Jeffrey Schein

Otsuka (United States)

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Patrick Lefèbvre

Group for Research in Decision Analysis

Concetta Crivera

Janssen (United States)

François Laliberté

Group for Research in Decision Analysis

Winnie W. Nelson

Helsinn Therapeutics (United States)

Guillaume Germain

Group for Research in Decision Analysis

William H. Olson

Statistical Research (United States)

Brahim Bookhart

Janssen (United States)

Craig I Coleman

University of Connecticut

Mark Kosinski

IQVIA (United States)

Julie Vanderpoel

Janssen Scientific Affairs (United States)

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Ibero American University

107

Janssen (United States)

Janssen Scientific Affairs (United States)

Janssen (Belgium)

Harvard University

Johnson & Johnson (United States)

Analysis Group (United States)

Group for Research in Decision Analysis

University of California, San Francisco

University of Michigan–Ann Arbor

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Abstract 15386: Hospitalizations and Other Healthcare Resource Utilization Among Patients With Deep Vein Thrombosis Treated With Rivaroxaban versus Low-Molecular-Weight Heparin and Warfarin in the Outpatient Setting

Circulation (2015)

Steven Deitelzweig François Laliberté Monika Raut Guillaume Germain Brahim Bookhart

Introduction: Compared with low-molecular-weight heparin (LMWH) and warfarin, the oral anticoagulant rivaroxaban has advantages such as simplified care that may lead to less healthcare resource utilization (HRU). Objective: To compare HRU (hospitalization, emergency room [ER], and outpatient [OP] visit) among deep vein thrombosis (DVT) patients who received rivaroxaban or LMWH/warfarin in the outpatient setting. Methods: A retrospective matched-cohort analysis was conducted using the Truven Health Analytic MarketScan Claims database from 1/2011-12/2013. Adult patients with a primary diagnosis of DVT during an OP/ER visit after November 02, 2012, and who initiated treatment on the same day with rivaroxaban or LMWH/warfarin were identified. Patients were observed within 1, 2, 3, and 4 weeks after their DVT diagnosis. Mean number of all-cause and VTE (DVT or PE)-related hospitalizations and other HRU were evaluated using Lin’s method. Results: All of the 512 rivaroxaban patients were well-matched with LMWH/warfarin patients. Mean all-cause number of hospitalizations was significantly lower for rivaroxaban compared to LMWH/warfarin users within 1 week (0.012 vs 0.032; P=0.044) and 2 weeks (0.022 vs 0.048; P=0.040), and numerically lower within 3 weeks (0.038 vs 0.061; P=0.112) and 4 weeks (0.045 vs 0.078; P=0.058). Corresponding mean number of VTE-related hospitalizations was significantly lower for rivaroxaban within 1 week (0.008 vs 0.028; P=0.020) and 2 weeks (0.016 vs 0.042; P=0.020), numerically lower within 3 weeks (0.030 vs 0.052; P=0.074), and significantly lower within 4 weeks (0.034 vs 0.068; P=0.036). Corresponding all-cause OP visits were significantly lower for rivaroxaban users, while ER visits were similar between cohorts (Table 1). Conclusion: DVT patients treated with rivaroxaban following an OP/ER visits had significantly fewer hospitalizations and outpatient visits during the first weeks compared to matched LMWH/warfarin users.

Outpatient clinic

10.1161/circ.132.suppl_3.15386

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EE138 Healthcare Resource Utilization and Costs Associated with Psychiatric Comorbidities in Adult Patients with Attention-Deficit/Hyperactivity Disorder

Value in Health (2023)

Jeffrey Schein Martin Cloutier M. Gauthier-Loiselle R. Bungay K. Chen

Depression

Resource use

10.1016/j.jval.2023.03.441

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Adherence to Rivaroxaban Compared with Other Oral Anticoagulant Agents Among Patients with Nonvalvular Atrial Fibrillation

Journal of Managed Care & Specialty Pharmacy (2017)

Colleen A. McHorney Veronica Ashton François Laliberté Guillaume Germain Willy Wynant

Adherence to oral anticoagulant (OAC) agents is important for patients with nonvalvular atrial fibrillation (NVAF) to prevent potentially severe adverse events.To compare real-world adherence rates and time to discontinuation for rivaroxaban versus other OACs (apixaban, dabigatran, and warfarin) among patients with NVAF using claims-based data.Health care claims from the IMS Health Real-World Data Adjudicated Claims database (July 2012-June 2015) were analyzed. Adherence rate was defined as the percentage of patients with proportion of days covered (PDC) ≥ 0.80 and ≥ 0.90. Discontinuation was defined as a gap of more than 30 days between the end of a dispensing days of supply and the start date of the next fill, if any. Patients were included if they had ≥ 2 dispensings of rivaroxaban, apixaban, dabigatran, or warfarin at least 180 days apart (the first was considered the index date), had > 60 days of supply, had ≥ 6 months of pre-index eligibility, had ≥ 1 atrial fibrillation (AF) diagnosis pre-index or at index date, and had no valvular involvement. A logistic regression model was used to evaluate adherence to OAC therapy, while a Cox model was used to compare time to discontinuation; both models adjusted for baseline confounders.A total of 13,645 rivaroxaban, 6,304 apixaban, 3,360 dabigatran, and 13,366 warfarin patients were identified. A significantly higher proportion of rivaroxaban users (80.1%) was adherent to therapy (PDC ≥ 0.80 at 6 months) versus apixaban (75.8%), dabigatran (69.2%), and warfarin users (64.5%). After adjustment, the proportion of patients adherent to therapy remained significantly higher for rivaroxaban users versus apixaban (absolute difference [AD] = 5.8%), dabigatran (AD = 9.5%), and warfarin users (AD = 13.6%; all P < 0.001). More pronounced differences were found with a PDC ≥0.90. In addition, rivaroxaban users were significantly less likely to discontinue therapy compared with other OACs after adjustments (all P < 0.05).Among NVAF patients, rivaroxaban was associated with significantly higher adherence rates relative to other OACs whether using either a PDC of > 0.80 or > 0.90. Such differences in adherence could translate into improved patient outcomes and lower health care costs.This research was funded by Janssen Scientific Affairs. Ashton, Crivera, and Schein are employees and stockholders of Janssen Scientific Affairs. Laliberté, Germain, Wynant, and Lefebvre are employees of Analysis Group, a consulting company that received research grants from Janssen Scientific Affairs in connection with this study. McHorney is an employee of Evidera, a consulting company that received research grants from Janssen Scientific Affairs in connection with this study. Peterson received research grants from Janssen Scientific Affairs in connection with this study. All authors contributed to concept and design. The data were collected by Germain, Wynant, Laliberté, and Lefebvre and interpreted primarily by McHorney and Peterson, with the assistance of Lefebvre, Laliberté, Ashton, Crivera, and Schein. The manuscript was written primarily by Laliberté, Germain, and Lefebvre, with the assistance of Wynant. Revisions were made primarily by Ashton, Crivera, McHorney, Schein, and Peterson.

Apixaban

Discontinuation

10.18553/jmcp.2017.23.9.980

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Citations (42)

Out-of-range international normalized ratio values and healthcare cost among new warfarin patients with non-valvular atrial fibrillation

Journal of Medical Economics (2014)

Winnie W. Nelson Li Wang Onur Başer C.V. Damaraju Jeffrey Schein

Background:Patients with out-of-range international normalized ratio (INR) values <2.0 and >3.0 have been associated with increased risk of thromboembolic and bleeding events. INR monitoring is costly, because of associated physician and nurse time, laboratory resource use, and dose adjustments.Objectives:This study assessed the healthcare cost burden associated with out-of-range INR among warfarin initiator patients diagnosed with non-valvular atrial fibrillation (NVAF) in the US Veterans Health Administration (VHA) population.Methods:Adult NVAF patients (≥18 years) initiating warfarin were selected from the VHA dataset for the study period October 1, 2007–September 30, 2012. Only valid INR measurements (0.5 ≤ INR ≤ 20) were examined for the follow-up period, from the index date (warfarin initiation date) until the end of warfarin exposure or death. All-cause healthcare costs within 30 days were measured starting from the second month (31 days post-index date) to the end of the study period. Costs for inpatient stays, emergency room, outpatient facility, physician office visits, and other services were computed separately. Multiple regression was performed using the generalized linear model for overall cost analysis.Results:In total, 29,463 patients were included in the study sample. Mean costs for out-of-range INR ranged from $3419 to $5126. Inpatient, outpatient, outpatient pharmacy, and total costs were significantly higher after patients experienced out-of-range results (INR < 2, INR > 3), compared with in-range INR (2 ≤ INR ≤ 3). When exposed to out-of-range INR, patients also incurred higher mean total costs within 2–6 months ($3840–$5820) than after the first 6 months ($2789–$3503) of warfarin therapy.Conclusion:In the VHA population, INR measures outside of the 2–3 range were associated with significantly higher healthcare costs. Increased costs were especially apparent when INR values were below 2, although INR measures above 3 were also associated with higher costs relative to in-range values.

valvular heart disease

10.3111/13696998.2014.1001851

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Abstract 159: Evaluation of Clinical Outcomes among Nonvalvular Atrial Fibrillation Patients Treated With Warfarin or Rivaroxaban Stratified by Presence or Absence of CKD in a Claims Database

Circulation Cardiovascular Quality and Outcomes (2017)

Jiang He Lloyd Haskell Jeffrey S. Berger Veronica Ashton François Laliberté

Introduction: Renal functional impairment is linked to an increased risk of thromboembolic and bleeding events in patients with nonvalvular atrial fibrillation (NVAF) treated with warfarin and rivaroxaban. Anticoagulants such as warfarin and rivaroxaban are often recommended to reduce the risk of stroke in NVAF patients. The purpose of this study was to evaluate and compare thromboembolic and bleeding event rates for warfarin and rivaroxaban patients stratified by presence of chronic kidney disease (CKD). Methods: Claims from the IMS Health Real-World Data Adjudicated Claims database from 05/2011-6/2015 were analyzed. Adult patients with NVAF who had ≥6 months of baseline data prior to the first dispensing of warfarin or rivaroxaban after 11/2011 were included. Patients were followed until the end of index therapy or end of data availability/insurance coverage. Outcomes were stratified by presence of CKD for ischemic stroke, major bleeding, and a composite measure of thromboembolic events (ischemic stroke, myocardial infarction (MI) or venous thromboembolism (VTE)) and analyzed using hazard ratios (HRs). Adjustments for confounding were made with inverse probability of treatment weights (IPTW). Results: The analysis included 39,872 rivaroxaban (9.0% [3,572 of 39,872] with CKD) and 48,637 warfarin patients (16.9% [8,230 of 48,637] with CKD). As expected, thromboembolic and bleeding events were more common in patients with CKD than those without CKD. Rivaroxaban patients had significantly lower risk of ischemic stroke, both in the overall population (HR = 0.79 [0.68-0.90], p=0.0008) and for those with CKD (HR = 0.55 [0.40-0.77], p=0.0004). A composite of thromboembolic events were lower with rivaroxaban irrespective of CKD. Major bleeding rates were comparable across all groups. Table 1 reports incidence rates and HRs stratified by presence of CKD. Conclusions: This study suggests that, in an adult population with NVAF, rivaroxaban-treated patients had fewer ischemic strokes across all patients, including patients with renal impairment. Rivaroxaban-treated patients also had significantly better outcomes for the composite (VTE, MI, or stroke) measure across all groups. Bleeding rates were comparable across all groups.

Stroke

Thromboembolic stroke

10.1161/circoutcomes.10.suppl_3.159

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Patterns of international normalized ratio values among new warfarin patients with nonvalvular atrial fibrillation

Blood Coagulation & Fibrinolysis (2016)

Winnie W. Nelson Dejan Milentijevic Li Wang Onur Başer C. V. Damaraju

Limited information exists regarding the relationship between international normalized ratio (INR) control/stability and the discontinuation of warfarin therapy among patients with nonvalvular atrial fibrillation (NVAF). This study evaluated the association between INR stabilization and warfarin discontinuation and assessed INR patterns before and after INR stabilization among patients (≥18 years) with NVAF who newly initiated warfarin (Veterans Health Administration datasets; October 1, 2007 through September 30, 2012). Achievement of INR stabilization (≥3 consecutive in-range therapeutic INR measurements ≥7 days apart) was examined from warfarin initiation through the end of warfarin exposure. Proportion of time in therapeutic range during warfarin exposure was calculated (Rosendaal method) and categorized as at least 60% or less than 60%. Among 34 346 patients, 49.4% achieved INR stabilization (mean time to stabilization, 98 days). Approximately 40% of INR values were out-of-range, even after achieving stabilization. During 30 days following an INR 4.0 or higher, patients had more INR testing than the overall mean (2.51 vs. 1.67 tests). Warfarin discontinuation was 4.2 times more likely among patients without INR stabilization versus those with INR stabilization (P < 0.00001). Patients with poor INR control (time in therapeutic range <60%) were 1.76 times more likely to discontinue warfarin within 1 year (P < 0.0001). INR stabilization is a better predictor of warfarin discontinuation than poor INR control. Improved approaches are necessary to maintain appropriate anticoagulation levels among patients with NVAF.

Discontinuation

Therapeutic index

10.1097/mbc.0000000000000515

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Citations (2)

Influence of Low HDL on Progression of Coronary Artery Disease and Response to Fluvastatin Therapy

Circulation (1999)

Christie M. Ballantyne J. Alan Herd Laura Ferlic J. Kay Dunn John A. Farmer

Background —Patients with coronary artery disease (CAD) commonly have low HDL cholesterol (HDL-C) and mildly elevated LDL cholesterol (LDL-C), leading to uncertainty as to whether the appropriate goal of therapy should be lowering LDL-C or raising HDL-C. Methods and Results —Patients in the Lipoprotein and Coronary Atherosclerosis Study (LCAS) had mildly to moderately elevated LDL-C; many also had low HDL-C, providing an opportunity to compare angiographic progression and the benefits of the HMG-CoA reductase inhibitor fluvastatin in patients with low versus patients with higher HDL-C. Of the 339 patients with biochemical and angiographic data, 68 had baseline HDL-C <0.91 mmol/L (35 mg/dL), mean 0.82±0.06 mmol/L (31.7±2.2 mg/dL), versus 1.23±0.29 mmol/L (47.4±11.2 mg/dL) in patients with baseline HDL-C ≥0.91 mmol/L. Among patients on placebo, those with low HDL-C had significantly more angiographic progression than those with higher HDL-C. Fluvastatin significantly reduced progression among low–HDL-C patients: 0.065±0.036 mm versus 0.274±0.045 mm in placebo patients ( P =0.0004); respective minimum lumen diameter decreases among higher–HDL-C patients were 0.036±0.021 mm and 0.083±0.019 mm ( P =0.09). The treatment effect of fluvastatin on minimum lumen diameter change was significantly greater among low–HDL-C patients than among higher–HDL-C patients ( P =0.01); among low–HDL-C patients, fluvastatin patients had improved event-free survival compared with placebo patients. Conclusions —Although the predominant lipid-modifying effect of fluvastatin is to decrease LDL-C, patients with low HDL-C received the greatest angiographic and clinical benefit.

Fluvastatin

10.1161/01.cir.99.6.736

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(822)

Journal of Pain (2006)

Jeffrey Schein Mark Kosinski Sherif Sultan

Repeated measures design

Vitality

SF-36

10.1016/j.jpain.2006.01.224

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Citations (1)

Medication persistence and discontinuation of rivaroxaban versus warfarin among patients with non-valvular atrial fibrillation

Current Medical Research and Opinion (2014)

Winnie W. Nelson Xue Song Craig I Coleman Erin Thomson David M. Smith

AbstractObjectives:To compare real-world persistence and discontinuation among non-valvular atrial fibrillation (NVAF) patients on rivaroxaban and warfarin in the US.Research design and methods:A large nationally representative US claims database was used to conduct a retrospective cohort analysis of patients with NVAF treated with rivaroxaban or warfarin from 1 July 2010 through 31 March 2013. Index date was the date of the first prescription of rivaroxaban or warfarin. All patients were followed until the earliest of inpatient death, end of continuous enrollment, or end of study period. Rivaroxaban patients were matched 1:1 by propensity scores. Medication persistence was defined as absence of refill gap of ≥60 days. Discontinuation was defined as no additional refill for at least 90 days and until the end of follow-up. Cox proportional hazards models were estimated to examine the adjusted hazard ratios (aHRs) of rivaroxaban vs. warfarin on non-persistence and discontinuation.Results:A total of 32,886 NVAF patients on rivaroxaban or warfarin met the study inclusion criteria. Each of the 7259 rivaroxaban patients identified were matched 1:1 to warfarin patients. Patients on rivaroxaban had a significantly better rate of persistence (aHR: 0.63, 95% CI 0.59–0.68) and lower rate of discontinuation (aHR: 0.54, 95% CI 0.49–0.58) compared to warfarin recipients.Limitations:Claims data may have contained inaccuracies and miscoding. Confounding may remain even after propensity score matching and additional adjustments in model. Refill data may not fully reflect actual medication use. Longer follow-up may produce more precise estimates of persistence and discontinuation.Conclusion:This matched cohort analysis indicated that rivaroxaban was associated with significantly higher medication persistence and lower discontinuation rates compared to warfarin.Keywords:: Non-valvular atrial fibrillationPersistenceRivaroxabanWarfarin TransparencyDeclaration of fundingThe current study was sponsored by Janssen Scientific Affairs LLC.Declaration of financial/other relationshipsW.W.N., C.V.D., and J.R.S. have disclosed that they are employees of Janssen Scientific Affairs LLC. C.I.C. has disclosed that he has received research funding from Janssen Scientific Affairs LLC and serves on their speaker's bureau for Xarelto. X.S., E.T., and D.M.S. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no relevant financial or other relationships to disclose.AcknowledgmentsThe authors express gratitude to Monika Raut of Janssen Scientific Affairs LLC for editorial review of the author-prepared manuscript.

Discontinuation

10.1185/03007995.2014.933577

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Citations (83)

Effect of Rivaroxaban Versus Warfarin on Health Care Costs Among Nonvalvular Atrial Fibrillation Patients: Observations from Rivaroxaban Users and Matched Warfarin Users

Advances in Therapy (2015)

François Laliberté Michel Cloutier Concetta Crivera Winnie W. Nelson William H. Olson

New target-specific oral anticoagulants may have benefits, such as shorter hospital length of stay, compared to warfarin in patients with nonvalvular atrial fibrillation (NVAF). This study aimed to assess, among patients with NVAF, the effect of rivaroxaban versus warfarin on health care costs in a cohort of rivaroxaban users and matched warfarin users. Health care claims from the Humana database from 5/2011 to 12/2012 were analyzed. Adult patients newly initiated on rivaroxaban or warfarin with ≥2 atrial fibrillation (AF) diagnoses (The International Classification of Diseases, Ninth Revision, Clinical Modification: 427.31) and without valvular AF were identified. Based on propensity score methods, warfarin patients were matched 1:1 to rivaroxaban patients. Patients were observed up to end of data, end of insurance coverage, death, a switch to another anticoagulant, or treatment nonpersistence. Health care costs [hospitalization, emergency room (ER), outpatient, and pharmacy costs] were evaluated using Lin's method. Matches were found for all rivaroxaban patients, and characteristics of the matched groups (n = 2253 per group) were well balanced. Estimated mean all-cause and AF-related hospitalization costs were significantly lower for rivaroxaban versus warfarin patients (all-cause: $5411 vs. $7427, P = 0.047; AF-related: $2872 vs. $4147, P = 0.020). Corresponding estimated mean all-cause outpatient visit costs were also significantly lower, but estimated mean pharmacy costs were significantly higher for rivaroxaban patients ($5316 vs. $2620, P < 0.001). Although estimated mean costs of ER visits were higher for rivaroxaban users compared to those of warfarin users, differences were not statistically significant. Including anticoagulant costs, mean overall total all-cause costs were comparable for rivaroxaban versus warfarin users due to cost offset from a reduction in the number and length of hospitalizations and number of outpatient visits ($17,590 vs. $18,676, P = 0.542). Despite higher anticoagulant cost, mean overall total all-cause and AF-related cost remains comparable for patients with NVAF treated with rivaroxaban versus warfarin due to the cost offset from reduced health care resource utilization.

10.1007/s12325-015-0189-1

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Citations (27)