Comparison of tinzaparin and acenocoumarol for the secondary prevention of venous thromboembolism: a multicentre, randomized study.

Abstract

The objective of the present study was to evaluate the efficacy, safety and healthcare resource utilization of long-term treatment with tinzaparin in symptomatic patients with acute pulmonary embolism as compared to standard therapy. In this open-label trial, 102 patients with objectively confirmed pulmonary embolism were randomized to receive, after initial treatment with tinzaparin, either tinzaparin (175 IU/kg/day) or international normalized ratio-adjusted acenocoumarol for 6 months. Clinical endpoints were assessed during the 6 months of treatment. A pharmacoeconomic analysis was carried out to evaluate the cost of the long-term treatment with tinzaparin in comparison with the standard one. In an intention-to-treat analysis, one of 52 patients developed recurrent venous thromboembolism in the tinzaparin group compared with none of the 50 patients in the acenocoumarol group. One patient in each group had a major haemorrhagic complication. Six patients in the acenocoumarol group had minor bleeding compared with none in the tinzaparin group (P = 0.027). Median hospital length of stay was shorter in the tinzaparin group compared to the acenocoumarol group (7 versus 9 days; P = 0.014). When all the direct and indirect cost components were combined for the entire population, we found a slight, nonstatistically significant (mean difference €345; 95% CI 1382-2071; P = 0.69) reduction in total cost with tinzaparin. Symptomatic acute pulmonary embolism treatment with full therapeutic doses of tinzaparin for 6 months is a feasible alternative to conventional treatment with vitamin K antagonists.

• Authors: Luis A Pérez-de-Llano, Virginia Leiro-Fernández, Rafael Golpe, Jose M Núñez-Delgado, Ana Palacios-Bartolomé, Lidia Méndez-Marote, Esteve Colomé-Nafria
• Journal: Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis (Blood Coagul Fibrinolysis) Vol. 21 Issue 8 Pg. 744-9 (Dec 2010) ISSN: 1473-5733 [Electronic] England
• PMID: 20885298 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticoagulants
• Fibrinolytic Agents
• Heparin, Low-Molecular-Weight
• Tinzaparin
• Acenocoumarol

Topics

• Acenocoumarol (adverse effects, therapeutic use)
• Adult
• Aged
• Aged, 80 and over
• Anticoagulants (therapeutic use)
• Female
• Fibrinolytic Agents (adverse effects, therapeutic use)
• Heparin, Low-Molecular-Weight (adverse effects, therapeutic use)
• Humans
• Male
• Middle Aged
• Pulmonary Embolism (drug therapy)
• Tinzaparin
• Treatment Outcome
• Venous Thromboembolism (prevention & control)
• Young Adult