Adjusted value of thromboprophylaxis in hospitalized obese patients: A comparative study of two regimens of enoxaparin: The ITOHENOX study (original) (raw)
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Journal of Thrombosis and Haemostasis, 2007
Background: Selecting initial anticoagulant dose by patient weight for acute pulmonary embolism and deep vein thrombosis has clinical credibility; however, uncertainty remains regarding how to dose obese patients with newer anticoagulants because outcome data are sparse. Objectives: To use the Matisse trialsÕ comparison of sc fondaparinux once daily with control heparin therapies (intravenous unfractionated heparin for pulmonary embolism, sc enoxaparin 1 mg/kg b.i.d. for deep vein thrombosis) for initial treatment in order to compare primary outcomes (venous thromboembolism recurrence and major bleeding) in obese patients. Patients and methods: Primary outcomes were compared in subsets composed of patients weighing £ and > 100 kg and with body mass index (BMI) < 30 and ‡ 30 kg/m 2 . Medians and ranges for weight and BMI were compared for patients suffering either recurrence or major bleeding. Results: Twenty-two thousand and one patients received fondaparinux and 2217 received enoxaparin or unfractionated heparin. Four hundred and ninety-six patients (11%) weighed > 100 kg and 1216 (28%) had a BMI ‡ 30. Treatment groups had similar characteristics. The upper limit in subject weight for recurrence was 166 kg (BMI 58), and for major bleeding 120 kg (BMI 39). The incidences of recurrence and major bleeding were similar for each patient subset of weight and BMI for both fondaparinux and heparin treatment groups. Among patients with a primary outcome, median weights and BMIs were also similar. Conclusions: The current recommended doses of fondaparinux and heparins for the treatment of venous thromboembolism appear to provide similar protection against recurrence and major bleeding to one another and to obese and non-obese patients.
Hospital Pharmacy, 2016
Background Obese patients experience a higher risk of venous thromboembolism (VTE) than their nonobese counterparts, which may warrant a more aggressive approach to thromboprophylaxis in this population. Objective The purpose of this study was to compare rates of nosocomial VTE in obese patients treated with high-dose versus conventional-dose subcutaneous unfractionated heparin sodium (UFH) for thromboprophylaxis. Methods A retrospective, single-center, cohort study was conducted to evaluate obese, adult, hospitalized patients admitted between April 2011 and April 2014 who received heparin 5,000 or 7,500 units subcutaneously every 8 hours for thromboprophylaxis. The primary outcome assessed the rate of nosocomial VTE in obese patients treated with high-dose heparin (7,500 units subcutaneously q 8 h) versus conventional-dose heparin (5,000 units subcutaneously q 8 h). Additionally, a secondary outcome assessed safety by quantifying bleeding events. Results Nosocomial VTE occurred in ...
Venous Thromboembolism Prophylaxis in Obese Medical Patients: A Retrospective Cohort Study
Background: Obese patients are 2-3 times more likely to develop venous thromboembolism (VTE), and over 60% of VTE occurs in hospital. Our primary objective was to identify the incidence of objectively documented symptomatic VTE during hospitalization or up to ninety days post discharge. Our secondary objectives were to describe the prescribing patterns of VTE prophylaxis received in hospitalized obese medical patients (body mass index [BMI] ≥30 kg/m2) as well as risk factors for VTE in obese patients. Method: A retrospective design was used look at obese patients admitted to a general medicine service at three tertiary care academic teaching hospitals in Calgary, AB, Canada from January 1, 2012 to December 31, 2012. VTE was identified based on clinical diagnosis and incidence was calculated. Results: There were 443 patients included in the analysis. The average age and BMI were 58.5 years and 41 kg/m2 respectively, and 70.2% were males. The median length of stay in hospital was 7 days (IQR 4-13). A total of 122 patients (27.5%) of patients did not receive thromboprophylaxis during their hospitalization. Unfractionated heparin (UFH) was the most common agent prescribed (37.9%), and only seven patients received high-dose thromboprophylaxis. The median duration of prophylaxis was 6.5 days (IQR 4-12). Seven patients (1.6%) developed VTE (5 pulmonary embolism and 2 DVT) during the study period, and six of these patients received thromboprophylaxis. In terms of risk for VTE, the median Padua Prediction Score for the study group was 2 (IQR 1-3). Conclusion: There is very little literature on VTE prophylaxis and incidence of VTE in the obese medical patient. Given the low risk for and incidence of VTE in this study, particularly in the context of 27.5% of the study population not receiving thromboprophylaxis, there is a need for further research to evaluate the efficacy and safety of high dose thromboprophylaxis in the obese medical patient.
Asian Journal of Pharmaceutical and Clinical Research, 2022
Objective: The objective of the study was to evaluate peak antifactor Xa (aFXa) levels in low-weight patients receiving enoxaparin for VTE prophylaxis. Methods: Retrospective cohort of adult patients weighing <55 kg who was hospitalized at tertiary care Center between January 2019 through February 2020. All patients received enoxaparin for VTE prophylaxis with a peak aFXa level drawn. The primary end point was the proportion of patients achieving peak aFXa levels within the goal range of 0.2-0.5 units/ml. Results: Of 65 patients receiving enoxaparin for VTE prophylaxis with an appropriately timed peak aFXa level, 74% achieved goal peak aFXa levels and the median daily dose of enoxaparin was 30 mg. The mean weight was about 44 kg. No significant correlations between aFXa level and body mass index or body weight were found. Conclusion: A lower dose of enoxaparin may be reasonable in low-weight patients for VTE prophylaxis. There appears to be no safety concerns with reduced enoxaparin dosing in low-weight patients. More robust data are needed to confirm these findings.
Tropical Journal of Pharmaceutical Research, 2021
Purpose: To evaluate the effectiveness of adjusted body weight (AjBW)-based dosing of unfractionated heparin (UFH) in obese patients vis a vis actual body weight (ABW)-based dosing in non-obese patients with venous thromboembolism (VTE).Methods: A retrospective chart review was conducted for obese and non-obese patients initiated on UFH for treating VTE from September 2013 to December 2014. Patients were excluded from the study if they were under 18 years old, developed heparin-induced thrombocytopenia during treatment, received thrombolytic therapy prior to UFH, or received UFH at a dose that did not follow the institution’s protocol. The primary objective was to assess the efficacy of dosing UFH based on AjBW in achieving a therapeutic activated partial thromboplastin time (aPTT) within the first 24 h in obese patients, in comparison to the standard ABW-dosing for non-obese.Results: Of the 57 patients included in the study, 27 patients (47.4 %) were obese, and 30 patients (52.6 %)...
Thrombosis Research, 2018
To examine the laboratory anticoagulant effect of two thromboprophylactic low-molecular weight heparin (LMWH) regimens in post-cesarean obese patients. Methods: A prospective cohort study, performed during 2017-2018 at a university hospital, of post-cesarean obese (> 90 kg) patients receiving 40 mg/day (n = 30) or 60 mg/day (n = 30) enoxaparin, and a control group of non-obese (n = 30) post-cesarean patients receiving 40 mg/day enoxaparin. Thrombin generation and anti-Xa were measured twice on the third postoperative day: prior to and 3.5-4 h following the third LMWH dose. Results: Age, parity, weight and body mass index were comparable between the obese study groups. Compared to the control non-obese group, the 40 mg obese and 60 mg obese groups showed increased baseline thrombin generation: medians 491, 581, 571 nM, respectively (P = 0.001 and P = 0.04, respectively). At peak LMWH activity, thrombin generation was higher in the 40 mg than in the 60 mg obese and control groups: medians 2599, 2391, 2229 nM, respectively (P = 0.01 and P < 0.0001, respectively); and thrombin generation was comparable between the 60 mg obese and the control groups (P = 0.58). Similarly, a significantly lower proportion of patients in the 40 mg obese group (10%) had anti-Xa levels within the recommended prophylactic range (0.2-0.5 IU/mL) than in the other groups (P < 0.0001 for both comparisons). Conclusion: As determined by thrombin generation and anti-Xa testing, post-cesarean obese patients have an increased procoagulant potential, which was diminished only in those receiving higher dosages of LMWH. These findings support the need for clinical evaluation of LMWH dose adjustment in this setting.
Outcomes of thromboprophylaxis with enoxaparin vs. unfractionated heparin in medical inpatients
Thrombosis journal, 2006
Clinical trials have shown low-molecular weight heparin (LMWH) to be at least as safe and efficacious as unfractionated heparin (UFH) for preventing venous thromboembolism (VTE) in acutely-ill medical inpatients. To compare clinical and economic outcomes among acutely-ill medical inpatients receiving the LMWH enoxaparin versus UFH prophylaxis in clinical practice. Using a large, multi-hospital, US database, we identified persons aged > or =40 years hospitalized for > or =6 days for an acute medical condition (including circulatory disorders, respiratory disorders, infectious diseases, or neoplasms) from Q4 1999 to Q1 2002. From these patients, those who received thromboprophylaxis with either enoxaparin or UFH were identified. Surgical patients and those requiring or ineligible for anticoagulation were excluded. We compared the incidence of deep-vein thrombosis (DVT), pulmonary embolism (PE), and all VTE (i.e., DVT and/or PE). Secondary outcomes were occurrence of side-effects...
Surgery for Obesity and Related Diseases, 2015
Background: Prophylaxis for venous thromboembolism is routinely performed for all patients undergoing bariatric surgery. However, there is disagreement regarding the optimal dosing and duration of anticoagulant therapy. Furthermore, there is little data regarding the incidence of asymptomatic deep venous thrombosis (DVT) in this population. Our objective was to conduct a pilot randomized double blind study to evaluate the pharmacodynamic parameters of 2 different anticoagulation medications (enoxaparin and fondaparinux) administered to patients undergoing bariatric surgery. Methods: From July 2010 to August 2013, 198 consecutive bariatric surgery patients from an academic institution were randomized in a double blinded manner to receive either 40mg enoxaparin twice daily or 5mg fondaparinux sodium once daily. Antifactor Xa activity was measured on all patients in both study arms, 3 hours after the first dose (on the day of the operation), immediately before the second dose (postoperative day one), and 3 hours after the second dose. At the routine 2 week postoperative visit, patients underwent magnetic resonance venography (MRV) to detect DVT. The primary outcome was attainment of therapeutic antifactor Xa levels. The secondary outcome was DVT, as detected by MRV. Safety outcomes were perioperative bleeding, perioperative complications, and death. Results: Of 198 patients randomized, 177 underwent MRV and 137 had interpretable antifactor Xa levels. Nearly half of the patients (47.4%) did not attain target prophylactic antifactor Xa levels. Adequate antifactor Xa levels were more common with fondaparinux (74.2%) than with enoxaparin (32.4%). Antifactor Xa levels were also associated with preoperative D-dimer level. 4 of the 175 patients who underwent MRV developed DVT, 2 in each arm of the study. No major adverse events occurred in either arm.