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1.
Cancer Med J ; 3(2): 75-84, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32405630

RESUMO

Background: Somatostatin Analogues (SSAs) are used to treat Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and acromegaly. Side effects of SAAs usually include biliary disorders, gastrointestinal disorders, injection-site pain and hyperglycemia. Exocrine Pancreatic Insufficiency (EPI) is often misdiagnosed as disease progression or failure to SAAs or diagnosed after a delay in patients receiving SAAs. We present our experience with EPI developing in patients following use of SAAs. Methods: We reviewed chart and pharmacy records of 110 GEP-NETs patients who received SSAs. Data was collected including demographics, pathology, stage, dose/duration of long and short-acting SA, use of antidiarrheal, pancreatic enzyme replacement (PER), proton pump inhibitors (PPI) or H2 blockers). Laboratory data include chromogranin-A (CgA), urine 5-HIAA and quantitative fecal fat test (QFFT) or fecal elastase test (FE). EPI was defined by a FE below normal level OR by a reduction of ≥ 21.2% or steatorrhea on QFFT. Patients who were identified to develop EPI were treated with pancreatic exocrine replacement therapy (PERT). Results: Among, 110 GEP-NETs patients, 104 received LA Octreotide and 6 Somatuline Depot Injection. Of these, 23 received short-acting SSA for worsening diarrhea, 96 had intensification of antidiarrheal and 1 got telotristat ethyl. QFFT confirmed EPI in 19, 11 based on clinical symptoms, and 16 had sample error or refusal to collect specimen. CTCAE 4.0 grades of EPI were: grade 2(69%), grade 3(22%) and grade 4(9%). Median time to development of EPI was 12 months (95%CI 3 - 23). Except 1, all patients received PERT either with concomitant PPI (13) or later if no improvement with PERT (6) and 2 on H2 blockers. 37% of the patients had improvement in EPI within 4-8 weeks. Deficiency of vitamins and trace elements was found in 11 of 19 patients, who received supplementation. Conclusions: Our experience constitutes the first and the largest study addressing EPI as a rare but serious complication of chronic use of SAAs. Although SAAs are used to treat diarrhea, paradoxically they can worsen diarrhea secondary to EPI. Early recognition and diagnosis of this under-diagnosed and under-reported side effect of SAAs, such as EPI, can improve not only diarrhea and weight loss in these patients but also can reduce cost of using short-acting SAAs and antidiarrheal.

2.
Artigo em Inglês | MEDLINE | ID: mdl-31658965

RESUMO

The aim of this work was to describe optimized dosing regimens of ceftolozane-tazobactam for critically ill patients receiving continuous venovenous hemodiafiltration (CVVHDF). We conducted a prospective observational pharmacokinetic study in adult critically ill patients with clinical indications for ceftolozane-tazobactam and CVVHDF. Unbound drug concentrations were measured from serial prefilter blood, postfilter blood, and ultrafiltrate samples by a chromatographic assay. Population pharmacokinetic modeling and dosing simulations were performed using Pmetrics. A four-compartment pharmacokinetic model adequately described the data from six patients. The mean (± standard deviation [SD]) extraction ratios for ceftolozane and tazobactam were 0.76 ± 0.08 and 0.73 ± 0.1, respectively. The mean ± SD sieving coefficients were 0.94 ± 0.24 and 1.08 ± 0.30, respectively. Model-estimated CVVHDF clearance rates were 2.7 ± 0.8 and 3.0 ± 0.6 liters/h, respectively. Residual non-CVVHDF clearance rates were 0.6 ± 0.5 and 3.3 ± 0.9 liters/h, respectively. In the initial 24 h, doses as low as 0.75 g every 8 h enabled cumulative fractional response of ≥85% for empirical coverage against Pseudomonas aeruginosa, considering a 40% fT>MIC (percentage of time the free drug concentration was above the MIC) target. For 100% fT>MIC, doses of at least 1.5 g every 8 h were required. The median (interquartile range) steady-state trough ceftolozane concentrations for simulated regimens of 1.5 g and 3.0 g every 8 h were 28 (21 to 42) and 56 (42 to 84) mg/liter, respectively. The corresponding tazobactam concentrations were 6.1 (5.5 to 6.7) and 12.1 (11.0 to 13.4) mg/liter, respectively. We suggest a front-loaded regimen with a single 3.0-g loading dose followed by 0.75 g every 8 h for critically ill patients undergoing CVVHDF with study blood and dialysate flow rates.


Assuntos
Antibacterianos/farmacocinética , Antibacterianos/uso terapêutico , Cefalosporinas/farmacocinética , Cefalosporinas/uso terapêutico , Hemodiafiltração/métodos , Tazobactam/farmacocinética , Tazobactam/uso terapêutico , Injúria Renal Aguda/tratamento farmacológico , Injúria Renal Aguda/microbiologia , Antibacterianos/administração & dosagem , Cefalosporinas/administração & dosagem , Intervalos de Confiança , Terapia de Substituição Renal Contínua , Estado Terminal , Humanos , Testes de Sensibilidade Microbiana , Estudos Prospectivos , Pseudomonas aeruginosa/efeitos dos fármacos , Pseudomonas aeruginosa/patogenicidade , Tazobactam/administração & dosagem
3.
Gut ; 68(Suppl 3): s1-s106, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31562236

RESUMO

Ulcerative colitis and Crohn's disease are the principal forms of inflammatory bowel disease. Both represent chronic inflammation of the gastrointestinal tract, which displays heterogeneity in inflammatory and symptomatic burden between patients and within individuals over time. Optimal management relies on understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This guideline for management of inflammatory bowel disease in adults over 16 years of age was developed by Stakeholders representing UK physicians (British Society of Gastroenterology), surgeons (Association of Coloproctology of Great Britain and Ireland), specialist nurses (Royal College of Nursing), paediatricians (British Society of Paediatric Gastroenterology, Hepatology and Nutrition), dietitians (British Dietetic Association), radiologists (British Society of Gastrointestinal and Abdominal Radiology), general practitioners (Primary Care Society for Gastroenterology) and patients (Crohn's and Colitis UK). A systematic review of 88 247 publications and a Delphi consensus process involving 81 multidisciplinary clinicians and patients was undertaken to develop 168 evidence- and expert opinion-based recommendations for pharmacological, non-pharmacological and surgical interventions, as well as optimal service delivery in the management of both ulcerative colitis and Crohn's disease. Comprehensive up-to-date guidance is provided regarding indications for, initiation and monitoring of immunosuppressive therapies, nutrition interventions, pre-, peri- and postoperative management, as well as structure and function of the multidisciplinary team and integration between primary and secondary care. Twenty research priorities to inform future clinical management are presented, alongside objective measurement of priority importance, determined by 2379 electronic survey responses from individuals living with ulcerative colitis and Crohn's disease, including patients, their families and friends.


Assuntos
Consenso , Tratamento Conservador/normas , Gerenciamento Clínico , Gastroenterologia , Doenças Inflamatórias Intestinais/terapia , Guias de Prática Clínica como Assunto/normas , Sociedades Médicas , Adulto , Humanos , Reino Unido
4.
Clin Appl Thromb Hemost ; 25: 1076029619870249, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31418293

RESUMO

We compared the risks of switching to another oral anticoagulant (OAC) and discontinuation of direct oral anticoagulants (DOACs) among elderly patients with nonvalvular atrial fibrillation (NVAF) who were prescribed rivaroxaban or dabigatran versus apixaban. Patients (≥65 years of age) with NVAF prescribed DOACs (January 1, 2013 to September 30, 2017) were identified from the Humana research database and grouped into DOAC cohorts. Cox regression analyses were used to evaluate whether the risk for switching to another OAC or discontinuing index DOACs differed among cohorts. Of the study population (N = 38 250), 55.9% were prescribed apixaban (mean age: 78.6 years; 49.8% female), 37.3% rivaroxaban (mean age: 77.4 years; 46.7% female), and 6.8% dabigatran (mean age: 77.0 years; 44.0% female). Compared to patients prescribed apixaban, patients prescribed rivaroxaban (hazard ratio [HR]: 2.08; 95% confidence interval [CI], 1.92-2.25; P < .001) or dabigatran (HR: 3.74; 95% CI, 3.35-4.18, P < .001) had a significantly higher risk of switching to another OAC during the follow-up; compared to patients prescribed apixaban, the risks of discontinuation were also higher for patients treated with rivaroxaban (HR: 1.10; 95% CI, 1.07-1.13, P < .001) or dabigatran (HR: 1.29; 95% CI, 1.23-1.35, P < .001).


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Substituição de Medicamentos/estatística & dados numéricos , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Antitrombinas/uso terapêutico , Dabigatrana/uso terapêutico , Inibidores do Fator Xa/uso terapêutico , Feminino , Humanos , Masculino , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Estudos Retrospectivos , Rivaroxabana/uso terapêutico
5.
Adv Ther ; 36(1): 162-174, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30499067

RESUMO

INTRODUCTION: Continuous usage of direct oral anticoagulants (DOACs) among nonvalvular atrial fibrillation (NVAF) patients is essential to maintain stroke prevention. We examined switching and discontinuation rates for the three most frequently initiated DOACs in NVAF patients in the USA. METHODS: Patients who initiated apixaban, rivaroxaban, or dabigatran (index event/date) were identified from the Pharmetrics Plus claims database (Jan 1, 2013-Sep 30, 2016, includes patients with commercial and Medicare coverage) and grouped into cohorts by index DOAC. Patients were required to have a diagnosis of NVAF and continuous health plan enrollment for 12 months prior to the index date (baseline period) and at least 3 months during the follow-up period. Drug switching rates to any other DOAC or warfarin and index DOAC discontinuation rate were evaluated separately with descriptive statistics, Kaplan-Meier analysis, and multivariable Cox regression analysis. RESULTS: Of the NVAF study population (n = 41,864), 37% initiated apixaban (n = 15,352; mean age 62 years), 51% initiated rivaroxaban (n = 21,250; mean age 61 years), and 13% initiated dabigatran (n = 5262; mean age 61 years). During the follow-up period, the unadjusted drug switching rates of patients treated with apixaban, rivaroxaban, and dabigatran were 3.6%, 6.3%, and 11.1%, respectively (p < 0.001 across the three cohorts); while the index DOAC discontinuation rates were 52.8%, 60.3%, and 62.9%, respectively (p < 0.001). After we controlled for differences in patient characteristics, patients treated with rivaroxaban (HR 1.8; 95% CI 1.6-2.0; p < 0.001) and dabigatran (HR 3.4; 95% CI 3.0-3.8, p < 0.001) had a significantly greater likelihood for drug switching than patients treated with apixaban. Also, both rivaroxaban (HR 1.1; 95% CI 1.1-1.2, p < 0.001) and dabigatran (HR 1.3; 95% CI 1.2-1.3, p < 0.001) treated patients were more likely to discontinue treatment. CONCLUSION: In the real-world setting, patients with NVAF newly treated with apixaban were less likely to switch or discontinue treatment compared to patients treated with rivaroxaban or dabigatran. FUNDING: Pfizer and Bristol-Myers Squibb.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Cooperação e Adesão ao Tratamento/estatística & dados numéricos , Idoso , Dabigatrana/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Estudos Retrospectivos , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Estados Unidos , Varfarina/uso terapêutico
6.
J Med Econ ; 21(10): 1036-1040, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30071761

RESUMO

BACKGROUND: Regular molecular monitoring with reverse-transcription quantitative PCR (RT-qPCR) analysis of BCR-ABL1 transcripts is associated with reduced disease progression among patients with chronic myeloid leukemia (CML). Molecular monitoring assists in the timely detection of primary or secondary resistance to tyrosine kinase inhibitor (TKI) therapy and is a recommended practice by the National Comprehensive Cancer Network guidelines. An economic model was developed to estimate the potential impact of CML monitoring vs lack of monitoring on patient healthcare costs. METHODS: An Excel-based decision-analytic economic model was developed from a US payer perspective. The model was used to estimate the expected healthcare cost differences between regular molecular monitoring of CML patients and lack of monitoring. CML progression rates among patients with vs without monitoring, the annual cost of CML progression, the average number of monitoring tests per year, and the average cost per RT-qPCR monitoring test were incorporated into the model. Univariate and multivariable sensitivity analyses were conducted. RESULTS: Based on estimates in published literature, disease progression to the accelerated/blast phase occurs among 0.35% of patients with monitoring and 5.12% of patients without monitoring, and the annual cost of CML progression is $136,308 per patient year. The analysis found that total healthcare costs, including the costs associated with CML progression and RT-qPCR monitoring tests (three tests per year), were $1,142 for patients with monitoring and $6,982 for patients without monitoring (difference = $5,840). In a hypothetical cohort of 100 patients with CML, achieving a 100% monitoring rate was associated with a total cost-savings of $584,005 compared to a 0% monitoring rate. This cost-savings remained consistent under both univariate and multivariable sensitivity analyses. CONCLUSION: Regular CML monitoring was associated with improved outcomes among CML patients and, consequently, reduced healthcare costs.


Assuntos
Resistencia a Medicamentos Antineoplásicos , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Leucemia Mielogênica Crônica BCR-ABL Positiva/economia , Leucemia Mielogênica Crônica BCR-ABL Positiva/fisiopatologia , Proteínas Tirosina Quinases/antagonistas & inibidores , Reação em Cadeia da Polimerase Via Transcriptase Reversa/economia , Crise Blástica/economia , Crise Blástica/fisiopatologia , Técnicas de Apoio para a Decisão , Progressão da Doença , Gastos em Saúde/estatística & dados numéricos , Humanos , Modelos Econômicos , Estados Unidos
7.
Int J Med Mushrooms ; 20(12): 1173-1183, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30806298

RESUMO

Ganoderma lucidum, a mushroom that has been used to treat disease in East Asia for centuries, has been shown to be effective against many types of tumors, but the exact cellular mechanism of action is unknown. In this study we examined proliferation of a lung cancer cell line after treatment with 12 concentrations of powdered G. lucidum for 24, 48, and 120 hours. Based on half-maximal inhibitory concentrations values, proliferation of the H1793 cell line seemed to be sensitive to the extract in a time- and dose-dependent manner. We used immunoblot analysis to examine the amounts of cell cycle proteins (cyclin D, Cdk4, and Cdc2) and apoptotic proteins (Bcl-xL and Bax) after treatment with a range of G. lucidum concentrations. Changes in amounts of proteins that regulate the cell cycle were consistent with longer G1 and G2 phases. Proapoptotic protein (Bax) levels increased 6.5-fold, with a commensurate increase in the Bax-to-Bcl ratio, especially at 48 and 120 hours. These results suggest that the decrease in cellular proliferation correlated with a change in both cell cycle progression and apoptosis, and that the triterpenoid in G. lucidum is the bioactive component. Further biochemical characterization of this ancient herbal remedy could hold promise for treating lung cancer.


Assuntos
Proliferação de Células/efeitos dos fármacos , Neoplasias Pulmonares/fisiopatologia , Extratos Vegetais/farmacologia , Reishi/química , Triterpenos/farmacologia , Apoptose/efeitos dos fármacos , Ciclo Celular/efeitos dos fármacos , Linhagem Celular Tumoral , Quinase 4 Dependente de Ciclina/genética , Quinase 4 Dependente de Ciclina/metabolismo , Humanos , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/metabolismo , Extratos Vegetais/química , Triterpenos/química , Proteína X Associada a bcl-2/genética , Proteína X Associada a bcl-2/metabolismo
8.
BMJ Case Rep ; 20172017 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-29269364

RESUMO

Long-acting anticoagulant rodenticides, also called superwarfarins, are known for their greater potency, longer half-life and delayed onset of symptoms. Cases of superwarfarin poisoning can pose a diagnostic and clinical challenge due to a wide array of presentations and prolonged severe coagulopathy requiring months of high-dose oral vitamin K therapy. The most common presentation of long-acting anticoagulant rodenticide poisoning is mucocutaneous bleeding, with other common presentations including haematuria, gingival bleeding, epistaxis and gastrointestinal bleeding. We discuss a case of deliberate self-poisoning with long-acting anticoagulant rodenticides presenting with haematuria and coagulation values above measurable limits. This case is important as it required immediate and maintenance therapy in order to prevent profound bleeding, as well as the evaluation of the patient's psychosocial factors to ensure medical compliance and to prevent refractory complications or repeated self-harm.


Assuntos
Anticoagulantes/intoxicação , Antifibrinolíticos/administração & dosagem , Dor Crônica/psicologia , Preparações de Ação Retardada/intoxicação , Hemorragia Gastrointestinal/induzido quimicamente , Tentativa de Suicídio , Vitamina K/administração & dosagem , Varfarina/intoxicação , Dor Abdominal/psicologia , Transtornos de Ansiedade , Coagulação Sanguínea , Transtornos da Coagulação Sanguínea/induzido quimicamente , Comorbidade , Hematúria/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Encaminhamento e Consulta , Resultado do Tratamento
9.
Curr Med Res Opin ; 33(10): 1745-1754, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28849676

RESUMO

OBJECTIVE: To compare the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) of elderly (≥65 years of age) nonvalvular atrial fibrillation (NVAF) patients initiating apixaban vs. rivaroxaban, dabigatran, or warfarin. METHODS: NVAF patients with Medicare Advantage coverage in the US initiating oral anticoagulants (OACs, index event) were identified from the Humana database (1 January 2013-30 September 2015) and grouped into cohorts depending on OAC initiated. Propensity score matching (PSM), 1:1, was conducted among patients treated with apixaban vs. each other OAC, separately. Rates of S/SE and MB were evaluated in the follow-up. Cox regressions were used to compare the risk of S/SE and MB between apixaban and each of the other OACs during the follow-up. RESULTS: The matched pairs of apixaban vs. rivaroxaban (n = 13,620), apixaban vs. dabigatran (n = 4654), and apixaban vs. warfarin (n = 14,214) were well balanced for key patient characteristics. Adjusted risks for S/SE (hazard ratio [HR] vs. rivaroxaban: 0.72, p = .003; vs. warfarin: 0.65, p < .001) and MB (HR vs. rivaroxaban: 0.49, p < .001; vs. warfarin: 0.53, p < .001) were significantly lower during the follow-up for patients treated with apixaban vs. rivaroxaban and warfarin. Adjusted risks for S/SE (HR: 0.78, p = .27) and MB (HR: 0.82, p = .23) of NVAF patients treated with apixaban vs. dabigatran trended to be lower, but did not reach statistical significance. CONCLUSIONS: In the real-world setting after controlling for differences in patient characteristics, apixaban is associated with significantly lower risk of S/SE and MB than rivaroxaban and warfarin, and a trend towards better outcomes vs. dabigatran among elderly NVAF patients in the US.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Hemorragia/induzido quimicamente , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Dabigatrana/administração & dosagem , Dabigatrana/efeitos adversos , Feminino , Humanos , Masculino , Pontuação de Propensão , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Estudos Retrospectivos , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Varfarina/efeitos adversos , Varfarina/uso terapêutico
10.
J Med Econ ; 20(9): 952-961, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28604139

RESUMO

AIMS: This study compared the risk for major bleeding (MB) and healthcare economic outcomes of patients with non-valvular atrial fibrillation (NVAF) after initiating treatment with apixaban vs rivaroxaban, dabigatran, or warfarin. METHODS: NVAF patients who initiated apixaban, rivaroxaban, dabigatran, or warfarin were identified from the IMS Pharmetrics Plus database (January 1, 2013-September 30, 2015). Propensity score matching (PSM) was used to balance differences in patient characteristics between study cohorts: patients treated with apixaban vs rivaroxaban, apixaban vs dabigatran, and apixaban vs warfarin. Risk of hospitalization and healthcare costs (all-cause and MB-related) were compared between matched cohorts during the follow-up. RESULTS: During the follow-up, risks for all-cause (hazard ratio [HR] = 1.44, 95% confidence interval [CI] = 1.2-1.7) and MB-related (HR = 1.57, 95% CI = 1.0-2.4) hospitalizations were significantly greater for patients treated with rivaroxaban vs apixaban. Adjusted total all-cause healthcare costs were significantly lower for patients treated with apixaban vs rivaroxaban ($3,950 vs $4,333 per patient per month [PPPM], p = .002) and MB-related medical costs were not statistically significantly different ($100 vs $233 PPPM, p = .096). Risk for all-cause hospitalization (HR = 1.98, 95% CI = 1.6-2.4) was significantly greater for patients treated with dabigatran vs apixaban, although total all-cause healthcare costs were not statistically different. Risks for all-cause (HR = 2.22, 95% CI = 1.9-2.5) and MB-related (HR = 2.05, 95% CI = 1.4-3.0) hospitalizations were significantly greater for patients treated with warfarin vs apixaban. Total all-cause healthcare costs ($3,919 vs $4,177 PPPM, p = .025) and MB-related medical costs ($96 vs $212 PPPM, p = .026) were significantly lower for patients treated with apixaban vs warfarin. LIMITATIONS: This retrospective database analysis does not establish causation. CONCLUSIONS: In the real-world setting, compared with rivaroxaban and warfarin, apixaban is associated with reduced risk of hospitalization and lower healthcare costs. Compared with dabigatran, apixaban is associated with lower risk of hospitalizations.


Assuntos
Anticoagulantes/economia , Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Gastos em Saúde/estatística & dados numéricos , Idoso , Anticoagulantes/efeitos adversos , Comorbidade , Dabigatrana/economia , Dabigatrana/uso terapêutico , Feminino , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Econométricos , Pontuação de Propensão , Pirazóis/economia , Pirazóis/uso terapêutico , Piridonas/economia , Piridonas/uso terapêutico , Estudos Retrospectivos , Rivaroxabana/uso terapêutico , Varfarina/economia , Varfarina/uso terapêutico
11.
Clin Lymphoma Myeloma Leuk ; 15(12): 797-802, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26603185

RESUMO

BACKGROUND: The National Comprehensive Cancer Network (NCCN) guidelines state that based on toxicity profiles, 1 second-generation tyrosine kinase inhibitor (TKI) indicated for first-line therapy (ie, dasatinib, nilotinib) may be preferred over the other for treatment of chronic myelogenous leukemia (CML) patients with certain comorbidities. This study assessed the prevalence of comorbid conditions relevant to TKI treatment choice among CML patients in the US real-world setting. PATIENTS AND METHODS: Patients who had CML and initiated TKI treatment were identified from the MarketScan Commercial and Medicare databases (January 1, 2006, to June 30, 2013). Demographics and prevalence of comorbid conditions relevant to TKI treatment choice per NCCN guidelines (heart disease, arrhythmia, diabetes, pancreatitis, pleural effusion, lung disease) were assessed among the overall study population and among subgroups. RESULTS: The median age of the CML study population newly initiated on TKI treatment (ie, imatinib, dasatinib, or nilotinib; n = 2296) was 56 years. Approximately 41% of the CML study population had at least 1 comorbid condition that may influence the choice of TKI treatment as recommended by NCCN guidelines. The most prevalent comorbid condition was heart disease (23%), followed by diabetes (18%) and lung disease (13%). The prevalence of comorbid conditions relevant to TKI treatment choice varied among patients of different age groups, gender, and US regions. CONCLUSION: The results of this analysis provide real-world evidence that the prevalence of relevant comorbid conditions is substantial among CML patients in the US managed care setting and therefore needs to be considered throughout various health care decision-making processes related to CML.


Assuntos
Diabetes Mellitus/epidemiologia , Cardiopatias/epidemiologia , Leucemia Mielogênica Crônica BCR-ABL Positiva/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Bases de Dados Factuais , Feminino , Humanos , Revisão da Utilização de Seguros , Cobertura do Seguro , Leucemia Mielogênica Crônica BCR-ABL Positiva/terapia , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Prevalência , Estudos Retrospectivos
12.
J Med Econ ; 18(6): 399-409, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25586203

RESUMO

OBJECTIVE: Medical costs that may be avoided when any of the four new oral anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban, and edoxaban, are used instead of warfarin for the treatment of non-valvular atrial fibrillation (NVAF) were estimated and compared. Additionally, the overall differences in medical costs were estimated for NVAF and venous thromboembolism (VTE) patient populations combined. METHODS: Medical cost differences associated with NOAC use vs warfarin or placebo among NVAF and VTE patients were estimated based on clinical event rates obtained from the published trial data. The clinical event rates were calculated as the percentage of patients with each of the clinical events during the trial periods. Univariate and multivariate sensitivity analyses were conducted for the medical-cost differences determined for NVAF patients. A hypothetical health plan population of 1 million members was used to estimate and compare the combined medical-cost differences of the NVAF and VTE populations and were projected in the years 2015-2018. RESULTS: In a year, the medical-cost differences associated with NOAC use instead of warfarin were estimated at -$204, -$140, -$495, and -$340 per patient for dabigatran, rivaroxaban, apixaban, and edoxaban, respectively. In 2014, among the hypothetical population, the medical-cost differences were -$3.7, -$4.2, -$11.5, and -$6.6 million for NVAF and acute VTE patients treated with dabigatran, rivaroxaban, apixaban, and edoxaban, respectively. In 2014, for the combined NVAF, acute VTE, and extended VTE patient populations, medical-cost differences were -$10.0, -$10.9, -$21.0, and -$21.0 million for dabigatran, rivaroxaban, 2.5 mg apixaban, and 5 mg apixaban, respectively. Medical-cost differences associated with use of NOACs were projected to steadily increase from 2014 to 2018. CONCLUSIONS: Medical costs are reduced when NOACs are used instead of warfarin/placebo for the treatment of NVAF or VTE, with apixaban being associated with the greatest reduction in medical costs.


Assuntos
Anticoagulantes/economia , Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Tromboembolia Venosa/tratamento farmacológico , Varfarina/economia , Varfarina/uso terapêutico , Análise Custo-Benefício , Custos e Análise de Custo , Dabigatrana/economia , Dabigatrana/uso terapêutico , Gastos em Saúde , Hemorragia/economia , Humanos , Modelos Econométricos , Infarto do Miocárdio/economia , Embolia Pulmonar/economia , Pirazóis/economia , Pirazóis/uso terapêutico , Piridinas/economia , Piridinas/uso terapêutico , Piridonas/economia , Piridonas/uso terapêutico , Rivaroxabana/economia , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/economia , Tiazóis/economia , Tiazóis/uso terapêutico , Estados Unidos/epidemiologia
13.
J Med Econ ; 17(11): 763-70, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25078794

RESUMO

OBJECTIVE: This study evaluated differences in medical costs associated with clinical end-points from randomized clinical trials that compared the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban, and edoxaban, to standard therapy for treatment of patients with venous thromboembolism (VTE). RESEARCH DESIGN AND METHODS: Event rates of efficacy and safety end-points from the clinical trials (RE-COVER, RE-COVER II, EINSTEIN-Pooled, AMPLIFY, Hokusai-VTE trial) were obtained from published literature. Incremental annual medical costs among patients with clinical events from a US payer perspective were obtained from the literature or healthcare claims databases and inflation adjusted to 2013 costs. Differences in total medical costs associated with clinical end-points for the NOACs vs standard therapy were then estimated. One-way and Monte Carlo sensitivity analyses were carried out. RESULTS: A lower rate of major bleedings was associated with use of any of the NOACs vs standard therapy. Except for dabigatran, use of NOACs was also associated with a lower rate of recurrent VTE/death. As a result of the reduction in clinical event rates, the overall medical cost differences were -$146, -$482, -$918, and -$344 for VTE patients treated with dabigatran, rivaroxaban, apixaban, and edoxaban, respectively, vs patients treated with standard therapy. CONCLUSIONS: When any of the four NOACs are used instead of standard therapy for acute VTE, treatment medical costs are reduced. Apixaban is associated with the greatest reduction in medical costs, which is driven by medical cost reductions associated with both efficacy and safety end-points. Further evaluation may be needed to validate these results in the real-world setting.


Assuntos
Anticoagulantes/economia , Anticoagulantes/uso terapêutico , Gastos em Saúde/estatística & dados numéricos , Tromboembolia Venosa/tratamento farmacológico , Anticoagulantes/efeitos adversos , Benzimidazóis/economia , Benzimidazóis/uso terapêutico , Dabigatrana , Honorários Farmacêuticos , Hemorragia/induzido quimicamente , Humanos , Modelos Econométricos , Método de Monte Carlo , Morfolinas/economia , Morfolinas/uso terapêutico , Pirazóis/economia , Pirazóis/uso terapêutico , Piridinas/economia , Piridinas/uso terapêutico , Piridonas/economia , Piridonas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Rivaroxabana , Tiazóis/economia , Tiazóis/uso terapêutico , Tiofenos/economia , Tiofenos/uso terapêutico , beta-Alanina/análogos & derivados , beta-Alanina/economia , beta-Alanina/uso terapêutico
14.
J Clin Psychol ; 65(2): 172-84, 2009 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-19132738

RESUMO

The authors describe a psychological treatment for women with eating disorders who have theistic spiritual beliefs and illustrate its application with a case report. They begin by briefly summarizing a theistic view of eating disorders. Then they illustrate how a theistic approach can complement traditional treatment by describing the processes and outcomes of their work with a 23-year-old Christian woman receiving inpatient treatment for an eating disorder not otherwise specified and a major depressive disorder (recurrent severe).


Assuntos
Transtornos da Alimentação e da Ingestão de Alimentos/psicologia , Psicoterapia , Espiritualidade , Transtornos da Alimentação e da Ingestão de Alimentos/terapia , Feminino , Humanos , Adulto Jovem
15.
Plast Reconstr Surg ; 122(5): 1425-1430, 2008 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-18971726

RESUMO

BACKGROUND: Seroma formation is the most commonly occurring complication in plastic surgery abdominal procedures. Continuous local anesthetic pain pump delivery systems are often used to decrease postoperative pain. An unreported concern with use of these devices in abdominal procedures is the effect of continuous fluid infiltration of the surgical site and a possible increase in the incidence of seroma formation. METHODS: The authors performed a retrospective chart review to evaluate all patients (n = 159) who underwent abdominal procedures (abdominoplasty, panniculectomy, and transverse rectus abdominis myocutaneous flap harvest) over a 3-year period. Patient charts were evaluated for sex, age, body mass index, procedure performed, surgeon, operation length, pain pump use, postoperative seroma formation, and any complications. In cases with pain pump use, catheter placement location, anesthetic medication and strength, continuous-infusion rate, and duration of pain pump use were also reviewed. If a postoperative seroma formation was identified, treatment and outcomes were also recorded. RESULTS: The overall seroma formation rate was 11.3 percent (18 of 159 patients). Other complications occurred at a rate of 2.5 percent (four of 159). The incidence of seroma was 11.0 percent (11 of 100) in patients with pain pump use versus 11.9 percent (7 of 59) in those who did not use a pain pump. There was no statistically significant difference (p = 0.9) in the incidence of seroma formation between those who did and did not use a pain pump device. CONCLUSION: There was no correlation between increased rate of seroma formation and use of a continuous-infusion local anesthetic pain pump system in our patient population.


Assuntos
Analgesia Controlada pelo Paciente/efeitos adversos , Analgesia Controlada pelo Paciente/estatística & dados numéricos , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/epidemiologia , Seroma/epidemiologia , Abdome/cirurgia , Adulto , Anestesia Local/efeitos adversos , Anestesia Local/estatística & dados numéricos , Índice de Massa Corporal , Feminino , Humanos , Incidência , Bombas de Infusão , Masculino , Pessoa de Meia-Idade , Reto do Abdome/cirurgia , Estudos Retrospectivos , Seroma/etiologia , Retalhos Cirúrgicos
16.
Gastroenterol Nurs ; 25(5): 213-7, 2002.
Artigo em Inglês | MEDLINE | ID: mdl-12394398

RESUMO

A bidirectional pathway between the brain and immune system known as psychoneuroimmunology has been the basis of much research and discussion within this interdisciplinary field over the past 25 years. An overly aggressive immune response in inflammatory bowel disease makes the psychoneuroimmunology framework applicable in establishing evidence-based outcomes. Mind-body and mind-gut connections and behavioral interventions can influence outcomes for patients with inflammatory bowel disease. Professional nurses can help develop behavioral interventions to improve quality of life with symptom management for this patient population. Healthcare providers and patients through partnerships should consider the effects of psychosocial factors in manifestations of health and illness.


Assuntos
Doenças Inflamatórias Intestinais/imunologia , Doenças Inflamatórias Intestinais/psicologia , Relações Metafísicas Mente-Corpo/fisiologia , Psiconeuroimunologia , Humanos , Doenças Inflamatórias Intestinais/complicações , Transtornos Psicofisiológicos/complicações
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