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1.
Circ Arrhythm Electrophysiol ; 16(8): 456-467, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37485722

RESUMEN

BACKGROUND: Sotalol and dronedarone are both used for maintenance of sinus rhythm for patients with atrial fibrillation. However, while sotalol requires initial monitoring for QT prolongation and proarrhythmia, dronedarone does not. These treatments can be used in comparable patients, but their safety and effectiveness have not been compared head to head. Therefore, we retrospectively evaluated the effectiveness and safety using data from a large health care system. METHODS: Using Veterans Health Administration data, we identified 11 296 antiarrhythmic drug-naive patients with atrial fibrillation prescribed dronedarone or sotalol in 2012 or later. We excluded patients with prior conduction disease, pacemakers or implantable cardioverter-defibrillators, ventricular arrhythmia, cancer, renal failure, liver disease, or heart failure. We used natural language processing to identify and compare baseline left ventricular ejection fraction between treatment arms. We used 1:1 propensity score matching, based on patient demographics, comorbidities, and medications, and Cox regression to compare strategies. To evaluate residual confounding, we performed falsification analysis with nonplausible outcomes. RESULTS: The matched cohort comprised 6212 patients (3106 dronedarone and 3106 sotalol; mean [±SD] age, 71±10 years; 2.5% female; mean [±SD] CHA2DS2-VASC, 2±1.3). The mean (±SD) left ventricular ejection fraction was 55±11 and 58±10 for dronedarone and sotalol users, correspondingly. Dronedarone, compared with sotalol, did not demonstrate a significant association with risk of cardiovascular hospitalization (hazard ratio, 1.03 [95% CI, 0.88-1.21]) or all-cause mortality (hazard ratio, 0.89 [95% CI, 0.68-1.16]). However, dronedarone was associated with significantly lower risk of ventricular proarrhythmic events (hazard ratio, 0.53 [95% CI, 0.38-0.74]) and symptomatic bradycardia (hazard ratio, 0.56 [95% CI, 0.37-0.87]). The primary findings were stable across sensitivity analyses. Falsification analyses were not significant. CONCLUSIONS: Dronedarone, compared with sotalol, was associated with a lower risk of ventricular proarrhythmic events and conduction disorders while having no difference in risk of incident cardiovascular hospitalization and mortality. These observational data provide the basis for prospective efficacy and safety trials.


Asunto(s)
Amiodarona , Fibrilación Atrial , Veteranos , Femenino , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Masculino , Antiarrítmicos/efectos adversos , Dronedarona/efectos adversos , Sotalol/efectos adversos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/inducido químicamente , Estudios Retrospectivos , Estudios Prospectivos , Volumen Sistólico , Función Ventricular Izquierda , Amiodarona/efectos adversos
2.
Nephrol Dial Transplant ; 38(10): 2350-2357, 2023 09 29.
Artículo en Inglés | MEDLINE | ID: mdl-37061786

RESUMEN

BACKGROUND: Fabry disease (FD) is an X-linked lysosomal storage disorder caused by deficient α-galactosidase A activity. The spectrum of disease includes phenotypes ranging from "classic" to "later-onset," with varying kidney disease progression. Identifying patterns of declining kidney function and involvement of other major organs in patients with FD is important to guide therapy decisions. METHODS: Clusters of patients with FD and similar estimated glomerular filtration rate (eGFR) decline and age were created using agglomerative clustering of data captured between 2007 and 2020 in the United States Optum Market Clarity database. Male patients with a diagnosis of FD and two or more eGFR values ≥6 months apart were included. Disease progression was compared with a control cohort of patients without an FD diagnosis. RESULTS: eGFR values from 234 male patients with FD were analysed, yielding seven clusters. Five clusters demonstrated disease progression from "natural" eGFR decline, with a slight decrease in kidney function and eGFR usually within the normal range, to rapid, early decline in eGFR and cardiac complications. When compared with the control cohort, a more rapid decline and a higher percentage of cardiac hypertrophy, heart failure, arrhythmias and stroke were noted in the study group. An inflection point was observed in each cluster when deterioration of kidney function accelerated. CONCLUSIONS: Clustering of male patients with FD by decline in kidney function, organ involvement and phenotype through analysis of real-world data provides a reference that could help determine the optimal time for initiation of FD-specific treatment and facilitate management decisions made by healthcare professionals.


Asunto(s)
Enfermedad de Fabry , Humanos , Masculino , Estados Unidos/epidemiología , Enfermedad de Fabry/complicaciones , Enfermedad de Fabry/epidemiología , Enfermedad de Fabry/diagnóstico , Registros Electrónicos de Salud , Riñón , alfa-Galactosidasa/genética , Progresión de la Enfermedad
3.
Pharmacoepidemiol Drug Saf ; 32(1): 44-55, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36215113

RESUMEN

PROBLEM: Ambiguity in communication of key study parameters limits the utility of real-world evidence (RWE) studies in healthcare decision-making. Clear communication about data provenance, design, analysis, and implementation is needed. This would facilitate reproducibility, replication in independent data, and assessment of potential sources of bias. WHAT WE DID: The International Society for Pharmacoepidemiology (ISPE) and ISPOR-The Professional Society for Health Economics and Outcomes Research (ISPOR) convened a joint task force, including representation from key international stakeholders, to create a harmonized protocol template for RWE studies that evaluate a treatment effect and are intended to inform decision-making. The template builds on existing efforts to improve transparency and incorporates recent insights regarding the level of detail needed to enable RWE study reproducibility. The overarching principle was to reach for sufficient clarity regarding data, design, analysis, and implementation to achieve 3 main goals. One, to help investigators thoroughly consider, then document their choices and rationale for key study parameters that define the causal question (e.g., target estimand), two, to facilitate decision-making by enabling reviewers to readily assess potential for biases related to these choices, and three, to facilitate reproducibility. STRATEGIES TO DISSEMINATE AND FACILITATE USE: Recognizing that the impact of this harmonized template relies on uptake, we have outlined a plan to introduce and pilot the template with key international stakeholders over the next 2 years. CONCLUSION: The HARmonized Protocol Template to Enhance Reproducibility (HARPER) helps to create a shared understanding of intended scientific decisions through a common text, tabular and visual structure. The template provides a set of core recommendations for clear and reproducible RWE study protocols and is intended to be used as a backbone throughout the research process from developing a valid study protocol, to registration, through implementation and reporting on those implementation decisions.


Asunto(s)
Comités Consultivos , Evaluación de Resultado en la Atención de Salud , Humanos , Reproducibilidad de los Resultados , Evaluación de Resultado en la Atención de Salud/métodos , Farmacoepidemiología
4.
BMC Cancer ; 22(1): 1178, 2022 Nov 16.
Artículo en Inglés | MEDLINE | ID: mdl-36384474

RESUMEN

BACKGROUND: Biliary tract cancer (BTC) includes intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of Vater cancer (AVC). Although BTC is rare in the US, incidence is increasing and elevated in certain populations. This study examined BTC epidemiology in the US by age, sex, race/ethnicity, geographic region, and anatomic site. METHODS: BTC incidence, prevalence, mortality, and survival from 2001 to 2015 were evaluated using the National Cancer Institute's Surveillance, Epidemiology, and End Results Program and the Centers for Disease Control and Prevention's National Program of Cancer Registries databases. Incidence and mortality rates were calculated and reported as age-standardized rates. Data were assessed by age, anatomic sites, geographic region, and race/ethnicity, and a joinpoint regression model was used to predict trends for age-adjusted BTC incidence and mortality rates. RESULTS: BTC incidence increased during the study period (annual percent change = 1.76, 95% confidence interval [1.59-1.92]), with the highest increase in ICC (6.65 [6.11-7.19]). Incidence of unspecified BTC initially increased but has recently begun to drop. Hispanic, Asian/Pacific Islander, Black, or American Indian/Alaska Native race/ethnicity was associated with higher BTC mortality rates than White race/ethnicity. Patients with ICC had the highest mortality rate (age-standardized rate = 1.87/100,000 person-years [1.85-1.88]). Five-year survival was 15.2% for all BTC, ranging from 8.5% (ICC) to 34.5% (AVC), and patients with distant disease at diagnosis had lower survival (3%) compared with those with regional (19.1%) or locally advanced disease (31.5%). CONCLUSIONS: BTC incidence increased, survival was low across all subtypes, and mortality was greatest in patients with ICC. This underscores the serious, increasing unmet need among patients with BTC. Treatment options are limited, although clinical studies investigating immunotherapy, targeted therapies, and alternative chemotherapy combinations are ongoing. Epidemiological insights may improve patient care and inform the integration of novel therapies for BTC.


Asunto(s)
Neoplasias de los Conductos Biliares , Neoplasias del Sistema Biliar , Colangiocarcinoma , Neoplasias de la Vesícula Biliar , Estados Unidos/epidemiología , Humanos , Neoplasias del Sistema Biliar/epidemiología , Colangiocarcinoma/epidemiología , Colangiocarcinoma/terapia , Neoplasias de la Vesícula Biliar/epidemiología , Neoplasias de los Conductos Biliares/epidemiología , Neoplasias de los Conductos Biliares/terapia , Conductos Biliares Intrahepáticos
5.
Value Health ; 25(10): 1663-1672, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-36241338

RESUMEN

OBJECTIVES: Ambiguity in communication of key study parameters limits the utility of real-world evidence (RWE) studies in healthcare decision-making. Clear communication about data provenance, design, analysis, and implementation is needed. This would facilitate reproducibility, replication in independent data, and assessment of potential sources of bias. METHODS: The International Society for Pharmacoepidemiology (ISPE) and ISPOR-The Professional Society for Health Economics and Outcomes Research (ISPOR) convened a joint task force, including representation from key international stakeholders, to create a harmonized protocol template for RWE studies that evaluate a treatment effect and are intended to inform decision-making. The template builds on existing efforts to improve transparency and incorporates recent insights regarding the level of detail needed to enable RWE study reproducibility. The over-arching principle was to reach for sufficient clarity regarding data, design, analysis, and implementation to achieve 3 main goals. One, to help investigators thoroughly consider, then document their choices and rationale for key study parameters that define the causal question (e.g., target estimand), two, to facilitate decision-making by enabling reviewers to readily assess potential for biases related to these choices, and three, to facilitate reproducibility. STRATEGIES TO DISSEMINATE AND FACILITATE USE: Recognizing that the impact of this harmonized template relies on uptake, we have outlined a plan to introduce and pilot the template with key international stakeholders over the next 2 years. CONCLUSION: The HARmonized Protocol Template to Enhance Reproducibility (HARPER) helps to create a shared understanding of intended scientific decisions through a common text, tabular and visual structure. The template provides a set of core recommendations for clear and reproducible RWE study protocols and is intended to be used as a backbone throughout the research process from developing a valid study protocol, to registration, through implementation and reporting on those implementation decisions.


Asunto(s)
Comités Consultivos , Informe de Investigación , Humanos , Evaluación de Resultado en la Atención de Salud/métodos , Farmacoepidemiología , Reproducibilidad de los Resultados
6.
JCO Clin Cancer Inform ; 5: 658-667, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-34110931

RESUMEN

PURPOSE: In 2014, the ASCO developed CancerLinQ (CLQ), a health technology platform for oncology. The CLQ Discovery (CLQD) database was created to make data available for research and this paper provides a summary of this database. METHODS: This study described the clinical and demographic characteristics of the 12 most common cancers in the CLQD database. We included patients with a new malignant tumor diagnosis between January 1, 2013, and December 31, 2018, of the following cancers: breast, lung and bronchus, prostate, colon and rectum, melanoma of the skin, bladder, non-Hodgkin lymphoma, kidney and renal pelvis, uterus, leukemia, pancreas, and thyroid. Patients with an in-situ diagnosis were excluded. Summary statistics and Kaplan-Meier survival estimates were calculated for each tumor. RESULTS: From 2013 to 2018, 491,360 patients were diagnosed with the study tumors. Breast cancer (139,506) was the most common, followed by lung and bronchus (70,959), prostate (63,303), and colon and rectum (53,504). The median age at diagnosis (years) was 61, 68, 68, and 64 in breast, lung and bronchus, prostate, and colon and rectum cohorts, respectively. Compared to the SEER 5-year overall survival estimates for several tumor types were higher in the CLQD database, possibly because of incomplete mortality capture in electronic health records. CONCLUSION: This paper presents the first description of the CLQD database since its inception. CLQ will continue to evolve over time, and the breadth and depth of this data asset will continue to grow. ASCO and CLQ's long-term goal is to improve the quality of patient care and create a sustainable database for oncology researchers. These results demonstrate that CLQ built a scalable database that can be used for oncology research.


Asunto(s)
Neoplasias de la Mama , Bases de Datos Factuales , Femenino , Humanos , Masculino
7.
Leuk Lymphoma ; 62(6): 1325-1334, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33966583

RESUMEN

Most data on overall survival (OS) and adverse events (AEs) in patients with mantle cell lymphoma (MCL) are from controlled trials; therefore, in this population-based study, we retrospectively assessed treatment patterns, OS, and AEs in MCL patients initiating systemic treatment during 2013-2015 using the United States Medicare claims database. Among 1390 eligible patients (median age = 74 years), chemoimmunotherapy with bendamustine/rituximab (BR) was the preferred choice in first-line (35.3%), followed by ibrutinib (33.5%), rituximab (9.1%), and rituximab/cyclophosphamide/doxorubicin/vincristine (R-CHOP) (6.8%). Twenty-four-month OS was 73% for BR; 47%, ibrutinib; 72%, rituximab; and 71%, R-CHOP. For the four most commonly used regimens, neutropenia, anemia, hypertension, and infection were the most frequent AEs. Patients with ≥3 AEs had nearly four times higher monthly costs than those with 0-2 AEs in the first observed therapy line. Findings demonstrate a substantial increase in the economic burden as the number of AEs increased among the Medicare MCL patients.


Asunto(s)
Linfoma de Células del Manto , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Clorhidrato de Bendamustina/uso terapéutico , Ciclofosfamida/uso terapéutico , Atención a la Salud , Doxorrubicina/uso terapéutico , Humanos , Linfoma de Células del Manto/tratamiento farmacológico , Medicare , Prednisona/uso terapéutico , Estudios Retrospectivos , Rituximab/efectos adversos , Estados Unidos/epidemiología , Vincristina/uso terapéutico
8.
Cancer Med ; 10(8): 2690-2702, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33734606

RESUMEN

BACKGROUND: Information on overall survival (OS) and adverse events (AEs) in patients with chronic lymphocytic leukemia (CLL) is mostly available from clinical trials. We therefore conducted a population-based retrospective cohort study to assess OS, incidence of AEs, and economic burden in real-world practice among Medicare patients treated for CLL. METHODS: Patients with CLL receiving ≥1 systemic therapy from 2013 to 2015 were selected from the Medicare claims database and followed from the start of first observed systemic therapy (index date) through December 2016 or death. OS for patients receiving each of the most commonly observed treatments was estimated by the Kaplan-Meier method. AEs were assessed among patients receiving these treatments across all observed lines of therapy. All-cause direct medical costs were assessed from the Medicare system perspective. RESULTS: Among 7,965 eligible patients across all observed therapy lines, ibrutinib monotherapy (Ibr; n = 2,708), chlorambucil monotherapy (Clb; n = 1,620), and bendamustine/rituximab (BR; n = 1,485) were the most common treatments. For first observed therapy, 24-month OS estimates for Ibr, Clb, and BR recipients were 69% (95% CI = 68%-71%), 68% (95% CI = 65%-71%), and 79% (95% CI = 77%-81%) respectively. The most frequently recorded AEs in patients receiving these treatments in any observed line of therapy were neutropenia, hypertension, anemia, and infection. For all patients, the mean monthly all-cause cost during the follow-up period was $8,974 (SD = $11,562); cost increased by the number of AEs, from $5,144 (SD = $5,409) among those with 1-2 AEs to $10,077 (SD = $12,542) among those with ≥6 AEs. CONCLUSION: Over two-thirds of patients survived at least 2 years after starting their first observed therapy for CLL. Our findings highlight considerable susceptibility to AEs and unmet medical need in Medicare patients with CLL treated in routine practice. Medicare incurred substantial economic burden following initiation of systemic therapy, and patients with greater numbers of AEs accounted disproportionately for the high overall cost of CLL management.


Asunto(s)
Leucemia Linfocítica Crónica de Células B/tratamiento farmacológico , Leucemia Linfocítica Crónica de Células B/economía , Leucemia Linfocítica Crónica de Células B/mortalidad , Adulto , Anciano , Anciano de 80 o más Años , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Costo de Enfermedad , Costos de los Medicamentos , Femenino , Costos de la Atención en Salud , Humanos , Masculino , Medicare , Persona de Mediana Edad , Estudios Retrospectivos , Estados Unidos
9.
Anticancer Res ; 41(2): 927-936, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33517299

RESUMEN

BACKGROUND/AIM: Limited published real-world data describe adverse events (AEs) among patients treated for mantle-cell lymphoma (MCL). The aim of this retrospective study was to describe treatment patterns, AEs, and associated healthcare costs. PATIENTS AND METHODS: Patients had two or more claims coded for MCL diagnosis, the first claim date (07/01/2012-05/31/2017) was the index date. Patients with pre-index MCL diagnosis or systemic treatment, or hematopoietic stem cell transplantation were excluded. Cohorts by regimen were followed for up to three lines of therapy. RESULTS: Patients (n=395; median age 72 years; 31% female) were observed over a total of 576 lines of therapy, the most common being bendamustine plus rituximab; rituximab monotherapy; R-CHOP; and ibrutinib. The most frequent AEs were hypertension (40.5%), anemia (37.7%), and infection (36.1%). However, hepatotoxicity ($19,645), stroke ($18,893), and renal failure ($9,037) were associated with the highest medical costs per patient per month. CONCLUSION: Among patients receiving common systemic treatments for MCL, AEs occurred frequently; some imposed substantial inpatient care costs.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Enfermedad Hepática Inducida por Sustancias y Drogas/economía , Linfoma de Células del Manto/tratamiento farmacológico , Insuficiencia Renal/economía , Accidente Cerebrovascular/economía , Adenina/efectos adversos , Adenina/análogos & derivados , Adenina/economía , Adenina/uso terapéutico , Anciano , Anciano de 80 o más Años , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Clorhidrato de Bendamustina/efectos adversos , Clorhidrato de Bendamustina/economía , Clorhidrato de Bendamustina/uso terapéutico , Ciclofosfamida/efectos adversos , Ciclofosfamida/economía , Ciclofosfamida/uso terapéutico , Doxorrubicina/efectos adversos , Doxorrubicina/economía , Doxorrubicina/uso terapéutico , Femenino , Costos de la Atención en Salud , Humanos , Masculino , Persona de Mediana Edad , Piperidinas/efectos adversos , Piperidinas/economía , Piperidinas/uso terapéutico , Prednisona/efectos adversos , Prednisona/economía , Prednisona/uso terapéutico , Insuficiencia Renal/inducido químicamente , Estudios Retrospectivos , Rituximab/efectos adversos , Rituximab/economía , Rituximab/uso terapéutico , Accidente Cerebrovascular/inducido químicamente , Vincristina/efectos adversos , Vincristina/economía , Vincristina/uso terapéutico
10.
Br J Haematol ; 192(4): 737-746, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33095453

RESUMEN

The experience of patients with mantle cell lymphoma (MCL) in community oncology practices, including reasons for treatment discontinuation, is sparse. This retrospective study sought to elucidate treatment patterns and outcomes of patients with MCL treated with ibrutinib in the community setting. Patients were identified from the US Oncology Network electronic medical records database, iKnowMedTM , between 1 November 2013 and 31 October 2016. Descriptive analysis was performed to describe the demographic and clinical characteristics of the population. Kaplan-Meier estimates were performed to determine clinical outcomes. A Cox proportional hazards model was used to identify predictors of survival. Of the 1914 patients identified with MCL, 159 were treated with ibrutinib. The median age was 71 years and the majority were male (76%) and Caucasian (89%). The overall discontinuation rate was 83·6%; the most common reasons were progression (35%) and toxicities (25·6%). The median overall survival and progression-free survival was 25·82 months (95% confidence interval [CI] 19·94, NR) and 19·55 months (95% CI 16·52, 24·28) respectively. In multivariate modelling, patient age was predictive of survival (hazard ratio 1·041, P = 0·0186). Ibrutinib was temporarily reduced in 16·4% (n = 26) and held in 30·2% (n = 48), primarily due to toxicity 66·7% (n = 32). Survival data showed similarities between community oncology practices and clinical trials.


Asunto(s)
Adenina/análogos & derivados , Linfoma de Células del Manto/tratamiento farmacológico , Piperidinas/uso terapéutico , Inhibidores de Proteínas Quinasas/uso terapéutico , Adenina/uso terapéutico , Anciano , Anciano de 80 o más Años , Registros Electrónicos de Salud , Femenino , Humanos , Linfoma de Células del Manto/epidemiología , Persona de Mediana Edad , Análisis de Supervivencia , Resultado del Tratamiento , Estados Unidos/epidemiología
11.
Semin Arthritis Rheum ; 50(4): 759-768, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-32531505

RESUMEN

OBJECTIVE: To estimate the economic burden of systematic lupus erythematous (SLE), stratified by disease severity, in commercially- and Medicaid-insured US populations. METHODS: Adults (≥18 years) with SLE treated with antimalarials, selected biologics, immunosuppressants, and systemic glucocorticoids (2010-2014) were identified within the commercial and Medicaid insurance IBM MarketScan® databases (index date = first SLE medication claim). Both cohorts were stratified into mild (receiving antimalarial or glucocorticoid monotherapy ≤5 mg/day) versus moderate/severe SLE (receiving glucocorticoids >5 mg/day, biologic, immunosuppressant, or combination therapy) during a 6-month exposure period. All-cause healthcare utilization and costs were evaluated during the 12 months following the exposure period. RESULTS: Among 8231 commercially-insured patients, 32.6% had mild and 67.4% had moderate/severe SLE by our definition. Among 802 Medicaid-insured patients, 25.2% had mild and 74.8% had moderate/severe SLE. Adjusted mean total healthcare costs, excluding pharmacy, for moderate/severe SLE patients were higher than for mild SLE patients in the commercially-insured ($39,021 versus $23,519; p < 0.0001) and Medicaid-insured populations ($56,050 versus $44,932; p = 0.06). In both SLE severity populations total unadjusted costs were significantly higher among Medicaid-insured than commercially-insured patients. CONCLUSION: Commercially-insured patients with treatment suggesting moderate/severe SLE incurred significantly higher adjusted mean healthcare costs, excluding pharmacy, compared with mild SLE patients. While not reaching statistical significance, moderate/severe Medicaid-insured patients had higher costs then mild SLE patients. Total unadjusted healthcare costs were significantly higher among Medicaid-insured than commercially-insured patients. These differential costs are important to consider and monitor when implementing interventions to improve health and reduce healthcare spending for SLE.


Asunto(s)
Costos de la Atención en Salud/estadística & datos numéricos , Lupus Eritematoso Sistémico/economía , Índice de Severidad de la Enfermedad , Adulto , Estudios de Cohortes , Bases de Datos Factuales , Femenino , Humanos , Seguro de Salud/estadística & datos numéricos , Lupus Eritematoso Sistémico/epidemiología , Masculino , Medicaid/estadística & datos numéricos , Persona de Mediana Edad , Estados Unidos/epidemiología
12.
Adv Ther ; 37(7): 3149, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32535853

RESUMEN

In the original article, it has been noticed that the abbreviation ''CLL'' is incorrectly published throughout the paper as the abbreviation "CCL". The correct abbreviation is "CLL".

13.
Adv Ther ; 37(7): 3129-3148, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32399812

RESUMEN

INTRODUCTION: Amidst a changing treatment landscape, real-world evidence on the burden of chronic lymphocytic leukemia (CLL) is limited. The purpose of this study was to describe treatment patterns, adverse events (AEs), and economic burden among treated patients with CLL. METHODS: A retrospective cohort study was conducted with IQVIA PharMetrics® Plus. Patients at least 18 years old with CLL treatment between November 1, 2013 and May 31, 2018 were identified; index date was first observed CLL treatment. Patients had at least one CLL diagnosis pre-index and a second diagnosis anytime during the study period, at least 1-year pre- and at least 30-day post-index continuous enrollment and no pre-index CLL treatment. Analyses focused on patients receiving one of the four most common regimens observed. Outcomes included treatment patterns, frequency of incident AEs, and healthcare resource use and costs. Multivariable logistic regression and generalized linear modelling were used to evaluate risk of hospitalization and all-cause costs per patient per month (PPPM). RESULTS: A total of 1706 patients were included in the study (median [interquartile range] age 58 [55-62] years, 66% male, median Charlson Comorbidity Index 2 [2-3], median follow-up 16 [8-28] months). Common regimens, irrespective of treatment line, were bendamustine-rituximab (B-R, 27%), ibrutinib monotherapy (I, 27%), rituximab monotherapy (R, 19%), and fludarabine combined with cyclophosphamide and rituximab (FCR, 16%); 59% had at least one incident AE (B-R, 62%; I, 60%; R, 25%; FCR, 79%). Mean total all-cause healthcare cost over follow-up was $13,858 ± 14,626 PPPM. Increased number of AEs was associated with increased odds of hospitalization (odds ratio = 2.9; 95% confidence interval [CI] 2.5-3.4) and increased mean cost PPPM (cost ratio = 1.2; 95% CI 1.1-1.2). CONCLUSION: This study highlights the treatment toxicity and associated economic burden among patients with CLL in the USA. As novel therapies are increasingly used, further research examining outcomes will inform the risks, benefits, and value of novel agents to prescribers and patients.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Costos de la Atención en Salud/estadística & datos numéricos , Leucemia Linfocítica Crónica de Células B/tratamiento farmacológico , Leucemia Linfocítica Crónica de Células B/economía , Leucemia Linfocítica Crónica de Células B/epidemiología , Adenina/análogos & derivados , Adenina/economía , Adenina/uso terapéutico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Ciclofosfamida/economía , Ciclofosfamida/uso terapéutico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Piperidinas/economía , Piperidinas/uso terapéutico , Estudios Retrospectivos , Rituximab/economía , Rituximab/uso terapéutico , Estados Unidos/epidemiología , Vidarabina/economía , Vidarabina/uso terapéutico , Adulto Joven
14.
Orphanet J Rare Dis ; 15(1): 47, 2020 02 13.
Artículo en Inglés | MEDLINE | ID: mdl-32054500

RESUMEN

BACKGROUND: Purine nucleoside analogs (PNAs) are the recommended first-line treatment for patients with hairy cell leukemia (HCL), but they are associated with adverse events (AEs). Due to a lack of real-world evidence regarding AEs that are associated with PNAs, we used commercial data to assess AE rates, AE-related health care resource utilization (HCRU), and costs among PNA-treated patients with HCL. Adults aged ≥18 years with ≥2 claims for HCL ≥30 days apart from 1 January 2006 through 31 December 2015 were included. Included patients had ≥1 claim for HCL therapy (cladribine ± rituximab or pentostatin ± rituximab [index date: first claim date]) and continuous enrollment for a ≥ 6-month baseline and ≥ 12-month follow-up period. Patient sub-cohorts were based on the occurrence of myelosuppression and opportunistic infections (OIs). Generalized linear models were used to compare HCRU and costs. RESULTS: In total, 647 PNA-treated patients were identified (mean age: 57.1 years). Myelosuppression and OI incidence were 461 and 42 per 1000 patient-years, respectively. Adjusted results indicated that those with myelosuppression had higher rates of hospitalization (47.4% vs 12.4%; P < .0001) and incurred higher mean inpatient costs ($23,517 vs $12,729; P = .011) and total costs ($57,325 vs $34,733; P = .001) as compared with those without myelosuppression. Similarly, patients with OIs had higher rates of hospitalization (53.8% vs 30.8%; P = .025) and incurred higher mean inpatient costs ($21,494 vs $11,229; P < .0001) as compared with those without OIs. CONCLUSIONS: PNA therapy is highly effective but associated with significant toxicities that increase costs; these findings indicate a need for therapies with improved toxicity profiles and better risk stratification of patients at risk of developing myelosuppression and OIs.


Asunto(s)
Leucemia de Células Pilosas , Adolescente , Adulto , Costo de Enfermedad , Costos de la Atención en Salud , Humanos , Revisión de Utilización de Seguros , Leucemia de Células Pilosas/tratamiento farmacológico , Persona de Mediana Edad , Nucleósidos , Nucleósidos de Purina , Estudios Retrospectivos
15.
Clin Ther ; 41(11): 2357-2379.e1, 2019 11.
Artículo en Inglés | MEDLINE | ID: mdl-31699438

RESUMEN

PURPOSE: Mantle cell lymphoma (MCL) is a rare subtype of B-cell non-Hodgkin lymphoma that can be either aggressive or indolent. Although MCL usually responds well to initial treatment with chemotherapy-based regimens, the disease often relapses or becomes refractory within a few years. Acalabrutinib is a highly selective, potent, covalent Bruton tyrosine kinase inhibitor with minimal off-target activity. WIthout head-to-head clinical trial data, estimation of the comparative efficacy and safety of new therapeutic entities provides valuable information for patients, clinicians, and health care payers. The objective of this analysis was to compare the efficacy and safety of acalabrutinib versus other targeted therapies employed for the treatment of relapsed/refractory MCL by using matching-adjusted indirect comparisons. METHODS: Individual data from 124 patients treated with acalabrutinib in the Phase II ACE-LY-004 trial were adjusted to match average baseline characteristics of populations from studies using alternative targeted treatment regimens for relapsed/refractory MCL (for monotherapy: ibrutinib, bortezomib, lenalidomide, and temsirolimus; for combination therapies: ibrutinib + rituximab, bendamustine + rituximab, and lenalidomide + rituximab). Patient populations were matched on age, sex, race, Eastern Cooperative Oncology Group performance status, Simplified MCL International Prognostic Index score, tumor bulk, lactate dehydrogenase concentration, extranodal disease, bone marrow involvement, and number of previous treatment regimens. Outcomes assessed included overall response rate (ORR), complete response (CR) rate, overall survival (OS), progression-free survival (PFS), and adverse events. FINDINGS: After matching, acalabrutinib was associated with significant increases in ORR and CR rate (estimated treatment difference [95% CI]) versus ibrutinib (ORR, 9.3% [0.3-18.3]; CR, 14.9% [5.4-24.3]), bortezomib (ORR, 50.6% [40.2-61.0]; CR, 18.8% [9.1-28.5]), lenalidomide (ORR, 38.1% [27.1-49.1]; CR, 43.5% [34.8-52.3]), and temsirolimus (ORR, 40.7% [31.0-50.4]; CR, 27.1% [19.2-35.0]). PFS (hazard ratio [95% CI]) with acalabrutinib was significantly increased versus bortezomib (0.36 [0.26-0.51]), lenalidomide (0.65 [0.48-0.89]), lenalidomide + rituximab (0.57 [0.35-0.93]), and temsirolimus (0.33 [0.24-0.45]). Acalabrutinib was associated with significantly increased OS (hazard ratio) versus bortezomib (0.36 [0.22-0.61]) and temsirolimus (0.32 [0.23-0.44]). The overall safety profile of acalabrutinib was similar or better compared with the monotherapies; however, infection risk increased versus bendamustine + rituximab, and anemia increased risk versus lenalidomide + rituximab and ibrutinib + rituximab. IMPLICATIONS: This comparison of targeted therapies used in the treatment of relapsed/refractory MCL showed that acalabrutinib has the potential to provide increased response rates, with trends for increased PFS and OS, and an improved safety profile.


Asunto(s)
Antineoplásicos/uso terapéutico , Benzamidas/uso terapéutico , Linfoma de Células del Manto/tratamiento farmacológico , Pirazinas/uso terapéutico , Adenina/análogos & derivados , Bortezomib/uso terapéutico , Humanos , Lenalidomida/uso terapéutico , Recurrencia Local de Neoplasia , Piperidinas , Pirazoles/uso terapéutico , Pirimidinas/uso terapéutico , Rituximab/uso terapéutico , Sirolimus/análogos & derivados , Sirolimus/uso terapéutico , Resultado del Tratamiento
16.
Cancer Med ; 8(17): 7174-7185, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31595715

RESUMEN

INTRODUCTION: There are limited data on treatment patterns, adverse events (AEs), and economic burden in younger, commercially insured patients treated for mantle cell lymphoma (MCL). METHODS: Adults with ≥1 treatment for MCL between 1 November 2013-31 December 2017 were identified from IQVIA Real-World Data Adjudicated Claims-US; index date was first treatment. Patients carried ≥1 MCL diagnosis, were newly treated, and were enrolled continuously for ≥12 months prior to and ≥30 days following index. Patients receiving the four most common MCL regimens were included. Measures included frequency of incident AEs, resource use, and costs overall and by number of AEs. Adjusted logistic regression and generalized linear modeling evaluated risk of hospitalization and all-cause costs per patient per month (PPPM). RESULTS: Two thousand five hundred and nine treated patients had a drug-specific code and were classified to a specific treatment regimen. Of those patients, 1785 patients received at least one of the four most commonly used MCL regimens (R-CHOP, rituximab monotherapy, B-R, and ibrutinib) at some point over follow-up (median 23 months). R-CHOP was the most common regimen observed in the first line (26%), followed by rituximab monotherapy (19%), B-R (15%), and ibrutinib (5%). The median age was 57 years; median Charlson Comorbidity Index was 0. Among patients receiving the four most common regimens, 63% of patients experienced ≥1 incident AE (R-CHOP 77%, B-R 58%, and ibrutinib 52%). An increasing number of incident AEs was associated with increased hospitalization risk (odds ratio = 2.4; 95% Confidence Interval [CI] 2.1-2.7) and increased mean costs PPPM (cost ratio = 1.1; 95% CI 1.1-1.2). DISCUSSION: This is the largest study describing treatment patterns and clinical and economic impact of MCL treatment. The most common regimens were R-CHOP, rituximab monotherapy, B-R, and ibrutinib. The majority of treated patients experienced at least one incident AE, with hospitalization risk and all-cause costs increasing as the number of AEs increased.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Costo de Enfermedad , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/economía , Costos de la Atención en Salud/estadística & datos numéricos , Linfoma de Células del Manto/tratamiento farmacológico , Adenina/análogos & derivados , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Ciclofosfamida/administración & dosificación , Ciclofosfamida/efectos adversos , Ciclofosfamida/economía , Doxorrubicina/administración & dosificación , Doxorrubicina/efectos adversos , Doxorrubicina/economía , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Femenino , Estudios de Seguimiento , Asignación de Recursos para la Atención de Salud/economía , Asignación de Recursos para la Atención de Salud/estadística & datos numéricos , Hospitalización/economía , Hospitalización/estadística & datos numéricos , Humanos , Incidencia , Seguro de Salud/economía , Seguro de Salud/estadística & datos numéricos , Linfoma de Células del Manto/economía , Masculino , Persona de Mediana Edad , Piperidinas , Pautas de la Práctica en Medicina/economía , Pautas de la Práctica en Medicina/estadística & datos numéricos , Prednisona/administración & dosificación , Prednisona/efectos adversos , Prednisona/economía , Pirazoles/administración & dosificación , Pirazoles/efectos adversos , Pirazoles/economía , Pirimidinas/administración & dosificación , Pirimidinas/efectos adversos , Pirimidinas/economía , Estudios Retrospectivos , Rituximab/administración & dosificación , Rituximab/efectos adversos , Rituximab/economía , Resultado del Tratamiento , Estados Unidos/epidemiología , Vincristina/administración & dosificación , Vincristina/efectos adversos , Vincristina/economía , Adulto Joven
17.
Cancer Med ; 8(8): 3803-3810, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-31144473

RESUMEN

INTRODUCTION: Contemporary data describing treatment patterns, adverse events (AEs), and outcomes in patients with chronic lymphocytic leukemia (CLL) in clinical practice are lacking. We conducted a retrospective cohort study and assessed treatment patterns, AEs, health-care resource use (HCRU), and costs in patients with diagnosis of CLL. METHODS: Using a nationally representative population of privately insured patients in the US, adult patients with CLL diagnosis (July 2012-June 2015) were selected if they had continuous health plan enrollment for ≥12 months before the first CLL diagnosis without any evidence of any CLL-directed treatment. Treatment patterns up to four lines of therapy (LOT) and occurrence of AEs during CLL therapies were assessed. Mean per-patient monthly HCRU and costs were assessed overall and by number of unique AEs. RESULTS: Of all patients meeting the selection criteria (n = 7,639; median age, 66 years), 18% (n = 1,379) received a systemic therapy during study follow-up. Of these, bendamustine/rituximab (BR) was the most common first observed regimen (28.1%), while ibrutinib was the most common therapy in the second (20.8%) and third (25.5%) observed regimens. The mean monthly all-cause and CLL-related costs, among patients treated with a systemic therapy, were $7,943 (SD = $15,757) and $5,185 (SD = $9,935), respectively. Mean monthly all-cause costs increased by the number of AEs (from $905 [SD = $1,865] among those with no AEs to $6,032 [SD = $13,290] among those with ≥6 AEs). CONCLUSIONS: Chemoimmunotherapy, particularly BR, was the most common first observed therapy for CLL, whereas ibrutinib was most preferred in the second and third observed lines of therapy during the study period. Findings demonstrate that the economic burden of AEs in CLL is substantial.


Asunto(s)
Costo de Enfermedad , Cobertura del Seguro , Leucemia Linfocítica Crónica de Células B/epidemiología , Pautas de la Práctica en Medicina , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Manejo de la Enfermedad , Femenino , Costos de la Atención en Salud , Humanos , Seguro de Salud , Leucemia Linfocítica Crónica de Células B/diagnóstico , Leucemia Linfocítica Crónica de Células B/mortalidad , Leucemia Linfocítica Crónica de Células B/terapia , Masculino , Persona de Mediana Edad , Selección de Paciente , Estados Unidos/epidemiología , Adulto Joven
18.
J Oncol Pharm Pract ; 25(8): 1897-1906, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-30823852

RESUMEN

PURPOSE: Existing studies evaluating patient adherence to oral targeted therapies such as tyrosine kinase inhibitors focus on small populations with single malignancies. This study evaluated patterns of use of oral agents in a larger population across multiple hematologic malignancies. METHODS: Adult patients diagnosed with a hematologic malignancy and prescribed oral targeted therapy between 2011 and 2016 (N = 18,976) were identified from the MarketScan Commercial Claims and Encounters, and Medicare Supplemental databases. Eligible patients were enrolled in monthly prescription plans 6 months before and 12 months after the index date (date of first prescription claim; n = 2442). Multivariable logistic regressions were used to determine predictors of adherence using the medication possession ratio (MPR) and persistence through prescription refill gaps. RESULTS: The overall median adherence was 0.9 (MPR ≥ 80%) and was comparable between once-daily (QD) and twice-daily (BID) groups. Overall, 59% of patients were persistent at 12 months. Patients on QD and BID products did not have any significant differences in adherence (fixed-interval MPR, odds ratio 0.94; 95% confidence interval (CI), 0.75-1.18) or persistence (odds ratio 0.93; 95% CI, 0.75-1.17) 12 months from index. Significant predictors of adherence and persistence included patient age, total inpatient admissions, number of adverse events, and total hospital visits. CONCLUSION: Patient-specific clinical factors, rather than regimen-specific factors, were the main predictors of oral targeted therapy adherence and persistence. Adherence to oral targeted therapies appears to be similar for patients on QD and BID regimens in the real-world setting.


Asunto(s)
Antineoplásicos/administración & dosificación , Neoplasias Hematológicas/tratamiento farmacológico , Cumplimiento de la Medicación , Terapia Molecular Dirigida , Administración Oral , Adolescente , Adulto , Anciano , Estudios de Cohortes , Bases de Datos Factuales , Esquema de Medicación , Femenino , Humanos , Masculino , Programas Controlados de Atención en Salud , Persona de Mediana Edad , Estudios Retrospectivos , Adulto Joven
19.
Leuk Lymphoma ; 60(4): 955-963, 2019 04.
Artículo en Inglés | MEDLINE | ID: mdl-30277099

RESUMEN

In view of recent therapeutic advances in mantle cell lymphoma (MCL), the aim of this retrospective cohort analysis was to assess treatment patterns, adverse events (AEs), resource utilization, and health care costs in patients with MCL in a US-based commercial claims database. A total of 783 patients with MCL (median age = 65 years) were selected. Among patients receiving systemic therapy (n = 457), the most common treatment regimens were bendamustine/rituximab (BR) (41.1%), rituximab/cyclophosphamide/doxorubicin/vincristine (RCHOP) (26.7%), rituximab monotherapy (20.4%), and ibrutinib monotherapy (14.2%). Mean monthly costs during treatments with BR, RCHOP, rituximab, and ibrutinib were $12,958, $24,719, $13,153, and $21,690, respectively. Mean monthly cost during follow-up was $13,650 among patients with ≥6 AEs versus $5131 among those without AEs. The costs of MCL varied considerably by treatment regimen and care setting. The overall economic burden of managing patients with MCL can be substantially affected by costs associated with managing AEs occurring during treatment.


Asunto(s)
Costo de Enfermedad , Recursos en Salud , Seguro de Salud , Linfoma de Células del Manto/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Comorbilidad , Femenino , Humanos , Linfoma de Células del Manto/diagnóstico , Linfoma de Células del Manto/terapia , Masculino , Persona de Mediana Edad , Pautas de la Práctica en Medicina , Modelos de Riesgos Proporcionales , Vigilancia en Salud Pública , Factores de Riesgo , Estados Unidos/epidemiología , Adulto Joven
20.
J Comp Eff Res ; 7(8): 807-816, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-29792516

RESUMEN

Aim: To estimate budget impact of adopting lesinurad as add-on to allopurinol for urate-lowering therapy in gout. Methods: A budget impact model was developed for a US payer perspective, using a Markov model to estimate costs, survival and discontinuation in a one-million-member health plan. The population included patients failing first-line gout therapy, followed for 5 years. Results: Incremental costs of adding lesinurad versus no lesinurad were US$241,907 and US$1,098,220 in first and fifth years, respectively. Cumulative 5-year incremental cost was US$3,633,440. Estimated incremental mean cost per treated patient with gout per year was US$112. The mean per-member per-month cost increased by US$0.06. Conclusion: Initiating lesinurad would result in an incremental per-member per-month cost of US$0.06 over 5 years.


Asunto(s)
Alopurinol/economía , Presupuestos/estadística & datos numéricos , Supresores de la Gota/economía , Gota/tratamiento farmacológico , Tioglicolatos/economía , Triazoles/economía , Alopurinol/uso terapéutico , Supresores de la Gota/uso terapéutico , Humanos , Cadenas de Markov , Modelos Econométricos , Tioglicolatos/uso terapéutico , Triazoles/uso terapéutico , Estados Unidos
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