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1.
Int J Clin Pract ; 70(9): 752-63, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27550177

RESUMO

BACKGROUND: Limited data are available about the real-world safety of non-vitamin K antagonist oral anticoagulants (NOACs). OBJECTIVES: To compare the major bleeding risk among newly anticoagulated non-valvular atrial fibrillation (NVAF) patients initiating apixaban, warfarin, dabigatran or rivaroxaban in the United States. METHODS AND RESULTS: A retrospective cohort study was conducted to compare the major bleeding risk among newly anticoagulated NVAF patients initiating warfarin, apixaban, dabigatran or rivaroxaban. The study used the Truven MarketScan(®) Commercial & Medicare supplemental US database from 1 January 2013 through 31 December 2013. Major bleeding was defined as bleeding requiring hospitalisation. Cox model estimated hazard ratios (HRs) of major bleeding were adjusted for age, gender, baseline comorbidities and co-medications. Among 29 338 newly anticoagulated NVAF patients, 2402 (8.19%) were on apixaban; 4173 (14.22%) on dabigatran; 10 050 (34.26%) on rivaroxaban; and 12 713 (43.33%) on warfarin. After adjusting for baseline characteristics, initiation on warfarin [adjusted HR (aHR): 1.93, 95% confidence interval (CI): 1.12-3.33, P=.018] or rivaroxaban (aHR: 2.19, 95% CI: 1.26-3.79, P=.005) had significantly greater risk of major bleeding vs apixaban. Dabigatran initiation (aHR: 1.71, 95% CI: 0.94-3.10, P=.079) had a non-significant major bleeding risk vs apixaban. When compared with warfarin, apixaban (aHR: 0.52, 95% CI: 0.30-0.89, P=.018) had significantly lower major bleeding risk. Patients initiating rivaroxaban (aHR: 1.13, 95% CI: 0.91-1.41, P=.262) or dabigatran (aHR: 0.88, 95% CI: 0.64-1.21, P=.446) had a non-significant major bleeding risk vs warfarin. CONCLUSION: Among newly anticoagulated NVAF patients in the real-world setting, initiation with rivaroxaban or warfarin was associated with a significantly greater risk of major bleeding compared with initiation on apixaban. When compared with warfarin, initiation with apixaban was associated with significantly lower risk of major bleeding. Additional observational studies are required to confirm these findings.


Assuntos
Anticoagulantes/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Hemorragia/induzido quimicamente , Adolescente , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial/estatística & dados numéricos , Fibrilação Atrial/epidemiologia , Dabigatrana/efeitos adversos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Fatores de Risco , Rivaroxabana/efeitos adversos , Estados Unidos/epidemiologia , Varfarina/efeitos adversos , Adulto Jovem
2.
Value Health ; 15(5): 632-8, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22867771

RESUMO

OBJECTIVES: A recent randomized trial demonstrated significant reductions in hemoglobin A(1c) levels with sensor-augmented pump therapy (SAPT) compared with multiple daily injections of insulin (MDI) in type 1 diabetes. We analyzed resource use in the trial and estimated the long-term cost-effectiveness of SAPT from the perspective of the US health care system. METHODS: We undertook a cost-effectiveness analysis combining estimates from the trial and the literature to populate the previously validated Center for Outcomes Research (CORE) Diabetes Model. Results represent the use of 3-day sensors, as in the trial, and 6-day sensors, approved in most markets but not yet approved in the United States. RESULTS: Within-trial hospital days, emergency department visits, and outpatient visits did not differ significantly between the treatment groups. Assuming 65% use of 3-day sensors, treatment-related costs in year 1 were an estimated $10,760 for SAPT and $5072 for MDI. Discounted lifetime estimates were $253,493 in direct medical costs and 10.794 quality-adjusted life-years (QALYs) for SAPT and $167,170 in direct medical costs and 10.418 QALYs for MDI. For 3-day and 6-day sensors, the incremental cost-effectiveness ratios were $229,675 per QALY (95% confidence interval $139,071-$720,865) and $168,104 per QALY (95% confidence interval $102,819-$523,161), respectively. The ratios ranged from $69,837 to $211,113 per QALY with different strategies for incorporating utility benefits resulting from less fear of hypoglycemia with SAPT. CONCLUSION: Despite superior clinical benefits of SAPT compared with MDI, SAPT does not appear to be economically attractive in the United States for adults with type 1 diabetes in its current state of development. However, further clinical developments reducing disposable costs of the system could significantly improve its economic attractiveness.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Custos de Cuidados de Saúde , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina/economia , Insulina/administração & dosagem , Adulto , Análise Custo-Benefício , Diabetes Mellitus Tipo 1/economia , Feminino , Seguimentos , Hemoglobinas Glicadas/metabolismo , Humanos , Hipoglicemiantes/economia , Insulina/economia , Masculino , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Fatores de Tempo , Estados Unidos
3.
Value Health ; 15(8): 1108-18, 2012 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23244814

RESUMO

OBJECTIVE: 1) To compare the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategies (REMS) and European Medicines Agency's (EMA's) Risk Management Plan (RMP) guidances and 2) to compare REMS and RMPs for specific chemical entities and biological products. METHODS: FDA, EMA, and pharmaceutical company Web sites were consulted for details pertaining to REMS and RMPs. REMS requirements include medication guides, communication plans, elements to ensure safe use, implementation systems, and specified assessment intervals. RMP requirements are increased pharmacovigilance and risk minimization activities. We compared these requirements for drugs requiring both REMS and RMPs. RESULTS: We identified 95 drugs on FDA's REMS list as of March 2010. Of these, there were 29 drugs (11 biologics and 18 new chemical entities) with EMA RMPs. REMS and RMPs are similar in objectives, with comparable toolkits. Both allow flexibility in product-specific actions, recognizing adverse effects of potential concern. Of the 29 drugs reviewed, REMS requirements not included in RMPs were patient medication guides (100% of the drugs), provider communication plans (38%), and routine monitoring of REMS (66%). RMP requirements not included in REMS were specific adverse event reporting (45% of the drugs), prospective registry studies (34%), prospective epidemiology studies (24%), additional trial data (28%), and Summary of Product Characteristics contraindications (76%). CONCLUSIONS: Both REMS and RMPs provide positive guidance for identification, monitoring, and minimization of risk to patient safety. Currently, neither agency provides specific guidance on how risk should be related to benefit either qualitatively or quantitatively.


Assuntos
Aprovação de Drogas/organização & administração , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/induzido quimicamente , Vigilância de Produtos Comercializados/métodos , Gestão de Riscos/organização & administração , United States Food and Drug Administration/organização & administração , Aprovação de Drogas/estatística & dados numéricos , Farmacoeconomia , Europa (Continente) , Guias como Assunto , Humanos , Medição de Risco , Gestão de Riscos/estatística & dados numéricos , Estados Unidos , United States Food and Drug Administration/estatística & dados numéricos
4.
J Asthma ; 47(6): 660-6, 2010 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-20615167

RESUMO

PURPOSE: An annual time frame for risk assessment may not account for the variable course of asthma. The purpose of this study was to determine whether excessive short-acting beta(2)-adrenergic agonist (SABA) dispensed quarterly was associated with asthma exacerbations in the subsequent quarter. PATIENTS AND METHODS: This retrospective cohort analysis included 93,604 health plan members aged 6-56 years with >or=2 years of continuous enrollment (2003-2007), an asthma diagnosis, and asthma prescription claims. The amount of SABA dispensed in claims (metered-dose inhaler and nebulized) was converted to canister equivalents (CEs) in the first observation quarter and categorized as 0, 0.5-3, and >or=3 (excessive SABA use). Asthma exacerbation risk (hospitalization, emergency department [ED] visit, or oral corticosteroid [OCS] claim in the subsequent quarter) was assessed using logistic regression. Covariates used in the regression models were age, sex, geographic region, comorbidities, specialist consultation, asthma controller medication use, and asthma severity. RESULTS: The cohort included 33,951 patients aged 6-17 years (36%) and 59,653 aged 18-56 years (64%); 64% had 0 SABA CE, and 5% had >3 SABA CEs. Compared with 0 CE, excessive SABA use (>3 CEs) was associated with an increased likelihood of hospitalization (adjusted odds ratio [OR]: 3.15, 95% confidence interval [CI]: 1.89-5.27) and an ED/urgent care (UC) visit (adjusted OR: 3.14, 95% CI: 2.32-4.28). CONCLUSION: The risk of an asthma exacerbation was associated with excessive SABA use in the previous quarter. Assessment of excessive SABA dispensed during a calendar quarter can be used to identify patients at increased exacerbation risk in the subsequent quarter.


Assuntos
Agonistas Adrenérgicos beta/administração & dosagem , Antiasmáticos/administração & dosagem , Asma/tratamento farmacológico , Adolescente , Agonistas Adrenérgicos beta/efeitos adversos , Adulto , Antiasmáticos/efeitos adversos , Asma/induzido quimicamente , Asma/fisiopatologia , Criança , Estudos de Coortes , Feminino , Hospitalização , Humanos , Masculino , Inaladores Dosimetrados/efeitos adversos , Pessoa de Meia-Idade , Análise de Regressão , Estudos Retrospectivos , Estados Unidos , Adulto Jovem
5.
Med Care ; 47(7): 794-802, 2009 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-19536028

RESUMO

BACKGROUND: Previous studies have documented substantial differences by patient race/ethnicity and insurance in the use of high-volume surgical providers. The extent to which regional availability of surgical capabilities explains such differences has not been examined. OBJECTIVES: To examine the existence of racial/ethnic and payer differences in using high-volume hospitals and surgeons for coronary artery bypass graft (CABG) in the state of Florida and to study the role of regional availability of high-volume providers in explaining the differences. RESEARCH DESIGN: We conducted descriptive analysis of the distribution of CABG providers and patient populations by race/ethnicity and insurance across the 19 Hospital Referral Regions (HRRs) in Florida. We estimated logistic regressions of using a high-volume provider to derive estimates of overall group differences. We further estimated models with HRR fixed effects to derive within-HRR differences. We derived implications by comparing findings based on the 2 sets of models. RESULTS: Non-Hispanic black patients were 58% as likely (95% CI: 52%, 65%), Hispanic patients were 84% as likely (95% CI: 77%, 90%), to have received CABGs at a high-volume hospital, compared with non-Hispanic whites. Controlling for inter-HRR differences eliminated almost all racial/ethnic differences. Substantial differences in using high-volume providers existed between Medicaid/uninsured and privately insured patients and such differences persisted within HRRs. CONCLUSIONS: Unequal distribution of CABG capabilities coupled with racial/ethnic concentration in residence across Florida HRRs accounted for almost all racial/ethnic differences in using high-volume hospitals. Factors other than availability of surgical resources were responsible for differences between Medicaid/uninsured and privately insured patients.


Assuntos
Ponte de Artéria Coronária/estatística & dados numéricos , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Disparidades em Assistência à Saúde/organização & administração , Padrões de Prática Médica/estatística & dados numéricos , Cirurgia Torácica , Negro ou Afro-Americano/etnologia , Negro ou Afro-Americano/estatística & dados numéricos , Certificação/estatística & dados numéricos , Competência Clínica/estatística & dados numéricos , Florida/epidemiologia , Pesquisas sobre Atenção à Saúde , Tamanho das Instituições de Saúde/estatística & dados numéricos , Cardiopatias/etnologia , Cardiopatias/cirurgia , Hispânico ou Latino/etnologia , Hispânico ou Latino/estatística & dados numéricos , Humanos , Seguro Saúde/estatística & dados numéricos , Modelos Logísticos , Medicaid/estatística & dados numéricos , Medicare/estatística & dados numéricos , Alta do Paciente/estatística & dados numéricos , Características de Residência/estatística & dados numéricos , Cirurgia Torácica/educação , Cirurgia Torácica/estatística & dados numéricos , Estados Unidos , População Branca/etnologia , População Branca/estatística & dados numéricos
6.
J Asthma ; 46(1): 73-80, 2009 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-19191142

RESUMO

OBJECTIVE: There is a wide range in the estimates of cost of asthma that are available in the literature. Given the growing prevalence of asthma and its associated healthcare resource use in the United States (U.S.), it is important to obtain current and precise cost estimates attributable to asthma treatment. The objectives of this study were to estimate the incremental direct expenditures associated with asthma in the U.S. METHODS: Retrospective analysis was conducted using the 2004 Medical Expenditure Panel Survey (MEPS) data that are representative of the civilian non-institutionalized population of the U.S. Asthma respondents were identified as those with International Classification of Diseases-9-Clinical Modification (ICD-9-CM) diagnosis codes for asthma in 2004 or those who had a self-report of having asthma in 2004. Incremental total expenditures and expenditures for various categories of resource use including physician office visits, emergency room visits, outpatient visits, inpatient visits, medications, and other medical visits associated with asthma were estimated separately in children (age < 18 years) and in adults (age > or = 18 years) using generalized linear regression models. The models were adjusted for covariates including age, gender, race, ethnicity, education, marital status (for age group > or = 18 years), geographic region, insurance status, and comorbidities. RESULTS: The prevalence of asthma among children and adults in 2004 was estimated at 8.7% (6.4 million persons) and 6.72% (14.8 million persons), respectively. The annual adjusted mean incremental total expenditure associated with asthma was $1,004.6 (SE: $326.1; p = 0.002) per person among children and was $2,077.5 (SE: $544.5; p < 0.0001) per person among adults, after adjusting for covariates. Prescription medications and physician office visits were the major drivers of total expenditures and constituted approximately 38% and 49% of the total incremental expenditures for asthma in children and adults, respectively. Inpatient visit expenditures were high in both age groups but were not significantly different from zero. CONCLUSION: Given the prevalence of asthma among U.S. children and adults and its associated incremental expenditures, the annual direct medical expenditure attributable to asthma treatment is estimated at approximately $37.2 billion in 2007 U.S. dollars representing a significant portion of healthcare resource use in the U.S.


Assuntos
Asma/economia , Asma/terapia , Gastos em Saúde , Adulto , Assistência Ambulatorial/economia , Asma/epidemiologia , Criança , Bases de Dados Factuais , Serviço Hospitalar de Emergência/economia , Feminino , Hospitalização/economia , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Visita a Consultório Médico/economia , Medicamentos sob Prescrição/economia , Estudos Retrospectivos , Estados Unidos/epidemiologia
7.
J Cult Divers ; 15(3): 132-42, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-19025201

RESUMO

This review of minority health describes the existing health disparities, the barriers to healthcare access and utilization, the role of three social determinants of health [i.e., (1) socioeconomic status, (2) education, and (3) stress and/or depression], the existing public-policies; and a health literacy strategy addressing social determinants of health to reduce disparities and improve outcomes in African-American women undergoing Percutaneous Coronary Intervention (PCI). Insurance, geography, facility-types, physician referral-bias, and cultural-differences pose as potential significant barriers to healthcare access and utilization. Likewise, lower socioeconomic-status, lack of education, and higher stress and/or depression is associated with adverse health-outcomes for this population. Although the elimination of health disparities is a national priority, comprehensive educational approaches focusing on cross-cultural communication, language barriers, cultural-sensitivity, and cultural-competence are needed.


Assuntos
Angioplastia Coronária com Balão , Negro ou Afro-Americano , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde/organização & administração , Mulheres , Negro ou Afro-Americano/educação , Negro ou Afro-Americano/etnologia , Negro ou Afro-Americano/estatística & dados numéricos , Angioplastia Coronária com Balão/educação , Angioplastia Coronária com Balão/psicologia , Angioplastia Coronária com Balão/estatística & dados numéricos , Depressão/etnologia , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Política de Saúde , Acessibilidade aos Serviços de Saúde/organização & administração , Necessidades e Demandas de Serviços de Saúde , Humanos , Pessoas sem Cobertura de Seguro de Saúde/etnologia , Pessoas sem Cobertura de Seguro de Saúde/estatística & dados numéricos , Avaliação de Resultados em Cuidados de Saúde , Aceitação pelo Paciente de Cuidados de Saúde/etnologia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Educação de Pacientes como Assunto , Preconceito , Encaminhamento e Consulta , Fatores Socioeconômicos , Estresse Psicológico/etnologia , Gestão da Qualidade Total , Estados Unidos , Mulheres/educação , Mulheres/psicologia
8.
PLoS One ; 13(11): e0205989, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30383768

RESUMO

Limited real-world data are available regarding the comparative safety of non-vitamin K antagonist oral anticoagulants (NOACs). The objective of this retrospective claims observational cohort study was to compare the risk of bleeding among non-valvular atrial fibrillation (NVAF) patients prescribed apixaban, dabigatran, or rivaroxaban. NVAF patients aged ≥18 years with a 1-year baseline period were included if they were new initiators of NOACs or switched from warfarin to a NOAC. Cox proportional hazards modelling was used to estimate the adjusted hazard ratios of any bleeding, clinically relevant non-major (CRNM) bleeding, and major inpatient bleeding within 6 months of treatment initiation for rivaroxaban and dabigatran compared to apixaban. Among 60,227 eligible patients, 8,785 were prescribed apixaban, 20,963 dabigatran, and 30,529 rivaroxaban. Compared to dabigatran or rivaroxaban patients, apixaban patients were more likely to have greater proportions of baseline comorbidities and higher CHA2DS2-VASc and HAS-BLED scores. After adjusting for baseline clinical and demographic characteristics, patients prescribed rivaroxaban were more likely to experience any bleeding (HR: 1.35, 95% confidence interval [CI]: 1.26-1.45), CRNM bleeding (HR: 1.38, 95% CI: 1.27-1.49), and major inpatient bleeding (HR: 1.43, 95% CI: 1.17-1.74), compared to patients prescribed apixaban. Dabigatran patients had similar bleeding risks as apixaban patients. In conclusion, NVAF patients treated with rivaroxaban appeared to have an increased risk of any bleeding, CRNM bleeding, and major inpatient bleeding, compared to apixaban patients. There was no significant difference in any bleeding, CRNM bleeding, or inpatient major bleeding risks between patients treated with dabigatran and apixaban.


Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Hemorragia/tratamento farmacológico , Acidente Vascular Cerebral/tratamento farmacológico , Administração Oral , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anti-Inflamatórios não Esteroides/administração & dosagem , Fibrilação Atrial/patologia , Estudos de Coortes , Dabigatrana/administração & dosagem , Feminino , Humanos , Pacientes Internados , Masculino , Pessoa de Meia-Idade , Pacientes Ambulatoriais , Modelos de Riscos Proporcionais , Pirazóis/administração & dosagem , Piridonas/administração & dosagem , Medição de Risco , Rivaroxabana/administração & dosagem , Vitamina K/antagonistas & inibidores , Varfarina/administração & dosagem
9.
PLoS One ; 13(4): e0195950, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29709012

RESUMO

Discontinuation of oral anticoagulants may expose non-valvular atrial fibrillation (NVAF) patients to an increased risk of stroke. This study describes the real-world discontinuation rates and compared the risk of drug discontinuation among NVAF patients initiating apixaban, warfarin, dabigatran, or rivaroxaban. This retrospective cohort study evaluated newly-anticoagulated NVAF patients in the MarketScan® data population from 01/01/2012 through 12/31/2014. Discontinuation was defined as a lack of subsequent prescription of the index drug within 30 days after the last supply day of the last prescription. A Cox model was used to estimate the hazard ratio (HR) of discontinuation, adjusted for age, sex, and comorbidities. Among 45,361 eligible NVAF patients, 15,461 (34.1%) initiated warfarin; 7,438 (16.4%) apixaban; 4,661 (10.3%) dabigatran; and 17,801 (39.2%) initiated rivaroxaban treatment. Compared to warfarin, patients who initiated dabigatran (adjusted HR [aHR]: 0.84, 95% confidence interval [CI]: 0.80-0.87, P<0.001), rivaroxaban (aHR: 0.70, 95% CI: 0.68-0.73, P<0.001), or apixaban (aHR: 0.57, 95% CI: 0.55-0.60, P<0.001) were 16%, 30%, and 43% less likely to discontinue treatment, respectively. When compared to apixaban, patients who initiated dabigatran (aHR: 1.46, 95% CI: 1.38-1.54, P<0.001) or rivaroxaban (aHR: 1.23, 95% CI: 1.17-1.28, P<0.001) were more likely to discontinue treatment. Among newly-anticoagulated NVAF patients in the real-world setting, initiation on rivaroxaban, dabigatran, or apixaban was associated with a significantly lower risk of discontinuation compared to warfarin. When compared to apixaban, patients who initiated treatment with warfarin, dabigatran, or rivaroxaban were more likely to discontinue treatment.


Assuntos
Anticoagulantes/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Hemorragia/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Suspensão de Tratamento/estatística & dados numéricos , Adolescente , Adulto , Idoso , Dabigatrana/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Prognóstico , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Estudos Retrospectivos , Fatores de Risco , Rivaroxabana/efeitos adversos , Acidente Vascular Cerebral/induzido quimicamente , Estados Unidos/epidemiologia , Varfarina/efeitos adversos , Adulto Jovem
10.
J Clin Oncol ; 36(8): 773-779, 2018 03 10.
Artigo em Inglês | MEDLINE | ID: mdl-29355075

RESUMO

Purpose Nivolumab provides clinical benefit (objective response rate [ORR], 31%; 95% CI, 20.8 to 42.9; disease control rate, 69%; 12-month overall survival [OS], 73%) in previously treated patients with DNA mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC); nivolumab plus ipilimumab may improve these outcomes. Efficacy and safety results for the nivolumab plus ipilimumab cohort of CheckMate-142, the largest single-study report of an immunotherapy combination in dMMR/MSI-H mCRC, are reported. Patients and Methods Patients received nivolumab 3 mg/kg plus ipilimumab 1 mg/kg once every 3 weeks (four doses) followed by nivolumab 3 mg/kg once every 2 weeks. Primary end point was investigator-assessed ORR. Results Of 119 patients, 76% had received ≥ two prior systemic therapies. At median follow-up of 13.4 months, investigator-assessed ORR was 55% (95% CI, 45.2 to 63.8), and disease control rate for ≥ 12 weeks was 80%. Median duration of response was not reached; most responses (94%) were ongoing at data cutoff. Progression-free survival rates were 76% (9 months) and 71% (12 months); respective OS rates were 87% and 85%. Statistically significant and clinically meaningful improvements were observed in patient-reported outcomes, including functioning, symptoms, and quality of life. Grade 3 to 4 treatment-related adverse events (AEs) occurred in 32% of patients and were manageable. Patients (13%) who discontinued treatment because of study drug-related AEs had an ORR (63%) consistent with that of the overall population. Conclusion Nivolumab plus ipilimumab demonstrated high response rates, encouraging progression-free survival and OS at 12 months, manageable safety, and meaningful improvements in key patient-reported outcomes. Indirect comparisons suggest combination therapy provides improved efficacy relative to anti-programmed death-1 monotherapy and has a favorable benefit-risk profile. Nivolumab plus ipilimumab provides a promising new treatment option for patients with dMMR/MSI-H mCRC.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Colorretais/tratamento farmacológico , Ipilimumab/uso terapêutico , Nivolumabe/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/farmacologia , Neoplasias Colorretais/mortalidade , Neoplasias Colorretais/patologia , Reparo de Erro de Pareamento de DNA , Feminino , Humanos , Ipilimumab/farmacologia , Masculino , Instabilidade de Microssatélites , Pessoa de Meia-Idade , Metástase Neoplásica , Nivolumabe/farmacologia , Taxa de Sobrevida
11.
Blood Adv ; 1(23): 1983-1992, 2017 Oct 24.
Artigo em Inglês | MEDLINE | ID: mdl-29296845

RESUMO

Sickle cell disease (SCD) is a chronic, debilitating disorder. Chronically ill patients are at risk for depression, which can affect health-related quality of life (HRQoL), health care utilization, and cost. We performed an analytic epidemiologic prospective study to determine the prevalence of depression in adult patients with SCD and its association with HRQoL and medical resource utilization. Depression was measured by the Beck Depression Inventory and clinical history in adult SCD outpatients at a comprehensive SCD center. HRQoL was assessed using the SF36 form, and data were collected on medical resource utilization and corresponding cost. Neurocognitive functions were assessed using the CNS Vital Signs tool. Pain diaries were used to record daily pain. Out of 142 enrolled patients, 42 (35.2%) had depression. Depression was associated with worse physical and mental HRQoL scores (P < .0001 and P < .0001, respectively). Mean total inpatient costs ($25 000 vs $7487, P = .02) and total health care costs ($30 665 vs $13 016, P = .01) were significantly higher in patients with depression during the 12 months preceding diagnosis. Similarly, during the 6 months following diagnosis, mean total health care costs were significantly higher in depressed patients than in nondepressed patients ($13 766 vs $8670, P = .04). Depression is prevalent in adult patients with SCD and is associated with worse HRQoL and higher total health care costs. Efforts should focus on prevention, early diagnosis, and therapy for depression in SCD.

12.
Thromb Haemost ; 116(5): 975-986, 2016 Oct 28.
Artigo em Inglês | MEDLINE | ID: mdl-27538358

RESUMO

In addition to warfarin, there are four non-vitamin K antagonist oral anticoagulants (NOACs) available for stroke prevention in non valvular atrial fibrillation (NVAF). There are limited data on the comparative risks of major bleeding among newly anticoagulated NVAF patients who initiate warfarin, apixaban, dabigatran, or rivaroxaban, when used in 'real world' clinical practice. The study used the Truven MarketScan® Commercial & Medicare supplemental US claims database. NVAF patients aged ≥18 years newly prescribed an oral anticoagulant 01JAN2013-31DEC2014, with a ≥1-year baseline period, were included (study period: 01JAN2012-31DEC2014). Major bleeding was defined as bleeding requiring hospitalisation. Propensity score matching (PSM) was used to balance age, sex, region, baseline comorbidities, and comedications. Cox proportional hazards models were used to estimate the PSM hazard ratio (HR) of major bleeding. Among 45,361 newly anticoagulated NVAF patients, 15,461 (34.1 %) initiated warfarin, 7,438 (16.4 %) initiated apixaban, 17,801 (39.2 %) initiated rivaroxaban, and 4,661 (10.3 %) initiated dabigatran. Compared to matched warfarin initiators, apixaban (HR: 0.53; 95 % CI: 0.39-0.71) and dabigatran (HR: 0.69; 95 % CI: 0.50-0.96) initiators had a significantly lower risk of major bleeding. Patients initiating rivaroxaban (HR: 0.98; 95 % CI: 0.83-1.17) had a non-significant difference in major bleeding risk compared to matched warfarin patients. When comparisons were made between NOACs, matched rivaroxaban patients had a significantly higher risk of major bleeding (HR: 1.82; 95 % CI: 1.36-2.43) compared to apixaban patients. The differences for apixaban-dabigatran and dabigatran-rivaroxaban matched cohorts were not statistically significant. Among newly anticoagulated NVAF patients in the real-world setting, apixaban and dabigatran initiation was associated with significantly lower risk of major bleeding compared to warfarin initiation. When compared to apixaban, rivaroxaban initiation was associated with significantly higher risk of major bleeding.


Assuntos
Fibrilação Atrial , Dabigatrana/efeitos adversos , Hemorragia/epidemiologia , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Rivaroxabana/efeitos adversos , Varfarina/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Estudos Retrospectivos , Risco , Acidente Vascular Cerebral
14.
Med Decis Making ; 33(2): 215-24, 2013 02.
Artigo em Inglês | MEDLINE | ID: mdl-23128579

RESUMO

BACKGROUND: Sensor-augmented pump therapy (SAPT) leads to lower glycated hemoglobin levels than multiple daily injections of insulin (MDI) in patients with type 1 diabetes. Patient time and costs associated with SAPT are not known. OBJECTIVE: We compared time spent on diabetes-related care, changes in time, and associated patient time costs between patients randomly assigned to SAPT or MDI. DESIGN, SETTING, AND PARTICIPANTS. During a 52-week clinical trial, participants aged 7 to 70 years (n = 483) reported total time per week spent on diabetes-related care. MEASUREMENTS: Patient time, including comparisons during pump initiation, 52-week patient time costs, and changes in weekly time estimates after pump initiation. RESULTS: At baseline, patients in the MDI group reported spending an average of 4.0 hours per week on diabetes-related care. During the pump initiation period (weeks 1-7), SAPT patients spent 1.9 hours more per week than MDI patients (95% confidence interval [CI], 1.2-2.6). After the initiation period (weeks 8-52), SAPT patients spent 1 hour more per week (95% CI, 0.4-1.7) than MDI patients (i.e., 4.4 v. 3.4 hours); patients in both groups spent progressively less time on diabetes-related care by 1.2 minutes per week (95% CI, -1.7 to -0.7). Overall, mean time costs per person were $4600 with the SAPT group and $3523 with the MDI group (difference, $1077; 95% CI, $491-$1638). LIMITATIONS: Time spent on specific activities was not collected, and the estimates do not explicitly account for caregiver time associated with diabetes care activities. CONCLUSIONS: Patients receiving SAPT v. MDI spent approximately 2 hours more per week on diabetes-related care during pump initiation and 1 hour more per week thereafter, resulting in higher patient time costs.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Custos de Cuidados de Saúde , Bombas de Infusão/economia , Insulina/administração & dosagem , Adolescente , Adulto , Idoso , Criança , Humanos , Insulina/uso terapêutico , Pessoa de Meia-Idade , Estudos de Tempo e Movimento , Adulto Jovem
15.
Circ Cardiovasc Qual Outcomes ; 5(1): 113-9, 2012 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-22147884

RESUMO

BACKGROUND: Patient-centered health care interventions, such as heart failure disease management programs, are under increasing pressure to demonstrate good value. Variability in costing methods and assumptions in economic evaluations of such interventions limit the comparability of cost estimates across studies. Valid cost estimation is critical to conducting economic evaluations and for program budgeting and reimbursement negotiations. METHODS AND RESULTS: Using sound economic principles, we developed the Tools for Economic Analysis of Patient Management Interventions in Heart Failure (TEAM-HF) Costing Tool, a spreadsheet program that can be used by researchers and health care managers to systematically generate cost estimates for economic evaluations and to inform budgetary decisions. The tool guides users on data collection and cost assignment for associated personnel, facilities, equipment, supplies, patient incentives, miscellaneous items, and start-up activities. The tool generates estimates of total program costs, cost per patient, and cost per week and presents results using both standardized and customized unit costs for side-by-side comparisons. Results from pilot testing indicated that the tool was well-formatted, easy to use, and followed a logical order. Cost estimates of a 12-week exercise training program in patients with heart failure were generated with the costing tool and were found to be consistent with estimates published in a recent study. CONCLUSIONS: The TEAM-HF Costing Tool could prove to be a valuable resource for researchers and health care managers to generate comprehensive cost estimates of patient-centered interventions in heart failure or other conditions for conducting high-quality economic evaluations and making well-informed health care management decisions.


Assuntos
Insuficiência Cardíaca/economia , Modelos Econômicos , Software , Análise Custo-Benefício , Custos de Cuidados de Saúde , Insuficiência Cardíaca/epidemiologia , Humanos , Administração dos Cuidados ao Paciente , Assistência Centrada no Paciente , Estados Unidos , Interface Usuário-Computador
16.
Am J Manag Care ; 17(1): 19-27, 2011 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-21348565

RESUMO

OBJECTIVE: To assess whether increased short-acting ß(2)-adrenergic agonist (SABA) claims are associated with asthma exacerbations and increased healthcare costs. STUDY DESIGN: Cross-sectional study. METHODS: Patients (N = 93,604) were health plan members aged 6-56 years with at least 2 years of enrollment between July 1, 2003, and June 30, 2007, an asthma diagnosis, and at least 1 asthma medication claim per study year. Two years of administrative claims were collected. SABA use was categorized as 0 (none), (1/2) to 2 (low), 2(1/2) to 6 (moderate), 6(1/2) to 12 (high), and more than 12 (excessive) canister equivalents per year. Multivariate analyses were adjusted for age, sex, geographic region, comorbidities, specialist consultation, controller medication use, and asthma severity. RESULTS: Half of high and excessive SABA users had few or no controller claims. Compared with SABA nonusers, high and excessive SABA users had significantly higher odds (odds ratio [95% confidence interval]) of asthma-related emergency department/urgent care visits (6.47 [5.25, 7.98] and 7.68 [6.04, 9.76], respectively), hospitalizations (5.37 [6.04, 9.76]; 6.90 [4.90, 9.73]), and oral corticosteroid use (2.89 [2.72, 3.08]; 3.71 [3.41, 4.03]). Excessive SABA users had 3.0 times ($1791) and high SABA users had 2.2 times ($1326) higher asthma-related healthcare costs than low SABA users ($595). Total costs also increased with higher SABA use, but with smaller incremental differences between excessive and high SABA users and low SABA users. CONCLUSIONS: Increased SABA use is associated with higher total and asthma-related healthcare costs. Opportunity exists to lessen overreliance on SABAs.


Assuntos
Corticosteroides/uso terapêutico , Agonistas Adrenérgicos beta/economia , Asma/economia , Gerenciamento Clínico , Adolescente , Corticosteroides/economia , Agonistas Adrenérgicos beta/uso terapêutico , Adulto , Asma/tratamento farmacológico , Asma/prevenção & controle , Criança , Redução de Custos , Estudos Transversais , Feminino , Custos de Cuidados de Saúde , Indicadores Básicos de Saúde , Hospitalização/economia , Hospitalização/tendências , Humanos , Revisão da Utilização de Seguros , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Retrospectivos , Índice de Gravidade de Doença , Estados Unidos , Adulto Jovem
17.
Am J Prev Med ; 38(3): 311-6, 2010 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-20171533

RESUMO

BACKGROUND: Communities with locally generated special healthcare taxes have demonstrated a generally favorable association with selected population health status outcomes. PURPOSE: This research attempted to determine if that positive association with health outcomes is race differentiated. METHODS: Florida counties with multiple special taxing districts were grouped and compared against counties that had either no special healthcare taxing authority or had such authority but were inactive (did not tax). Outcomes of interest were five combined groups and eight cause-specific mortality indicators and five categories of hospitalizations from the 6-year period 2000-2005 analyzed in 2007. Standard mortality ratios and standard hospitalization ratios were calculated separately for white and black populations in four age bands. RESULTS: Compared to blacks and whites living in communities without special taxing districts, black residents of communities with such districts had larger reductions in mortality for chronic conditions such as cancers, diabetes, stroke, and pneumonia/influenza. The same holds true for hospitalizations for diabetes, congestive heart failure, hypertension, and asthma. These differences were not found in mortality due to HIV, homicide, or motor vehicle crashes. Some differences by taxing district were also age and race differentiated. CONCLUSIONS: In communities with health-related taxing authorities, reductions in health disparities between whites and blacks can be demonstrated. These differences are not uniform and vary by the specific type of outcome, race, and age. These findings support the need for studies that prospectively determine whether implementing new taxing strategies may help reduce health disparities.


Assuntos
Disparidades nos Níveis de Saúde , Indicadores Básicos de Saúde , Impostos , Adolescente , Adulto , Idoso , População Negra , Criança , Pré-Escolar , Florida , Nível de Saúde , Humanos , Lactente , Recém-Nascido , Pessoa de Meia-Idade , População Branca , Adulto Jovem
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