| Abstract | Recombinant factor VIIa (rFVIIa) represents a major therapeutic advance in the treatment of haemophilia patients with inhibitors. The efficacy and safety of rFVIIa has been extensively studied in over 1900 surgical and non-surgical bleeding episodes in over 400 patients with haemophilia A or B (with or without inhibitors) or acquired haemophilia. Of 103 evaluable surgical bleeding episodes, the response to treatment with rFVIIa was considered to be either excellent or effective in 81%, 86% and 92% of major, minor and dental bleeding episodes, respectively. Treatment has been evaluated in 518 serious bleeding episodes and the response was considered either excellent or effective in 62% of muscle, 80% of ear, nose and throat, 88% of central nervous system, 76% of joint, and 75% of internal or retroperitoneal bleeding episodes. An excellent safety profile has also been demonstrated: of 1957 treatments with rFVIIa, only 16 serious adverse events have been reported that were considered to be possibly, but not necessarily, related to treatment. |
| Authors | J Lusher, J Ingerslev, H Roberts, U Hedner
(Affiliation: Children's Hospital of Michigan, Wayne State University School of Medicine, Detroit, USA.)
|
| Journal | Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis
(Blood Coagul Fibrinolysis)
Vol. 9
Issue 2
Pg. 119-28
(Mar 1998)
ISSN: 0957-5235 ENGLAND |
| PMID | 9622209
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
|
| Chemical References |
- Recombinant Proteins
- Factor VIIa
|
| Topics |
- Clinical Trials as Topic
- Dose-Response Relationship, Drug
- Drug Monitoring
- Factor VIIa
(adverse effects, therapeutic use)
- Hemophilia A
(drug therapy)
- Hemophilia B
(drug therapy)
- Humans
- Recombinant Proteins
(adverse effects, therapeutic use)
|
