Subcutaneous adjusted-dose unfractionated heparin vs fixed-dose low-molecular-weight heparin in the initial treatment of venous thromboembolism.

Abstract

BACKGROUND:

Few reports have addressed the value of unfractionated heparin (UFH) or low-molecular-weight heparin in treating the full spectrum of patients with venous thromboembolism (VTE), including recurrent VTE and pulmonary embolism.

METHODS:

In an open, multicenter clinical trial, 720 consecutive patients with acute symptomatic VTE, including 119 noncritically ill patients (16.5%) with pulmonary embolism and 102 (14.2%) with recurrent VTE, were randomly assigned to treatment with subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm (preceded by an intravenous loading dose), or fixed-dose (adjusted only to body weight) subcutaneous nadroparin calcium. Oral anticoagulant therapy was started concomitantly and continued for at least 3 months. We recorded the incidence of major bleeding during the initial heparin treatment and that of recurrent VTE and death during 3 months of follow-up.

RESULTS:

Fifteen (4.2%) of the 360 patients assigned to UFH had recurrent thromboembolic events, as compared with 14 (3.9%) of the 360 patients assigned to nadroparin (absolute difference between rates, 0.3%; 95% confidence interval, -2.5% to 3.1%). Four patients assigned to UFH (1.1%) and 3 patients assigned to nadroparin (0.8%) had episodes of major bleeding (absolute difference between rates, 0.3%; 95% confidence interval, -1.2% to 1.7%). Overall mortality was 3.3% in each group.

CONCLUSIONS:

Subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm is as effective and safe as fixed-dose nadroparin for the initial treatment of patients with VTE, including those with pulmonary embolism and recurrent VTE.

• Authors: Paolo Prandoni, Marino Carnovali, Antonio Marchiori, Galilei Investigators
• Journal: Archives of internal medicine (Arch Intern Med) Vol. 164 Issue 10 Pg. 1077-83 (May 24 2004) ISSN: 0003-9926 [Print] United States
• PMID: 15159264 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Heparin, Low-Molecular-Weight
• Heparin

Topics

• Adult
• Aged
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Heparin (administration & dosage, adverse effects)
• Heparin, Low-Molecular-Weight (administration & dosage, adverse effects)
• Humans
• Injections, Subcutaneous
• Male
• Middle Aged
• Pulmonary Embolism (diagnosis, drug therapy, mortality)
• Recurrence
• Risk Assessment
• Severity of Illness Index
• Single-Blind Method
• Survival Rate
• Treatment Outcome
• Venous Thrombosis (diagnosis, drug therapy, mortality)