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1.
Ann Hematol ; 2019 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-31552445

RESUMO

Patients with polycythemia vera (PV) have a high incidence of thrombotic events (TEs), contributing to a greater mortality risk than the general population. The relationship between hematocrit (HCT) levels and TE occurrence among patients with PV from the Veterans Health Administration (VHA) was evaluated to replicate findings of the CYTO-PV trial with a real-world patient population. This retrospective study used VHA medical record and claims data from the first claim with a PV diagnosis (index) until death, disenrollment, or end of study, collected between October 1, 2005, and September 30, 2012. Patients were aged ≥ 18 years at index, had ≥ 2 claims for PV (ICD-9-CM code, 238.4) ≥ 30 days apart during the identification period, continuous health plan enrollment from 12 months pre-index until end of study, and ≥ 3 HCT measurements per year during follow-up. This analysis focused on patients with no pre-index TE, and with all HCT values either < 45% or ≥ 45% during the follow-up period. The difference in TE risk between HCT groups was assessed using unadjusted Cox regression models based on time to first TE. Patients (N = 213) were mean (SD) age 68.9 (11.5) years, 98.6% male, and 61.5% white. TE rates for patients with HCT values < 45% versus ≥ 45% were 40.3% and 54.2%, respectively. Among patients with ≥ 1 HCT before TE, TE risk hazard ratio was 1.61 (95% CI, 1.03-2.51; P = 0.036). This analysis of the VHA population further supports effective monitoring and control of HCT levels < 45% to reduce TE risk in patients with PV.

2.
Adv Ther ; 36(10): 2941-2953, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31396809

RESUMO

INTRODUCTION: There is limited literature on treatment patterns, healthcare resource utilization (HRU), and costs among patients who transition from once-monthly paliperidone palmitate (PP1M) to once-every-3-month paliperidone palmitate (PP3M) in a real-world setting. Hence, this study compared treatment patterns, HRU, and costs 12-month pre- and post-PP3M transition among Veteran's Health Administration (VHA) patients with schizophrenia. METHODS: Patients with schizophrenia (aged ≥ 18 years) who initiated PP1M and transitioned per on-label criteria to PP3M (no treatment gap of > 45 days in PP1M during the 4 months prior, same dose strength of the last two PP1M claims, and appropriate dose conversion from last PP1M to first PP3M claim) from January 2015 to March 2017 were included from the VHA database. The first transition date to PP3M was identified as the index date. Patients were required to have 12-month pre- and post-PP3M continuous health plan eligibility. Outcomes were compared using the Wilcoxon-signed rank and McNemar's test, appropriately. RESULTS: The study included 122 patients [mean (SD) age: 54 (13.7) years]. Pre- and post-PP3M transition, 64.8% and 61.5% of patients were adherent (proportion of days covered ≥ 80%) to PP1M and PP3M, respectively. Comparison of HRU outcomes pre- and post-PP3M transition exhibited lower all-cause outpatient (37.5 vs. 31.1, p < 0.0001) and pharmacy visits (56.1 vs. 46.7, p < 0.0001). Similar trends were seen for mental health and schizophrenia-related outpatient and pharmacy HRU. Comparison of cost outcomes resulted in lower all-cause outpatient ($27,221 vs. $22,356, p = 0.0033), higher pharmacy ($16,349 vs. $17,003, p = 0.0076), lower total medical ($35,834 vs. $28,900, p = 0.0257), and no difference in total costs ($52,183 vs. $45,903, p = 0.3118). Similar trends were seen for mental health and schizophrenia-related costs. CONCLUSIONS: Transition to PP3M was associated with a decline in outpatient and pharmacy visits. All-cause medical cost reduction fully offset increased pharmacy costs among VHA patients with schizophrenia who transitioned from PP1M to PP3M. FUNDING: Janssen Scientific Affairs.

3.
Plast Reconstr Surg ; 144(3): 560-568, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31461002

RESUMO

BACKGROUND: New York State passed the Breast Cancer Provider Discussion Law in 2010, mandating discussion of insurance coverage for reconstruction and expedient plastic surgical referral, two significant factors found to affect reconstruction rates. This study examines the impact of this law. METHODS: A retrospective cohort study of the New York State Planning and Research Cooperative System database to examine breast reconstruction rates 3 years before and 3 years after law enactment was performed. Difference-interrupted time series models were used to compare trends in the reconstruction rates by sociodemographic factors and provider types. RESULTS: The study included 32,452 patients. The number of mastectomies decreased from 6479 in 2008 to 5235 in 2013; the rate of reconstruction increased from 49 percent in 2008 to 62 percent in 2013. This rise was seen across all median income brackets, races, and age groups. When comparing before to after law enactment, the increase in risk-adjusted reconstruction rates was significantly higher for African Americans and elderly patients, but the disparity in reconstruction rates did not change for other races, different income levels, or insurance types. Reconstruction rates were also not significantly different between those treated in various hospital settings. CONCLUSIONS: The aim of the Breast Cancer Provider Discussion Law is to improve reconstruction rates through provider-driven patient education. The authors' data show significant change following law passage in African American and elderly populations, suggesting effectiveness of the law. The New York State Provider Discussion Law may provide a template for other states to model legislation geared toward patient-centered improvement of health outcomes.

4.
J Comp Eff Res ; 8(11): 889-905, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31167554

RESUMO

Aim: Real-world effectiveness of canagliflozin 300 mg versus glucagon-like peptide-1 receptor agonists (GLP1RAs) was examined in patients with Type II diabetes. Patients & methods: Patients were selected from the Optum integrated database of administrative claims and electronic health record data (1 January 2013 to 31 March 2015). Results: Patients were less likely to discontinue (p < 0.0001) or switch (p = 0.0048), more likely to add-on treatment (p = 0.0314), and achieve HbA1c <8.0% (p = 0.0364) or weight loss ≥5% (p < 0.0001) with canagliflozin versus GLP1RAs over 9 months. Mean HbA1c was similar at 3-month intervals over 9 months with canagliflozin and GLP1RAs. Conclusion: Patients were less likely to discontinue or switch with canagliflozin than GLP1RA, and were more likely to add-on. Canagliflozin patients were more likely to achieve HbA1c <8.0% and weight loss ≥5% than GLP1RA patients.

5.
Plast Reconstr Surg ; 2019 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-31181051

RESUMO

BACKGROUND: New York State (NYS) passed the Breast Cancer Provider Discussion Law in 2010 mandating discussion of insurance coverage for reconstruction and expedient plastic surgical referral, two significant factors found to affect reconstructive rates. This study examines the impact of this law. METHODS: A retrospective cohort study of the NYS Planning and Research Cooperative System (SPARCS) database to examine breast reconstruction rates 3 years before and 3 years after law enactment was performed. Difference-interrupted time series models were used to compare trends in the reconstruction rates by socio-demographic factors and provider types. RESULTS: The study included 32,452 patients. Volume of mastectomies decreased from 5577 in 2008 to 4566 in 2013; the rate of reconstruction increased from 56% in 2008 to 61% in 2013. This rise was seen across all median income brackets (MIB), races, and age groups. When comparing pre- and post-law enactment, the increase in risk-adjusted reconstruction rates was significantly higher for African Americans (AA) and elderly patients but the disparity in reconstruction rates did not change for other races, different income levels or insurance types. Reconstructive rates were also not significantly different between those treated at various hospital settings. CONCLUSIONS: The aim of the Breast Cancer Provider Discussion Law is to improve reconstructive rates through provider-driven patient education. Our data shows significant change following law passage in AA and elderly populations, suggesting effectiveness of the law. The NYS Provider Discussion Law may provide a template for other states to model legislation geared towards patient-centered improvement of health outcomes.

6.
Am J Surg ; 218(3): 447-451, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30808508

RESUMO

BACKGROUND: Recent AHRQ/Joint Commission guidelines mandate additional barrier attire for all operating room personnel to target infection. The scientific basis for this is unclear. STUDY DESIGN: Patients undergoing abdominal surgery at our institution were identified from institutional NSQIP database before and after March 2016, when guidelines were implemented. Patient-level variables were compared for the pre- and post-implementation groups. Multivariable regression evaluated associations between implementation and surgical site infection (SSI) and other outcomes. RESULTS: 1122 patients (including 60.9% laparoscopic and 16.4% bowel resection procedures) were included. There were 607 patients post-implementation and 515 pre-implementation; cohorts were similar in risk factors for SSI. Fifty-seven patients developed SSI. On multivariable analysis, laparoscopy, bowel resection and operating duration, but not barrier attire, were associated with SSI. Implementation of attire did not significantly impact SSI (p = 0.4), hospital readmission (p = 0.4), or reoperation (p = 0.9). CONCLUSIONS: These data question the rationale for the new more stringent operating room attire guidelines which burden hospitals with additional cost, time and resources, and could detract efforts to target important factors that really influence outcomes.

7.
J Thromb Thrombolysis ; 48(1): 149-157, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30729377

RESUMO

INTRODUCTION: Various risk stratification methods exist for patients with pulmonary embolism (PE). We used the simplified Pulmonary Embolism Severity Index (sPESI) as a risk-stratification method to understand the Veterans Health Administration (VHA) PE population. MATERIALS AND METHODS: Adult patients with ≥ 1 inpatient PE diagnosis (index date = discharge date) from October 2011-June 2015 as well as continuous enrollment for ≥ 12 months pre- and 3 months post-index date were included. We defined a sPESI score of 0 as low-risk (LRPE) and all others as high-risk (HRPE). Hospital-acquired complications (HACs) during the index hospitalization, 90-day follow-up PE-related outcomes, and health care utilization and costs were compared between HRPE and LRPE patients. RESULTS: Of 6746 PE patients, 95.4% were men, 67.7% were white, and 22.0% were African American; LRPE occurred in 28.4% and HRPE in 71.6%. Relative to HRPE patients, LRPE patients had lower Charlson Comorbidity Index scores (1.0 vs. 3.4, p < 0.0001) and other baseline comorbidities, fewer HACs (11.4% vs. 20.0%, p < 0.0001), less bacterial pneumonia (10.6% vs. 22.3%, p < 0.0001), and shorter average inpatient lengths of stay (8.8 vs. 11.2 days, p < 0.0001) during the index hospitalization. During follow-up, LRPE patients had fewer PE-related outcomes of recurrent venous thromboembolism (4.4% vs. 6.0%, p = 0.0077), major bleeding (1.2% vs. 1.9%, p = 0.0382), and death (3.7% vs. 16.2%, p < 0.0001). LRPE patients had fewer inpatient but higher outpatient visits per patient, and lower total health care costs ($12,021 vs. $16,911, p < 0.0001) than HRPE patients. CONCLUSIONS: Using the sPESI score identifies a PE cohort with a lower clinical and economic burden.

8.
BMC Cardiovasc Disord ; 19(1): 19, 2019 01 15.
Artigo em Inglês | MEDLINE | ID: mdl-30646855

RESUMO

BACKGROUND: Coronary artery disease accelerates heart failure progression, leading to poor prognosis and a substantial increase in morbidity and mortality. This study was aimed to assess the impact of coronary artery disease on all-cause mortality, myocardial infarction (MI), and ischemic stroke (IS) among hospitalized newly-diagnosed heart failure (HF) patients with left ventricular systolic dysfunction (LVSD). METHODS: This retrospective cohort study included Medicare patients (aged ≥65 years) with ≥1 inpatient heart failure claim (index date = discharge date) during 01JAN2007-31DEC2013. Patients were required to have continuous enrollment for ≥1-year pre-index date (baseline: 1-year pre-index period) without a prior heart failure claim (in the 1 year pre-index prior to the index hospital admission); follow-up ran from the index date to death, disenrollment from the health plan, or the end of the study period, whichever occurred first. HF with LVSD patients, identified with diagnosis codes of systolic dysfunction (excluding baseline atrial fibrillation), were stratified based on prevalent coronary artery disease at baseline into coronary artery disease and non-coronary artery disease cohorts. Main outcomes were occurrence of major adverse cardiovascular events including all-cause mortality, myocardial infarction, and ischemic stroke. Propensity score matching (PSM) was used to balance patient characteristics. Kaplan-Meier curves of ACM and cumulative incidence distribution of MI/IS were presented. RESULTS: Of 22,230 HF with LVSD patients, 15,827 (71.2%) had coronary artery disease and were overall more likely to be younger (79.8 vs 80.9 years), male (49.6% vs. 35.6%), white (86.2% vs 81.4%), with more prevalent comorbidities including hypertension (80.7% vs 74.3%), hyperlipidemia (67.7% vs 46.7%), and diabetes (46.3% vs 35.8%) (all p < 0.0001). After propensity score matching, cohorts included 5792 patients each. The coronary artery disease cohort had significantly higher cumulative incidence of myocardial infarction and ischemic stroke at the end of 7-year follow-up vs non-coronary artery disease (myocardial infarction = 50.0% vs 18.0%; ischemic stroke = 23.3% vs 18.7%; all p < 0.0001). Follow-up all-cause mortality rates were similar between the two cohorts. CONCLUSIONS: HF with LVSD patients with coronary artery disease had significantly higher incidence of ischemic stroke and myocardial infarction, but similar all-cause mortality compared to those without coronary artery disease.

9.
Stroke ; 49(12): 2933-2944, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30571400

RESUMO

Background and Purpose- This ARISTOPHANES study (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) used multiple data sources to compare stroke/systemic embolism (SE) and major bleeding (MB) among a large number of nonvalvular atrial fibrillation patients on non-vitamin K antagonist oral anticoagulants (NOACs) or warfarin. Methods- A retrospective observational study of nonvalvular atrial fibrillation patients initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015, was conducted pooling Centers for Medicare and Medicaid Services Medicare data and 4 US commercial claims databases. After 1:1 NOAC-warfarin and NOAC-NOAC propensity score matching in each database, the resulting patient records were pooled. Cox models were used to evaluate the risk of stroke/SE and MB across matched cohorts. Results- A total of 285 292 patients were included in the 6 matched cohorts: 57 929 apixaban-warfarin, 26 838 dabigatran-warfarin, 83 007 rivaroxaban-warfarin, 27 096 apixaban-dabigatran, 62 619 apixaban-rivaroxaban, and 27 538 dabigatran-rivaroxaban patient pairs. Apixaban (hazard ratio [HR], 0.61; 95% CI, 0.54-0.69), dabigatran (HR, 0.80; 95% CI, 0.68-0.94), and rivaroxaban (HR, 0.75; 95% CI, 0.69-0.82) were associated with lower rates of stroke/SE compared with warfarin. Apixaban (HR, 0.58; 95% CI, 0.54-0.62) and dabigatran (HR, 0.73; 95% CI, 0.66-0.81) had lower rates of MB, and rivaroxaban (HR, 1.07; 95% CI, 1.02-1.13) had a higher rate of MB compared with warfarin. Differences exist in rates of stroke/SE and MB across NOACs. Conclusions- In this largest observational study to date on NOACs and warfarin, the NOACs had lower rates of stroke/SE and variable comparative rates of MB versus warfarin. The findings from this study may help inform the discussion on benefit and risk in the shared decision-making process for stroke prevention between healthcare providers and nonvalvular atrial fibrillation patients. Clinical Trial Registration- URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT03087487.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/complicações , Dabigatrana/uso terapêutico , Feminino , Humanos , Hemorragias Intracranianas/epidemiologia , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Estudos Retrospectivos , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento , Varfarina/uso terapêutico
10.
J Bone Joint Surg Am ; 100(21): 1819-1828, 2018 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-30399076

RESUMO

BACKGROUND: Osteoporosis is prevalent in the United States, with an increasing need for management. In this study, we evaluated the effectiveness of a private orthopaedic practice-based osteoporosis management service (OP MS) in reducing subsequent fracture risk and improving other aspects of osteoporosis management of patients who had sustained fractures. METHODS: This was a retrospective cohort study using the 100% Medicare data set for Michigan residents with any vertebral; hip, pelvic or femoral; or other nonvertebral fracture during the period of April 1, 2010 to September 30, 2014. Patients who received OP MS care with a follow-up visit within 90 days of the first fracture, and those who did not seek OP MS care but had a physician visit within 90 days of the first fracture, were considered as exposed and unexposed, respectively (first follow-up visit = index date). Eligible patients with continuous enrollment in Medicare Parts A and B for the 90-day pre-index period were followed until the earliest of death, health-plan disenrollment, or study end (December 31, 2014) to evaluate rates of subsequent fracture, osteoporosis medication prescriptions filled, and bone mineral density (BMD) assessments. Health-care costs were evaluated among patients with 12 months of post-index continuous enrollment. Propensity-score matching was used to balance differences in baseline characteristics. Each exposed patient was matched to an unexposed patient within ± 0.01 units of the propensity score. After propensity-score matching, Cox regression examined the hazard ratio (HR) of clinical and economic outcomes in the exposed and unexposed cohorts. RESULTS: Two well-matched cohorts of 1,304 patients each were produced. The exposed cohort had a longer median time to subsequent fracture (998 compared with 743 days; log-rank p = 0.001), a lower risk of subsequent fracture (HR = 0.8; 95% confidence interval [CI] = 0.7 to 0.9), and a higher likelihood of having osteoporosis medication prescriptions filled (HR = 1.7; 95% CI = 1.4 to 2.0) and BMD assessments (HR = 4.3; 95% CI = 3.7 to 5.0). The total 12-month costs ($25,306 compared with $22,896 [USD]; p = 0.082) did not differ significantly between the cohorts. CONCLUSIONS: A private orthopaedic practice-based OP MS effectively reduced subsequent fracture risk, likely through coordinated and ongoing comprehensive patient care, without a significant overall higher cost. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

11.
Plast Reconstr Surg ; 142(6): 1633-1643, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30489536

RESUMO

BACKGROUND: Smoking as a risk factor for postoperative complications is more relevant in elective plastic surgery than in urgent general surgery. From 2005 to 2014, the U.S. smoking rate decreased from 20.9 percent to 16.8 percent. This study compares smoking prevalence in plastic and general surgery patients, and postoperative complications when smoking is isolated as an independent risk factor. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was used to examine smoking and 30-day postoperative complications for plastic and general surgery procedures. Patients were propensity score matched for demographics and comorbidities. RESULTS: The authors examined 294,903 patients from 2005 to 2014. The smoking rates in general surgery mirrored national trends (R = -0.85), whereas those in plastic surgery were significantly lower (p < 0.01). General surgery smokers were more comorbid and experienced more superficial surgical-site infections, pulmonary embolism, and myocardial infarction (p < 0.02) than general surgery nonsmokers. Plastic surgery smokers were not significantly different than plastic surgery nonsmokers. The general surgery cohort was more comorbid than the plastic surgery cohort. All smokers had increased dehiscence, deep surgical-site infection, and reoperation (p ≤ 0.01). Plastic surgery patients suffered more wound complications and bleeding than general surgery patients (p < 0.01). CONCLUSIONS: This is the first propensity score-matched, large-scale database analysis isolating smoking as a risk factor for postoperative complications. Smoking may have different risk factor profiles for postoperative complications in plastic surgical versus general surgical patient populations, emphasizing the need for caution when generalizing general surgical evidence for use in the plastic surgical population. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

12.
J Manag Care Spec Pharm ; 24(9): 911-920, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30156450

RESUMO

BACKGROUND: Clinical trials have shown that direct oral anticoagulants (DOACs)-including dabigatran, rivaroxaban, apixaban, and edoxaban-are at least as effective and safe as warfarin for the risk of stroke/systemic embolism (SE) and major bleeding (MB) in patients with atrial fibrillation (AF). However, few studies have compared oral anticoagulants (OACs) among elderly patients. OBJECTIVE: To compare hospitalization risks (all-cause, stroke/SE-related, and MB-related) and associated health care costs among elderly nonvalvular AF (NVAF) patients in the Medicare population who initiated warfarin, dabigatran, rivaroxaban, or apixaban. METHODS: Patients (aged ≥ 65 years) initiating warfarin or DOACs (apixaban, rivaroxaban, and dabigatran) were selected from the Centers for Medicare & Medicaid Services database from January 1, 2013, to December 31, 2014. Patients initiating each OAC were matched 1:1 to apixaban patients using propensity score matching to balance demographic and clinical characteristics. Cox proportional hazards models were used to estimate the risk of hospitalization of each OAC versus apixaban. Generalized linear models and two-part models with bootstrapping were used to compare all-cause health care costs and stroke/SE- and MB-related medical costs between matched cohorts. RESULTS: Of the 186,132 eligible patients, 41,606 warfarin-apixaban, 30,836 dabigatran-apixaban, and 41,608 rivaroxaban-apixaban pairs were matched. The OACs were associated with a significantly higher risk of all-cause hospitalization compared with apixaban (warfarin: HR = 1.33, 95% CI = 1.27-1.38, P < 0.001; dabigatran: HR = 1.17, 95% CI = 1.11-1.23, P < 0.001; and rivaroxaban: HR = 1.27, 95% CI = 1.22-1.32, P < 0.001) and were associated with a significantly higher risk of hospitalization due to stroke/SE (warfarin: HR = 2.51, 95% CI = 1.92-3.29, P < 0.001; dabigatran: HR = 2.24, 95% CI = 1.60-3.13, P < 0.001; and rivaroxaban: HR = 1.74, 95% CI = 1.31-2.30, P < 0.001). Also, the OACs were associated with significantly higher risk of hospitalization due to MB-related conditions compared with apixaban (warfarin: HR = 1.96, 95% CI = 1.71-2.23, P < 0.001; dabigatran: HR = 1.48; 95% CI = 1.25-1.76, P < 0.001; and rivaroxaban: HR = 2.17, 95% CI = 1.91-2.48, P < 0.001). Compared with apixaban, warfarin ($3,747 vs. $3,061, P < 0.001); dabigatran ($3,230 vs. $2,951, P < 0.001); and rivaroxaban ($3,950 vs. $3,060, P < 0.001) had significantly higher all-cause total health care costs per patient per month. Patients initiating the OACs also had significantly higher stroke/SE- and MB-related medical costs compared with apixaban: warfarin (stroke/SE = $135 vs. $60, P = 0.001; MB = $537 vs. $286, P < 0.001); dabigatran (stroke/SE = $94 vs. $62, P = 0.045; MB = $373 vs. $277, P = 0.010); and rivaroxaban (stroke/SE = $91 vs. $60, P = 0.008; MB = $524 vs. $287, P < 0.001). CONCLUSIONS: This real-world study showed that among elderly NVAF patients in the Medicare population, apixaban was associated with significantly lower risks of all-cause, stroke/SE-related, and MB-related hospitalizations compared with warfarin, dabigatran, and rivaroxaban. Accordingly, apixaban showed significantly lower all-cause health care costs and stroke/SE- and MB-related medical costs. DISCLOSURES: This study was funded by Bristol-Myers Squibb and Pfizer. Amin is an employee of the University of California, Irvine, and was a paid consultant to Bristol-Myers Squibb in connection with this study and the development of this manuscript. Keshishian and Zhang are employees of STATinMED Research, a paid consultant to Pfizer and Bristol-Myers Squibb in connection with this study and the development of this manuscript. Trocio, Dina, Mardekian, and Liu are employees of Pfizer, with ownership of stocks in Pfizer. Le, Rosenblatt, Nadkarni, and Vo are employees of Bristol-Myers Squibb. Rosenblatt and Vo have ownership of stocks in Bristol-Myers Squibb. Baser has no conflicts to disclose.

13.
J Gastrointest Surg ; 2018 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-29987738

RESUMO

BACKGROUND: Previous analyses evaluating alvimopan included patients at varying risk for ileus after intestinal resection, which may have precluded its widespread adoption. We assess the early and delayed effects of alvimopan in patients stratified by risk for ileus after intestinal and colon resection. METHODS: From the Premier Perspective database, patients with elective small and large bowel resections from 2012 to 2014 were identified. Multivariable analysis identified 14 perioperative risk factors for postoperative ileus. Within low- (0-4 factors), intermediate- (5 factors), and high-risk (6-12 factors) ileus categories, alvimopan and no-alvimopan patients were propensity-score matched for demographics, morbidities, diagnosis, surgery and approach, postoperative complications, surgeon specialty, and hospital features. In-hospital postoperative ileus, length of stay, discharge destination, and ileus-related readmission were compared. RESULTS: Of 52,948 patients, 15,719 (29.7%) received alvimopan. Risk for ileus in low- (18,784), intermediate- (14,370), and high-risk (19,794) categories was 8.9, 13, and 22% (p ≤ .0001) respectively. After matching, alvimopan was associated with significantly reduced in-hospital postoperative ileus in all (low, 6%; intermediate, 9.4%; and high risk, 16.2%) categories. Hospital stay and 30-, 60-, and 90-day postdischarge ileus were also significantly lower with alvimopan. For low-risk patients, alvimopan increased discharge to home, while 90-day emergency readmission was reduced. CONCLUSIONS: Alvimopan, regardless of ileus risk, improves ileus, hospital stay, and ileus-related readmission after intestinal resection and these effects are sustained over the long term. Since fewer than a third of patients currently receive alvimopan, its routine adoption with small and large intestinal resection will significantly impact patients and health systems.

14.
Leuk Lymphoma ; : 1-8, 2018 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-29936866

RESUMO

While health care costs can be considerable in individuals with diffuse large B-cell lymphoma (DLBCL), the degree to which health care expenditures vary following first-line treatment for non-relapsed versus relapsed DLBCL is unknown. Using 100% Medicare claims, we identified beneficiaries with DLBCL treated with first-line therapy between 1 January 2010 and 30 June 2014. We then compared health care expenditures of patients who received a second-line immunochemotherapy (relapse cohort) to those who did not begin a second-line therapy during follow-up (non-relapse cohort). After propensity score matching, the relapsed cohort incurred significantly higher health care costs ($6998 vs $3314 per month; p < .001), driven by inpatient ($2548 vs $1943 per month; p < .001) and outpatient office visit costs ($3581 vs $753 per month; p < .001). Our analysis confirms older adults with relapsed DLBCL incur higher medical costs and suggests improved first-line treatment would not only reduce the likelihood of relapse, but also contain health care costs.

15.
J Manag Care Spec Pharm ; 24(7): 654-663, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29952710

RESUMO

BACKGROUND: Psoriasis is a chronic, hyper-proliferative dermatological condition associated with joint symptoms known as psoriatic arthritis (PsA). In a 2013 review, the total economic burden of PsA was estimated at $51.7-$63.2 billion. The economic burden of moderate to severe psoriasis patients has reduced significantly with the advent of biologics, but there remains a dearth of real-world evidence of the impact of treatment persistence on the economic burden of moderate to severe psoriasis and/or PsA patients. OBJECTIVE: To evaluate the overall and psoriasis and/or PsA-related health care utilization and costs among patients who were persistent versus those nonpersistent on index biologic among the moderate to severe psoriasis and/or PsA population. METHODS: Adult patients with ≥ 2 claims with diagnosis of psoriasis and/or PsA during the period of November 2010-October 2015 were identified from the U.S. Department of Defense database; the first diagnosis date during November 2011-October 2014 was defined as the index date. As of the index date, patients were considered to have moderate to severe psoriasis or PsA if they had ≥ 1 nontopical systemic therapy or phototherapy during the 1-year pre- or 1-month post-index date. Persistence to index therapy, defined as the first biologic used (etanercept, adalimumab, ustekinumab, infliximab) on or within 30 days post-index date, was determined based on the biologic dosing schedule and a 90-day gap. Generalized linear models were used to compare the health care utilization and costs between persistent and nonpersistent patients during the 1-year post-index period. RESULTS: A total of 2,945 moderate to severe psoriasis and/or PsA patients were identified. Of those, 1,899 (64.5%) were persistent and 1,046 (35.5%) were nonpersistent. Compared with nonpersistent patients, persistent patients were older (49.2 vs. 45.5 years; P < 0.001) and more likely to be male (52% vs. 45%; P < 0.001). More persistent patients were diagnosed with dyslipidemia (40% vs. 35%; P = 0.002), had lower antidepressant use (23.4% vs. 27.4%; P < 0.001), and had lower anxiolytic use (30% vs. 37%; P < 0.001) compared with nonpersistent patients. After adjusting for demographic and clinical characteristics, nonpersistent patients had higher total medical costs ($12,457 vs. $8,964; P < 0.001) compared with persistent patients, and ambulatory visits (23.9 vs. 21.4; P = 0.007) were a major contributor. Approximately 40% of the total overall medical costs were attributed to psoriasis and PsA. Although persistent patients incurred higher pharmacy costs ($10,684 vs. $7,849; P < 0.001) due to higher biologic use and the potentially high per-unit cost of biologics, their psoriasis- and/or PsA-related medical costs were significantly lower than those of nonpersistent patients ($3,395 vs. $5,041; P < 0.001). Total overall costs combining medical and pharmacy costs were similar between the cohorts ($22,678 vs. $21,477; P = 0.122). CONCLUSIONS: Moderate to severe psoriasis and/or PsA patients who were persistent on index biologic treatment had higher pharmacy utilization and costs, albeit with lower medical costs and similar total costs, compared with nonpersistent patients. DISCLOSURES: This study was funded by Janssen Scientific Affairs. Lee is a paid employee of Janssen Scientific Affairs. Xie, Wang, Vaidya, and Baser are paid employees of STATinMED Research, which is a paid consultant to Janssen Scientific Affairs. This study was presented as an abstract at the Academy of Managed Care Pharmacy 2017 Annual Meeting, March 27-30, 2017, in Denver, CO.


Assuntos
Efeitos Psicossociais da Doença , Custos de Cuidados de Saúde/estatística & dados numéricos , Cooperação do Paciente/estatística & dados numéricos , Psoríase/economia , United States Department of Defense/estatística & dados numéricos , Adulto , Idoso , Antirreumáticos/economia , Antirreumáticos/uso terapêutico , Produtos Biológicos/economia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Fototerapia/economia , Fototerapia/estatística & dados numéricos , Psoríase/terapia , Estudos Retrospectivos , Índice de Gravidade de Doença , Estados Unidos , Adulto Jovem
16.
Curr Med Res Opin ; 34(9): 1679-1685, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29874942

RESUMO

OBJECTIVE: This study identifies the health care costs and utilization, as well as comorbidities, in a Medicare population of inclusion body myositis (IBM) patients. METHODS: Medicare patients aged ≥65 years with a diagnosis claim for IBM were identified and matched to a cohort of non-IBM patients based on age, sex, race, calendar year and census region. Generalized linear models were used to estimate health care costs and utilization during the follow-up period. RESULTS: The prevalence of IBM in this population, aged ≥65 years, was 83.7 cases per 1 million patients. Mean 1 year costs for the IBM cohort (N = 361) were $44,838 compared to $10,182 for the matched non-IBM cohort (N = 1805), an excess of $34,656. IBM was significantly associated with multiple unsuspected comorbidities, including hypertension (66% vs. 22%), hyperlipidemia (47% vs. 18%) and myocardial infarction (13% vs. 2%) (all p < .0001). CONCLUSIONS: IBM patients utilize more health care resources and incur higher health care costs than patients without IBM. Furthermore, IBM patients were more likely to have multiple comorbidities, including cardiovascular risk factors and events, muscle and joint pain, and pulmonary complications compared to those without IBM. LIMITATIONS: The presence of a diagnosis code for a condition on a medical claim does not necessarily indicate the presence of the disease condition because the diagnosis code could be incorrectly entered in the database. Clinical and disease-specific parameters were not available in the claims data. Additionally, due to the observational study design, the analysis may be affected by unobserved differences between patients.

17.
Am J Med ; 131(9): 1075-1085.e4, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29807001

RESUMO

BACKGROUND: Direct oral anticoagulants (DOAC) are at least non-inferior to warfarin in efficacy and safety among patients with nonvalvular atrial fibrillation. Limited evidence is available regarding outcomes for nonvalvular atrial fibrillation patients with coronary/peripheral artery disease. METHODS: Non-valvular atrial fibrillation patients aged ≥65 years diagnosed with coronary/peripheral artery disease in the US Medicare population, newly initiating DOACs (apixaban, rivaroxaban, dabigatran) or warfarin were selected from January 1, 2013 to September 30, 2015. Propensity score matching was used to compare DOACs vs warfarin. Cox proportional hazards models were used to estimate the risk of stroke/systemic embolism, major bleeding, and composite of stroke/myocardial infarction/all-cause mortality. RESULTS: There were 15,527 apixaban-warfarin, 6,962 dabigatran-warfarin, and 25,903 rivaroxaban-warfarin-matched pairs, with a mean follow-up of 5-6 months. Compared with warfarin, apixaban was associated with lower rates of stroke/systemic embolism (hazard ratio [HR] 0.48; 95% confidence interval [CI], 0.37-0.62), major bleeding (HR 0.66; 95% CI, 0.58-0.75), and stroke/myocardial infarction/all-cause mortality (HR 0.63; 95% CI, 0.58-0.69); dabigatran and rivaroxaban were associated with lower rates of stroke/myocardial infarction/all-cause mortality (HR 0.79; 95% CI, 0.70-0.90 and HR 0.87; 95% CI, 0.81-0.92, respectively). Rivaroxaban was associated with a lower rate of stroke/systemic embolism (HR 0.72; 95% CI, 0.60-0.89) and a higher rate of major bleeding (HR 1.14; 95% CI, 1.05-1.23) vs warfarin. CONCLUSIONS: All DOACs were associated with lower stroke/myocardial infarction/all-cause mortality rates compared with warfarin; differences were observed in rates of stroke/systemic embolism and major bleeding. Findings from this observational analysis provide important insights about oral anticoagulation therapy among non-valvular atrial fibrillation patients with coronary/peripheral artery disease and may help physicians in the decision-making process when treating this high-risk group of patients.

18.
BMC Cancer ; 18(1): 528, 2018 May 04.
Artigo em Inglês | MEDLINE | ID: mdl-29728092

RESUMO

BACKGROUND: Polycythemia vera (PV) is a myeloproliferative neoplasm associated with increased thrombotic and cardiovascular risk, which are key contributors to patient morbidity and mortality. The Veterans Health Administration (VHA) is the largest integrative health network in the United States. Available data concerning patients with PV in this population are limited. METHODS: This retrospective observational study evaluated the characteristics, management, and outcomes of patients with PV in the VHA Medical SAS® Dataset (October 1, 2005, to September 30, 2012). Inclusion criteria were ≥ 2 claims for PV (ie, PV diagnostic code was recorded) ≥30 days apart during the identification period, age ≥ 18 years, and continuous health plan enrollment from ≥12 months before the index date until the end of follow-up. All data were analyzed using descriptive statistics. RESULTS: The analysis included 7718 patients (median age, 64 years; male, 98%; white, 64%). The most common comorbidities before the index date were hypertension (72%), dyslipidemia (54%), and diabetes (24%); 33% had a history of smoking. During the follow-up period (median, 4.8 years), most patients did not receive treatment with cytoreductive therapy, including phlebotomy (53%), or antiplatelet agents, such as aspirin (57%). The thrombotic and cardiovascular event rates per 1000 patient-years were 60.5 and 83.8, respectively. Among patients who received cytoreductive treatment, the thrombotic event rate was 48.9 per 1000 patient-years. The overall mortality rate was 51.2 per 1000 patient-years. CONCLUSION: The notable rates of thrombotic and cardiovascular events observed in this analysis, even among patients receiving cytoreductive treatment, highlight the important unmet clinical needs of patients with PV in the VHA.

19.
Int J Colorectal Dis ; 33(8): 1019-1028, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29658059

RESUMO

PURPOSE: Colectomy for cancer in obese patients is technically challenging and may be associated with worse outcomes. Whether visceral obesity, as measured on computed tomography, is a better predictor of complication than body mass index (BMI) or determines long-term oncologic outcomes has not been well characterized. This study examines the association between derived anthropometrics and postoperative complication and long-term oncologic outcomes. METHODS: Retrospective review of patients undergoing elective colectomy for cancer at a single tertiary-care center from 2010 to 2016. Adipose tissue distribution measurements, including visceral fat area (VFA), were determined from preoperative imaging. The primary outcome was 30-day postoperative complication; secondary outcomes included overall and disease-free survival. Multivariable logistic regression was performed to determine association between obesity metrics and outcome. RESULTS: Two hundred and sixty-four patients underwent 266 primary resections of colon cancer. Twenty-eight patients (10.5%) developed major morbidity (Clavien-Dindo grade ≥ III). VFA but not BMI was significantly associated with morbidity in multivariate analysis (p = 0.004, odds ratio 1.99, 95% confidence interval 1.25-3.19). No other imaging-derived anthropometric was associated with increased morbidity. In receiver operating characteristic analysis, VFA was predictive of major morbidity (area under curve 0.660). A cutoff value of VFA ≥ 191 cm2 was associated with 50% sensitivity and 76% specificity for predicting major morbidity. Patients with VFA ≥ 191cm2 had 19.4% risk of morbidity, whereas those with < 191 cm2 had 7.2% risk (relative risk ratio 2.69, unadjusted p = 0.004). Neither VFA nor BMI was associated with overall or disease-free survival. CONCLUSION: VFA but not BMI predicts morbidity following elective surgery for colon cancer.

20.
J Thorac Cardiovasc Surg ; 156(1): 278-286, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29576261

RESUMO

BACKGROUND: The optimal management and prognostic factors of postsurgical pulmonary vein stenosis remain controversial. We sought to determine current postsurgical pulmonary vein stenosis outcomes and prognostic factors in a multicentric study in the current era. METHODS: Seventy-five patients with postsurgical pulmonary vein stenosis who underwent 103 procedures in 14 European/North American centers (2000-2012) were included retrospectively. A specific pulmonary vein stenosis severity score was developed on the basis of the assessment of each pulmonary vein. End points were death, pulmonary vein reintervention, and restenosis. A univariate and multivariate risk analysis was performed. RESULTS: Some 76% of postsurgical pulmonary vein stenosis occurred after repair of a total anomalous pulmonary venous return. Sutureless repair was used in 42 of 103 procedures (41%), patch veinoplasty was used in 28 procedures (27%), and endarterectomy was used in 16 procedures (16%). Overall pulmonary vein restenosis, reintervention, and mortality occurred in 56% (n = 58/103), 49% (n = 50/103), and 27% (n = 20/75), respectively. Sutureless repair was associated with less restenosis (40% vs 67%; P = .007) and less reintervention (31% vs 61%; P = .003). Mortality after sutureless repair (20%; 7/35) tends to be lower than after nonsutureless repair (33%; 13/40) (P = .22). A high postoperative residual pulmonary vein stenosis score at the time of hospital discharge was an independent risk factor for restenosis (hazard ratio [HR], 1.55; P < 10-4), reintervention (HR, 1.33; P < 10-4), and mortality (HR, 1.37; P < 10-4). The sutureless technique was an independent protective factor against restenosis (HR, 0.27; P = .006). CONCLUSIONS: Postsurgical pulmonary vein stenosis still has a guarded prognosis in the current era. The sutureless technique is an independent protective factor against restenosis. The severity of the residual disease evaluated by a new severity score is an independent risk factor for poor outcomes regardless of surgical technique.

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