Abstract 301: Evaluation Of Net Clinical Benefits Of New Oral Anticoagulants Used For Acute Venous Thromboembolism Treatment vs. Standard Therapy

2014 ◽  
Vol 7 (suppl_1) ◽  
Author(s):  
Alpesh Amin ◽  
Yonghua Jing ◽  
Jeffrey Trocio ◽  
Jay Lin ◽  
Melissa Lingohr-Smith ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Standard Therapy ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Primary Efficacy ◽  
Clinical Benefits ◽  
Recurrent Vte ◽  
Event Rates

Background: Venous thromboembolism (VTE) is a significant healthcare burden, but is a preventable and treatable condition. The new oral anticoagulants (NOACs), apixaban, rivaroxaban, dabigatran, and edoxaban have all been shown in phase III trials to be noninferior in efficacy to standard therapies for acute VTE treatment, although there may be some differences in the bleeding rates among the NOACs. This study evaluated the net clinical benefits (NCB) of NOACs vs. standard therapies based on the AMPLIFY, EINSTEIN-Pooled analysis, RECOVER-1, RE-COVER II, and Hokusai-VTE trial results. Methods: Event rates of the primary efficacy and safety outcomes, as defined in each original trial, among VTE patients during trial periods were obtained from the published clinical trial data. Data from RECOVER-I and -II trials were combined to represent the findings for dabigatran since the two trials were of similar design. EINSTEIN-pooled (DVT and PE combined) data were used to represent findings for rivaroxaban. The combinations of rates for the primary efficacy endpoint, representing recurrent VTE or death and major bleedings (MB) were evaluated and defined as the NCB of each NOAC. Additionally, the number of VTE patients needed to treat (NNT) to avoid one event (e.g. VTE or MB) with each NOAC was also determined. Results: For patients treated in the VTE clinical trials, the differences in event rates of recurrent VTE or death for apixaban, rivaroxaban, dabigatran, and edoxaban vs. standard therapy were -0.43%, -0.23%, 0.20%, and -0.34%, respectively. The differences in event rates of MB for apixaban, rivaroxaban, dabigatran, and edoxaban vs. standard therapy were -1.26%, -0.78%, -0.43%, and -0.24%, respectively. The NCB improved for all NOAC treated patients, with those treated with apixaban (-1.69%) vs. standard therapy having the greatest NCB, followed by those treated with rivaroxaban (-1.01%), edoxaban (-0.58%), and dabigatran ( -0.23%) (Table 1). Conclusions: All NOACs were shown to be non-inferior to standard VTE treatments in clinical trials; however, apixaban may provide the optimal NCB with the lowest NNT. How these results translate into real-world outcomes or medical cost reductions will require further evaluation.

Treatment and secondary prevention of venous thromboembolism in cancer patients

2012 ◽  
Vol 03 (03) ◽  
pp. 121-125
Author(s):  
I. Pabinger ◽  
C. Ay
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Patients With Cancer ◽  
Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

scholarly journals Efficacy and safety of new oral anticoagulants in prophylaxis and treatment of venous thromboembolism

2010 ◽  
Vol 1 (1) ◽  
pp. 7
Author(s):  
Luca Masotti
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Oral Anticoagulants ◽  
Clinical Development ◽  
Ease Of Use ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Thrombin Inhibitors ◽  
Phase Iii Clinical Trials ◽  
Phase Iii Trials

One of the main innovation emerged in recent years in the field of venous thromboembolism (VTE) has been represented by the clinical development and marketing of new oral anticoagulant agents used for prophylaxis and acute treatment. These drugs are represented by direct thrombin inhibitors (anti-factor IIa) and the direct inhibitors of activated factor X (anti-Xa). The main achievementof these new agents is represented by their ease of use without laboratory monitoring or dose adjustment. Dabigatran (anti-factor IIa), rivaroxaban, and apixaban (anti-Xa) are in advanced phase of clinical development with concluded phase III trials. Up to now the results of efficacy and safetyof phase III clinical trials are available, while phase IV studies are currently ongoing. Overall, the phase III clinical trials showed the non inferiority of new oral anticoagulants in VTE prophylaxis of patients undergone to major orthopedic surgery, such as hip and knee arthroplasty, compared toconventional prophylaxis represented by subcutaneous low molecular weight heparin with similar safety. Moreover dabigatran has shown to be not inferior when compared to warfarin for the prevention of six months VTE recurrences, with a significative lower incidence of bleedings. Awaitingthe results of many other ongoing phase III trials, since now it is possible to think that, in the next future, new oral anticoagulants will be widely diffused in clinical practice for their ease of use and feasibility. In this review the Authors analyse the available results of phase III clinical trials for dabigatran, rivaroxaban and apixaban, focusing on the antithrombotic endpoints for prevention andtreatment of VTE and the bleeding risk. Moreover synthesis of ongoing trials will be displayed.

scholarly journals Efficacy and safety of new oral anticoagulants in prophylaxis and treatment of venous thromboembolism

2010 ◽  
Vol 1 (1) ◽  
pp. 7-26 ◽  
Author(s):  
Luca Masotti ◽  
Cecilia Becattini ◽  
Roberto Cappelli ◽  
Giancarlo Landini ◽  
Alessandro Pampana ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Oral Anticoagulants ◽  
Clinical Development ◽  
Ease Of Use ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Iii Clinical Trials ◽  
Phase Iii Trials

One of the main innovation emerged in recent years in the field of venous thromboembolism (VTE) has been represented by the clinical development and marketing of new oral anticoagulant agents used for prophylaxis and acute treatment. These drugs are represented by direct thrombin inhibitors (anti-factor IIa) and the direct inhibitors of activated factor X (anti-Xa). The main achievement of these new agents is represented by their ease of use without laboratory monitoring or dose adjustment. Dabigatran (anti-factor IIa), rivaroxaban, and apixaban (anti-Xa) are in advanced phase of clinical development with concluded phase III trials. Up to now the results of efficacy and safety of phase III clinical trials are available, while phase IV studies are currently ongoing. Overall, the phase III clinical trials showed the non inferiority of new oral anticoagulants in VTE prophylaxis of patients undergone to major orthopedic surgery, such as hip and knee arthroplasty, compared to conventional prophylaxis represented by subcutaneous low molecular weight heparin with similar safety. Moreover dabigatran has shown to be not inferior when compared to warfarin for the prevention of six months VTE recurrences, with a significative lower incidence of bleedings. Awaiting the results of many other ongoing phase III trials, since now it is possible to think that, in the next future, new oral anticoagulants will be widely diffused in clinical practice for their ease of use and feasibility. In this review the Authors analyse the available results of phase III clinical trials for dabigatran, rivaroxaban and apixaban, focusing on the antithrombotic endpoints for prevention and treatment of VTE and the bleeding risk. Moreover synthesis of ongoing trials will be displayed.

Comparison of Medical Costs Avoided When New Oral Anticoagulants Are Used for the Treatment of Patients with Atrial Fibrillation and Venous Thromboembolism in the U.S

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2181-2181
Author(s):  
Alpesh N Amin ◽  
Amanda Bruno ◽  
Jeffrey Trocio ◽  
Jay Lin ◽  
Melissa Lingohr-Smith
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Medical Cost ◽  
Oral Anticoagulants ◽  
Medical Costs ◽  
Nonvalvular Atrial Fibrillation ◽  
Equity Ownership ◽  
Acute Venous Thromboembolism ◽  
Event Rates

Abstract Introduction: Clinical trials have demonstrated that the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, and apixaban are either superior or non-inferior to standard therapies/placebo for the treatment of nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). This study estimated and compared the medical costs from a U.S. payer perspective that may be potentially avoided when NOACs are used instead of standard therapies/placebo for the treatment of patients with NVAF or VTE. Methods: Event rates of efficacy and safety clinical endpoints as defined in clinical trials (Table), were obtained from published trial data. Medical cost avoidances associated with NOAC usage vs. standard therapies/placebo for NVAF patients, acute VTE treatment patients, and extended VTE treatment patients were derived from previous publications. All costs were inflation adjusted to 2013 cost level. A hypothetical health plan population with 1 million members in 2014 was used to estimate and compare the NVAF and VTE combined medical cost avoidances for patients treated with NOACs vs. standard therapies/placebo. Prevalence rates of NVAF and VTE were derived from published literature. The same usage rate for each NOAC was assumed for comparison purpose. The medical cost avoidances are also projected in the years 2015-2018 and compared among the NOACs. Results: In 2014, in the hypothetical population of one million insured lives, the medical costs were projected to be reduced by -$3.0, -$2.1, and -$7.3 million for NVAF patients treated with dabigatran, rivaroxaban, and apixaban, respectively; by -$0.7, -$2.2, and -$4.1 million for patients treated for acute VTE with dabigatran, rivaroxaban, and apixaban, respectively; and by -$6.3, -$6.6, -$9.6, and -$9.5 million for VTE patients treated for extended periods with dabigatran, rivaroxaban, 2.5 mg apixaban, and 5.0 mg apixaban, respectively (2 arms with different apixaban dosages were included in extended VTE treatment trial). In 2014, for the combined NVAF and VTE patient populations, within the hypothetical population of one million insured lives, medical costs were projected to be reduced by -$10.0, -$10.9, -$21.0, and -$21.0 million for dabigatran, rivaroxaban, 2.5 mg apixaban, and 5.0 mg apixaban, respectively. In the model, the reductions in medical costs associated with usage of the NOACs were projected to steadily increase in the years 2015 to 2018 (Figure). Conclusions: Medical costs are reduced, when any of the three NOACs are used instead of standard therapy/placebo for the treatment of NVAF or VTE. Apixaban is associated with the greatest reduction in medical costs, which is driven by medical cost reductions associated with both efficacy and safety endpoints among patients with NVAF or VTE. Further evaluation may be needed to validate these results in the real-world setting. Table 1 Clinical Trials from which Clinical Event Rates were Obtained Trial Drug Indication RE-LY Dabigatran Nonvalvular atrial fibrillation ROCKET-AF Rivaroxaban Nonvalvular atrial fibrillation ARISTOTLE Apixaban Nonvalvular atrial fibrillation RE-COVER I Dabigatran Acute venous thromboembolism RE-COVER II Dabigatran Acute venous thromboembolism EINSTEIN-Pooled Rivaroxaban Acute venous thromboembolism AMPLIFY Apixaban Acute venous thromboembolism RE-SONATE Dabigatran Extended venous thromboembolism EINSTEIN-EXT Rivaroxaban Extended venous thromboembolism AMPLIFY-EXT Apixaban Extended venous thromboembolism Figure 1 Figure 1. Disclosures Amin: Bristol-Myers Squibb, Pfizer: Consultancy. Off Label Use: Apixaban for the indication of VTE.. Bruno:Bristol-Myers Squibb: Employment, Equity Ownership. Trocio:Pfizer: Employment, Equity Ownership. Lin:Bristol-Myers Squibb, Pfizer: Consultancy, Research Funding. Lingohr-Smith:Bristol-Myers Squibb, Pfizer: Consultancy, Research Funding.

Evaluation of Net Clinical Benefits of New Oral Anticoagulants for Extended Treatment of Patients With Acute Venous Thromboembolism

CHEST Journal ◽  
2014 ◽  
Vol 146 (4) ◽  
pp. 505A
Author(s):  
Alpesh Amin ◽  
Yonghua Jing ◽  
Jeffrey Trocio ◽  
Jay Lin ◽  
Melissa Lingohr-Smith ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Extended Treatment ◽  
Clinical Benefits ◽  
Acute Venous Thromboembolism

scholarly journals Effectiveness and Safety of Apixaban for Treatment of Venous Thromboembolism in Daily Practice

TH Open ◽  
2020 ◽  
Vol 04 (02) ◽  
pp. e119-e126 ◽  
Author(s):  
Stephan V. Hendriks ◽  
Frederikus A. Klok ◽  
Wilhelmina J.E. Stenger ◽  
Albert T.A. Mairuhu ◽  
Jeroen Eikenboom ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Daily Practice ◽  
Phase Iii ◽  
Comparable Efficacy ◽  
Phase 3 ◽  
Recurrent Vte

Abstract Introduction Phase 3 trials have shown comparable efficacy of direct oral anticoagulants (DOACs) and vitamin K antagonists in patients with acute venous thromboembolism (VTE), with less major bleeding events in patients randomized to DOAC treatment. With DOACs being increasingly used in clinical practice, evaluation of the DOACs in daily practice-based conditions is needed to confirm their safety and effectiveness. The aim of this study is to evaluate the effectiveness and safety of apixaban in VTE patients in daily practice. Methods In this retrospective cohort study, consecutive patients diagnosed with VTE in two Dutch hospitals (Leiden University Medical Center, Leiden and Haga Teaching Hospital, The Hague) were identified based on administrative codes. We assessed recurrent VTE, major bleeding and mortality during a 3-month follow-up period in those treated with apixaban. Results Of 671 consecutive VTE patients treated with apixaban, 371 presented with acute pulmonary embolism (PE) and 300 patients with deep-vein thrombosis. During 3 months treatment, 2 patients had a recurrent VTE (0.3%; 95% confidence interval [CI]: 0.08–1.1), 12 patients had major bleeding (1.8%; 95% CI: 1.0–3.2), and 11 patients died (1.6%; 95% CI: 0.9–2.9), of which one patient with recurrent PE and one because of a intracerebral bleeding. Conclusion In this daily practice-based cohort, apixaban yielded a low incidence of recurrent VTE, comparable to the phase 3 AMPLIFY study patients. The incidence of major bleeding was higher than in the AMPLIFY-study patients, reflecting the importance of daily practice evaluation and the fact that results from phase III clinical studies cannot be directly extrapolated toward daily practice.

Evaluation of medical costs associated with use of new oral anticoagulants compared with standard therapy among venous thromboembolism patients

2014 ◽  
Vol 17 (11) ◽  
pp. 763-770 ◽  
Author(s):  
Alpesh Amin ◽  
Yonghua Jing ◽  
Jeffrey Trocio ◽  
Jay Lin ◽  
Melissa Lingohr-Smith ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Standard Therapy ◽  
Oral Anticoagulants ◽  
Medical Costs ◽  
New Oral Anticoagulants
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