a distinct and consistent seasonal fill pattern for all asthma medications. The lowest fill rate was observed in the month of July. Fills increased in the autumn and remained high throughout the winter and spring. Compared with the month of May with high medication fills, July represented a relative decrease of fills ranging from 13% (rate ratio, RR: 0.87, 95% confidence interval, 95%CI: 0.72-1.04) for the combination of inhaled corticosteroids (ICS) + long acting beta agonists (LABA) to 45% (RR: 0.55, 95%CI: 0.49-0.61) for oral corticosteroids. Such a seasonal pattern was observed each year across the 16-year study period, among healthcare plans, sexes, and ages. LABA containing control medication (ICS+LABA and LABA) fill rates were more prevalent in older asthmatics, while leukotriene receptor antagonists were more prevalent in the younger population. CONCLUSIONS: A seasonal pattern of asthma medication fill rates likely represents a reactive response to a loss of disease control and increased symptoms. Adherence to and consistent use of asthma medications among individuals who use medications in reaction to seasonal exacerbations might be a key component in reducing the risk of asthma exacerbations.
Asunto(s)
Antiasmáticos/uso terapéutico , Asma/tratamiento farmacológico , Prescripciones de Medicamentos/estadística & datos numéricos , Estaciones del Año , Administración por Inhalación , Administración Oral , Adolescente , Agonistas Adrenérgicos beta/uso terapéutico , Adulto , Niño , Preescolar , Quimioterapia Combinada , Femenino , Glucocorticoides/uso terapéutico , Humanos , Masculino , Cumplimiento de la Medicación/estadística & datos numéricos , Persona de Mediana Edad , Estudios Retrospectivos , Estados Unidos , Adulto JovenRESUMEN
BACKGROUND: Safety concerns associated with long-acting ß2-agonists (LABAs) have led to many US Food and Drug Administration (FDA) regulatory activities for this class of drugs. Little is known about the effect of these regulatory activities on use of LABA-containing agents or other asthma medications. METHODS: We created rolling cohorts of pediatric and adult asthmatic patients in the Mini-Sentinel Distributed Database between January 2005 and June 2011. The proportions of asthmatic patients using LABA-containing products, inhaled corticosteroids (ICSs), leukotriene modifiers, short-acting ß2-agonists, oral corticosteroids, other bronchodilators, and no medications were measured on a monthly basis, and the changes were evaluated by using interrupted time series with segmented regression analysis. RESULTS: When the 2005 regulatory activity was announced, there were statistically significant decreases in the use of fixed-dose ICS-LABA agents in children (-0.98 percentage points) and adults (-1.24 percentage points). Increased use of ICSs and leukotriene modifiers was observed just after the regulatory activities were announced in both children and adults. Although of smaller magnitude, continued favorable changes in the use of LABA agents were observed after the 2010 FDA regulatory activity. CONCLUSION: The 2005 and 2010 FDA regulatory activities might have contributed to reduced use of LABA agents, as intended; however, their effect, independent of other factors, cannot be determined. Use of other classes of asthma medications was similarly affected.
Asunto(s)
Agonistas de Receptores Adrenérgicos beta 2/uso terapéutico , Antiasmáticos/uso terapéutico , Asma/tratamiento farmacológico , Pautas de la Práctica en Medicina , Adolescente , Agonistas de Receptores Adrenérgicos beta 2/administración & dosificación , Agonistas de Receptores Adrenérgicos beta 2/efectos adversos , Adulto , Antiasmáticos/administración & dosificación , Antiasmáticos/efectos adversos , Niño , Preescolar , Control de Medicamentos y Narcóticos/historia , Femenino , Historia del Siglo XXI , Humanos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Estados Unidos , United States Food and Drug Administration , Adulto JovenRESUMEN
BACKGROUND: Among patients with diabetes, racial differences in cardiometabolic risk factor control are common. The extent to which differences in medication adherence contribute to such disparities is not known. We examined whether medication adherence, controlling for treatment intensification, could explain differences in risk factor control between black and white patients with diabetes. METHODS: We identified three cohorts of black and white patients treated with oral medications and who had poor risk factor control at baseline (2009): those with glycated hemoglobin (HbA1c) >8 % (n = 37,873), low-density lipoprotein cholesterol (LDL-C) >100 mg/dl (n = 27,954), and systolic blood pressure (SBP) >130 mm Hg (n = 63,641). Subjects included insured adults with diabetes who were receiving care in one of nine U.S. integrated health systems comprising the SUrveillance, PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) consortium. Baseline and follow-up risk factor control, sociodemographic, and clinical characteristics were obtained from electronic health records. Pharmacy-dispensing data were used to estimate medication adherence (i.e., medication refill adherence [MRA]) and treatment intensification (i.e., dose increase or addition of new medication class) between baseline and follow-up. County-level income and educational attainment were estimated via geocoding. Logistic regression models were used to test the association between race and follow-up risk factor control. Models were specified with and without medication adherence to evaluate its role as a mediator. RESULTS: We observed poorer medication adherence among black patients than white patients (p < 0.01): 50.6 % of blacks versus 39.7 % of whites were not highly adherent (i.e., MRA <80 %) to HbA1c oral medication(s); 58.4 % of blacks and 46.7 % of whites were not highly adherent to lipid medication(s); and 33.4 % of blacks and 23.7 % of whites were not highly adherent to BP medication(s). Across all cardiometabolic risk factors, blacks were significantly less likely to achieve control (p < 0.01): 41.5 % of blacks and 45.8 % of whites achieved HbA1c <8 %; 52.6 % of blacks and 60.8 % of whites achieved LDL-C <100; and 45.7 % of blacks and 53.6 % of whites achieved SBP <130. Adjusting for medication adherence/treatment intensification did not alter these patterns or model fit statistics. CONCLUSIONS: Medication adherence failed to explain observed racial differences in the achievement of HbA1c, LDL-C, and SBP control among insured patients with diabetes.
Asunto(s)
Negro o Afroamericano/psicología , Enfermedades Cardiovasculares/etnología , Diabetes Mellitus/etnología , Cumplimiento de la Medicación/etnología , Población Blanca/psicología , Adolescente , Adulto , Negro o Afroamericano/estadística & datos numéricos , Anciano , Presión Sanguínea/fisiología , Enfermedades Cardiovasculares/prevención & control , LDL-Colesterol/sangre , Diabetes Mellitus/sangre , Diabetes Mellitus/tratamiento farmacológico , Diabetes Mellitus/psicología , Femenino , Estudios de Seguimiento , Hemoglobina Glucada/metabolismo , Humanos , Masculino , Cumplimiento de la Medicación/estadística & datos numéricos , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo , Factores Socioeconómicos , Estados Unidos , Población Blanca/estadística & datos numéricos , Adulto JovenRESUMEN
An observational cohort analysis was conducted within the Surveillance, Prevention, and Management of Diabetes Mellitus (SUPREME-DM) DataLink, a consortium of 11 integrated health-care delivery systems with electronic health records in 10 US states. Among nearly 7 million adults aged 20 years or older, we estimated annual diabetes incidence per 1,000 persons overall and by age, sex, race/ethnicity, and body mass index. We identified 289,050 incident cases of diabetes. Age- and sex-adjusted population incidence was stable between 2006 and 2010, ranging from 10.3 per 1,000 adults (95% confidence interval (CI): 9.8, 10.7) to 11.3 per 1,000 adults (95% CI: 11.0, 11.7). Adjusted incidence was significantly higher in 2011 (11.5, 95% CI: 10.9, 12.0) than in the 2 years with the lowest incidence. A similar pattern was observed in most prespecified subgroups, but only the differences for persons who were not white were significant. In 2006, 56% of incident cases had a glycated hemoglobin (hemoglobin A1c) test as one of the pair of events identifying diabetes. By 2011, that number was 74%. In conclusion, overall diabetes incidence in this population did not significantly increase between 2006 and 2010, but increases in hemoglobin A1c testing may have contributed to rising diabetes incidence among nonwhites in 2011.
Asunto(s)
Análisis Químico de la Sangre/tendencias , Diabetes Mellitus/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Glucemia/análisis , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/etnología , Femenino , Hemoglobina Glucada/análisis , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estados Unidos/epidemiologíaRESUMEN
We compared the impact of 3 confounding adjustment procedures-covariate-adjusted regression, propensity score regression, and high-dimensional propensity score regression-to assess the effects of selected asthma controller medication use (leukotriene antagonists and inhaled corticosteroids) on the following 4 asthma-related adverse outcomes: emergency department visits, hospitalizations, oral corticosteroid use, and the composite outcome of these. We examined a cohort of 24,680 new users who were 4-17 years of age at the incident dispensing from the Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) Network of 5 commercial health plans and TennCare, the Tennessee Medicaid program, during the period January 1, 2004, to December 31, 2010. The 3 methods yielded similar results, indicating that pediatric patients treated with leukotriene antagonists were no more likely than those treated with inhaled corticosteroids to experience adverse outcomes. Children in the TennCare population who had a diagnosis of allergic rhinitis and who then initiated the use of leukotriene antagonists were less likely to experience an asthma-related emergency department visit. A plausible explanation is that our data set is large enough that the 2 advanced propensity score-based analyses do not have advantages over the traditional covariate-adjusted regression approach. We provide important observations on how to correctly apply the methods in observational data analysis and suggest statistical research areas that need more work to guide implementation.
Asunto(s)
Antiasmáticos/uso terapéutico , Asma/tratamiento farmacológico , Adolescente , Corticoesteroides/uso terapéutico , Niño , Preescolar , Factores de Confusión Epidemiológicos , Interpretación Estadística de Datos , Servicio de Urgencia en Hospital/estadística & datos numéricos , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Antagonistas de Leucotrieno/uso terapéutico , Masculino , Puntaje de Propensión , Análisis de Regresión , Resultado del TratamientoRESUMEN
PURPOSE: Antihyperglycemic medication intensification practices among patients with incident diabetes are incompletely understood. We characterized the first intensification the year after oral antihyperglycemic medication initiation among incident diabetes patients. METHODS: This retrospective cohort study across 11 US health systems included adults identified with incident diabetes between 2005 and 2009 who started oral antihyperglycemic monotherapy or combination therapy within 6 months after diabetes identification. We determined intensification, defined as increased index medication dosage, addition of another oral medication, or switch to/addition of insulin 31-365 days after initial antihyperglycemic dispensing. Cox regression was used to assess intensification for patient, temporal, and system covariates, adjusting for glycosylated hemoglobin (HbA1c) as a time-dependent variable. RESULTS: Among 41,233 patients, 33.5% and 45.3% had treatment intensified within 6 and 12 months, respectively. This first intensification was most often with increased index medication dosage (78%), least often with insulin (<1%). HbA1c% was strongly associated with intensification (adjusted hazard ratios [HR] 1.59, 3.62, 4.44, and 5.52 for HbA1c 6.5% to <7%, 7% to <7.5%, 7.5 to <8%, and ≥8%, respectively, all P < 0.001, compared with HbA1c < 6.5%). In patients initially on monotherapy, age modified the HbA1c effect: at HbA1c < 7%, the HR differed little between middle-aged and older patients; at HbA1c ≥ 7%, the HR decreased with older age (e.g., age 40-49 years and HbA1c ≥ 8%: HR 8.14; age ≥ 80 years and HbA1c ≥ 8%: HR 4.44; compared with age ≥ 80 years and HbA1c < 6.5%). Within 1 year, 84.3% achieved HbA1c < 8%; 65.1% achieved HbA1c < 7%. CONCLUSIONS: Clinicians appear to be applying treatment intensification guidelines and individualizing therapy by considering patient age, achieving glycemic control among most incident diabetes patients.
Asunto(s)
Glucemia/efectos de los fármacos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Guías de Práctica Clínica como Asunto , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Quimioterapia Combinada , Femenino , Hemoglobina Glucada/metabolismo , Humanos , Hipoglucemiantes/administración & dosificación , Insulina/administración & dosificación , Insulina/uso terapéutico , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Tiempo , Estados UnidosRESUMEN
RATIONALE: Statins, or HMG-CoA reductase inhibitors, may aid in the treatment of asthma through their pleiotropic antiinflammatory effects. OBJECTIVES: To examine the effect of statin therapy on asthma-related exacerbations using a large population-based cohort. METHODS: Statin users aged 31 years or greater with asthma were identified from the Population-Based Effectiveness in Asthma and Lung population, which includes data from five health plans. Statin exposure and asthma exacerbations were assessed over a 24-month observation period. Statin users with a statin medication possession ratio greater than or equal to 80% were matched to non-statin users by age, baseline asthma therapy, site of enrollment, season at baseline, and propensity score, which was calculated based on patient demographics and Deyo-Charlson conditions. Asthma exacerbations were defined as two or more oral corticosteroid dispensings, asthma-related emergency department visits, or asthma-related hospitalizations. The association between statin exposure and each of the three outcome measures was assessed using conditional logistic regression. MEASUREMENTS AND MAIN RESULTS: Of the 14,566 statin users, 8,349 statin users were matched to a nonuser. After adjusting for Deyo-Charlson conditions that remained unbalanced after matching, among statin users, statin exposure was associated with decreased odds of having asthma-related emergency department visits (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.53-0.77; P < 0.0001) and two or more oral corticosteroid dispensings (OR, 0.90; 95% CI, 0.81-0.99; P = 0.04). There were no differences in asthma-related hospitalizations (OR, 0.91; 95% CI, 0.66-1.24; P = 0.52). CONCLUSIONS: Among statin users with asthma, statin exposure was associated with decreased odds of asthma-related emergency department visits and oral corticosteroid dispensings.
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Corticoesteroides/uso terapéutico , Asma/tratamiento farmacológico , Servicio de Urgencia en Hospital/estadística & datos numéricos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Hiperlipidemias/tratamiento farmacológico , Administración Oral , Adulto , Anciano , Asma/complicaciones , Estudios de Casos y Controles , Estudios de Cohortes , Progresión de la Enfermedad , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Hiperlipidemias/complicaciones , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Puntaje de Propensión , Resultado del TratamientoRESUMEN
OBJECTIVE: To understand the burden of medication use for patients with newly diagnosed diabetes both before and after diabetes diagnosis and to identify subpopulations of patients with newly diagnosed diabetes who face a relatively high drug burden. DESIGN: Retrospective cohort study. SETTING: 11 integrated health systems in the United States. PARTICIPANTS: 196,654 insured adults 20 years of age or older newly diagnosed with type 1 or type 2 diabetes from January 2005 through December 2009. MAIN OUTCOME MEASURES: Number of unique therapeutic classes of drugs dispensed in the 12 months before and 12 months after diagnosis of diabetes in five categories: overall, antihypertensive agents, antihyperlipidemic agents, mental health agents, and antihyperglycemic agents (in the postdiagnosis period only). RESULTS: The mean number of drug classes used by newly diagnosed patients with diabetes is high before diagnosis (5.0) and increases significantly afterward (6.6). Of this increase, 81% is due to antihyperglycemic initiation and increased use of medications to control hypertension and lipid levels. Multivariate analyses showed that overall drug burden after diabetes diagnosis was higher in women, older, white, and obese patients, as well as among those with higher glycosylated hemoglobin concentrations and comorbidity levels (significant for all comparisons). The overall number of drug classes used by newly diagnosed patients with diabetes after diagnosis decreased slightly but significantly between 2005 and 2009. CONCLUSION: Patients newly diagnosed with diabetes face a substantially increased burden of medications used to control diabetes and other comorbidities. This study shows an increased focus on cardiovascular disease risk factor control after diagnosis of diabetes. However, total drug burden may be slightly decreasing over time.
Asunto(s)
Diabetes Mellitus/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Medicamentos bajo Prescripción/uso terapéutico , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Estados UnidosRESUMEN
PURPOSE: To validate an algorithm based upon International Classification of Diseases, 9(th) revision, Clinical Modification (ICD-9-CM) codes for acute myocardial infarction (AMI) documented within the Mini-Sentinel Distributed Database (MSDD). METHODS: Using an ICD-9-CM-based algorithm (hospitalized patients with 410.x0 or 410.x1 in primary position), we identified a random sample of potential cases of AMI in 2009 from four Data Partners participating in the Mini-Sentinel Program. Cardiologist reviewers used information abstracted from hospital records to assess the likelihood of an AMI diagnosis based on criteria from the Joint European Society of Cardiology and American College of Cardiology Global Task Force. Positive predictive values (PPVs) of the ICD-9-based algorithm were calculated. RESULTS: Of the 153 potential cases of AMI identified, hospital records for 143 (93%) were retrieved and abstracted. Overall, the PPV was 86.0% (95% confidence interval; 79.2%, 91.2%). PPVs ranged from 76.3% to 94.3% across the four Data Partners. CONCLUSIONS: The overall PPV of potential AMI cases, as identified using an ICD-9-CM-based algorithm, may be acceptable for safety surveillance; however, PPVs do vary across Data Partners. This validation effort provides a contemporary estimate of the reliability of this algorithm for use in future surveillance efforts conducted using the Food and Drug Administration's MSDD.
Asunto(s)
Algoritmos , Bases de Datos Factuales/estadística & datos numéricos , Infarto del Miocardio/diagnóstico , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Clasificación Internacional de Enfermedades , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Evaluación de Resultado en la Atención de Salud/métodos , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Estados Unidos , United States Food and Drug AdministrationRESUMEN
PURPOSE: To describe a protocol for active surveillance of acute myocardial infarction (AMI) in users of a recently approved oral antidiabetic medication, saxagliptin, and to provide the rationale for decisions made in drafting the protocol. METHODS: A new-user cohort design is planned for evaluating data from at least four Mini-Sentinel data partners from 1 August 2009 (following US Food and Drug Administration's approval of saxagliptin) through mid-2013. New users of saxagliptin will be compared in separate analyses with new users of sitagliptin, pioglitazone, long-acting insulins, and second-generation sulfonylureas. Two approaches to controlling for confounding will be evaluated: matching by exposure propensity score and stratification by AMI risk score. The primary analyses will use Cox regression models specified in a way that does not require pooling of patient-level data from the data partners. The Cox models are fit to summarized data on risk sets composed of saxagliptin users and similar comparator users at the time of an AMI. Secondary analyses will use alternative methods including Poisson regression and will explore whether further adjustment for covariates available only at some data partners (e.g., blood pressure) modifies results. RESULTS: The results of this study are pending. CONCLUSIONS: The proposed protocol describes a design for surveillance to evaluate the safety of a newly marketed agent as postmarket experience accrues. It uses data from multiple partner organizations without requiring sharing of patient-level data and compares alternative approaches to controlling for confounding. It is hoped that this initial active surveillance project of the Mini-Sentinel will provide insights that inform future population-based surveillance of medical product safety.
Asunto(s)
Adamantano/análogos & derivados , Dipéptidos/efectos adversos , Hipoglucemiantes/efectos adversos , Infarto del Miocardio/epidemiología , Adamantano/efectos adversos , Estudios de Cohortes , Factores de Confusión Epidemiológicos , Inhibidores de la Dipeptidil-Peptidasa IV/efectos adversos , Aprobación de Drogas , Estudios de Seguimiento , Humanos , Infarto del Miocardio/etiología , Distribución de Poisson , Vigilancia de Productos Comercializados/métodos , Modelos de Riesgos Proporcionales , Análisis de Regresión , Estados Unidos/epidemiología , United States Food and Drug AdministrationRESUMEN
OBJECTIVE: To examine changes in children's albuterol use and out-of-pocket (OOP) costs in response to increased copayments after the Food and Drug Administration banned inhalers with chlorofluorocarbon (CFC) propellants. SETTING: Four health maintenance organizations (HMOs), two that increased copayments for albuterol inhalers that went from generic CFC-containing to branded CFC-free versions, and two that retained generic copayments for CFC-free inhalers (controls). We included children with asthma aged 4-17 years with commercial coverage from 2007 to 2010. DESIGN: Interrupted time series with comparison series. DATA: We obtained enrollee and plan characteristics from enrollment files, and utilization data from pharmacy and medical claims; OOP expenditures were extracted from pharmacy claims for two HMOs with cost data available. FINDINGS: There were no significant differences in albuterol use between the group with increased cost-sharing and controls with respect to changes after the policy change. There was a postpolicy increase of $6.11 OOP per month per child using albuterol among those with increased cost-sharing versus $0.36 in controls; the difference between groups was significant (p < .01). CONCLUSIONS: Increased copayments for brand-name CFC-free albuterol after the CFC ban did not lead to a decrease in children's albuterol use, but it led to a modest increase in OOP costs.
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Albuterol/economía , Asma/tratamiento farmacológico , Clorofluorocarburos , Seguro de Costos Compartidos/estadística & datos numéricos , Nebulizadores y Vaporizadores/economía , Adolescente , Niño , Preescolar , Femenino , Sistemas Prepagos de Salud/economía , Sistemas Prepagos de Salud/estadística & datos numéricos , Humanos , Revisión de Utilización de Seguros , Análisis de Series de Tiempo Interrumpido , Masculino , SueloRESUMEN
OBJECTIVE: The cardiovascular safety of saxagliptin, a dipeptidyl-peptidase 4 inhibitor, compared with other antihyperglycemic treatments is not well understood. We prospectively examined the association between saxagliptin use and acute myocardial infarction (AMI). RESEARCH DESIGN AND METHODS: We identified patients aged ≥18 years, starting from the approval date of saxagliptin in 2009 and continuing through August 2014, using data from 18 Mini-Sentinel data partners. We conducted seven sequential assessments comparing saxagliptin separately with sitagliptin, pioglitazone, second-generation sulfonylureas, and long-acting insulin, using disease risk score (DRS) stratification and propensity score (PS) matching to adjust for potential confounders. Sequential testing kept the overall chance of a false-positive signal below 0.05 (one-sided) for each pairwise comparison. RESULTS: We identified 82,264 saxagliptin users and more than 1.5 times as many users of each comparator. At the end of surveillance, the DRS-stratified hazard ratios (HRs) (95% CI) were 1.08 (0.90-1.28) in the comparison with sitagliptin, 1.11 (0.87-1.42) with pioglitazone, 0.79 (0.64-0.98) with sulfonylureas, and 0.57 (0.46-0.70) with long-acting insulin. The corresponding PS-matched HRs were similar. Only one interim analysis of 168 analyses met criteria for a safety signal: the PS-matched saxagliptin-pioglitazone comparison from the fifth sequential analysis, which yielded an HR of 1.63 (1.12-2.37). This association diminished in subsequent analyses. CONCLUSIONS: We did not find a higher AMI risk in saxagliptin users compared with users of other selected antihyperglycemic agents during the first 5 years after U.S. Food and Drug Administration approval of the drug.
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Adamantano/análogos & derivados , Dipéptidos/uso terapéutico , Inhibidores de la Dipeptidil-Peptidasa IV/uso terapéutico , Infarto del Miocardio/tratamiento farmacológico , Infarto del Miocardio/epidemiología , Vigilancia de Productos Comercializados , Enfermedad Aguda , Adamantano/uso terapéutico , Femenino , Estudios de Seguimiento , Humanos , Hipoglucemiantes/uso terapéutico , Incidencia , Insulina de Acción Prolongada/uso terapéutico , Masculino , Persona de Mediana Edad , Pioglitazona , Puntaje de Propensión , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Fosfato de Sitagliptina/uso terapéutico , Compuestos de Sulfonilurea/uso terapéutico , Tiazolidinedionas/uso terapéutico , Estados UnidosRESUMEN
AIMS: Seven-year surveillance study (2005-2011) to evaluate race/ethnic differences in the trends in rates of severe hypoglycemia (SH) in a population of insured, at-risk adults with diabetes. METHODS: SH events were identified via any primary or principal diagnosis from emergency department or inpatient encounters among African American, Asian, Latino and White adult diabetes patients treated with insulin or secretagogues (Sulfonylureas or Meglitinides), receiving care from integrated healthcare delivery systems across the United States. We calculated age- and sex-standardized annual SH rates and average annual percent change (AAPC) in SH rates. RESULTS: Annual SH rates ranged from 1.8% to 2.1% during this 7-year observation period (2,200,471 person-years). African Americans had consistently higher SH rates compared with Whites, while Latinos and Asians had consistently lower rates compared with Whites in each of the 7 years (all p < 0.01). The trend increased significantly only among African Americans (AAPC = +4.3%; 95% CI: +2.1, +6.5%); in the other groups, the AAPC was not significantly different from zero. CONCLUSIONS: Surveillance efforts should monitor the racial/ethnic-specific rates. The factors underlying substantially higher rates of hypoglycemia in African Americans should be evaluated. Clinically and culturally-appropriate strategies to reduce the risk of SH need to be developed and tested.
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Prestación Integrada de Atención de Salud , Diabetes Mellitus/terapia , Disparidades en el Estado de Salud , Hipoglucemia/prevención & control , Adolescente , Adulto , Negro o Afroamericano , Factores de Edad , Estudios de Cohortes , Terapia Combinada/efectos adversos , Diabetes Mellitus/sangre , Diabetes Mellitus/etnología , Femenino , Humanos , Hipoglucemia/epidemiología , Hipoglucemia/etnología , Hipoglucemia/fisiopatología , Masculino , Programas Controlados de Atención en Salud , Persona de Mediana Edad , Vigilancia de la Población , Estudios Retrospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores Sexuales , Estados Unidos/epidemiología , Adulto JovenRESUMEN
BACKGROUND: Underuse of controller medicines among children with asthma remains widespread despite national guidelines. OBJECTIVES: To (1) assess provider prescribing patterns for asthma controller medications; (2) assess how frequently parents' reports of their child's asthma controller medicine use were mismatched with their provider's recommendations; and (3) evaluate parent attitudes and demographic characteristics associated with these mismatches. METHODS: In this cross-sectional study, we conducted linked surveys of parents and providers of children with probable persistent asthma in a Medicaid program and 4 commercial health plans in 2011. Probable persistent asthma was defined as a diagnosis of asthma and 1 or more controller medication dispensing. RESULTS: This study included 740 children (mean age, 8.6 years). Providers for 50% of the children reported prescribing controller medications for daily year-round use, 41% for daily use during active asthma months, and 9% for intermittent use for relief. Among parents, 72% knew which class of controller medication the provider prescribed and 49% knew the administration frequency and the medication class. Parents were less likely to report the same controller medication type as the provider, irrespective of dose and frequency, if they were Latino (odds ratio [OR], 0.23; CI, 0.057-0.90), had a household smoker (OR, 2.87; CI, 0.42-19.6), or believed the controller medicine was not helping (OR, 0.15; CI, 0.048-0.45). CONCLUSIONS: Mismatches between parent reports and providers intentions regarding how the child was supposed to use inhaled steroids occurred for half of the children. Efforts should focus on ways to reduce mismatches between parent and provider intentions regarding controller medication use.
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Antiasmáticos/uso terapéutico , Asma/tratamiento farmacológico , Padres , Guías de Práctica Clínica como Asunto , Pautas de la Práctica en Medicina , Corticoesteroides/uso terapéutico , Agonistas Adrenérgicos beta/uso terapéutico , Niño , Preescolar , Femenino , Personal de Salud , Humanos , Antagonistas de Leucotrieno/uso terapéutico , Masculino , Encuestas y CuestionariosRESUMEN
OBJECTIVE To determine the effect of graft choice (allograft, bone-patellar tendon-bone autograft, or hamstring autograft) on deep tissue infections following anterior cruciate ligament (ACL) reconstructions. DESIGN Retrospective cohort study. SETTING AND POPULATION Patients from 6 US health plans who underwent ACL reconstruction from January 1, 2000, through December 31, 2008. METHODS We identified ACL reconstructions and potential postoperative infections using claims data. A hierarchical stratified sampling strategy was used to identify patients for medical record review to confirm ACL reconstructions and to determine allograft vs autograft tissue implanted, clinical characteristics, and infection status. We estimated infection rates overall and by graft type. We used logistic regression to assess the association between infections and patients' demographic characteristics, comorbidities, and choice of graft. RESULTS On review of 1,452 medical records, we found 55 deep wound infections. With correction for sampling weights, infection rates varied by graft type: 0.5% (95% CI, 0.3%-0.8%) with allografts, 0.6% (0.1%-1.5%) with bone-patellar tendon-bone autografts, and 2.5% (1.9%-3.1%) with hamstring autograft. After adjusting for potential confounders, we found an increased infection risk with hamstring autografts compared with allografts (odds ratio, 5.9; 95% CI, 2.8-12.8). However, there was no difference in infection risk among bone-patellar tendon-bone autografts vs allografts (odds ratio, 1.2; 95% CI, 0.3-4.8). CONCLUSIONS The overall risk for deep wound infections following ACL reconstruction is low but it does vary by graft type. Infection risk was highest in hamstring autograft recipients compared with allograft recipients and bone-patellar tendon-bone autograft recipients. Infect Control Hosp Epidemiol 2016;37:827-833.
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Reconstrucción del Ligamento Cruzado Anterior/efectos adversos , Infección de la Herida Quirúrgica/etiología , Adolescente , Adulto , Factores de Edad , Reconstrucción del Ligamento Cruzado Anterior/métodos , Trasplante Óseo/efectos adversos , Trasplante Óseo/métodos , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Ligamento Rotuliano/trasplante , Estudios Retrospectivos , Factores de Riesgo , Factores Sexuales , Adulto JovenRESUMEN
Heart failure (HF) hospitalization length of stay (LOS) has been associated with the risk of subsequent readmission and mortality. We identified 19,927 hospitalized patients with HF who were discharged alive from 2008 to 2011 from 3 Kaiser Permanente regions. In adjusted Cox models using LOS 3 to 4 days as the reference category, shorter LOS was not significantly associated with hospital readmissions. LOS of 5 to 10 days was associated with 17% greater risk of readmission within 30 days (hazard ratio [HR] 1.17, 95% confidence interval [CI] 1.07 to 1.28) and 9% greater risk within 1 year (HR 1.09, 95% CI 1.03 to 1.15). LOS of 11 to 29 days was associated with increased readmission risk of 52% at 30 days (HR 1.52, 95% CI 1.30 to 1.76) and 25% at 1 year (HR 1.25, 95% CI 1.16 to 1.35). Mortality risk within 30 days among those with LOS of 1 day was 47% lower (HR 0.53, 95% CI 0.43 to 0.65) and 32% lower at 1 year (HR 0.68, 95% CI 0.62 to 0.74). LOS of 2 days was associated with lower mortality risk of 17% (HR 0.83, 95% CI 0.76 to 0.90) at 1 year. At LOS 5 to 10 days, 30-day and 1-year risk of mortality was increased by 52% (HR 1.52, 95% CI 1.30 to 1.76) and 25% (HR 1.25, 95% CI 1.16 to 1.35), respectively. LOS of 11 to 29 days was associated with 171% higher mortality risk at 30 days (HR 2.71, 95% CI 2.19 to 3.35) and 73% at 1 year (HR 1.73, 95% CI 1.53 to 1.97). Longer LOS during the index HF hospitalization was associated with readmission and mortality within 30 days and 1 year independent of co-morbidities and cardiovascular risk factors. These results suggest that LOS may be a proxy for the severity of HF during the index hospitalization.
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Insuficiencia Cardíaca/mortalidad , Tiempo de Internación/tendencias , Readmisión del Paciente/tendencias , Enfermedad Aguda , Anciano , California/epidemiología , Femenino , Estudios de Seguimiento , Insuficiencia Cardíaca/terapia , Mortalidad Hospitalaria/tendencias , Humanos , Masculino , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Factores de TiempoRESUMEN
RATIONALE: Few previous studies have evaluated primary adherence (whether a new prescription is filled within 30 d) to controller medications in individuals with persistent asthma. OBJECTIVE: To compare adherence to the major controller medication regimens for asthma. METHODS: This was a retrospective cohort study of enrollees from five large health plans. We used electronic medical data on patients of all ages with asthma who had experienced an asthma-related exacerbation in the prior 12 months. We studied adherence measures including proportion of days covered and primary adherence (first prescription filled within 30 d). MEASUREMENTS AND MAIN RESULTS: Our population included 69,652 subjects who had probable persistent asthma and were prescribed inhaled corticosteroids (ICSs), leukotriene antagonists (LTRAs), or ICS/long-acting ß-agonists (ICS/LABAs). The mean age was 37 years and 58% were female. We found that 14-20% of subjects who were prescribed controller medicines for the first time did not fill their prescriptions. The mean proportion of days covered was 19% for ICS, 30% for LTRA, and 25% for ICS/LABA over 12 months. Using multivariate logistic regression, subjects prescribed LTRA were less likely to be primary adherent than subjects prescribed ICS (odds ratio, 0.82; 95% confidence interval, 0.74-0.92) or ICS/LABA (odds ratio, 0.88; 95% confidence interval, 0.80-0.97). Black and Latino patients were less likely to fill the prescription compared with white patients. CONCLUSIONS: Adherence to controller medications for asthma is poor. In this insured population, primary adherence to ICSs was better than to LTRAs and ICS/LABAs. Adherence as measured by proportion of days covered was better for LTRAs and ICS/LABAs than for ICSs.
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Corticoesteroides/uso terapéutico , Agonistas Adrenérgicos beta/uso terapéutico , Antiasmáticos/uso terapéutico , Asma/tratamiento farmacológico , Antagonistas de Leucotrieno/uso terapéutico , Cumplimiento de la Medicación/estadística & datos numéricos , Administración por Inhalación , Adolescente , Adulto , Negro o Afroamericano/estadística & datos numéricos , Anciano , Niño , Preescolar , Estudios de Cohortes , Femenino , Hispánicos o Latinos/estadística & datos numéricos , Humanos , Lactante , Recién Nacido , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Estudios Retrospectivos , Adulto JovenRESUMEN
Considerable debate exists about the optimal treatment of ductal carcinoma in situ (DCIS). Using electronic data sources, we examined first course treatment patterns among women aged 18 years and older diagnosed with DCIS between 2000-2010 from six Kaiser Permanente (KP) regions. We calculated the proportion of patients receiving breast conserving surgery (BCS), BCS plus radiation therapy, unilateral mastectomy, bilateral mastectomy, and hormone therapy. Multinomial logistic regression was used to assess the association between patient characteristics and treatment. We included 9,437 women: 1,086 (11.5%) African-American; 1,455 (15.4%) Asian; 918 (9.7%) Hispanic; and 5,978 (63.3%) non-Hispanic white. Most cases (42.2%) received BCS plus radiation as their initial treatment. Nearly equal numbers of women received BCS without radiation (28.5%) or unilateral mastectomy (24.6%). Use of bilateral mastectomy was uncommon (4.7%), and most women (72.2%) did not receive hormone therapy has part of their first course treatment. We observed statistically significant differences in treatment patterns for DCIS by KP region and patient age. Predictably, nuclear grade and the presence of comorbidities were associated with first course treatment for DCIS. We observed statistically significant increases in BCS plus radiation therapy and bilateral mastectomy over time. Although still uncommon, the frequency of bilateral mastectomy increased from 2.7% in 2000 to 7.0% in 2010. We also observed differences in treatment by race/ethnicity. Our findings help illustrate the complex nature of DCIS treatment in the United States, and highlight the need for evidence based guidelines for DCIS care.