Edoxaban Versus Enoxaparin for the Prevention of Venous Thromboembolism: Pooled Analysis of Coagulation Biomarkers From Stars E-3 and Stars J-V.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2260-2260
Author(s):  
Takeshi Fuji ◽  
Satoru Fujita ◽  
Shintaro Tachibana ◽  
Yohko Kawai
Keyword(s):  
Venous Thromboembolism ◽  
Factor Xa ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Bleeding Events ◽  
Double Blind ◽  
Once Daily ◽  
Treatment Groups ◽  
Post Operation ◽  
D Dimer

Abstract Abstract 2260 Introduction: Edoxaban is an oral, once-daily, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic events. Two randomized, double-blind, double-dummy, phase III studies (STARS E-3 and STARS J-V) have been conducted to evaluate the efficacy and safety of edoxaban compared to enoxaparin for the prevention of venous thromboembolism (VTE) after total knee arthroplasty (TKA) or total hip arthroplasty (THA). The objective of this pooled analysis was to investigate the effects of edoxaban on key coagulation biomarkers. Methods: Patients (N=1,326) undergoing TKA or THA in Japan and Taiwan were randomized to receive oral edoxaban 30 mg once daily (qd) or subcutaneous enoxaparin 2,000 IU twice daily (bid; equivalent to 20 mg bid) for 11–14 days. Edoxaban was initiated 6–24 hours after surgery and enoxaparin was initiated 24–36 hours after surgery, which is the standard of care in Japan. Blood samples were collected for coagulation biomarker measurements pre-operation, post-operation (pre-treatment, Day 0), Day 7 (prior to administration of the next dose) and completion day (Day 11–14). The primary efficacy outcome was the composite of symptomatic and asymptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). The principal safety outcome was the incidence of major and clinically relevant non-major (CRNM) bleeding. Pharmacodynamic endpoints included key coagulation biomarkers such as D-dimer, prothrombin fragment F1+2 (F1+2) and soluble fibrin monomer complex (SFMC). Results: A total of 1,307 patients received at least 1 dose of edoxaban or enoxaparin. There were no clinically relevant differences in baseline characteristics between the treatment groups. The mean age was 68 years, mean body weight was 58.8 kg and 83% of patients were female. Overall, edoxaban significantly reduced the incidence of the composite of symptomatic and asymptomatic DVT and PE compared with enoxaparin (5.1% vs 10.7%, P<0.001). The incidence of major and CRNM bleeding events was 4.6% vs 3.7% in the edoxaban and enoxaparin groups, respectively (P=0.427). For both treatment groups, D-dimer and SFMC levels were reduced at Day 7 compared to post-operation/pretreatment levels, then increased slightly by Day 11–14. Levels of F1+2 also decreased by Day 7 in both treatment groups and further decreased by Day 11–14. However, for each coagulation biomarker, levels were significantly lower in the edoxaban group compared to the enoxaparin group at both Day 7 and Day 11–14. (Table, P<0.001). Conclusion: Edoxaban 30 mg qd is superior to enoxaparin 20 mg bid in the prevention of VTE events with significant reduction of D-dimer, F1+2 and SFMC following TKA and THA. Disclosures: Fuji: Daiichi Sankyo: Consultancy; Bayer: Consultancy; Century Medical: Consultancy; Showa Ikakogyo: Consultancy. Fujita:Daiichi Sankyo: Consultancy; Bayer: Consultancy. Tachibana:Daiichi Sankyo: Consultancy. Kawai:Daiichi Sankyo: Consultancy; Bayer: Consultancy; Toyama Chemical: Consultancy.

Edoxaban Versus Enoxaparin for the Prevention of Venous Thromboembolism: Pooled Analysis of Venous Thromboembolism and Bleeding From STARS E-3 and STARS J-V

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 208-208 ◽  
Author(s):  
Takeshi Fuji ◽  
Satoru Fujita ◽  
Shintaro Tachibana ◽  
Yohko Kawai
Keyword(s):  
Body Weight ◽  
Venous Thromboembolism ◽  
Subgroup Analysis ◽  
Factor Xa ◽  
Pooled Analysis ◽  
Bleeding Events ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive ◽  
Patient Subgroups

Abstract Abstract 208 Introduction: Edoxaban is an oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic events. Two randomized, double-blind, double-dummy, phase 3 studies (STARS E-3 and STARS J-V) have been conducted to evaluate the efficacy and safety of edoxaban compared with enoxaparin for the prevention of venous thromboembolism (VTE) after total knee (TKA) or hip arthroplasty (THA). The objective of this pooled analysis was to investigate the effects of edoxaban on VTE and bleeding in key subgroups. Methods: Patients (N=1326) undergoing TKA or THA in Japan and Taiwan were randomized to receive oral edoxaban 30 mg once daily (qd) or subcutaneous enoxaparin 2000 IU twice daily (bid, equivalent to 20 mg bid) for 11–14 days. Edoxaban was initiated 6–24 hours after surgery and enoxaparin was initiated 24–36 hours after surgery, which is the standard of care in Japan. The primary efficacy outcome was the composite of symptomatic and asymptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). The principal safety outcome was the incidence of major and clinically relevant nonmajor (CRNM) bleeding. Results: A total of 1307 patients received at least 1 dose of edoxaban or enoxaparin. There were no clinically relevant differences in baseline characteristics between the treatment groups. The mean age was 68 years and mean body weight was 58.8 kg. Over 70% of patients received physiotherapy (intermittent pneumatic compression, elastic stocking). Overall, edoxaban significantly reduced the incidence of the composite of symptomatic and asymptomatic DVT and PE compared with enoxaparin (5.1% vs 10.7%, P<0.001). Subgroup analysis showed that edoxaban numerically reduced the incidence of the composite efficacy endpoint regardless of age or body weight. The effect was statistically significant in patients <75 years of age and in those <70 kg. Edoxaban was also significantly more effective than enoxaparin in the presence or absence of concomitant physiotherapy. The incidence of major and CRNM bleeding events was 4.6% vs 3.7% in the edoxaban and enoxaparin groups, respectively (P=0.427). Subgroup analysis of major and CRNM bleeding indicated no significant difference between edoxaban and enoxaparin in any of the patient subgroups evaluated, based on age, weight, or creatinine clearance. Conclusion: Edoxaban 30 mg qd is superior to enoxaparin 20 mg bid in the prevention of VTE events following TKA and THA without a statistically significant increase in bleeding in important patient subgroups likely to receive this treatment. Disclosures: Fuji: Daiichi Sankyo: Consultancy; Astellas: Consultancy; Showa Ikakogyo: Consultancy; Bayer: Consultancy. Fujita:Astellas: Consultancy; GlaxoSmithKline: Consultancy; Daiichi Sankyo: Consultancy; Bayer: Consultancy. Tachibana:Daiichi Sankyo: Consultancy. Kawai:Daiichi Sankyo: Consultancy; Toyama Chemical: Consultancy; Bayer: Consultancy.

Abstract 5063: Cardiovascular Effects of Transdermal Testosterone in Postmenopausal Women

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
C Vitale ◽  
P Collins ◽  
G Marazzi ◽  
G Caminiti ◽  
I Lodhi ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clinical Trials ◽  
Hormone Replacement ◽  
Cardiovascular Effects ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Double Blind ◽  
Treatment Groups ◽  
Clinical Program ◽  
Large Phase

Testosterone Transdermal Patch (TTP) has been developed for the treatment of postmeno-pausal women (PMW) with hypoactive sexual desire disorder (HSDD). Since the cardiovascular (CV) effects of testosterone in women are still unclear we conducted a pooled analysis of the large phase III clinical program to evaluate the efficacy and safety of 300 μg/day TTP, alone or in association with hormone replacement therapy (HRT), versus placebo in surgical or natural PMW. Design & Methods: A total of 2795 women aged between 26 –70 years (mean age 52(SD=6.8) years) were included in 5 phase III randomized, double-blind, placebo-controlled clinical trials (treatment duration range 24 – 52 weeks) as part of the TTP Clinical program. 4 studies included PMW (natural and surgical, two each respectively) receiving HRT while 1 study was conducted without HRT, in either surgical or natural PMW. Women with known CV disorders were excluded from the studies. Changes from baseline in standard metabolic and CV risk factors were compared. The incidence of stroke, myocardial infarction (MI) and venous thromboembolism (VTE) alone or as a composite CV endpoint was assessed. Results: The 2795 PMW were randomized to receive either placebo (n=1297) or TTP (n=1498). Baseline mean BMI was 27 kg/m2 (SD=5.3 kg/m2) and 56% were naturally menopausal. The demographic and baseline parameters were similar among the treatment groups. No significant changes in CV risk factors (Total Cholesterol, Triglycerides, Insulin, Glucose, Systolic and Diastolic Blood Pressure) were detected during the study period, apart from a blunting of the increases in HDL-C by TTP at 24 and 52 weeks (Placebo 52-week mean change 2.59 mg/dl vs. TTP 52-week mean change 1.20 mg/dl, p<0.005) and of the decrease in LDL-C by TTP at 24 (p<0.05), but not at 52 weeks. During the double-blind (24 weeks), placebo-controlled period of the combined studies, 4 major CV events (2 MIs and 2 strokes) were reported in placebo patients and 3 (2 MIs and 1 stroke) in those receiving TTP. One VTE occurred in a patient receiving TTP and HRT. Conclusion: TTP therapy in these clinical trials did not adversely affect CV risk profile and did not change the risk of major CV events in these surgical and naturally PMW with or without concomitant HRT.

A Pooled Analysis of Four Pivotal Studies of Rivaroxaban for the Prevention of Venous Thromboembolism after Orthopaedic Surgery: Effects of Specified Co-Medications.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1986-1986
Author(s):  
Bengt Eriksson ◽  
Alexander GG Turpie ◽  
Michael Rud Lassen ◽  
Ajay K Kakkar ◽  
Frank Misselwitz ◽  
...  
Keyword(s):  
Placebo Group ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Medication Use ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Bleeding Events ◽  
Time Periods ◽  
Rate Ratios ◽  
Over Time

Abstract RECORD is a pivotal clinical trial program investigating rivaroxaban – an oral, direct Factor Xa inhibitor – for the prevention of venous thromboembolism (VTE) following elective total hip and knee replacement (THR and TKR). The four multinational, randomized, double-blind, double-dummy phase III studies (RECORD1, 2, 3 and 4) in patients undergoing THR or TKR surgery, comparing rivaroxaban with enoxaparin 40 mg once daily (od) or 30 mg twice daily (bid), have been completed. Patients (N=12,729) were randomized to receive oral rivaroxaban 10 mg od starting 6–8 hours after surgery, or subcutaneous enoxaparin 40 mg od starting the evening before surgery (RECORD1–3) or 30 mg bid starting 12–24 hours after wound closure or adequate hemostasis (RECORD4). Those undergoing THR received rivaroxaban or enoxaparin for 31–39 days in RECORD1, and rivaroxaban for 31–39 days or enoxaparin for 10–14 days followed by placebo in RECORD2. In RECORD3 and 4 (TKR), prophylaxis was for 10–14 days. A pooled analysis of the results of all four RECORD studies evaluated the effect of rivaroxaban on the composite of symptomatic VTE and death, and bleeding. The aim of the present subgroup analysis was to investigate potential drug–drug interactions with specified co-medications, by describing the risk of on-treatment bleeding in the total study duration pool of all four RECORD studies. The co-medications investigated were non-steroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid (ASA), which are commonly used pain medications known to have a pharmacodynamic effect on bleeding. There was no restriction on the choice of specific drug or on the dose of ASA in the study protocols. These pre-specified analyses focused on on-treatment, adjudicated bleeding events – any bleeding, and the composite of major bleeding, and clinically relevant non-major bleeding – after the first tablet intake (rivaroxaban or matching placebo) and up to 2 days after the last dose of medication. Co-medication use was considered a time-dependent covariate, and relative bleeding rates with and without the co-medication were calculated for the rivaroxaban and enoxaparin/placebo groups separately. The time relative to surgery (day of surgery was day 1) was stratified into three time periods (days 1–3, days 4–7, and day 7 onwards), based on the consideration that the risk of a first bleeding event decreases over time after surgery, and because the prevalence of co-medication use can vary over time. Bleeding rates were recorded for each of these time periods over the at-risk period, which extended from the day of surgery until the last day of study medication intake +2 days or until event onset (recurrent bleeds were not included in the analyses). Rate ratios were derived using stratified Mantel–Haenszel methods. The ratios of the bleeding rate for exposed versus unexposed patient-days in the rivaroxaban group were compared with the corresponding rate ratio for the enoxaparin/placebo group for bleeding events. The concomitant use of ASA in the rivaroxaban groups showed rate ratios similar to those obtained in the enoxaparin/placebo group, for all bleeding endpoints. Rate ratios for bleeding endpoints were also similar between the rivaroxaban and the enoxaparin/placebo groups with concomitant use of NSAIDs. This RECORD1–4 subanalysis indicates that the use of these co-medications does not increase bleeding risk in patients taking rivaroxaban, compared with enoxaparin

Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty

2011 ◽  
Vol 105 (03) ◽  
pp. 444-453 ◽  
Author(s):  
Michael Rud Lassen ◽  
Bengt Eriksson ◽  
Michael Gent ◽  
Scott Berkowitz ◽  
Frank Misselwitz ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Treatment Period ◽  
Knee Arthroplasty ◽  
Phase Iii ◽  
Primary Efficacy ◽  
Primary Efficacy Endpoint ◽  
Bleeding Events ◽  
Once Daily ◽  
All Cause Mortality ◽  
Total Treatment

SummaryFour phase III studies compared oral rivaroxaban with subcutaneous enoxaparin for the prevention of venous thromboembolism (VTE) after total hip or knee arthroplasty (THA or TKA). A pooled analysis of these studies compared the effect of rivaroxaban with enoxaparin on symptomatic VTE plus all-cause mortality and bleeding events, and determined whether these effects were consistent in patient subgroups. Patients (N=12,729) aged ≥18 years and scheduled for elective THA or TKA received rivaroxaban 10 mg once daily or enoxaparin 40 mg once daily or 30 mg every 12 hours. The composite of symptomatic VTE and all-cause mortality, the prespecified primary efficacy endpoint and adjudicated bleeding events were analysed in the day 12 ± 2 active treatment pool. Subgroup analyses of these outcomes were performed over the total treatment period. In the day 12 ± 2 pool, the primary efficacy endpoint occurred in 29/6,183 patients receiving rivaroxaban (0.5%) versus 60/6,200 patients receiving enoxaparin (1.0%; p=0.001). Major bleeding occurred in 21 (0.3%) versus 13 (0.2%) patients, p=0.23; major plus non-major clinically relevant bleeding in 176 (2.8%) versus 152 (2.5%) patients, p=0.19; and any bleeding in 409 (6.6%) versus 384 (6.2%) patients, p=0.38, respectively. The reduction of symptomatic VTE plus all-cause mortality was consistent across prespecified subgroups (age, gender, body weight, creatinine clearance) in the total treatment period. Compared with enoxaparin regimens, rivaroxaban reduces the composite of symptomatic VTE and all-cause mortality after elective THA or TKA, with a small increase in bleeding, no signs of compromised liver safety and fewer serious adverse events.

scholarly journals Rivaroxaban for Preventing Venous Thromboembolism in High-Risk Ambulatory Patients with Cancer: Rationale and Design of the CASSINI Trial

2017 ◽  
Vol 117 (11) ◽  
pp. 2135-2145 ◽  
Author(s):  
Alok Khorana ◽  
Saroj Vadhan-Raj ◽  
Nicole Kuderer ◽  
Ted Wun ◽  
Howard Liebman ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
High Risk ◽  
Factor Xa ◽  
Routine Care ◽  
Bleeding Events ◽  
Double Blind ◽  
Primary Brain Tumours ◽  
Incidental Pulmonary Embolism ◽  
Increased Risk ◽  
Ambulatory Patients

AbstractVenous thromboembolism (VTE) is a frequent complication of cancer associated with morbidity, mortality, increased hospitalizations and higher health care costs. Cancer patients at increased risk for VTE can be identified using a validated risk assessment score, and the incidence of VTE can be reduced in high-risk settings using anticoagulation. Rivaroxaban is a potent, oral, direct, factor Xa inhibitor approved for the prevention and treatment of thromboembolic events, including VTE. CASSINI is a double-blind, randomized, parallel-group, multicentre study comparing rivaroxaban with placebo in adult ambulatory patients with various cancers who are initiating systemic cancer therapy and are at high risk of VTE (Khorana score ≥ 2). Patients with primary brain tumours or those at risk for bleeding are excluded. Approximately 700 patients will be randomized 1:1 to rivaroxaban 10 mg daily or placebo for up to 6 months if there is no evidence of VTE from compression ultrasonography (CU) during screening or from routine care imaging within 30 days prior to randomization. Mandatory CU will also be performed at weeks 8 and 16 (±7 days), and at study end (±3 days). The primary efficacy hypothesis is that anticoagulation with rivaroxaban reduces the composite of objectively confirmed symptomatic or asymptomatic, lower-extremity, proximal deep-vein thrombosis (DVT); symptomatic, upper-extremity DVT; symptomatic or incidental pulmonary embolism; and VTE-related death compared with placebo. The primary safety objective is to assess major bleeding events (Clinical trial information: NCT02555878).

A Comparative, Double-blind, Randomised Trial of a New Second Generation LMWH (Bemiparin) and UFH in the Prevention of Post-operative Venous Thromboembolism

2000 ◽  
Vol 83 (04) ◽  
pp. 523-529 ◽  
Author(s):  
J. Howes ◽  
V. Sharma ◽  
Z. Kadziola ◽  
V. V. Kakkar ◽  
Keyword(s):  
Venous Thromboembolism ◽  
Hip Arthroplasty ◽  
Randomised Trial ◽  
Factor Xa ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Double Blind ◽  
Subcutaneous Dose ◽  
Number Of Patients ◽  
Risk Patients

SummaryA randomised, prospective, double-blind trial was performed, to compare the safety and efficacy of a new low-molecular-weight heparin (LMWH) Bemiparin and standard unfractionated heparin (UFH), for the prophylaxis of postoperative venous thromboembolism. 300 patients scheduled to undergo elective hip arthroplasty were included. The principal outcome measures were the incidence of thromboembolic events and bleeding complications. 149 patients received 3,500 anti-Xa IU of bemiparin plus a placebo injection daily and 149 patients received 5,000 IU of UFH twice a day.The two groups were similar with respect to factors likely to affect the risk of developing post-operative venous thromboembolism (VTE) and risk of bleeding events. During the post-operative period, 34 patients developed VTE complications; 9 (7.2%) in the bemiparin group and 25 (18.7%) in the UFH group. VTE in the two groups was statistically significant (OR of 2.96; 95% CI 1.32-6.62 and p = 0.01).There were no significant differences in the frequency of bleeding complications: major bleeding requiring discontinuation of prophylaxis, (OR 1.21; 95% CI 0.36-4.05; p = 1.00), the measured median operative blood loss (p = 0.77) or the median postoperative drain loss (p = 0.97), and the number of patients who developed wound haematoma (OR 0.87; 95% CI 0.31-2.46; p = 1.00).A comparison of coagulation parameters on the preoperative day with post-operative day 2 ± 1, day 6 ± 1 and day of discharge showed a significantly higher AT concentration, anti-factor Xa activity and TFPI levels in the bemiparin group when compared with UFH.This study demonstrates that bemiparin, in a single daily subcutaneous dose of 3,500 anti-Xa IU in high risk patients undergoing hip arthroplasty is more effective than UFH administered twice daily at a dose of 5,000 IU in the prevention of postoperative VTE. Both agents are equally safe.List of participants, their affiliations and current addresses are listed in the appendix on p. 528

scholarly journals Treatment Challenges in Venous Thromboembolism: An Appraisal of Rivaroxaban Studies

2018 ◽  
Vol 118 (S 01) ◽  
pp. S23-S33 ◽  
Author(s):  
Jeffrey Weitz ◽  
Alok Khorana
Keyword(s):  
Venous Thromboembolism ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
Bleeding Risk ◽  
Phase Iii ◽  
Double Blind ◽  
Patients With Cancer ◽  
Patient Profile ◽  
Recurrent Vte ◽  
Cancer Associated Thrombosis

AbstractVenous thromboembolism (VTE) presents a continuing clinical burden to healthcare systems and there are patient groups for whom VTE management is challenging. Depending on the patient profile, the optimal duration of anticoagulation for VTE treatment can be unclear. EINSTEIN CHOICE was a Phase III, randomized, double-blind trial that compared the safety and efficacy of two once-daily (od) doses of the direct, oral factor Xa inhibitor rivaroxaban (20 and 10 mg) with acetylsalicylic acid (ASA; 100 mg daily) for prevention of recurrent VTE. Extended therapy with rivaroxaban at either dose was more effective than ASA at preventing recurrent VTE without increasing bleeding risk. Another group that is challenging to treat in the context of VTE is patients with cancer-associated thrombosis. Cancer is associated with a hypercoagulable state, while cancer treatment itself may increase VTE risk. Evidence supporting the use of non-vitamin K antagonist oral anticoagulants in patients with cancer is growing through specifically designed studies. Cancer Associated thrombosis—expLoring soLutions for patIentS through Treatment and prevention with rivarOxaban (CALLISTO) is an international research program exploring the role of rivaroxaban for the prevention and treatment of cancer-associated thrombosis. Here, we present overviews of three CALLISTO studies: PRO-LAPS II, CASTA-DIVA and COSIMO. Currently available and anticipated results from studies in a variety of patients at risk of or with VTE will provide valuable insights and seek to optimize future VTE management.

scholarly journals Factor Xa Inhibition Reduces Coagulation Activity but Not Inflammation Among People With HIV: A Randomized Clinical Trial

2020 ◽  
Vol 7 (2) ◽  
Author(s):  
Jason V Baker ◽  
Julian Wolfson ◽  
Tess Peterson ◽  
Micah Mooberry ◽  
Matthew Gissel ◽  
...  
Keyword(s):  
Immune Activation ◽  
Disease Risk ◽  
Substantial Reduction ◽  
Factor Xa ◽  
Factor Xa Inhibitor ◽  
Direct Factor ◽  
Bleeding Events ◽  
Double Blind ◽  
Coagulation Activity ◽  
D Dimer

Abstract Background Coagulation activity among persons with HIV is associated with end-organ disease risk, but the pathogenesis is not well characterized. We tested a hypothesis that hypercoagulation contributes to disease risk, in part, via upregulation of inflammation. Methods Treatment effects of edoxaban (30 mg), a direct factor Xa inhibitor, vs placebo were investigated in a randomized, double-blind crossover trial among participants with HIV and viral suppression and D-dimer levels ≥100 ng/mL. During each 4-month crossover period, blood measures of coagulation, inflammation, and immune activation were assessed. Analyses of change on edoxaban vs change on placebo used linear mixed models. Results Forty-four participants were randomized, and 40 completed at least 1 visit during each study period. The mean age was 49 years, and the CD4+ count was 739 cells/mm3. Edoxaban treatment led to declines in D-dimer (44%) and thrombin-antithrombin complex (26%) but did not lower inflammatory or immune activation measures. More bruising or bleeding events occurred during edoxaban (n = 28) than during placebo or no drug periods (n = 15). Conclusions The direct factor Xa inhibitor edoxaban led to a substantial reduction in coagulation but no effect on inflammation or immune activation. These results do not support that hypercoagulation contributes to ongoing inflammation during chronic antiretroviral therapy–treated HIV disease.

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.

Sign in / Sign up

Export Citation Format

Share Document