Impact of recombinant soluble thrombomodulin (thrombomodulin alfa) on disseminated intravascular coagulation
| Autor: | Tadashi Matsushita, Yoichi Sakata, Hoyu Takahashi, Tatsuhiko Kuroda, Isao Kitajima, Yutaka Eguchi, Jun Mimuro, Hajime Tsuji |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
Thrombomodulin Gastroenterology Risk Factors hemic and lymphatic diseases Internal medicine Product Surveillance Postmarketing medicine Humans Adverse effect Survival rate Randomized Controlled Trials as Topic Disseminated intravascular coagulation business.industry Hematology Odds ratio Disseminated Intravascular Coagulation medicine.disease Recombinant Proteins Surgery Survival Rate Systemic inflammatory response syndrome Clinical Trials Phase III as Topic Thrombomodulin Alfa Concomitant business circulatory and respiratory physiology |
| Zdroj: | Thrombosis Research. 131:436-443 |
| ISSN: | 0049-3848 |
| Popis: | article i nfo Introduction: We assessed the safety and effectiveness of recombinant soluble thrombomodulin (thrombomodulin alfa, TM-α) in the treatment of disseminated intravascular coagulation (DIC) in a post-marketing surveillance. Methods: The cases of 3548 patients with DIC caused by infection (n = 2516, Infection-DIC) or hematological malignancy (n = 1032, Hemat-DIC) were analyzed and compared to the results of a phase III (P-III) study. Results: The DIC scores were significantly decreased in the Infection-DIC and Hemat-DIC groups with TM-α treat- ment (both P b 0.001). The incidences of critical bleeding adverse drug reactions (ADRs) in the Infection-DIC and Hemat-DIC groups were 2.6% and 2.4%, and the survival rates were 64.1% and 70.7%, respectively. Patients with DIC were subcategorized into three groups (Infection-DIC-1 or Hemat-DIC-1, P-III criteria-matched patients; Infection-DIC-2 or Hemat-DIC-2, P-III criteria-non-matched patients treated solely with TM-α ;a nd Infection-DIC-3 or Hemat-DIC-3, P-III criteria-non-matched patients treated with TM-α and other concomitant anticoagulants). Subcategory analysis revealed that the incidences of critical bleeding ADRs of Hemat-DIC-2 and Hemat-DIC-3 were significantly higher and their survival rates were significantly lower than those of Hemat-DIC-1. By multivariate analysis in Hemat-DIC, younger age (odds ratio: 2.629, P = 0.0033) and pre- existing bleeding (odds ratio: 2.044, P = 0.019) were found to affect bleeding ADRs and the severity of underlying disease was the most important factor for survival rate (odds ratio: 0.288, P b 0.001). Conclusions:This surveillance provided real-world data for the safety and effectiveness of TM-α in the treatment of Infection-DIC and Hemat-DIC in general practice settings. |
| Databáze: | OpenAIRE |
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