Generic Versus Branded Enoxaparin in the Prevention of Venous Thromboembolism Following Major Abdominal Surgery

2011 ◽  
Vol 17 (6) ◽  
pp. 633-639 ◽  
Author(s):  
Marise Gomes ◽  
Eduardo Ramacciotti ◽  
Alexandre Cruz Henriques ◽  
Gilson Roberto Araujo ◽  
Luiz Arnaldo Szultan ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Abdominal Surgery ◽  
The United States ◽  
Major Abdominal Surgery ◽  
Low Molecular Weight Heparins ◽  
Bleeding Events ◽  
Once Daily ◽  
Vein Thrombosis ◽  
Deep Vein ◽  
To Receive

Introduction: Several generic low-molecular-weight heparins (LMWHs) have recently become available worldwide, including the United States. Companies have filed for regulatory approval of generic versions in many countries, based only on compound biochemical characteristics or its immunogenicity. Methods: Prospective study to evaluate the comparative effect of 2 enoxaparins (Sanofi-Aventis branded enoxaparin [SAe] vs eurofarma-enoxaparin [Ee], a generic version) as prophylaxis for venous thromboembolism (VTE) following major abdominal surgery. A total of 200 patients were randomized in a 1:1 ratio either to receive 40 mg of SAe or Ee subcutaneously (sc) once daily (od) postoperatively for 7 to 10 days. Compressive ultrasound was performed on day 10 + 4. Results: No statistically significant differences between the 2 groups were detected. In all, 2 SAe patients presented deep vein thrombosis ([DVT] 2.1%), none of the Ee group. No major bleeding events occurred. Conclusions: This exploratory trial suggests that the generic LMWH is probably as safe and as effective as the branded enoxaparin (Lovenox, Brazil) in the prophylaxis of VTE in this population.

Fondaparinux Combined with Intermittent Pneumatic Compression (IPC) Versus IPC Alone in the Prevention of Venous Thromboembolism after Major Abdominal Surgery: The Randomized APOLLO Study.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 279-279 ◽  
Author(s):  
Alexander G.G. Turpie ◽  
Kenneth A. Bauer ◽  
Joseph A. Caprini ◽  
Philip P. Comp ◽  
Michael Gent ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Abdominal Surgery ◽  
Major Bleeding ◽  
Intermittent Pneumatic Compression ◽  
Major Abdominal Surgery ◽  
Bleeding Events ◽  
Double Blind ◽  
Vein Thrombosis ◽  
Deep Vein

Abstract Background: The selective factor Xa inhibitor fondaparinux has been shown to be at least as effective and as safe as the low-molecular-weight heparin dalteparin for venous thromboembolism (VTE) prevention after major abdominal surgery (Agnelli GA, et al. Br J Surg, 2005, In press). The benefit of fondaparinux in addition to intermittent pneumatic compression (IPC) in VTE prevention after abdominal surgery has not been evaluated. Objective: We performed a randomized, double-blind, placebo-controlled, superiority trial to compare the efficacy and safety of fondaparinux in conjunction with IPC versus IPC alone in patients undergoing major abdominal surgery. Methods: Patients aged at least 40 years undergoing abdominal surgery of at least 45 minutes were included. Patients at highest risk of VTE, requiring pharmacologic prophylaxis in addition to IPC were excluded at the investigator’s discretion. Patients were randomized to receive either fondaparinux 2.5 mg or placebo once daily subcutaneously for 5 to 9 days, starting 6 to 8 hours postoperatively. All patients received IPC. The primary efficacy outcome was the composite of deep-vein thrombosis detected by mandatory bilateral venography, or documented symptomatic deep-vein thrombosis or pulmonary embolism up to day 10. The main safety outcome was major bleeding during the treatment period. A blinded independent committee adjudicated all these outcomes. Follow-up lasted 32 days. Results: Of the 1309 patients randomized between November 2001 and October 2004 (fondaparinux+IPC, n=650; placebo+IPC, n=659), 842 (64.3%) were evaluable for efficacy. The treatment groups were comparable with regard to VTE risk factors, demographic and surgical characteristics; 82% had at least one VTE risk factor (over and above being at least 40 years old and undergoing abdominal surgery). Fondaparinux significantly reduced the VTE rate from 5.3% (22/418) with placebo to 1.7% (7/424), an odds ratio reduction of 69.8% (95% CI: 27.9 to 87.3; p=0.004). Similarly, fondaparinux significantly reduced the proximal deep-vein thrombosis rate from 1.7% (7/417) to 0.2% (1/423; p=0.037). Major bleeding occurred in 1.6% (10/635) and 0.2% (1/650) of fondaparinux- and placebo-treated patients, respectively (p=0.006). None of the bleeding events were fatal or involved a critical organ. Conclusions: Fondaparinux combined with IPC was significantly more effective than IPC alone for VTE prevention after major abdominal surgery. Although the bleeding risk was increased with fondaparinux compared with placebo, this risk was low and consistent with that observed in previous fondaparinux studies in surgical patients.

scholarly journals Treatment Patterns and Clinical Outcomes in Korean Cancer Patients With Venous Thromboembolism: A Retrospective Cohort Study

2021 ◽  
Vol 27 ◽  
pp. 107602962097957
Author(s):  
Soo-Mee Bang ◽  
Jin-Hyoung Kang ◽  
Min Hee Hong ◽  
Jin-Seok Ahn ◽  
So Yeon Oh ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Events ◽  
Factors Associated ◽  
Vein Thrombosis ◽  
Medical Chart Review ◽  
Deep Vein

This study assessed epidemiologic data and clinical outcomes, including venous thromboembolism (VTE) recurrence and bleeding events, in patients with cancer-associated VTE, and assessed factors associated with clinical outcomes. Data were extracted from retrospective medical-chart review of adult patients diagnosed with cancer-associated deep vein thrombosis or pulmonary embolism who received anticoagulation treatment for ≥3 months. Patients were classified by: low-molecular-weight heparin (LMWH), direct oral anticoagulants (DOACs), and other anticoagulants. First VTE recurrence and bleeding events, and factors associated with their occurrence, were assessed during the initial 6 months of treatment. Overall, 623 patients (age: 63.7 ± 11.3 years, 49.3% male) were included (119, 132, and 372 patients in LMWH, DOACs and other anticoagulants groups, respectively). The cumulative 6-month incidence of VTE recurrence was 16.6% (total), 8.3% (LMWH), 16.7% (DOACs), and 20.7% (other); respective bleeding events were 22.5%, 11.0%, 12.3%, and 30.7%). VTE recurrence and bleeding rates differed only between LMWH and other anticoagulants (HR 2.4, 95% CI: 1.2-5.0 and 3.6, 1.9-6.8, respectively). These results highlight the importance of initial VTE treatment choice for preventing VTE recurrence and bleeding events. LMWH or DOACs for ≥3 months can be considered for effective VTE management in cancer patients.

Venous Thromboembolism

2017 ◽  
Author(s):  
Guillermo A. Escobar ◽  
Peter K. Henke ◽  
Thomas W. Wakefield
Keyword(s):  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Lower Extremity ◽  
The United States ◽  
Laboratory Evaluation ◽  
Individual Risk ◽  
Vein Thrombosis ◽  
Clinical Scenarios ◽  
Deep Vein

Deep vein thrombosis (DVT) and pulmonary embolism (PE) comprise venous thromboembolism (VTE). Together, they comprise a serious health problem as there are over 275,000 new VTE cases per year in the United States, resulting in a prevalence of one to two per 1,000 individuals, with some studies suggesting that the incidence may even be double that. This review covers assessment of a VTE event, initial evaluation of a patient suspected of having VTE, medical history, clinical presentation of VTE, physical examination, laboratory evaluation, imaging, prophylaxis against perioperative VTE, indications for immediate intervention (threat to life or limb), indications for urgent intervention, and management of nonemergent VTE. Figures show a modified Caprini score questionnaire used at the University of Michigan to determine individual risk of VTE and the indicated prophylaxis regimen; Wells criteria for DVT and PE; phlegmasia cerulea dolens secondary to acute left iliofemoral DVT after thigh trauma; compression duplex ultrasonography of lower extremity veins; computed tomographic angiogram of the chest demonstrating a thrombus in the pulmonary artery, with extension into the right main pulmonary; management of PE according to Wells criteria findings; management of PE with right heart strain in cases of massive or submassive PE; treatment of DVT according to clinical scenario; a lower extremity venogram of a patient with May-Thurner syndrome and its subsequent endovascular treatment; and various examples of retrievable vena cava filters (not drawn to scale). Tables list initial clinical assessment for VTE, clinical scenarios possibly benefiting from prolonged anticoagulation after VTE, indications for laboratory investigation of secondary thrombophilia, venous thromboembolic risk accorded to hypercoagulable states, and Pulmonary Embolism Rule-out Criteria Score to avoid the need for D-dimer in patients suspected of having PE.   This review contains 11 highly rendered figures, 5 tables, and 167 references. Key words: anticoagulation; deep vein thrombosis; postthrombotic syndrome; pulmonary embolism; recurrent venous thromboembolism; thrombophilia; venous thromboembolism; PE; VTE; DVT 

Tinzaparin in Outpatients with Pulmonary Embolism or Deep Vein Thrombosis

2005 ◽  
Vol 39 (7-8) ◽  
pp. 1182-1187 ◽  
Author(s):  
William E Dager ◽  
Jeff H King ◽  
Jennifer M Branch ◽  
Stacey L Chow ◽  
Ruby E Ferrer ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Warfarin Therapy ◽  
Outpatient Setting ◽  
Minor Bleeding ◽  
Low Molecular Weight Heparins ◽  
Bleeding Events ◽  
Vein Thrombosis ◽  
The University ◽  
Deep Vein

BACKGROUND The low-molecular-weight heparins (LMWHs) have been shown to be effective in the outpatient treatment of deep vein thrombosis (DVT). Data regarding outpatient use of any LMWH in pulmonary embolism (PE) or tinzaparin in DVT while transitioning therapy to a vitamin K antagonist are limited. OBJECTIVE To determine the safety and efficacy of tinzaparin in patients with either DVT or PE being transitioned to warfarin during LMWH therapy in the outpatient setting. METHODS All patients who were treated with at least one outpatient dose of tinzaparin for venous thromboembolism (VTE) were identified. Charts of all patients followed within the University of California Davis healthcare system were reviewed. The incidence of bleeding and recurrent thromboembolism over a minimum of the first 4 weeks to a maximum of 12 weeks after initiating anticoagulation was assessed. RESULTS A total of 178 patients with acute VTE were treated with tinzaparin, and outcomes could be determined in 140 cases. Forty-seven percent of these patients had objectively documented PE. Only one (0.7%) case of recurrent VTE was observed. Major bleeding was documented in 5 (3.6%) and minor bleeding in 8 (5.8%) patients. Two bleeding events, both major, occurred during tinzaparin therapy. CONCLUSIONS Outpatient use of tinzaparin during transition to warfarin therapy in the treatment of VTE, including PE, appears to be feasible in patients who are judged candidates for home therapy.

scholarly journals American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism

2020 ◽  
Vol 4 (19) ◽  
pp. 4693-4738 ◽  
Author(s):  
Thomas L. Ortel ◽  
Ignacio Neumann ◽  
Walter Ageno ◽  
Rebecca Beyth ◽  
Nathan P. Clark ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Secondary Prevention ◽  
Conflicts Of Interest ◽  
The United States ◽  
Primary Treatment ◽  
Vein Thrombosis ◽  
American Society ◽  
Deep Vein

Background: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), occurs in ∼1 to 2 individuals per 1000 each year, corresponding to ∼300 000 to 600 000 events in the United States annually. Objective: These evidence-based guidelines from the American Society of Hematology (ASH) intend to support patients, clinicians, and others in decisions about treatment of VTE. Methods: ASH formed a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process, including updating or performing systematic evidence reviews. The panel prioritized clinical questions and outcomes according to their importance for clinicians and adult patients. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment. Results: The panel agreed on 28 recommendations for the initial management of VTE, primary treatment, secondary prevention, and treatment of recurrent VTE events. Conclusions: Strong recommendations include the use of thrombolytic therapy for patients with PE and hemodynamic compromise, use of an international normalized ratio (INR) range of 2.0 to 3.0 over a lower INR range for patients with VTE who use a vitamin K antagonist (VKA) for secondary prevention, and use of indefinite anticoagulation for patients with recurrent unprovoked VTE. Conditional recommendations include the preference for home treatment over hospital-based treatment for uncomplicated DVT and PE at low risk for complications and a preference for direct oral anticoagulants over VKA for primary treatment of VTE.

National Healthcare Utilization Trends for Deep Vein Thrombosis in the United States.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3183-3183
Author(s):  
Prabhu Viswanathan ◽  
Upasna Goswami ◽  
Lakshmanan Krishnamurti
Keyword(s):  
Large Scale ◽  
The United States ◽  
Primary Diagnosis ◽  
Care Utilization ◽  
P Value ◽  
Upward Trend ◽  
Low Molecular Weight Heparins ◽  
Vein Thrombosis ◽  
Rate Of Increase ◽  
Deep Vein

Abstract Abstract 3183 Poster Board III-120 Background Over the past 15 years, increased awareness and advances in management such as the widespread adoption of low molecular weight heparins and new anticoagulants have had a dramatic impact on practice; there are no large scale studies to determine the impact of these changes on the health care utilization and outcomes of DVT. We examined national statistics of the trends in hospital utilization for Deep Vein Thrombosis in the United States. Methods The Nationwide Inpatient Sample (NIS) is one in a family of databases and software tools developed as part of the Healthcare Cost and Utilization Project (HCUP), sponsored by the Agency for Healthcare Research and Quality. For 2007 NIS contains all discharge data from 1,044 hospitals located in 40 States, approximating a 20-percent stratified sample of U.S. community hospitals. We examined trends for hospital utilization available through the NIS dataset. All descriptive statistics have been reported for DVT as ‘primary discharge diagnosis’ as well as ‘All discharge diagnoses’. Presence of ICD-9-CM diagnosis codes 453.0-453.9 were used to define DVT related hospitalizations. Results From 1993 to 2007 the number of annual diagnosis of DVT as one of “All Diagnoses' of DVT annually increased from 224,739 to 526,105 while the number of DVT as ‘Principal Diagnosis’ increased from 110,445 to 146,612. The average length of hospital stay has decreased from 7.6 days to 5 days (p-value <0.01). The average annual proportion of in-hospital deaths from DVT decreased during his period from 1.6% vs. 0.8% (p-value <0.01). FIG 1 For DVT as one of all diagnoses, the trends show a polynomial upward trend and the rate of increase is increasing every year (p value using T Test: 0.007). For annual number of discharges with DVT as primary diagnosis, there is a polynomial upward trend, with an index less than 1 and the curve is flattening out and the rate of increase is decreasing year over year (p value using T Test=0.0028). These findings suggest that the increase in DVT as primary diagnosis is not keeping pace with rapid increase in DVT as one of all diagnosis. For DVT as primary diagnosis, mortality rate was 1.6% and 0.3% respectively among those who underwent a procedure vs. those who did not undergo a procedure. Mortality for DVT as one of all diagnoses was 8.9% and 3.3% respectively among those who underwent a procedure vs. those did not undergo a procedure. Notably, a death in patients with DVT as one of all diagnosis was attributed to a variety of diagnoses, such as malignancies, infections and complications of implantation device. Rate of postoperative pulmonary embolism or thrombosis per 1000 surgical patients age 18 and over as a marker of Hospital-level Patient Safety Indicators age 18 and over adjusted for age, gender, comorbidities and DRG clusters, has increased from 6.3 in 1994 to 11.2 in 2006 FIG 2. From 1997 to 2006, the proportion of male patients increased from 43.1% to 45% while female patients decreased from 57% to 54.9%. (p-value <0.01) For the year 2007, with DVT as the primary or one of all diagnoses, OR procedures on vessels other than head and neck is the main principal procedure. DVT of extremities as primary diagnosis is associated with hypertension and hyperlipidemia as most important secondary diagnoses and for all DVT of the extremities as secondary diagnosis the most common primary diagnosis is pulmonary heart disease. Conclusions Survival for patients with DVT has improved and patients are likely to be discharged from acute care hospital earlier. We speculate that this could be the result of improved diagnosis and management including the use of low molecular weight heparins. Some of the changes in annual incidence may be attributed to earlier diagnosis and changes in ICD coding. However, the sustained increase in annual incidences of DVT as a secondary diagnosis and that of postoperative pulmonary embolism and thrombosis is a cause for concern and should prompt a review of strategies to prevent DVT among sick hospitalized patients. These data are subject to the well known limitations of administrative datasets, and underscore the need for large scale prospective study of the factors contributing to health care utilization and outcomes of DVT. Disclosures No relevant conflicts of interest to declare.

scholarly journals Incidence of deep vein thrombosis after major abdominal surgery in Brisbane

1988 ◽  
Vol 75 (10) ◽  
pp. 1046-1046
Author(s):  
J. O. Chelboun ◽  
M. M. D. Lawrence-Brown ◽  
S. Baker ◽  
P. G. Reasbeck
Keyword(s):  
Deep Vein Thrombosis ◽  
Abdominal Surgery ◽  
Major Abdominal Surgery ◽  
Vein Thrombosis ◽  
Deep Vein

Venous thromboembolism in patients with active cancer

2007 ◽  
Vol 98 (09) ◽  
pp. 656-661 ◽  
Author(s):  
Ali Seddighzadeh ◽  
Ranjith Shetty ◽  
Samuel Goldhaber
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Inferior Vena ◽  
The United States ◽  
Inferior Vena Caval ◽  
Vte Prophylaxis ◽  
Vein Thrombosis ◽  
Increased Risk ◽  
Deep Vein ◽  
Active Cancer

SummaryPatients with cancer have an increased risk of venous thromboembolism (VTE).To further define the demographics, comorbidities, and risk factors of VTE in these patients, we analyzed a prospective registry of 5,451 patients with ultrasound confirmed deep vein thrombosis (DVT) from 183 hospitals in the United States. Cancer was reported in 1,768 (39%), of whom 1,096 (62.0%) had active cancer. Of these, 599 (54.7%) were receiving chemotherapy, and 226 (20.6%) had metastases. Lung (18.5%), colorectal (11.8%), and breast cancer (9.0%) were among the most common cancer types. Cancer patients were younger (median age 66 years vs. 70 years; p<0.0001), were more likely to be male (50.4% vs. 44.5%; p=0.0005), and had a lower average body mass index (26.6 kg/m2 vs. 28.9 kg/m2; p<0.0001). Cancer patients less often received VTE prophylaxis prior to development of DVT compared to those with no cancer (308 of 1,096, 28.2% vs. 1,196 of 3,444, 34.6%; p<0.0001). For DVT therapy, low-molecular-weight heparin (LMWH) as monotherapy without warfarin (142 of 1,086, 13.1% vs. 300 of 3,429, 8.7%; p<0.0001) and inferior vena caval filters (234 of 1,086, 21.5% vs. 473 of 3,429, 13.8%; p<0.0001) were utilized more often in cancer patients than in DVT patients without cancer. Cancer patients with DVT and neurological disease were twice as likely to receive inferior vena caval filters than those with no cancer (odds ratio 2.17, p=0.005). In conclusion, cancer patients who develop DVT receive prophylaxis less often and more often receive filters than patients with no cancer who develop DVT. Future studies should focus on ways to improve implementation of prophylaxis in cancer patients and to further define the indications, efficacy, and safety of inferior vena caval filters in this population.

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