Introduction
In clinical trials, fixed-dose enoxaparin (40 mg once daily) reduces the risk of venous thromboembolism (VTE) in medically-ill patients. However, morbidly obese patients were under-represented in these trials and using fixed-dose enoxaparin in obese patients may be inadequate. We completed a pharmacokinetic study in morbidly obese, medically-ill patients to determine if weight-based dosing of enoxaparin for VTE prophylaxis was feasible, without excessive levels of anticoagulation, as determined by peak anti-Xa levels.
Materials and Methods
Twenty eight morbidly obese (BMI≥35 kg/m2) patients were enrolled and completed the study protocol. Enoxaparin 0.5 mg/kg was administered once daily subcutaneously and peak anti-Xa levels were measured approximately 4–6 hours after the enoxaparin dose.
Results and Conclusions
Overall, 46% of patients were female, the average age (±SD) was 54 (±11) years, and the average weight and BMI were 135.6 kg (±25.3) and 48.1 kg/m2 (±11.1), respectively. The average daily dose of enoxaparin was 67 mg (±12). The average peak anti-Xa level was 0.25 (SD±0.11, range 0.08 to 0.59) units/mL. Peak anti-Xa levels did not significantly correlate with weight or BMI. There were no bleeding events, symptomatic VTE, or significant thrombocytopenia.
In morbidly obese, medically-ill patients, use of weight-based enoxaparin dosed at 0.5 mg/kg once daily is feasible and results in peak anti-Xa levels within or near recommended range for thromboprophylaxis, without any evidence of excessive anti-Xa activity. These data suggest that this weight-based regimen may be more effective than standard fixed-dose enoxaparin. Clinical outcome studies are warranted to determine the clinical safety and efficacy of this regimen.
Venous thromboembolism (VTE) is common but often unrecognized in medically ill patients. Over the past 5 years, three large-scale placebo-controlled trials enrolling a total of 5500 medically ill patients have highlighted the risk of VTE in this group. These trials have helped to define a specific at-risk patient profile, including those admitted to the hospital with severe congestive heart failure, respiratory illness, acute infection, and inflammatory bowel disease. We performed a retrospective review of patients admitted to the medical service at our tertiary care center to define how common the at-risk medical patient is and to evaluate and improve prophylaxis rates in this patient group. The study was conducted in two phases. Based on admission characteristics, patients were stratified into high-risk or low-risk groups for the development of VTE. During the pre-intervention phase, 75% of patients admitted to the medical service were characterized as increased risk for VTE, yet only 43% of these high-risk patients received prophylaxis of any sort. After interventions designed to increase awareness of VTE, we conducted a second review period. In this post-intervention phase, where 79% of patients were at risk for VTE, prophylaxis rates improved to 72%. Based on these results, we conclude that the majority of patients admitted to the medical service at our tertiary care center constitute a high-risk population that warrants consideration for VTE prophylaxis. Implementation of strategies to improve prophylaxis rates, including educational sessions and risk stratification guidelines, can be successful and improve identification and prophylaxis of this population. Am.
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Use of a fixed-dose argatroban regimen without laboratory monitoring is a potential management strategy for patients with HIT/HITTS and an elevated baseline aPTT due to APS.
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