Search

To evaluate medication discontinuation, persistence, and adherence of moderate to severe psoriasis patients treated with adalimumab, apremilast, etanercept, secukinumab, and ustekinumab. Adult patients diagnosed with psoriasis and ≥1 psoriasis pharmacy or medical claim of any of the five psoriasis medications (index date) and continuous insurance enrollment were included from the Optum Clinformatics database during the intake period (7/1/2014–9/30/2017). Medication discontinuation, persistence, medication possession ratio (MPR), and proportion of days covered (PDC) were evaluated during a 12-month post-index follow-up period, using three gap definitions. Among the study population (n = 8524), 34.4% initiated adalimumab, 25.7% apremilast, 9.0% etanercept, 7.1% secukinumab, and 23.7% ustekinumab. Mean age ranged from 48.7 to 52.2 years. For all three gap definitions, discontinuation was lowest and persistence greatest among ustekinumab treated patients (48.4% and 59.8%, respectively using the default definition). A greater proportion of ustekinumab patients had an MPR ≥80% (81.8%) than adalimumab (67.9%), apremilast (54.9%), etanercept (56.4%), and secukinumab (68.0%) patients. Also, 50.6% of ustekinumab patients had a PDC ≥80% versus 35.6%, 23.9%, 19.5%, and 41.7% of adalimumab, apremilast, etanercept, and secukinumab patients, respectively. Although heterogeneity across cohorts may explain some medication utilization differences, ustekinumab was associated with lower discontinuation and greater persistence and adherence. [ABSTRACT FROM AUTHOR]

Objective: Atrial fibrillation (AF) is present in up to 17% of patients in skilled nursing facilities (SNFs). This study compared healthcare resource utilization (HRU) and costs between AF patients initiating rivaroxaban or warfarin in SNFs.Methods: Using de-identified claims from Optum Clinformatics Extended Data Mart (1 January 2013 to 31 December 2017), this retrospective cohort study indexed AF patients with first SNF admission during which rivaroxaban or warfarin was initiated within 3 days of admission. To adjust for selection bias, inverse probability of treatment weighting (IPTW) was applied for baseline characteristics. Logistic regression and generalized linear models were used to compare HRU and costs.Results: 519 rivaroxaban and 1129 warfarin patients met inclusion criteria. After IPTW, the cohorts were well balanced for baseline characteristics. The average length of index SNF stay was 32.07 and 37.44 days for rivaroxaban and warfarin patients, respectively. During SNF stay, rivaroxaban patients had 27% lower odds of hospitalization (p < .0001), 2.7 fewer international normalized ratio (INR) tests per-patient-per-month (PPPM; p < .001), and 2.3 fewer pathology/laboratory encounters PPPM (p < .0001) than warfarin patients. All-cause healthcare costs were $2638 lower with rivaroxaban versus warfarin (p < .0001) during the index SNF stay, with lower medical costs (p < .0001) but higher pharmacy costs (p < .0001). Total all-cause healthcare costs 100 days post-index SNF were $8746 lower with rivaroxaban versus warfarin (p < .0001).Conclusions: In the SNF setting, AF patients treated with rivaroxaban had 5-day shorter length of stay, lower HRU, and lower all-cause total and medical costs compared to warfarin, despite higher treatment costs. These findings may help inform clinical decision-making to reduce economic burden. [ABSTRACT FROM AUTHOR]

Background: Use of direct-acting oral anticoagulants for patients with nonvalvular atrial fibrillation (NVAF) in skilled nursing facilities (SNFs) is increasing. Rivaroxaban is commonly used in this setting as an alternative to warfarin, based on comparable or increased efficacy in preventing stroke and a similar or lower risk of major bleeding. Objective: The aim of this study was to compare healthcare resource utilization (HCRU) and costs between NVAF patients receiving rivaroxaban or warfarin in SNFs. Methods: This retrospective study examined de-identified claims from Optum® Clinformatics® Extended Data Mart (1 January 2013–31 December 2017). Eligible patients had an AF diagnosis, were prescribed rivaroxaban or warfarin during an SNF stay, and had one or more such prescriptions filled in the 6 months preceding the stay. Patients were excluded if they received another oral anticoagulant or had evidence of valvular heart disease, mitral stenosis, or organ/tissue transplant. HCRU, mean number of events, and all-cause healthcare costs during the index SNF stay were reported. Results were also reported on a per-patient-per-month (PPPM) basis. Exploratory analyses at different time periods were also conducted. Results: Overall, 4423 rivaroxaban patients and 22,796 warfarin patients were identified prior to inverse probability of treatment weighting adjustment. Index SNF stay was significantly shorter among rivaroxaban-treated patients (35.8 ± 35.8 days) versus warfarin (40.1 ± 46.3 days; p < 0.0001). During the SNF stay, overall HCRU was lower for the rivaroxaban cohort versus the warfarin cohort. All-cause total costs were significantly reduced for rivaroxaban ($6450 ± $10,379) versus warfarin ($7640 ± $16,556; p < 0.0001), and similar results were observed when calculated on a PPPM basis. During the 1-year post-index period, PPPM all-cause total costs were significantly lower with rivaroxaban versus warfarin ($4135 vs. $4561; p < 0.0001). Conclusion: In this SNF setting, HCRU and costs were lower among patients with NVAF who were experienced users of rivaroxaban compared with those who were experienced users of warfarin. These findings may help inform clinical decision making to reduce the economic burden of NVAF among older adults in SNFs. [ABSTRACT FROM AUTHOR]

Background: Most studies addressing the association between RSV and recurrent wheezing (RW) and asthma have been conducted in patients at risk for lung morbidity. Data in full‐term infants are limited. Methods: The risk of RW/asthma during the first 5 years of life in full‐term infants hospitalized with RSV during the first year (Y) of life was estimated using 2010‐16 data from three claims databases in USA (Truven MarketScan Commercial Claims and Encounters Database [CCAE], Truven Health MarketScan Multi‐State Medicaid [MDCD], and Optum Clinformatics Extended Data Mart‐Socio‐Economic Status [SES]). Full‐term infants with and without RSV infection and ≥ 2 years of continuous health plan enrollment from birth were included. Incidence rates of RW/asthma, cumulative incidence, adjusted incidence rate ratios (aIRR), and odds ratios (aOR) were calculated. Results: During the 16‐year study, 38,494 (CCAE), 62 846 (MDCD), and 23 099 (SES) matched infant pairs were included in each cohort. In the CCAE database, RW/asthma incidence/1000 patient‐years (69.7 vs 28.7, aIRR: 2.4 [2.3‐2.5]); cumulative incidence (17.6%‐25.2% vs 5.0%‐11.4%); and aOR (Y2: 4.1 [3.9‐4.4]; Y3: 3.2 [3.0‐3.3]; Y4: 2.9 [2.7‐3.1]; Y5: 2.6 [2.5‐2.9]) were higher in the RSV vs. non‐RSV cohort. Results in the SES insured population were comparable, while cumulative incidence and aIRR were higher in the Medicaid population (MDCD). Conclusion: Although there are limitations in this study, including possible coding errors and missing covariates, we showed that full‐term infants with severe RSV infection during the first year of life, spanning several respiratory seasons and a geographically diverse population, are at significant risk of RW/asthma during childhood. [ABSTRACT FROM AUTHOR]

Background: Many patients with major depressive disorder (MDD) fail to respond to antidepressant (AD) pharmacotherapy. The objectives of this study were to characterize MDD and treatment-resistant depression (TRD) at the level of pharmacologically treated episodes and to describe the sequential treatment patterns by lines of therapy (LOT) in the first two episodes. Methods: Adults (≥18 years of age) with continuous enrollment ≥12 months before and after the first MDD diagnosis and treated with an AD, with or without an MDD-indicated antipsychotic (AP), were identified (1/1/2010-12/31/2015). The MDD episode started on the date of MDD diagnosis that was preceded by a clean period without any MDD diagnosis. The MDD episode ended on the last MDD diagnosis or the end of the days’ supply of AD/AP medication, whichever came last. TRD was defined as an MDD episode with ≥3 AD/AP regimens. Measured outcomes included episode duration, number of LOT, relapse hospitalization, and sequential treatment patterns of MDD episode stratified by TRD and non-TRD episodes. Results: Of 48,440 patients who received AD/AP in the 1st MDD episode, 3,317 (6.8%) of episodes were considered TRD. Mean duration of 1st TRD episodes was 571 days, mean number of AD/AP LOTs was 3.47, and 13.7% involved relapse hospitalization. Mean duration of 1st non-TRD episodes was 200 days, mean number of AD/AP LOTs was 1.21, and 9.6% involved relapse hospitalization. Among 1st MDD episodes, 25.5% had a second LOT; 7.3% had a third LOT. Most patients received selective serotonin reuptake inhibitors (SSRIs) as the first LOT (63.0%), and the plurality of regimens were SSRIs in second (44.9%) and third LOT (41.1%). Conclusions: Compared to non-TRD episodes, TRD episodes were longer and more often involved relapse hospitalizations. SSRIs were the most common treatment; treatment changes and potential treatment unresponsiveness were frequent among MDD patients. [ABSTRACT FROM AUTHOR]

Purpose The goal of this study was to examine treatment patterns, utilization, and costs for complicated urinary tract infections (UTIs) requiring inpatient/emergency department (ED) and outpatient care. Methods This observational study evaluated inpatient/ED-treated and outpatient-treated patients (aged ≥18 years) with complicated UTIs from 2 large US administrative claims databases (HealthCore Integrated Research Environment and Premier Perspective Database). Patient identification depended on treatment setting: outpatients had 2 UTI diagnosis–related office visits and 2 claims for different antibiotics within 30 days, and inpatients had a UTI-related hospitalization/ED visit after 1 UTI diagnosis–related office visit plus 2 claims for different antibiotics within 30 days. The index date for outpatients was the date of the first office visit; for inpatients, it was the date of admission/ED visit. Both cohorts had continuous insurance eligibility. Outcomes were assessed by using univariate and multivariate statistics. Findings The study sample included 1118 inpatient/ED patients (76.6% female subjects; mean age, 62.4 years) and 41,605 outpatients (85.8% female subjects; mean age, 52.3 years). Mean (SD) pharmacy costs were $2971 ($7650) for inpatient/ED patients and $1882 ($3120) for outpatients during the full treatment period. Index hospitalization/ED averaged $38,422 ($51,161). Mean all-cause 90-day follow-up costs for the inpatient/ED cohort were $34,100 ($71,621) and $11,345 ($34,313) for the outpatient cohort. Implications Relative to outpatient-treated patients, inpatient/ED-treated patients were older, sicker, had higher costs across treatment periods, and had reduced antibiotic use at a lower rate during the 90-day follow-up. Strategies to avoid preventable inpatient/ED visits may help reduce costs in the management of outpatients with complicated UTIs. [ABSTRACT FROM AUTHOR]

To understand clinicians' current teclistamab step-up dosing (SUD) model and how they envision future administration models, as well as perceived barriers and facilitators to these models in day-to-day clinical practice. Interviews of clinicians with RW experience administering teclistamab, with a subsequent roundtable discussion to discuss interview findings. Topics of interest included managing adverse events (AE), and handling logistics of SUD and transition of care (ToC). 20 clinicians representing 19 practices participated. Of 14 practices administering inpatient teclistamab SUD, 12 (86%) utilized a single admission. A day 1-3-5 dosing schedule with a 7-day length of stay was planned in 10/14 (71%). The remaining 5 practices employed outpatient or hybrid SUD. SUD models depended on cellular therapy experience, patient volume, and monitoring capabilities. Clinicians desired to administer SUD outpatient for convenience and reduced healthcare resource use. 11% of practices reported using tocilizumab for cytokine release syndrome (CRS) prophylaxis, whilst it was uniformly used to treat grade 2+ CRS. Corticosteroids were the preferred treatment for neurotoxicity. Infection prophylaxis with intravenous immunoglobulin was reported by 89% of practices. Patient- and institution-level factors affected decision-making of transitioning patients back to referring sites after SUD. The results consolidated practice-based experiences and indicated diverse RW SUD models and patient management strategies in practices with familiarity with teclistamab AE management and ToC protocols. Inpatient SUD is common, with expectations that approaches will evolve toward outpatient or community-based administration. Further research is needed to investigate outcomes of different care models and AE management strategies. Multiple myeloma is a blood cancer that forms in plasma cells. Teclistamab is a new treatment for patients with multiple myeloma who have received prior treatment but for whom their multiple myeloma has come back or stopped responding to treatment multiple times. Because teclistamab works differently than other existing multiple myeloma treatments, there is a need to understand how oncologists who have experience with teclistamab are managing their patients in order to inform best practices for use by more healthcare providers. We interviewed oncologists that treat patients with multiple myeloma to understand their experiences with teclistamab, including how they manage initial dosing (step-up dosing) processes, treat adverse events, and transition patients to outpatient or external clinics for continued care. Most practices were administering step-up dosing of teclistamab in an inpatient setting soon after teclistamab became a treatment option, with a high level of desire to move the initial dosing to an outpatient setting in the near future. Those that were already administering step-up dosing in an outpatient setting had models unique to their practice. Oncologists described numerous processes for monitoring and managing adverse events of the treatment, including treating patients with preventative medications and regularly monitoring vital signs throughout step-up dosing. Oncologists expected that their teclistamab administration processes will likely evolve over time as they gain more familiarity with the treatment, and will need to consider patient-level factors to administer step-up dosing in an outpatient setting. [ABSTRACT FROM AUTHOR]

Adalimumab (ADA), certolizumab pegol (CER), etanercept (ETA), guselkumab (GUS), ixekizumab (IXE), secukinumab (SEC), and ustekinumab (UST) are biologics approved for the treatment of psoriasis (PsO) and psoriatic arthritis (PsA). We examined adherence and persistence among PsO patients with comorbid PsA who initiated treatment with any of these biologics. Adult patients with ≥1 pharmacy/medical claim for any of these seven biologics, and ≥1 diagnosis of both PsO and PsA were selected from the MarketScan Commercial database (July 2014–June 2019). Adherence and persistence rates were examined among the seven study cohorts during fixed follow-up periods (3, 6, 9, and 12 months). Among patients with ≥9 months of continuous enrollment, 3,251 initiated ADA, 418 CER, 1,563 ETA, 126 GUS, 422 IXE, 1,596 SEC, and 1,267 UST. During the 9-month follow-up period, the proportions of adherent patients were numerically highest among those treated with GUS (59.5%) and UST (57.0%), followed by SEC (47.9%), IXE (47.6%), ADA (46.8%), ETA (37.4%), and CER (22.0%); persistence rates were also numerically highest among those treated with GUS (65.9%) and UST (65.7%). Adjustment for potential confounders was not conducted. Adherence and persistence rates were numerically highest among patients who initiated GUS and UST. [ABSTRACT FROM AUTHOR]

Objectives: To assess characteristics and healthcare costs associated with pharmacologically treated episodes of treatment-resistant depression (TRD) in patients with major depressive disorder (MDD).Methods: Patients aged ≥18 years with continuous health plan enrollment for ≥12 months before and after a newly observed MDD diagnosis (observed between 1 January 2010 and 31 December 2015) were included in this retrospective claims-based analysis. A pharmacologically treated episode was defined as beginning at the date of the first MDD diagnosis and ending when a gap of 180 days occurred between MDD diagnoses, or when a gap of 180 days occurred following the end of the antidepressant (AD)/antipsychotic (AP) drug supply. When such a gap occurred, the episode end date was determined to be either the date of the last MDD diagnosis or date of the end of AD/AP drug supply, whichever was later. An episode was considered TRD if ≥3 AD regimens occurred. Episode duration, medication regimens used, and relapse hospitalization were reported for TRD and non-TRD MDD episodes. Total all-cause and per-patient-per-month (PPPM) healthcare costs (in 2016 $) were estimated.Results: Of 48,440 patients identified with ≥1 AD-treated MDD episode, the mean (SD) age was 39 (15) years, and 62% were female. Of all episodes, 7% were TRD, with a mean duration of 571 (285) days vs. 200 (198) days for non-TRD MDD episodes. Mean total all-cause costs were $19,626 ($44,160) for TRD and $7440 ($25,150) for non-TRD MDD episodes.Conclusions: Results show TRD episodes are longer and costlier than non-TRD MDD episodes, and that higher costs are driven by episode duration. Longer episodes imply protracted suffering for patients with TRD and increased burden on caregivers. Effective intervention to shorten TRD episodes may lessen disease burden and reduce costs. [ABSTRACT FROM AUTHOR]

This study compared utilization patterns of high-cost services and medications for patients receiving care from Accountable Care Organization (ACO)-participating physicians and those receiving care from non-ACO physicians during the initial phases of ACO development in a commercially insured environment. Patients ≥18 years (≥40 years for chronic obstructive pulmonary disease [COPD]) with prevalent rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, type 2 diabetes, COPD, or chronic low back pain between January 1, 2012, and August 31, 2014 were identified in the HealthCore Integrated Research DatabaseSM. Patients were assigned to the ACO cohort if their primary treating physician was contracted to the health plan through an ACO agreement. Each clinical condition was stratified for severity of illness. Cohort utilization patterns were compared for the 12-month period following the index encounter. The primary outcome measures show that there was no statistically significant utilization difference between the ACO and non-ACO cohorts for 90% of the 82 comparisons made. It is expected that some measures will achieve significant difference simply because of having this many comparisons, but no clear pattern was identified. This study did not observe statistically significant differences in utilization of high-cost services and medications between ACO and non-ACO cohorts with limited experience in the ACO model. Future analyses with longer study durations, at later stages of ACO development, tracking a more granular level of physician organizational structure, and with designs that integrate clinical and administrative data are essential to better understand the impact of payment innovation strategies using an ACO structure. [ABSTRACT FROM AUTHOR]

Limited data exist on direct-acting oral anticoagulants in morbidly obese patients with venous thromboembolism (VTE). We compared clinical and health/economic outcomes with rivaroxaban versus warfarin for VTE treatment in morbidly obese patients. This retrospective 1:1 propensity score matched cohort study analyzed data from 2 US claims databases. VTE patients initiating rivaroxaban or warfarin were identified who had diagnosis codes for morbid obesity (ICD-9:278.01,V85.4; ICD-10:E66.01,E66.2,Z68.4) 12 months pre- or 3 months post-initiation and followed ≥3 months. Intent-to-treat (ITT) and on-treatment (OT) analyses were conducted using conditional logistic regression and generalized linear models to compare recurrent VTE and major bleeding risks, healthcare resource utilization (HRU), and per patient per year (PPPY) costs. In total, 2890 matched pairs of morbidly obese VTE patients initiating rivaroxaban or warfarin were identified. Risks of recurrent VTE (ITT: OR: 0.99; 95% CI: 0.85–1.14) and major bleeding (OT: OR: 0.75; 95% CI: 0.47–1.19) were similar for cohorts. Anti-Factor Xa laboratory measurement was performed on <1% of rivaroxaban cohort. Hospitalizations (OR: 0.86; 95% CI: 0.77–0.96) and outpatient visits (OR: 0.23; 95% CI: 0.10–0.56), were lower with rivaroxaban versus warfarin (ITT analysis). Average total medical costs PPPY were $2829 lower with rivaroxaban versus warfarin ($34,824 vs $37,653), mainly driven by hospitalization costs. Total healthcare costs (including pharmacy) were similar ($43,034 vs $44,565). Morbidly obese VTE patients receiving rivaroxaban had similar risks of recurrent VTE and major bleeding versus warfarin. Rivaroxaban treatment yielded significantly less HRU and total medical costs, with similar total healthcare costs between groups. • Morbidly obese patients with venous thromboembolism were followed for 10 months. • Risk of recurrent venous thromboembolism was similar with rivaroxaban or warfarin. • Risk of major bleeding was similar with rivaroxaban or warfarin. • Anti-FXa levels were measured in <1% of patients receiving rivaroxaban. • Healthcare resource use/medical costs were lower with rivaroxaban versus warfarin. [ABSTRACT FROM AUTHOR]

Objective: This US retrospective cohort study compared the real-world effectiveness of canagliflozin 300 mg versus dapagliflozin 10 mg on HbA1c reduction in patients with type 2 diabetes mellitus (T2DM).Methods: Patients initiated on canagliflozin 300 mg or dapagliflozin 10 mg were identified from de-identified claims data in the Optum Clinformatics database (1 January 2014-30 September 2016). Propensity score matching was used to create balanced cohorts. The primary outcome was the proportion of patients with HbA1c <8.0% (HEDIS target); secondary outcomes included the proportion of patients with HbA1c <7.0% (ADA target) and >9.0% (HEDIS poor control), absolute change in HbA1c, and treatment patterns.Results: At 6 months post-index (intent-to-treat population), a significantly higher proportion of patients in the canagliflozin 300 mg versus dapagliflozin 10 mg cohort achieved HbA1c <8.0% (70.8% vs. 59.1%; OR [95% CI]: 1.60 [1.26, 2.04]; p = .0001) and HbA1c <7.0% (36.7% vs. 25.1%; OR [95% CI]: 1.75 [1.34, 2.27]; p < .0001). A similar proportion of patients had HbA1c >9.0%. Mean HbA1c reduction was -1.17% with canagliflozin 300 mg and -0.91% with dapagliflozin 10 mg (difference of -0.26%; p = .0049). HbA1c results from a sensitivity analysis in the on-treatment population were consistent with the primary analysis. Patients in the canagliflozin 300 mg versus dapagliflozin 10 mg cohort were less likely to discontinue treatment (OR [95% CI]: 0.75 [0.57, 0.99]; p = .0400) or switch medication (OR [95% CI]: 0.72 [0.54, 0.96]; p = .0229).Conclusions: In this real-world study, patients with T2DM initiated on canagliflozin 300 mg had better HbA1c goal attainment and larger HbA1c reduction than patients initiated on dapagliflozin 10 mg. [ABSTRACT FROM AUTHOR]

Objective: To quantify clinical and cost long-term outcomes in cardiovascular stable post-myocardial-infarction patients.Research Design and Methods: Subjects with a history of myocardial infarction (MI) who were 50-64 years old and MI- and stroke-free for ≥12 months (index date) were identified in a large US claims database. Individuals were followed for up to 5 years (mean: 2.0 years) after their index date.Main Outcome Measures: Rates of MI, stroke, all-cause death, and a composite of these were analyzed via Cox regression models, adjusted for covariates. Results are reported for the overall population and the subgroups of those with type 2 diabetes, additional prior MI, and non-end-stage renal disease. As a secondary endpoint healthcare costs were evaluated at baseline and during each year of follow-up. Results Over the follow-up period, which averaged 2 years, 7.6% of all 13,492 subjects (10.5% vs. 5.4% with and without the selected risk factors, respectively) experienced at least one of the outcome events. The cumulative incidence rates over the entire follow-up period for the primary composite outcome were 20.8% and 12.2% for those with and without the selected atherothrombotic risk factors, respectively. The cardiovascular-related per-person-per-year healthcare costs during follow-up were higher in those with ≥1 additional risk factor compared to those without: $15,247 versus $7521. Costs were elevated over baseline costs throughout follow-up.Limitations: Administrative claims data lack clinical detail. Generalizability of results is limited to the US commercially insured population of a similar age to that included in this study.Conclusions: High risk MI survivors who have been event free for ≥1 year remained at substantial risk of CV events and had increased healthcare costs for up to 5 years post-MI. These long-term risks have not been previously demonstrated in a working-age US population and suggest an unmet need for continuing secondary prevention long-term post-MI. [ABSTRACT FROM AUTHOR]

Background: Treatment for non-valvular atrial fibrillation (NVAF) is complicated among morbidly obese (MO) patients. Current ISTH guidelines do not recommend direct oral anticoagulant use (such as rivaroxaban) in MO patients (BMI >40 kg/m2 or weight of >120 kg) due to limited clinical data available. Objective: To compare the risk of ischemic stroke (IS), major bleeding (MB), healthcare resource utilization (HCRU), and costs between MO NVAF patients initiating rivaroxaban and warfarin treatment. Methods: This retrospective cohort study used combined Truven Health MarketScan Commercial Claims and Encounters and Medicare Supplemental database (12/1/2010 - 12/31/2016) to identify NVAF patients newly initiating rivaroxaban or warfarin treatment. ICD-9/ICD-10 codes were used to identify MO during a minimum continuous enrollment period of 12 months before or 3 months after treatment initiation. Rivaroxaban and warfarin patients were 1:1 propensity score matched. Conditional logistic regression was used to compare IS and MB risk. Generalized linear models were used to compare HCRU and costs. Results: We identified 3,563 matched pairs of patients with NVAF and MO treated with either rivaroxaban or warfarin, mean age was 63 (± 11) years and 46% were female. Mean follow-up time was 10.3 months and 10.6 months for rivaroxaban and warfarin, respectively. Compared with warfarin patients, those treated with rivaroxaban had similar risk of ischemic stroke (1.4% vs. 1.6%, OR: 0.89, 95% CI: 0.61-1.31, p=0.5565) and major bleeding (2.2% vs. 2.7%, OR: 0.80, 95% CI: 0.59-1.08, p=0.1447). However, rivaroxaban patients had an average $3,890 lower total healthcare costs per patient per year (PPPY) than warfarin patients ($48,552 vs. $52,418, p=0.0025), mainly driven by lower hospitalization rate (50.2% vs. 54.1%, p=0.0008), shorter length of stay (7.5 vs. 9.1 days, p=0.0010), and less outpatient service utilization (86 vs. 115 encounters, p<0.0001). Conclusions: In this large study of morbidly obese NVAF patients, those treated with rivaroxaban and warfarin treatment had similar risk of ischemic stroke and major bleeding. Treatment with rivaroxaban was associated with significantly lower PPPY costs and HCRU than treatment with warfarin in this patient population. [ABSTRACT FROM AUTHOR]

Background: Inhaled corticosteroid/long-acting β2-agonist combinations (ICS/LABA) have emerged as first line therapies for chronic obstructive pulmonary disease (COPD) patients with exacerbation history. No randomized clinical trial has compared exacerbation rates among COPD patients receiving budesonide/formoterol combination (BFC) and fluticasone/salmeterol combination (FSC) to date, and only limited comparative data are available. This study compared the real-world effectiveness of approved BFC and FSC treatments among matched cohorts of COPD patients in a large US managed care setting.Methods: COPD patients (≥40 years) naive to ICS/LABA who initiated BFC or FSC treatments between 03/01/2009-03/31/2012 were identified in a geographically diverse US managed care database and followed for 12 months; index date was defined as first prescription fill date. Patients with a cancer diagnosis or chronic (≥180 days) oral corticosteroid (OCS) use within 12 months prior to index were excluded. Patients were matched 1-to-1 on demographic and pre-initiation clinical characteristics using propensity scores from a random forest model. The primary efficacy outcome was COPD exacerbation rate, and secondary efficacy outcomes included exacerbation rates by event type and healthcare resource utilization. Pneumonia objectives included rates of any diagnosis of pneumonia and pneumonia-related healthcare resource utilization.Results: Matching of the identified 3,788 BFC and 6,439 FSC patients resulted in 3,697 patients in each group. Matched patients were well balanced on age (mean=64 years), gender (BFC: 52% female; FSC: 54%), prior COPD-related medication use, healthcare utilization, and comorbid conditions. During follow-up, no significant difference was seen between BFC and FSC patients for number of COPD-related exacerbations overall (rate ratio [RR]=1.02, 95% CI=[0.96,1.09], p=0.56) or by event type: COPD-related hospitalizations (RR=0.96), COPD-related ED visits (RR=1.11), and COPD-related office/outpatient visits with OCS and/or antibiotic use (RR=1.01). The proportion of patients diagnosed with pneumonia during the post-index period was similar for patients in each group (BFC =17.3%, FSC =19.0%, odds ratio=0.92 [0.81,1.04], p=0.19), and no difference was detected for pneumonia-related healthcare utilization by place of service.Conclusion: This study demonstrated no difference in COPD-related exacerbations or pneumonia events between BFC and FSC treatment groups for patients new to ICS/LABA treatment in a real-world setting.Trial Registration: ClinicalTrials.gov identifier NCT01921127 . [ABSTRACT FROM AUTHOR]