Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism in patients aged over 75 years or with moderate renal impairment undergoing total knee or hip replacement

2010 ◽  
Vol 103 (02) ◽  
pp. 360-371 ◽  
Author(s):  
Neil Roskell ◽  
Jonathan Plumb ◽  
Andreas Clemens ◽  
Herbert Noack ◽  
Paul Robinson ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Renal Impairment ◽  
Hip Replacement ◽  
Dabigatran Etexilate ◽  
Phase Iii ◽  
Moderate Renal Impairment ◽  
Sensitivity Analyses ◽  
Comparable Efficacy ◽  
Base Case ◽  
Total Knee

SummaryOral dabigatran etexilate is indicated for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement or total hip replacement. We investigated the cost-effectiveness of the 150 mg once daily (od) dose recommended for patients aged over 75 or with moderate renal impairment, from a United Kingdom National Health Service perspective. Dabigatran etexilate was compared with subcutaneous enoxaparin 40 mg od, using a decision model. Risks for VTE and bleeding were derived from subgroup analyses of the phase III trials. Dabigatran etexilate was less costly than enoxaparin; cost savings varied from £62 to £274 (base-case analyses) and were primarily due to differences in administration costs. Results were robust across a range of sensitivity analyses. Dabigatran etexilate 150 mg od is cost saving compared with enoxaparin 40 mg od in patients aged over 75 years and in patients with moderate renal impairment, with comparable efficacy and safety.

Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism after total knee and hip replacement surgery

2009 ◽  
Vol 31 (1) ◽  
pp. 194-212 ◽  
Author(s):  
Sorrel E. Wolowacz ◽  
Neil S. Roskell ◽  
Fiona Maciver ◽  
Stephen M. Beard ◽  
Paul A. Robinson ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Venous Thromboembolism ◽  
Hip Replacement ◽  
Dabigatran Etexilate ◽  
Replacement Surgery ◽  
Hip Replacement Surgery ◽  
Total Knee

Anticoagulant dosing in renal impairment

Phlebologie ◽  
2015 ◽  
Vol 44 (06) ◽  
pp. 316-319 ◽  
Author(s):  
S. Harder
Keyword(s):  
Risk Factor ◽  
Venous Thromboembolism ◽  
Renal Impairment ◽  
Anticoagulant Therapy ◽  
Severe Renal Impairment ◽  
Dabigatran Etexilate ◽  
The Elderly ◽  
Thrombin Inhibitor ◽  
Safety And Efficacy ◽  
Direct Acting

SummaryAnticoagulants are widely used for prophylaxis and treatment of venous thromboembolism in the elderly, who commonly have renal impairment and other comorbidities. Renal impairment is a risk factor for bleeding and thrombosis during anticoagulant therapy and can influence the balance between the safety and efficacy of such agents. Some anticoagulants, such as fondaparinux and the direct acting oral thrombin inhibitor dabigatran etexilate are contraindicated for use in patients with severe renal impairment (eGFR <30 ml/min). However, also the direct acting oral FXa-inhibitors rivaroxaban, edoxaban and apixaban need caution regarding dosing advice or contraindications when used in patients with renal impairment.

RE-COVERY DVT/PE: Rationale and design of a prospective observational study of acute venous thromboembolism with a focus on dabigatran etexilate

2017 ◽  
Vol 117 (02) ◽  
pp. 415-421 ◽  
Author(s):  
Walter Ageno ◽  
Ivan B. Casella ◽  
Chee Kok Han ◽  
Gary E. Raskob ◽  
Sebastian Schellong ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Vitamin K ◽  
Large Scale ◽  
Vitamin K Antagonists ◽  
Phase 1 ◽  
Dabigatran Etexilate ◽  
Oral Anticoagulants ◽  
Phase Iii ◽  
Real World Data ◽  
Phase Iii Studies

SummaryThe therapeutic management of venous thromboembolism (VTE) is rapidly evolving. Following the positive results of pivotal large-scale randomised trials, the non-vitamin K antagonist oral anticoagulants (NOACs) represent an important alternative to standard anticoagulation. In phase III studies, dabigatran was as effective as, and significantly safer than warfarin. Additional information on real-world data of dabigatran is now warranted. RE-COVERY DVT/PE is a multi-centre, international, observational (i. e. non-interventional) study enrolling patients with acute DVT and/or PE within 30 days after objective diagnosis. The study is designed with two phases. Phase 1 has a cross-sectional design, enrolling approximately 6000 patients independently of treatment choice, with the aim of providing a contemporary picture of the management of VTE worldwide. Phase 2 has a prospective cohort design, with follow-up of one year, enrolling 8000 patients treated with dabigatran or vitamin K antagonists (VKAs) with the aim of comparing their safety, defined by the occurrence of major bleeding, and effectiveness, defined by the occurrence of symptomatic recurrent VTE. RE-COVERY DVT/PE will complement both the results of other observational studies in this field and the results of phase III studies with dabigatran, in particular by assessing its clinical benefit in various patient subgroups treated in routine clinical practice.

Post Hoc Economic Analysis of Temozolomide Versus Dacarbazine in the Treatment of Advanced Metastatic Melanoma

2000 ◽  
Vol 18 (7) ◽  
pp. 1474-1480 ◽  
Author(s):  
Bruce E. Hillner ◽  
Sanjiv Agarwala ◽  
Mark R. Middleton
Keyword(s):  
Metastatic Melanoma ◽  
Phase Iii ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Survival Times ◽  
Economic Implications ◽  
Intention To Treat ◽  
Hazard Ratios ◽  
The Mean ◽  
Post Hoc

PURPOSE: To determine the potential economic implications resulting from oral temozolomide (TEM) compared with intravenous (IV) dacarbazine (DTIC) for metastatic melanoma. PATIENTS AND METHODS: We performed a cost-effectiveness (CE) analysis using hazard ratios (HRs) from the phase III (Schering I95–018) trial comparing TEM 200 mg/m2/d orally for 5 days every 28 days with DTIC 250 mg/m2/d IV for 5 days every 21 days. Sensitivity analyses assessed a range of TEM’s efficacy and costs, direct nonmedical costs, and the DTIC schedule. RESULTS: The trial found an overall survival trend favoring TEM; median survival times of patients treated with DTIC and TEM were 6.4 and 7.7 months, respectively (HR = 1.18; 95% confidence interval [CI], 0.92 to 1.52; intention to treat, P = .20). The mean increase in survival of TEM over DTIC was 1.1 months. The projected average costs per patient were greater with TEM than DTIC ($6,902 v $3,697, respectively). The incremental CE ratio using TEM was $36,990 per life-year or $101 per day of life gained. The CE ratio’s 95% CI ranged from −$65,180 (DTIC is more effective) to $18,670 per year of life gained. The CE ratios decreased 50% if direct nonmedical costs were included and increased 50% if DTIC’s efficacy was unchanged if given as a single daily dosage. Sixty percent of simulations found TEM with a CE threshold of less than $50,000 per life-year gained. CONCLUSION: Although the base-case efficacy of TEM compared with DTIC was not statistically significant, its associated incremental CE would be comparable with many interventions. TEM for metastatic melanoma illustrates the tension confronting providers choosing between similar agents that markedly differ in convenience and costs.

Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial

The Lancet ◽  
2007 ◽  
Vol 370 (9591) ◽  
pp. 949-956 ◽  
Author(s):  
Bengt I Eriksson ◽  
Ola E Dahl ◽  
Nadia Rosencher ◽  
Andreas A Kurth ◽  
C Niek van Dijk ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Total Hip Replacement ◽  
Hip Replacement ◽  
Dabigatran Etexilate ◽  
Double Blind ◽  
Total Hip

P3849Baseline profile of patients treated for acute venous thromboembolism in routine clinical practice according to age and renal function in the RE-COVERY DVT/PE global cohort study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
W Ageno ◽  
I B Casella ◽  
C K Han ◽  
S Schellong ◽  
S Schulman ◽  
...  
Keyword(s):  
Renal Function ◽  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Renal Impairment ◽  
Observational Study ◽  
Anticoagulant Therapy ◽  
Patient Characteristics ◽  
Routine Clinical Practice ◽  
Moderate Renal Impairment ◽  
Acute Venous Thromboembolism

Abstract Background Observational studies provide the opportunity to evaluate routine practice without the selection and treatment criteria imposed in randomized clinical trials (RCTs). Purpose Using data from the RE-COVERY DVT/PE global observational study (enrolment January 2016 to May 2017), we describe the baseline profile of patients treated for acute venous thromboembolism (VTE) in routine clinical practice according to age and renal function. Methods Baseline patient characteristics, clinical features (comorbidities/medical history), and anticoagulant therapy were tabulated descriptively for the subgroups of age (<75, ≥75 years) and creatinine clearance (<30, 30 to <50 [moderate impairment], 50 to <80 [mild impairment], ≥80 mL/min). Anticoagulant therapy at baseline and at hospital discharge or 14 days after diagnosis (whichever was later) was recorded. Results In this observational study of 6122 patients with acute deep vein thrombosis, the proportions of patients at baseline who were ≥75 years of age (25.2%) or who had mild to moderate renal impairment (38.1%) were higher than in RCTs of non-vitamin K antagonist oral anticoagulants (NOACs) for acute VTE treatment (∼12–13% elderly and ∼26–29% with mild or moderate renal impairment) (from analyses of the RE-COVER trials; Hokusai-VTE and AMPLIFY). Older patients and those with renal impairment were more often female and were more likely to have comorbidities than the younger or normal renal function groups (Table). At the time of hospital discharge or 14 days after diagnosis, whichever was later, the majority was treated with NOACs (54%). Vitamin K antagonists were prescribed to approximately 1 in 5 patients. The use of NOACs decreased with worsening renal function, whereas the proportions treated with parenteral anticoagulation alone increased in the moderate renal impairment group compared with patients with normal renal function. Conclusion The population treated for acute VTE in routine clinical practice includes more elderly and renally impaired patients than represented in RCTs. These baseline data provide a snapshot of patient characteristics and patterns of anticoagulant therapy. Acknowledgement/Funding Funded by Boehringer Ingelheim

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