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Objective: To assess the impact of the HealthPrize RespiPoints™ program on treatment adherence and persistence in adults with chronic obstructive pulmonary disease (COPD)., Methods: In this retrospective cohort study, program participants and nonparticipants receiving tiotropium bromide (TIO) or TIO and olodaterol between 1 January 2015-31 March 2020 were propensity score matched (PSM), from the linked database of the HealthPrize patient list and IQVIA PharMetrics® Plus. Treatment adherence, persistence, healthcare resource utilization, and costs were compared. Multivariable logistic regression models assessed the odds of adherence (≥80% proportion of days covered [PDC]), adjusted risk of discontinuation, and adjusted total healthcare costs., Results: Program participants ( n  = 262) demonstrated a 44% greater adherence during followup than nonparticipants ( n  = 262) (mean [standard deviation] PDC: 0.72 [0.27] vs 0.50 [0.36], p  < 0.0001). Participants had higher odds of adherence vs nonparticipants (adjusted odds ratio: 2.51; 95% confidence interval: 1.72-3.66, p  < 0.0001) and a lower percentage of participants discontinued their index medication (19.85% vs 33.59%, p  = 0.0004). Fewer participants were hospitalized during follow-up (13.74% vs 17.56%, p  = 0.23); adjusted total medical costs were 24% lower ( p  = 0.08). Higher pharmacy costs partially offset lower healthcare costs., Conclusions: Program participants showed improved COPD medication adherence and persistence compared to nonparticipants.

Background: It is unclear whether persistent inhaled steroid exposure in chronic obstructive pulmonary disease (COPD) patients before coronavirus disease 2019 (COVID-19) is associated with hospitalization risk., Objective: Our objective was to examine the association between persistent steroid exposure and COVID-19-related hospitalization risk in COPD patients., Study Design and Methods: This retrospective cohort study used electronic health records from the Kaiser Permanente Northern California health care system (February 2, 2020, to September 30, 2020) for patients aged ≥40 years with COPD and a positive polymerase chain reaction test result for COVID-19. Primary exposure was persistent oral and/or inhaled steroid exposure defined as ≥6 months of prescriptions filled in the year before the COVID-19 diagnosis. Multivariable logistic regression was performed for the primary outcome of COVID-19-related hospitalization or death/hospice referral. Steroid exposure in the month before a COVID-19 diagnosis was a covariate., Results: Of >4.3 million adults, 697 had COVID-19 and COPD, of whom 270 (38.7%) had COVID-19-related hospitalizations. Overall, 538 (77.2%) were neither exposed to steroids in the month before COVID-19 diagnosis nor persistently exposed; 53 (7.6%) were exposed in the month before but not persistently; 23 (3.3%) were exposed persistently but not in the month before; and 83 (11.9%) were exposed both persistently and in the month before. Adjusting for all confounders including steroid use in the month before, the odds ratio for hospitalization was 0.77 (95% confidence interval 0.41-1.46) for patients persistently exposed to steroids before a COVID-19 diagnosis., Interpretation: No association was observed between persistent steroid exposure and the risk of COVID-19-related hospitalization in COPD patients., (JCOPDF © 2022.)

Background and Objective: Patients with chronic obstructive pulmonary disease (COPD) may have worse coronavirus disease-2019 (COVID-19)-related outcomes. We compared COVID-19 hospitalization risk in patients with and without COPD., Methods: This retrospective cohort study included patients ≥40 years, SARS-CoV-2 positive, and with Kaiser Permanente Northern California membership ≥1 year before COVID-19 diagnosis (electronic health records and claims data). COVID-19-related hospitalization risk was assessed by sequentially adjusted logistic regression models and stratified by disease severity. Secondary outcome was death/hospice referral after COVID-19., Results and Discussion: Of 19,558 COVID-19 patients, 697 (3.6%) had COPD. Compared with patients without COPD, COPD patients were older (median age: 69 vs 53 years); had higher Elixhauser Comorbidity Index (5 vs 0) and more median baseline outpatient (8 vs 4), emergency department (2 vs 1), and inpatient (2 vs 1) encounters. Unadjusted analyses showed increased odds of hospitalization with COPD (odds ratio [OR]: 3.93; 95% confidence interval [CI]: 3.40-4.60). After full risk adjustment, there were no differences in odds of hospitalization (OR: 1.14, 95% CI: 0.93-1.40) or death/hospice referral (OR: 0.96, 95% CI: 0.72-1.27) between patients with and without COPD. Primary/secondary outcomes did not differ by COPD severity, except for higher odds of hospitalization in COPD patients requiring supplemental oxygen versus those without COPD (OR: 1.84, 95% CI: 1.02-3.33)., Conclusions: Except for hospitalization among patients using supplemental oxygen, no differences in odds of hospitalization or death/hospice referral were observed in the COVID-19 patient sample depending on whether they had COPD., Competing Interests: Declaration of competing interest Dr. Bonnie Donato, Dr. Asif Shaikh, and Dr. Jessica Franchino-Elder are employees of BI. Dr. Richard Murray is the Chief Medical Officer of Spire Health and reports receiving consulting fees from BI; he serves as the Chairman of the Board for the Allergy and Asthma Foundation of America. Dr. Vincent Liu, Dr. Laura Myers, and Dr. Patricia Kipnis received funding from BI to perform the study., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Patients with chronic obstructive pulmonary disease (COPD) can have low peak inspiratory flow (PIF), especially after hospitalization for acute exacerbation of COPD (AECOPD)., Purpose: To characterize patients hospitalized for AECOPD, and to assess the prevalence of low PIF, changes in PIF after hospitalization, and the association of low PIF with healthcare resource utilization (HRU) outcomes., Patients and Methods: A retrospective cohort study was conducted using electronic health record data of hospitalized COPD patients in the Wake Forest Baptist Health system (01/01/2017 through 06/30/2020). Patients with a first eligible AECOPD hospitalization (index hospitalization) who were discharged before 05/31/2020 were included. PIF was measured using the In-Check DIAL™ at both medium-low resistance (R-2) and high resistance (R-5) during the index hospitalization. For R-2 and R-5, PIF was divided into low PIF (< 60 L/min; < 30 L/min) and high PIF (≥ 60 L/min; ≥ 30 L/min) groups. The primary outcome was the prevalence of low PIF. The stability of PIF after hospitalization was described. Adjusted regression models evaluated associations between low PIF and subsequent 30-day readmissions, 90-day readmissions, and HRU outcomes, including hospitalizations, emergency department visits, inpatient days, and intensive care unit (ICU) days., Results: In total, 743 patients with PIF measured at R-2 and R-5 during a AECOPD hospitalization were included. The prevalence of low PIF was 56.9% at R-2 and 14.7% at R-5. PIF values were relatively stable after hospitalization. Adjusted analyses showed significant increases in HRU (all-cause hospitalizations [31%], COPD hospitalizations [33%], COPD inpatient days [46%], and COPD ICU days [24%]) during the follow-up period among patients with low PIF (< 60 L/min) at R-2. The 30- and 90-day readmission risks were similar between patients with low PIF and high PIF., Conclusion: Low PIF is common among patients hospitalized for AECOPD, relatively stable after hospital discharge, and associated with increased HRU., Competing Interests: Brendan Clark, Jessica Franchino-Elder, Asif Shaikh, and Bonnie MK Donato are employees of Boehringer Ingelheim Pharmaceuticals, Inc. Brian J Wells reports grants from Boehringer Ingelheim, during the conduct of the study. Jill A Ohar reports a research grant and publication assistance from Boehringer Ingelheim, during the conduct of the study; personal fees from and serving on the advisory board of Mylan, Sunovion, Boehringer Ingelheim, GlaxoSmithKline, Theravance, and Verona; and grants from Sunovion for a clinical study outside of the submitted work. The authors report no other potential conflicts of interest in relation to this work. This study was presented in part at the Virtual American Thoracic Society 2021 Conference, May 14–19 (Abstract A2165; available at: https://conference.thoracic.org/program/abstract-search.php?sid=P5762)., (© 2022 Clark et al.)

Background: Chronic obstructive pulmonary disease (COPD) is often managed with inhaled long-acting muscarinic antagonists (LAMAs), yet real-world data on healthcare resource utilization (HRU) by inhaler type are lacking. This study compared HRU after LAMA initiation with a soft mist inhaler (SMI) versus a dry powder inhaler (DPI)., Patients and Methods: Inclusion criteria were COPD diagnosis, age ≥40 years, LAMA initiation (index date = first LAMA SMI or DPI claim 9/1/14-6/30/18), and Medicare Advantage enrollment 1 year pre-index (baseline) to ≥30 days post-index (follow-up). Patients were followed to the earliest of discontinuation, switch, disenrollment, 1 year, or study end (7/31/18). Exclusion criteria were asthma, cystic fibrosis, or lung cancer diagnoses, unavailable demographics, multiple index LAMAs, or baseline LAMA use. Cohorts (SMI or DPI) were balanced on baseline characteristics using inverse probability of treatment weighting. Outcomes included per patient per month (PPPM) COPD-related HRU encounters, and exacerbations (defined as moderate [ambulatory visit with corticosteroid or antibiotic within ±7 days] or severe [emergency visit or inpatient admission]); and 30-day readmissions following COPD-related hospitalizations., Results: After weighting, cohorts (SMI [n=5360] and DPI [n=22,880]) were similar in age (72 and 73 years, respectively), gender (both 52% female), and COPD severity score (31.3 and 31.5, respectively). Cohorts had similar counts of follow-up HRU encounters. However, the SMI cohort had fewer (mean ± standard deviation) COPD-related exacerbations (0.054±0.082 vs DPI cohort 0.059±0.088 PPPM, p<0.001) overall. Moreover, the SMI cohort had fewer severe exacerbations (0.030±0.058 vs DPI: 0.034±0.065 PPPM, p<0.001). Hospitalizations among SMI patients had a lower adjusted odds of readmission versus hospitalizations among DPI patients (odds ratio: 0.656, 95% confidence interval= 0.460, 0.937; p=0.020)., Conclusion: SMI initiators had significantly fewer COPD-related exacerbations than DPI initiators. In addition, lower odds of readmissions were observed following COPD-related hospitalizations among the SMI cohort, as compared with the DPI cohort., Competing Interests: LGSB, CE, and ARB are employees of Optum, Eden Prairie, MN; employment is not contingent upon this work. DS and JF-E are employees of BIPI. The authors report no other conflicts of interest in this work., (© 2020 Singer et al.)

Background: The 2018 Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends combination long-acting muscarinic antagonists/long-acting beta2-agonists (LAMA + LABA) as preferred maintenance therapy for patients with symptomatic chronic obstructive lung disease (COPD) after monotherapy and stepping up to triple therapy (TT; LAMA + LABA + inhaled corticosteroids [ICS]) in case of further exacerbations. Restrictions on TT recommendations have primarily been driven by higher pneumonia risk associated with regular ICS use. Evidence suggests that TT is overprescribed, which may affect economic and clinical outcomes., Objective: To compare health plan-paid costs, COPD exacerbations, and pneumonia diagnoses among patients newly treated with a LAMA + LABA regimen composed of tiotropium (TIO) + olodaterol (OLO) in a fixed-dose combination inhaler (TIO + OLO) or TT in a U.S. Medicare Advantage Part D insured population., Methods: This retrospective study identified COPD patients aged ≥ 40 years who were initiating TIO + OLO or TT (index regimen) between January 1, 2014, and March 31, 2018, from a national administrative claims database. Continuous insurance coverage for 12 months pretreatment (baseline) and ≥ 30 days posttreatment (follow-up) was required. Patients were followed until the earliest of study end (May 31, 2018), discontinuation of index regimen (≥ 60-day gap in index regimen coverage), switch to a different regimen, or health plan disenrollment. Before analysis of outcomes, TIO + OLO and TT patients were 1:1 propensity score-matched on baseline demographics, comorbidities, COPD medication use, medical resource use, and costs. Cohort differences in post-match outcomes were assessed by Wald Z-test (annualized costs) and Kaplan-Meier method (time to first COPD exacerbation and pneumonia diagnosis)., Results: After matching, each cohort had 1,454 patients who were well balanced on baseline characteristics. Compared with TT, the TIO + OLO cohort incurred $7,041 (41.1%) lower mean COPD-related total costs ($10,094 vs. $17,135; P < 0.001); cohort differences in the medical component ($3,666 lower for TIO + OLO) were driven by lower mean acute inpatient costs ($3,053 lower for TIO + OLO). Combined mean COPD plus pneumonia-related medical costs were $5,212 (39.0%) lower for TIO + OLO versus TT ($8,209 vs. $13,421; P = 0.006), and total mean all-cause costs were $9,221 (30.4%) lower for TIO + OLO versus TT ($21,062 vs. $30,283; P < 0.001). Kaplan-Meier analysis found longer time to first severe COPD exacerbation ( P = 0.020) and first pneumonia diagnosis ( P = 0.002) for TIO + OLO versus TT and a lower percentage of TIO + OLO patients experiencing these events (severe COPD exacerbation: 9.0% vs. 16.1%; pneumonia: 14.5% vs. 19.3%). A secondary analysis, which expanded the TIO + OLO cohort to include any LAMA + LABA regimen, had similar findings for all outcomes., Conclusions: COPD patients initiating TIO + OLO incurred lower costs to health plans and experienced fewer COPD exacerbation and pneumonia events relative to TT. These findings provide important real-world economic and clinical insight into the GOLD recommendations for TIO + OLO and LAMA + LABA therapy. The study findings also indicate the continued inconsistency between the recommendations and real-world clinical practices pertaining to TT., Disclosures: This study was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). Palli and Franchino-Elder are employees of BIPI. Frazer, DuCharme, Buikema, and Anderson are employees of Optum, which was contracted by BIPI to conduct this study. The authors received no direct compensation related to the development of the manuscript. BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.

Introduction: Many patients exhibit subsyndromal clinical findings of schizophrenia prior to diagnosis. Early treatment may mitigate schizophrenia development, yet little is known about comorbidities and healthcare resource utilization (HCRU) in these patients before diagnosis., Methods: This retrospective, longitudinal cohort study, conducted between January 1, 2007 and April 30, 2016, used claims data from the US HealthCore Integrated Research Database. Newly diagnosed patients with schizophrenia (International Classification of Diseases, Ninth Revision: 295.x or ICD 10 F20.%) were identified and matched (1:4) with non-schizophrenia comparators. Patients were 15-54 years of age with either ≥1 inpatient/emergency room claim with a primary schizophrenia diagnosis, or ≥2 claims in any setting with any schizophrenia diagnosis. Demographics, comorbidities, physician specialties, medications, and related services, and other HCRU were compared between cohorts for up to 5 years before diagnosis., Results: The schizophrenia cohort included 6732 patients (57.4% male, mean age 30.3 years for males and 36.2 years for females). All outcomes were more prevalent in the schizophrenia cohort than the comparator cohort. Substantial comorbidity, medication use, and HCRU were observed in the schizophrenia cohort even 4-5 years before diagnosis with increasing findings approaching diagnosis. From 4-5 years to 0-12 months before diagnosis, resource use increased from 20.5% to 53.3% for atypical antipsychotics, 29.3% to 48.2% for antidepressants, and 15.1% to 35.5% for psychiatric diagnostic examinations., Conclusions: Patients with schizophrenia extensively use healthcare resources up to 5 years before diagnosis. Our findings may help with developing predictive models to identify patients at high risk of schizophrenia., Competing Interests: Declaration of competing interest The authors met the criteria for authorship as recommended by the International Committee of Medical Journal Editors. Three of the authors (M Sidovar, JF-E, and M Sand) are employees of Boehringer Ingelheim Pharmaceuticals, Inc., but received no direct compensation related to the development of this paper. WY, and JB are employees of HealthCore Inc. AW and M Shinde were employees of HealthCore Inc., at the time of study. KI is an employee of ANTHEM Inc. AW, JB, M Shinde, and KI own ANTHEM stock., (Copyright © 2019. Published by Elsevier B.V.)

Background: In preclinical models, benfotiamine efficiently ameliorates the clinical and biological pathologies that define Alzheimer's disease (AD) including impaired cognition, amyloid-β plaques, neurofibrillary tangles, diminished glucose metabolism, oxidative stress, increased advanced glycation end products (AGE), and inflammation., Objective: To collect preliminary data on feasibility, safety, and efficacy in individuals with amnestic mild cognitive impairment (aMCI) or mild dementia due to AD in a placebo-controlled trial of benfotiamine., Methods: A twelve-month treatment with benfotiamine tested whether clinical decline would be delayed in the benfotiamine group compared to the placebo group. The primary clinical outcome was the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog). Secondary outcomes were the clinical dementia rating (CDR) score and fluorodeoxyglucose (FDG) uptake, measured with brain positron emission tomography (PET). Blood AGE were examined as an exploratory outcome., Results: Participants were treated with benfotiamine (34) or placebo (36). Benfotiamine treatment was safe. The increase in ADAS-Cog was 43% lower in the benfotiamine group than in the placebo group, indicating less cognitive decline, and this effect was nearly statistically significant (p = 0.125). Worsening in CDR was 77% lower (p = 0.034) in the benfotiamine group compared to the placebo group, and this effect was stronger in the APOEɛ4 non-carriers. Benfotiamine significantly reduced increases in AGE (p = 0.044), and this effect was stronger in the APOEɛ4 non-carriers. Exploratory analysis derivation of an FDG PET pattern score showed a treatment effect at one year (p = 0.002)., Conclusion: Oral benfotiamine is safe and potentially efficacious in improving cognitive outcomes among persons with MCI and mild AD.

Aims: Non-valvular atrial fibrillation (NVAF) prevalence increases with age. Hence, evaluating the economic burden among older-aged patients is vital. This study aimed to compare healthcare resource utilization (HRU) and costs among newly-diagnosed older-aged NVAF patients treated with warfarin, rivaroxaban, or apixaban vs. dabigatran. Materials and Methods: Newly-diagnosed older-aged (aged ≥65 years) NVAF patients initiating dabigatran, warfarin, rivaroxaban, or apixaban (first prescription date = index date) from 01JAN2010-31DEC2015 and with continuous enrollment for ≥12 months pre-index date were included from 100% Medicare database. Patient data were assessed until drug discontinuation/switch/dose change/death/disenrollment/study end (up to 12 months). Dabigatran initiators were 1:1 propensity score-matched (PSM) with warfarin, rivaroxaban, or apixaban initiators. Generalized linear models were used to compare all-cause HRU and costs per-patient-per-month (PPPM) between the matched cohorts. Results: After PSM with dabigatran, 70,531 warfarin, 51,673 rivaroxaban, and 25,209 apixaban patients were identified. Dabigatran patients had significantly fewer generalized-linear-model-adjusted PPPM hospitalizations (0.114 vs. 0.123; 0.111 vs. 0.121), and outpatient visits (2.864 vs. 4.201; 2.839 vs. 2.949) than warfarin and rivaroxaban patients, respectively, but had significantly more PPPM hospitalizations (0.103 vs. 0.090) and outpatient visits (2.780 vs. 2.673) than apixaban patients (all p  < .0001). Dabigatran patients incurred significantly lower adjusted total PPPM costs ($3,309 vs. $3,362; $3,285 vs. $3,474) than warfarin and rivaroxaban patients, respectively (all p  < .01) but higher total PPPM costs ($3,192 vs. $2,986) than apixaban patients (all p  < .0001). Limitations: This study is subject to the inherent limitations of any claims dataset, including potential bias from coding errors and identification of medical conditions using diagnosis codes as opposed to clinical evidence. Medications filled over-the-counter or provided as samples by the physician are never captured in claims data. Conclusions: Newly-diagnosed older-aged NVAF patients initiating dabigatran incurred significantly lower adjusted all-cause HRU and costs than warfarin and rivaroxaban patients but higher adjusted HRU and costs than apixaban patients.

Background: The management of schizophrenia, a chronic, multifaceted mental health condition, is associated with considerable health care resource utilization (HCRU) and costs. Current evidence indicates that a high-risk and costly prodromal period, during which patients are likely symptomatic, precedes diagnosis. Better characterization and disease management during this stage could help to improve patient outcomes., Objective: To describe and compare HCRU and costs for up to 5 years before diagnosis in a cohort with schizophrenia versus a demographically matched cohort without schizophrenia in a commercially insured U.S., Methods: This retrospective study identified newly diagnosed schizophrenia patients using enrollee claims in the HealthCore Integrated Research Database between January 1, 2007, and April 30, 2016. The index date was defined as the date of the first medical claim with a schizophrenia diagnosis code. Schizophrenia patients were directly matched (1:4) by age, sex, and region to comparators without schizophrenia who were assigned the same index dates as their matched schizophrenia counterparts. Observation periods were 0-12, 13-24, 25-36, 37-48, and 49-60 months before the index date. Outcomes included HCRU and costs for inpatient admissions, emergency room visits, outpatient care (office visits and other outpatient services), and medications. Means, standard deviations, medians, and 95% confidence intervals were calculated for continuous variables; relative frequencies and percentages were calculated for categorical variables. Cohorts were compared with t-tests for continuous variables and chi-square tests for categorical variables. Differences across cohorts were estimated with individual generalized linear models for each observation period, controlling for gender, age, geographic region of residence, health plan type and subscriber status, behavioral pre-index comorbidities and chronic comorbidities during the period before diagnosis., Results: 6,732 schizophrenia patients were matched to 26,928 patients without schizophrenia. All-cause inpatient admissions were more prevalent among schizophrenia patients than their comparators for all time periods (49-60 months prediagnosis: 9% vs. 4%; 0-12 months prediagnosis: 33% vs. 4%). The schizophrenia cohort had higher adjusted all-cause per-patient per-month health care costs relative to comparators from the earliest period of 49-60 months prediagnosis ($557 [95% CI = 474-639] vs. $321 [95% CI = 288-355]) through 0-12 months prediagnosis ($1,058 [95% CI = 998-1,115] vs. $338 [95% CI = 320-355]). Behavioral health-related costs were different in each time period as were cost ratios (schizophrenia costs: comparator costs), which increased from 5.4 in the earliest period to 14.8 in the year before diagnosis., Conclusions: Schizophrenia patients had higher all-cause and behavioral health-related HCRU and costs before diagnosis than matched controls. Costs increased from 5 years to 1 year prediagnosis for schizophrenia patients driven primarily by inpatient hospital stays and prescription drug costs, but remained stable for comparators. Additional research is needed for the development of predictive models to aid in the identification of high-risk patients., Disclosures: This study was sponsored by Boehringer Ingelheim Pharmaceuticals. Barron is an employee of HealthCore, which received funding from Boehringer Ingelheim to conduct this study. Wallace and York were employed by HealthCore at time of this study. Isenberg is an employee of Anthem. Franchino-Elder, Sidovar, and Sand are employees of Boehringer Ingelheim.

Background: This is one of the first head-to-head real-world evidence studies comparing stroke-related and bleed-related healthcare and resource utilization (HCRU) and costs among non-valvular atrial fibrillation (NVAF) patients initiating oral anticoagulants., Methods: Adult NVAF patients newly diagnosed and treated with dabigatran, rivaroxaban, or warfarin between 10/01/2010 and 12/31/2014 were identified using MarketScan Commercial and Medicare Supplemental databases. Per-patient-per-month stroke and bleed-related HCRU and costs were reported., Results: Dabigatran patients were matched 1:1 to 26,592 rivaroxaban and 33,024 warfarin patients (mean age=68 years). Compared to rivaroxaban, dabigatran patients had lower bleed-related inpatient and outpatient HCRU (0.004 vs. 0.005; 0.099 vs. 0.145) and significantly lower adjusted bleed-related costs ($116 vs. $172), all p <0.05. Compared to warfarin, dabigatran patients had significantly lower stroke-related outpatient visits (0.034 vs. 0.048, p<0.001) and higher bleed-related outpatient visits (0.101 vs. 0.091, p=0.045). Multivariate adjusted bleed-related costs were significantly lower for dabigatran patients than warfarin patients ($94 vs. $138, p<0.001)., Conclusions: The results suggest that dabigatran patients had lower bleed-related HCRU and costs than rivaroxaban patients, and lower outpatient stroke-related HCRU, higher bleed-related outpatient HCRU, and lower bleed-related costs than warfarin patients. It provides valuable stroke-related and bleed-related HCRU and costs information among commercially insured and Medicare patients.

Objectives: With the approval of new non-vitamin K antagonist oral anticoagulants for stroke prevention in non-valvular atrial fibrillation (NVAF), it is anticipated that their introduction may change NVAF treatment patterns; however, there is limited supporting real-world evidence. This study investigated guideline-recommended oral anticoagulation (OAC) treatment and persistence in newly diagnosed patients with NVAF to understand demographic and clinical characteristics., Design: Retrospective observational administrative claims study in the USA., Setting: Patients with NVAF with ≥1 pharmacy claim for OAC (warfarin, dabigatran, rivaroxaban or apixaban) and no atrial fibrillation diagnosis within 12 months prior to the first claim were identified in the HealthCore Integrated Research Database between 1 November 2010 and 30 November 2013., Participants: 45 092 patients with NVAF were included., Outcomes: The proportion of OAC-treated patients was stratified by CHADS 2 score. Treatment persistence was measured from OAC initiation to discontinuation, end of eligibility or end of study period (30 November 2014), whichever occurred first., Results: Almost half of the patients (41.1%) received an OAC. The proportion treated differed slightly in baseline stroke risk (CHADS 2 <2: 39.8%; CHADS 2 =2 or 3: 42.4%; and CHADS 2 >3: 40.3%: p<0.001). Treated patients were slightly younger (70±12.2 vs 71±14.3 years; p<0.001), more likely male (59.7% vs 52.5%; p<0.001) and had a slightly elevated stroke risk (CHADS 2 : 2.03±1.3 vs 1.98±1.4; p<0.001) and a lower bleeding risk (HEMORR 2 HAGES: 2.55±1.8 vs 2.80±1.9; p<0.001) relative to untreated patients. Overall, patients with higher CHADS 2 scores had higher HEMORR 2 HAGES scores. The mean follow-up was 2.25 years (2.25±0.85) and 72.7% of patients discontinued OACs; nearly 25% within 3 months and 55% within 12 months. The mean time to discontinuation was 255±249 days., Conclusions: The proportion of patients with NVAF who received OAC treatment was lower than previously reported and differed slightly by stroke risk. Patients with an elevated stroke risk had a higher bleeding risk, suggesting that clinicians may incorporate both in the treatment decision., Competing Interests: Competing interests: All authors declare: financial support for the submitted work from Boehringer Ingelheim Pharmaceuticals, Inc (BIPI); HealthCore has received a research grant from BIPI during the conduct of the study; JFE, CW and SS are employees of BIPI; and HealthCore receives funding from multiple pharmaceutical companies to perform various research studies outside of the submitted work., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: Compare costs and healthcare resource utilization (HCRU) among newly-diagnosed non-valvular atrial fibrillation (NVAF) patients newly treated with dabigatran vs apixaban, rivaroxaban, or warfarin., Methods: Newly-diagnosed adult NVAF patients initiating dabigatran, apixaban, rivaroxaban, or warfarin (index event) between October 1, 2010-December 31, 2014 were identified using MarketScan claims data, and followed until medication discontinuation, switch, inpatient death, enrollment end, or study end (December 31, 2015). Dabigatran patients were propensity-score matched 1:1 separately with apixaban, rivaroxaban, and warfarin patients. Per-patient-per-month (PPPM) all-cause cost, HCRU, and 30-day re-admissions were reported. Costs were analyzed using generalized linear models., Results: Final cohorts, each matched with dabigatran patients, included 8,857 apixaban patients, 26,592 rivaroxaban patients, and 33,046 warfarin patients. Dabigatran patients had lower adjusted PPPM total healthcare, inpatient, and outpatient costs compared to rivaroxaban ($4,093 vs $4,636, $1,476 vs $1,862, and $2,016 vs $2,121, respectively, all p ≤ .001) and warfarin ($4,199 vs $4,872, $1,505 vs $1,851, and $2,049 vs $2,514, respectively, all p < .001). Adjusted costs were similar for dabigatran and apixaban. Dabigatran patients had significantly fewer hospitalizations, outpatient visits, and pharmacy claims than rivaroxaban patients (0.06 vs 0.07, 4.84 vs 4.96 and 4.80 vs 4.93, respectively, all p < .020) and warfarin patients (0.06 vs 0.07, 4.77 vs 6.88, and 4.76 vs 5.89, respectively, all p < .001). Dabigatran patients had similar hospitalizations to apixaban, but higher outpatient visits (4.70 vs 4.31) and pharmacy claims (4.86 vs 4.61), both p < .001., Conclusions: This real-world study found adjusted all-cause costs were lower for dabigatran compared to rivaroxaban and warfarin patients and similar to apixaban patients.