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- Alikhan, R, et al.
(författare)
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Prevention of venous thromboembolism in medical patients with enoxaparin: a subgroup analysis of the MEDENOX study
- 2003
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Ingår i: Blood Coagulation and Fibrinolysis. - 1473-5733. ; 14:4, s. 341-346
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Tidskriftsartikel (refereegranskat)abstract
- The Medical Patients with Enoxaparin (MEDENOX) trial was a randomized, placebo-controlled study that defined the risk of venous thromboembolism (VTE) in acutely ill, immobilized, general medical patients and the efficacy of the low-molecular-weight heparin, enoxaparin, in preventing thrombosis. We performed a post-hoc analysis to evaluate the effect of 40 mg enoxaparin once daily on MEDENOX patient outcome in different types of acute medical illness (heart failure, respiratory failure, infection, rheumatic disorder and inflammatory bowel disease) and pre-defined risk factors (chronic heart and chronic respiratory failure, age, immobility, previous VTE and cancer). The primary outcome was the occurrence of documented VTE between days 1 and 14. The relative risk reduction [95% confidence intervals (CI)] for VTE comparing 40 mg enoxaparin with placebo in the subgroups were: acute heart failure, 0.29 (95% CI, 0.10-0.84); acute respiratory failure, 0.25 (95% CI, 0.10-0.65); acute infectious disease, 0.28 (95% CI, 0.09-0.81); and acute rheumatic disorder, 0.48 (95% CI, 0.11-2.16). The relative risk reduction for VTE in the pre-defined risk factor subgroups were: chronic heart failure, 0.26 (95% Cl, 0.08-0.92); chronic respiratory failure, 0.26 (95% CI, 0.10-0.68); age, 0.22 (95% CI, 0.09-0.51); immobility, 0.53 (95% CI, 0.14-1.72); previous VTE, 0.49 (95% CI, 0.15-1.68); and cancer, 0.50 (95% CI, 0.14-1.72). The beneficial effects of enoxaparin extend to a wide range of acutely ill medical patients. (C) 2003 Lippincott Williams Wilkins.
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| 2. |
- Alikhan, R, et al.
(författare)
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Risk factors for venous thromboembolism in hospitalized patients with acute medical illness - Analysis of the MEDENOX study
- 2004
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Ingår i: Archives of Internal Medicine. - 0003-9926. ; 164:9, s. 963-968
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Tidskriftsartikel (refereegranskat)abstract
- Background: There is limited information about risk factors for venous thromboembolism (VTE) in acutely ill hospitalized general medical patients. Methods: An international, randomized, double-masked, placebo-controlled trial (MEDENOX) has previously been conducted in 1102 acutely ill, immobilized general medical patients and has shown the efficacy of using a low-molecular-weight heparin, enoxaparin sodium, in preventing thrombosis. We performed logistic regression analysis to evaluate the independent nature of different types of acute medical illness (heart failure, respiratory failure, infection, rheumatic disorder, and inflammatory bowel disease) and predefined factors (chronic heart and respiratory failure, age, previous VTE, and cancer) as risk factors for VTE. Results: The primary univariate analysis showed that the presence of an acute infectious disease, age older than 75 years, cancer, and a history of VTE were statistically significantly associated with an increased VTE risk. Multiple logistic regression analysis indicated that these factors were independently associated with VTE. Conclusions: Several independent risk factors for VTE were identified. These findings allow recognition of individuals at increased risk of VTE and will contribute to the formulation of an evidence-based risk assessment model for thromboprophylaxis in hospitalized general medical patients.
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| 3. |
- Bergqvist, D, et al.
(författare)
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Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer.
- 2002
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Ingår i: New England Journal of Medicine. - 0028-4793. ; 346:13, s. 975-980
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Tidskriftsartikel (refereegranskat)abstract
- Background: Abdominal surgery for cancer carries a high risk of venous thromboembolism, but the optimal duration of postoperative thromboprophylaxis is unknown. Methods: We conducted a double-blind, multicenter trial in which patients undergoing planned curative open surgery for abdominal or pelvic cancer received enoxaparin (40 mg subcutaneously) daily for 6 to 10 days and were then randomly assigned to receive either enoxaparin or placebo for another 21 days. Bilateral venography was performed between days 25 and 31, or sooner if symptoms of venous thromboembolism occurred. The primary end point with respect to efficacy was the incidence of venous thromboembolism between days 25 and 31. The primary safety end point was bleeding during the three-week period after randomization. The patients were followed for three months. Results: The intention-to-treat analysis of efficacy included 332 patients. The rates of venous thromboembolism at the end of the double-blind phase were 12.0 percent in the placebo group and 4.8 percent in the enoxaparin group (P=0.02). This difference persisted at three months (13.8 percent vs. 5.5 percent, P=0.01). Three patients in the enoxaparin group and six in the placebo group died within three months after surgery. There were no significant differences in the rates of bleeding or other complications during the double-blind or follow-up periods. Conclusions: Enoxaparin prophylaxis for four weeks after surgery for abdominal or pelvic cancer is safe and significantly reduces the incidence of venographically demonstrated thrombosis, as compared with enoxaparin prophylaxis for one week. (N Engl J Med 2002;346:975-80.) Copyright (C) 2002 Massachusetts Medical Society.
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| 7. |
- Desjardins, L, et al.
(författare)
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Correlation of plasma coagulation parameters with thromboprophylaxis, patient characteristics, and outcome in the MEDENOX study
- 2004
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Ingår i: Archives of pathology & laboratory medicine. - 0003-9985. ; 128:5, s. 519-526
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Tidskriftsartikel (refereegranskat)abstract
- 0 Context.-Plasma anti-Xa and anti-IIa activities correlate with the dose of low-molecular-weight heparin, and D-dimer and thrombin-antithrombin complexes are markers of procoagulant activity. Objective.-To investigate the relationship between plasma coagulation parameters and patient characteristics, including renal function, thromboprophylaxis, and incidence of venous thromboembolism (VTE) in the MEDENOX study population. Design.-Controlled, multicenter, double-blind, randomized study. Patients.-Two hundred twenty-four acutely ill medical patients. Interventions.-Either 20 or 40 mg of enoxaparin administered subcutaneously or a placebo once daily for 10 (+/-4) days. ain Outcome Measures.-VTE and plasma anti-Xa and anti-IIa activities, D-dimer, and thrombin-antithrombin levels in blood collected before prophylaxis was given (day 0) and after the last injection of the study drug. Results and Conclusions.-Anti-Xa activity correlated with the dose of enoxaparin. In patients with mild or moderate renal impairment, there was no significant relationship between anti-Xa activity and the creatinine clearance rate. D-dimer concentrations were lower at day 10 (+/-4) in the 40-mg group, which had a 63% lower VTE incidence, than at day 0. No venographically confirmed thromboses were found in patients with a normal D-dimer I concentration (<0.5 mug/mL [0.5 mg/L]). D-dimer levels were higher in patients with VTE than in those without VTE, but no predictive value could be demonstrated for individual patients.
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