0000000000482992
AUTHOR
Andreas Clemens
Population-based cohort study of warfarin-treated patients with atrial fibrillation: incidence of cardiovascular and bleeding outcomes
OBJECTIVES: Atrial fibrillation (AF) is the most common cardiac rhythm disorder with a significant health burden. The aim of this study was to characterise patients with recently diagnosed AF and to estimate the rates of comorbidities and outcome events requiring hospitalisation in routine clinical practice. DESIGN: Pharmacoepidemiological cohort study using observational data. METHODS/SETTING: This study included 16 513 patients with a first diagnosis of AF between 1 January 2005 and 28 February 2010 (newly diagnosed patients) using data from the UK Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) and the Office for National Statistics mortality data. …
Efficacy and Cost-Effectiveness of Dabigatran Etexilate Versus Warfarin in Atrial Fibrillation in Different Age Subgroups
This study aims to estimate the cost-effectiveness of dabigatran 150 mg twice daily versus warfarin for stroke and systemic embolism risk reduction in patients with nonvalvular atrial fibrillation initiating treatment before age 75 (<75), at or after age 75 (≥75), and the overall population (All) from a US Medicare payer perspective. Clinical event rates by age cohort with dabigatran or warfarin for safety-on-treatment and intent-to-treat populations were estimated from Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY). An economic model was adapted using these data to evaluate the impact of starting age on clinical and economic outcomes. Costs were obtained from Medicare p…
Prediction of bleeding events in patients with venous thromboembolism on stable anticoagulation treatment.
Attempts at identifying patients with an elevated risk of bleeding while on anticoagulation following acute venous thromboembolism (VTE) have largely been unsuccessful thus far. We sought to develop a clinical prediction score for bleeding during stable anticoagulation treatment after acute VTE.We performed a post hoc analysis of the pooled RE-COVER studies, two double-blind randomised “sister” trials evaluating dabigatran versus standard treatment in 5107 VTE patients.A score was derived from patients randomised to dabigatran using logistic regression analysis covering the complete follow-up period. The final model, named VTE-BLEED, included six variables and yielded a c-statistic of 0.72 …
Efficacy of delayed thromboprophylaxis with dabigatran: Pooled analysis
Abstract Introduction Oral thromboprophylaxis with dabigatran etexilate should be initiated as a half dose 1 to 4 h after major orthopaedic surgery. However, a delay in dosing could occur for clinical or logistical reasons. A post hoc analysis was carried out to determine if patients with delayed dosing received adequate anticoagulation. Patients and methods The RE-MODEL™ and RE-NOVATE® trials compared 220 mg and 150 mg dabigatran etexilate with 40 mg enoxaparin. Pooled data for major venous thromboembolism (VTE) and VTE-related mortality (efficacy outcome) and major bleeding events (MBE), MBE/clinically relevant bleeding events, and all bleeding events (safety outcomes) were analysed. Resu…
Treatment of venous thromboembolism – effects of different therapeutic strategies on bleeding and recurrence rates and considerations for future anticoagulant management
Abstract Effective treatment of venous thromboembolism (VTE) strikes a balance between prevention of recurrence and bleeding complications. The current standard of care is heparin followed by a vitamin K antagonist such as warfarin. However, this option is not without its limitations, as the anticoagulant effect of warfarin is associated with high inter- and intra-patient variability and patients must be regularly monitored to ensure that anticoagulation is within the narrow target therapeutic range. Several novel oral anticoagulant agents are in the advanced stages of development for VTE treatment, some of which are given after an initial period of heparin treatment, in line with current p…
Oral Dabigatran Etexilate Versus Enoxaparin for Prevention of Venous Thromboembolism After Total Hip or Knee Arthroplasty: A Pooled Analysis of Four Randomized Trials
Abstract Abstract 2312 Introduction: Thromboprophylaxis after major orthopaedic surgery reduces the risk of venous thromboembolism (VTE). Four randomized, double-blind, non-inferiority trials compared oral dabigatran etexilate doses of 220 mg or 150 mg once daily (qd) with subcutaneous enoxaparin for the primary prevention of VTE in patients undergoing elective total hip or knee arthroplasty. In the hip arthroplasty trials (RE-NOVATE® and RE-NOVATE® II) the treatment duration was 28–35 days; in the knee arthroplasty trials it was 6–10 days (RE-MODEL™) and 12–15 days (RE-MOBILIZE®). Three of the trials used a comparator enoxaparin regimen of 40 mg qd started the evening before surgery, while…