another paper...a competitor?
1: J Thromb Haemost. 2006 Oct 13; [Epub ahead of print] Links
Efficacy and safety of recombinant human soluble thrombomodulin (ART-123) in disseminated intravascular coagulation: results of phase III randomized, double-blind, clinical trial.
* Saito H,
* Maruyama I,
* Shimazaki S,
* Yamamoto Y,
* Aikawa N,
* Ohno R,
* Hirayama A,
* Matsuda T,
* Asakura H,
* Nakashima M,
* Aoki N.
JR TOKAI General Hospital, Nagoya, Japan.
Background: Soluble thrombomodulin is a promising therapeutic natural anticoagulant that is comparable to antithrombin, tissue factor pathway inhibitor and activated protein C. Objectives: We conducted a multicenter, double-blind, randomized parallel-group trial to compare the efficacy and safety of recombinant human soluble thrombomodulin (ART-123) to those of low-dose heparin for the treatment of disseminated intravascular coagulation (DIC) associated with hematologic malignancy or infection. Methods: DIC patients (n= 234) were assigned to receive ART-123 (0.06 mg kg(-1) for 30 min, once daily) or heparin sodium (8 units kg(-1) h(-1) for 24 h) for six days using a double dummy method. The primary efficacy endpoint was DIC resolution rate. The secondary endpoints included clinical course of bleeding symptoms and mortality rate at 28 days. Results: DIC was resolved in 66.1% of the ART-123 group, as compared with 49.9% of the heparin group (difference 16.2%; 95% CI 3.3-29.1). Patients in the ART-123 group also showed more marked improvement in clinical course of bleeding symptoms (P= 0.0271). The incidence of bleeding-related adverse events up to 7 days after the start of infusion was lower in the ART-123 group than in the heparin group (43.1% vs. 56.5%, P= 0.0487). Conclusions: When compared with heparin therapy, ART-123 therapy more significantly improves DIC and alleviates bleeding symptoms in DIC patients.
