Search

Background: Extended-duration low-molecular-weight heparin has been shown to prevent venous thromboembolism (VTE) in high-risk surgical patients. Objective: To evaluate the efficacy and safety of extended-duration enoxaparin thromboprophylaxis in acutely ill medical patients. Design: Randomized, parallel, placebo-controlled trial. Randomization was computer-generated. Allocation was centralized. Patients, caregivers, and outcome assessors were blinded to group assignment. (ClinicalTrials.gov registration number: NCT00077753) Setting: 370 sites in 20 countries across North and South America, Europe, and Asia. Patients: Acutely ill medical patients 40 years or older with recently reduced mobility (bed rest or sedentary without [level 1] or with [level 2] bathroom privileges). Eligibility criteria for patients with level 2 immobility were amended to include only those who had additional VTE risk factors (age >75 years, history of VTE, or active or previous cancer) after interim analyses suggested lower-than-expected VTE rates. Intervention: Enoxaparin, 40 mg/d subcutaneously (2975 patients), or placebo (2988 patients), for 28 [+ or -] 4 days after receiving open-label enoxaparin for an initial 10 [+ or -] 4 days. Measurements: Incidence of VTE up to day 28 and of major bleeding events up to 48 hours after the last study treatment dose. Results: Extended-duration enoxaparin reduced VTE incidence compared with placebo (2.5% vs. 4%; absolute risk difference favoring enoxaparin, -1.53% [95.8% CI, -2.54% to -0.52%]). Enoxaparin increased major bleeding events (0.8% vs. 0.3%; absolute risk difference favoring placebo, 0.51% [95% CI, 0.12% to 0.89%]). The benefits of extended-duration enoxaparin seemed to be restricted to women, patients older than 75 years, and those with level 1 immobility. Limitation: Estimates of efficacy and safety for the overall trial population are difficult to interpret because of the change in eligibility criteria during the trial. Conclusion: Use of extended-duration enoxaparin reduces V-I-E more than it increases major bleeding events in acutely ill medical patients with level 1 immobility, those older than 75 years, and women. Primary Funding Source: Sanofi-aventis.

Objectives: Though numerous studies have demonstrated the short-term efficacy of lung volume reduction surgery (LVRS) in select patients with emphysema, the longer-term follow-up studies are just being reported. The primary [...]

Most patients with severe COPD remain significantly symptomatic despite medical therapy, and they have a disturbingly high short-term mortality. Many patients desperately seek symptomatic relief, and they would consider undergoing [...]

Extramedullary hematopoiesis (EMH) associated with myelofibrosis uncommonly occurs within the thorax. We describe the first reported case of acute and rapidly fatal respiratory failure due to pulmonary interstitial EMH associated [...]

Background: Low-molecular-weight heparins administered subcutaneously once or twice daily have been reported to be as safe and efficacious as intravenous unfractionated heparin in the treatment of acute venous thromboembolic disease. Objective: To determine whether subcutaneous enoxaparin administered once or twice daily is as effective as continuously infused unfractionated heparin in acute symptomatic venous thromboembolic disease. Design: Randomized, controlled, partially blinded equivalence trial. Setting: 74 hospitals in 16 countries. Patients: 900 patients with symptomatic lower-extremity deep venous thrombosis, including 287 (32%) with confirmed pulmonary embolism. Interventions: Initial therapy with dose-adjusted intravenous unfractionated heparin compared with subcutaneous enoxaparin at fixed dosages of 1.0 mg/kg of body weight twice daily or 1.5 mg/kg once daily. Long-term oral anticoagulation was started in all patients within 72 hours of randomization. Measurements: Clinical end points assessed during a 3-month follow-up period. Results: Equivalent efficacy was seen in the heparin group and both enoxaparin groups. Symptomatic venous thromboembolism recurred in 12 of 290 patients receiving unfractionated heparin (4.1%), 13 of 298 patients receiving once-daily enoxaparin (4.4%), and 9 of 312 patients receiving twice-daily enoxaparin (2.9%). Compared with unfractionated heparin, the treatment difference was 0.2% (95% Cl, -3.04% to 3.49%) for once-daily enoxaparin and -1.2% (Cl, -4.2% to 1.7%) for twice-daily enoxaparin. Incidence of major hemorrhage did not differ among the three treatment groups. Major hemorrhage occurred in 6 of 290 patients (2.1%) in the unfractionated heparin group, 5 of 298 patients (1.7%) in the once-daily enoxaparin group, and 4 of 312 patients (1.3%) in the twice-daily enoxaparin group. Conclusions: Subcutaneous enoxaparin once or twice daily is as effective and safe as dose-adjusted, continuously infused unfractionated heparin in the prevention of recurrent symptomatic venous thromboembolic disease.

Traditionally, pulmonary physicians rely on measures of lung function to diagnose, to assess disease severity, and to determine response to therapy in patients with COPD. The [FEV.sub.1] has been used [...]

Background: Enoxaparin, a low-molecular-weight heparin administered to hospitalized patients once or twice daily, has shown efficacy and safety equivalent to unfractionated heparin in the treatment of acute venous thromboembolic disease. Although the cost of either enoxaparin regimen is greater than that of unfractionated heparin, the overall cost of care for each of these 3 treatment strategies is unknown. Methods: A cost minimization analysis of a 3-month, partially blinded, randomized, controlled efficacy and safety trial of anticoagulant therapy for deep vein thrombosis. Three hundred thirty-nine hospitalized patients with symptomatic lower extremity deep vein thrombosis were randomly assigned to initial therapy with subcutaneous enoxaparin either once (n = 112) or twice (n=123) daily, or with dose-adjusted intravenous unfractionated heparin (n=104), followed by long-term oral anticoagulant therapy. Estimated 1997 total cost from a third-party payer perspective for the 3-month episode of care was calculated by assigning standard unit costs to counts of medical resources used by each patient in the clinical trial. Results: Average total cost for the 3-month episode of care was similar across all 3 treatment regimens: once-daily dose of enoxaparin, $12166 (95% confidence interval [CI], $10 744-$13588); twice-daily dose of enoxaparin, $11558 (95% CI, $10 201-$12915); and unfractionated heparin, $12146 (95% CI, $10670-$12622). Bootstrapped estimates and sensitivity analyses did not significantly change findings. Conclusions: There was no significant difference in the overall cost for the 3-month episode of care for patients treated with either enoxaparin or unfractionated heparin. Additional acquisition costs for anticoagulant medication among patients treated with enoxaparin were offset by savings associated with lower incidence of hospital readmission and shorter duration of venous thromboembolism-related readmissions. Arch Intern Med. 2000;160:3160-3165

An Evidence-Based Guideline Objective: A panel was convened by the Health and Science Policy Committee of the American College of Chest Physicians to develop a clinical practice guideline on the [...]

Chian-Min Loo, MD(*); Roger D Yusen, MD; Stephen S Lefrak, MD; Peter G Tuteur, MD and Joel D Cooper, MD. Division of Pulmonary and Critical Care Medicine and Division of [...]

An Objective Model Based on Prior Clinical Decisions and Quantitative CT Analysis Objectives: We used whole-lung quantitative CT analysis (QCT)--an objective method of evaluating emphysema severity and distribution based on [...]

Purpose: To describe subjective health status and survival after bilateral lung volume reduction surgery (LVRS). Methods: Prospective data collection from 192 of our first 200 LVRS patients through 1/1/99; 8 [...]

Background: It is a common practice to anesthetize patients before performing a thoracentesis. We postulated that this technique may cause a clinically significant difference in the pH of the pleural [...]

Study objectives: To develop and to evaluate selection criteria for outpatient management of deep venous thrombosis (DVT). Design: We developed outpatient treatment eligibility criteria that incorporated demographic and clinical data. [...]