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Introduction: 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. Materials and methods: 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. Results: 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).

Background: Patients with coronary heart disease (CHD) and survivors of acute coronary syndrome (ACS) are at very high risk for adverse cardiovascular events. Lowering low-density lipoprotein cholesterol (LDL-C) can reduce the risk, with effective lipid-lowering therapy (LLT) readily available; however, dyslipidemia remains prevalent throughout Europe. Design: The observational Dyslipidemia International Study II (DYSIS II) aimed to identify unmet treatment needs in adult ACS and CHD patients. Data for the seven participating European countries are presented herein. Methods: The study was carried out from December 2012 to November 2014. Use of LLT and attainment of Europeanguideline-recommended LDL-C targets were assessed. For ACS patients, changes in lipid levels and LLT were evaluated 4 months post-hospitalization. Results: Of the 4344 patients enrolled, 2946 were attending a physician visit for the assessment of stable CHD, while 1398 had been hospitalized for an ACS event. In both patient sets, mean LDL-C levels were high (89.5 and 112.5 mg/dl, respectively) and <70 mg/dl target attainment extremely poor. The mean daily statin dosage (normalized to atorvastatin potency) was 27 AE 20 mg for CHD and 22 AE 17 mg for ACS patients. Treatment was intensified slightly for ACS subjects after hospitalization, with the dosage reaching 35 AE 24 mg/day. LDL-C target attainment was higher by the end of the 4-month follow up (30.9% and 41.5% for patients on LLT and without LLT at baseline, respectively; p < 0.05). Conclusion: Elevated blood cholesterol levels are highly prevalent across Europe, with low numbers of coronary patients reaching their recommended LDL-C target. While use of LLT is widespread, there is significant scope for intensifying treatment.

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.