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BACKGROUND: Immunosuppressive regimens are imperative for improving patient and graft survival following kidney transplantation in patients with kidney failure. However, real-world evidence regarding treatments and outcomes in these patients is scarce. We sought to describe the treatment switches (assessed by line of treatment [LOT]), patterns, and outcomes in patients who underwent kidney transplantation in the United States. METHODS: This retrospective cohort study used claims data from the Optum Research Database in the United States. Adult and pediatric patients undergoing a kidney transplantation between January 1, 2000, and June 30, 2019, who had ≥1 year of baseline and follow-up visits and continuous enrollment in the Optum Research Database, were included. RESULTS: Data from 7159 patients (6833, adult; 326, pediatric) were included. The mean age for adult and pediatric patients was 51.4 ± 12.8 years and 10.4 ± 5.1 years, respectively. The mean number of LOTs in patients with ≥1 LOT (n = 7004) was 4.1 ± 2.6 LOTs. Tacrolimus, antiproliferative agents, and prednisone were the most frequently prescribed immunosuppressants. No strong correlations were identified between switching from LOT1 to LOT2 and potential predictors of treatment switches. The proportion of patients who did not experience graft loss gradually decreased between month 3 and month 120 (72%-36%), driven by return to dialysis (66%-18%). A slower decrease was observed for graft rejection (98%-84%), retransplantation (98%-93%), and graft removal (98%-92%). CONCLUSIONS: We described treatment switches, patterns, and outcomes in patients who underwent kidney transplantation in the United States. Future analytical studies are needed to test hypotheses derived from these observations.
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Bases de Datos Factuales , Rechazo de Injerto , Supervivencia de Injerto , Inmunosupresores , Trasplante de Riñón , Humanos , Estudios Retrospectivos , Estados Unidos , Masculino , Inmunosupresores/uso terapéutico , Femenino , Niño , Persona de Mediana Edad , Adulto , Rechazo de Injerto/prevención & control , Resultado del Tratamiento , AdolescenteRESUMEN
BACKGROUND: Many types of interstitial lung diseases (ILDs) may transition to progressive chronic-fibrosing ILDs with rapid lung function decline and a negative survival prognosis. In real-world clinical settings, forced vital capacity (FVC) measures demonstrating progressive decline may be linked to negative outcomes, including increased risks of costly healthcare resource utilization (HRU). Thus, we assessed the relationship between rate of decline in lung function and an increase in HRU, specifically inpatient hospitalization, among patients with chronic fibrosing ILD. METHODS: This study utilized electronic health records from 01-Oct-2015 to 31-Oct-2019. Eligible patients (≥ 18 years old) had ≥ 2 fibrosing ILD diagnosis codes, clinical activity for ≥ 15 months, and ≥ 2 FVC tests occurring 6 months apart. Patients with missing demographic data, IPF, or use of nintedanib or pirfenidone were excluded. Two groups were defined by relative change in percent of predicted FVC (FVC% pred) from baseline to 6 months: significant decline (≥ 10%) vs. marginal decline/stable FVC (decrease < 10% or increase). The primary outcome was defined as the occurrence of an inpatient hospitalization 6 months after the first FVC value. Descriptive and multivariable analysis was conducted to examine the impact of FVC decline on occurrence of inpatient hospitalization. RESULTS: The sample included 566 patients: 13% (n = 75) with significant decline and 87% (n = 491) with marginal decline/stable FVC; their mean age (SD) was 65 (13.7) years and 56% were female. Autoimmune diagnoses were observed among 40% of patients with significant decline, and 27% with marginal decline/stable FVC. The significant decline group had better lung function at baseline than the marginal/stable group. For patients with FVC% <80% at baseline, reduction of FVC% ≥10% was associated with significantly increased odds of an inpatient hospitalization (odds ratio [OR] 2.85; confidence interval [CI] 1.17, 6.94 [p = 0.021]). CONCLUSION: Decline in FVC% ≥10% was associated with increased odds of inpatient hospitalization among patients with reduced lung function at baseline. These findings support the importance of preserving lung function among patients with fibrosing ILD.
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Pacientes Internos , Enfermedades Pulmonares Intersticiales , Humanos , Femenino , Anciano , Adolescente , Masculino , Registros Electrónicos de Salud , Hospitalización , Capacidad VitalRESUMEN
BACKGROUND: The impact of treatment-resistant depression (TRD) or prior suicidal ideation/suicide attempt (SI/SA) on mortality by suicide among patients with major depressive disorder (MDD) is not well known. This retrospective, observational, descriptive cohort study characterized real-world rates of suicide-specific mortality among patients with MDD with or without TRD or SI/SA. METHODS: Adult patients with MDD among commercially insured and Medicare enrollees in Optum Research Database were included and assigned to three cohorts: those with treatment-resistant MDD (TRD), those with MDD and SI/SA (MDD+SI/SA), and those with MDD without TRD or SI/SA (MDD alone). Suicide-specific mortality was obtained from the National Death Index. The effects of demographic characteristics and SI/SA in the year prior to the end of observation on suicide-specific mortality were assessed. RESULTS: For the 139,753 TRD, 85,602 MDD+SI/SA, and 572,098 MDD alone cohort patients, mean age ranged from 55 to 59 years and the majority were female. At baseline, anxiety disorders were present in 53.92%, 44.11%, and 21.72% of patients with TRD, MDD+SI/SA, and MDD alone, respectively. Suicide-mortality rates in the three cohorts were 0.14/100 person-years for TRD, 0.27/100 person-years for MDD+SI/SA, and 0.04/100 person-years for MDD alone. SI/SA during the year prior to the end of observation, younger age, and male sex were associated with increased suicide risk. CONCLUSIONS: Patients with TRD and MDD+SI/SA have a heightened risk of mortality by suicide compared with patients with MDD alone. Suicide rates were higher in patients with recent history versus older or no history of SI/SA, men versus women, and those of young age versus older age.
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Trastorno Depresivo Mayor , Adulto , Humanos , Masculino , Femenino , Anciano , Estados Unidos/epidemiología , Persona de Mediana Edad , Ideación Suicida , Intento de Suicidio , Estudios Retrospectivos , Estudios de Cohortes , MedicareRESUMEN
BACKGROUND: Racial and ethnic minority groups have been disproportionately affected by the US coronavirus disease 2019 (COVID-19) pandemic; however, nationwide data on COVID-19 outcomes stratified by race/ethnicity and adjusted for clinical characteristics are sparse. This study analyzed the impacts of race/ethnicity on outcomes among US patients with COVID-19. METHODS: This was a retrospective observational study of patients with a confirmed COVID-19 diagnosis in the electronic health record from 01 February 2020 through 14 September 2020. Index encounter site, hospitalization, and mortality were assessed by race/ethnicity (Hispanic, non-Hispanic Black [Black], non-Hispanic White [White], non-Hispanic Asian [Asian], or Other/unknown). Associations between racial/ethnic categories and study outcomes adjusted for patient characteristics were evaluated using logistic regression. FINDINGS: Among 202,908 patients with confirmed COVID-19, patients from racial/ethnic minority groups were more likely than White patients to be hospitalized on initial presentation (Hispanic: adjusted odds ratio 1·690, 95% CI 1·620-1·763; Black: 1·810, 1·743-1·880; Asian: 1·503, 1·381-1·636) and during follow-up (Hispanic: 1·700, 1·638-1·764; Black: 1·578, 1·526-1·633; Asian: 1·391, 1·288-1·501). Among hospitalized patients, adjusted mortality risk was lower for Black patients (0·881, 0·809-0·959) but higher for Asian patients (1·205, 1·000-1·452). INTERPRETATION: Racial/ethnic minority patients with COVID-19 had more severe disease on initial presentation than White patients. Increased mortality risk was attenuated by hospitalization among Black patients but not Asian patients, indicating that outcome disparities may be mediated by distinct factors for different groups. In addition to enacting policies to facilitate equitable access to COVID-19-related care, further analyses of disaggregated population-level COVID-19 data are needed.
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INTRODUCTION: This retrospective analysis aimed to characterize patients with migraine initiating erenumab and the shifting or trend of patient characteristics over time in a real-world setting. METHODS: Adult patients with at least one erenumab written prescription/administration between May 1, 2018 and September 30, 2019 were identified from the Optum De-identified Electronic Health Record (EHR) database (index date = date of the first erenumab prescription/administration). Patient demographics and characteristics, acute and preventive medications used prior to initiation of erenumab, and the initial prescriber specialty were examined. In addition, the shifting or trends of patient characteristics over time were analyzed among subgroups of patients based on when they initiated erenumab. RESULTS: A total of 14,774 eligible patients who met inclusion and exclusion criteria were included in the analysis. Most patients were female (86.4%), average age 46.3 (standard deviation [SD] = 13.1) years, Caucasian (88.7%), non-Hispanic (91.8%), and commercially insured (59.8%) at the index date. During the 12-month pre-index period, commonly observed selected comorbid conditions included anxiety (30.6%), depression (28.2%), and cardiovascular diseases (26.4%), and the mean (SD) Elixhauser comorbidity score was 1.7 (5.5). The most common provider specialty at erenumab initiation was neurologist/headache specialist (46.5%). Over time, there was a decrease in mean baseline Elixhauser comorbidity score at erenumab initiation, an increase in general practitioners prescribing initial erenumab, and increased utilization in patients with less severe migraine overall (a proxy of the declining trend in chronic migraine and triptan use). CONCLUSION: Early use of erenumab post approval focused on patients with more severe disease and a high comorbidity index rating. Over time, utilization of this preventive medication occurred in a broader population of patients with migraine, with increased use by general practitioners and those outside of headache centers.
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Anticuerpos Monoclonales Humanizados , Trastornos Migrañosos , Adulto , Bases de Datos Factuales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Trastornos Migrañosos/tratamiento farmacológico , Trastornos Migrañosos/epidemiología , Trastornos Migrañosos/prevención & control , Estudios Retrospectivos , Estados Unidos/epidemiologíaRESUMEN
Tuberous sclerosis complex (TSC) is a rare genetic disorder affecting the brain and other vital organs with varying symptoms and severity among patients. This study developed and validated a risk model to identify patients with TSC using large databases of medical and pharmacy claims.
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Esclerosis Tuberosa , Humanos , Enfermedades RarasRESUMEN
OBJECTIVE: To assess the burden of hypoglycemia among type 2 diabetes patients on antidiabetic drugs with or without use of insulin. RESEARCH DESIGN AND METHODS: We used mail surveys, administrative claims data, and enrollment information from a sample of adult commercial health plan enrollees (n=813) with type 2 diabetes during a 12-month period. Patients' experience of hypoglycemia, its impact on patient perspectives and healthcare utilization were the outcomes evaluated. RESULTS: A greater percentage of patients in the antidiabetic with insulin cohort reported experiencing hypoglycemia compared with patients from sulfonylurea (SU) without insulin and non-SU without insulin cohorts (50% vs. 21% and 12%, respectively; p<0.01 for both comparisons). While 71% of the sample reported experiencing hypoglycemic symptoms with 28% confirmed by low blood glucose levels, only 10% of the patients had evidence of hypoglycemia event in the claims database. Patients with confirmed hypoglycemia had the highest Hypoglycemia Fear Survey behavior score (8) and worry subscale score (14). Significant differences were noted between the confirmed hypoglycemia and no hypoglycemia cohorts for the 12-item Short Form Health Survey's Mental Component Score (p<0.001) and Physical Component Score (p=0.002), and for the EQ-5D index (p<0.001). Diabetes-related annualized mean total healthcare costs were significantly higher for confirmed hypoglycemia vs. no hypoglycemia cohorts (p=0.004). CONCLUSIONS: Symptomatic hypoglycemia is a more significant burden among type 2 diabetes patients treated with antidiabetic drugs than is estimated by administrative claims data and needs to be considered when choosing therapy.
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Costo de Enfermedad , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemia/inducido químicamente , Hipoglucemiantes/efectos adversos , Insulina/efectos adversos , Compuestos de Sulfonilurea/efectos adversos , Adulto , Anciano , Estudios de Cohortes , Estudios Transversales , Quimioterapia Combinada/efectos adversos , Femenino , Costos de la Atención en Salud , Encuestas de Atención de la Salud , Recursos en Salud/estadística & datos numéricos , Humanos , Hipoglucemia/economía , Hipoglucemia/terapia , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Seguro de Salud , Masculino , Persona de Mediana Edad , Calidad de Vida , Estudios Retrospectivos , Compuestos de Sulfonilurea/uso terapéutico , Estados UnidosRESUMEN
OBJECTIVE: The aim of this work was to compare rates of asthma-related health service utilization for Medicaid-eligible pediatric and adult patients with asthma treated with fixed-dose fluticasone propionate/salmeterol (FSC) or fluticasone propionate (FP) monotherapy. METHODS: A retrospective, observational claims analysis was conducted with Medicaid enrollees aged ≥4 years with ≥1 diagnosis code for asthma and a prescription fill for FSC or FP between January 1, 2002, and November 1, 2005. The end date allowed a follow-up period of ≥60 days; Medicaid data were available through December 31, 2005, and were obtained from 2 sources: a large US-managed Medicaid provider affiliated with i3 Innovus, and the Thomson Medstat Marketscan (Ann Arbor, Michigan) Medicaid claims database. Patients were new or continuing users of asthma controllers, but were new users of FSC or FP. Outcome measures included postindex use of systemic corticosteroid drugs and short-acting ß-agonists (SABAs), asthma-related utilization, and costs. Descriptive and multivariate techniques were used, adjusting for differences in baseline demographics and length of follow-up time in the study population. Patients were grouped into cohorts according to age: 4 to 17 or ≥18 years. RESULTS: The final study population was 50,428 patients, including 30,071 patients (59.6%) aged <18 years and 20,357 patients (40.4%) aged ≥18 years. Mean number of days of follow-up was 290.4, and 55.1% of patients (n = 27,793) were followed for ≥1 year after the index date. Among those aged <18 years, FSC treatment was associated with decreased adjusted risk of asthma-related emergency department (ED) visits (adjusted hazard ratio [HR] = 0.917; 95% CI, 0.855-0.984) and combined ED/inpatient (IP) visits (HR = 0.922; 95% CI, 0.860-0.988). Among those aged ≥18 years, FSC treatment was associated with decreased adjusted risk of asthma-related ED visits (HR = 0.907; 95% CI, 0.849-0.969) and combined ED/IP visits (HR = 0.907; 95% CI, 0.850-0.968). FSC treatment was also associated with significantly fewer prescription fills for SABAs compared with FP treatment in both age groups (aged <18 years: incident rate ratio [IRR] = 0.960 [95% CI, 0.929-0.992]; aged ≥18 years: IRR = 0.950 [95% CI, 0.905-0.998]). Total mean (SD) unadjusted asthma costs were $579 ($2429) for FSC and $551 ($3151) for FP in the <18-year age group and were $1764 ($10,006) for FSC and $1512 ($5543) for FP in the ≥18-year age group. CONCLUSION: In this retrospective database analysis, Medicaid-eligible patients who initiated FSC therapy experienced better asthma control compared with patients who initiated FP monotherapy, as measured by asthma-related ED/IP visits and use of SABAs.