Efficacy and safety of vapor-heated anti-inhibitor coagulant complex in hemophilia patients. FEIBA Study Group.
The study reported here was designed to measure the efficacy and safety of a vapor-heated anti-inhibitor coagulant complex (FEIBA-VH) for the treatment of bleeding episodes in patients with hemophilia A who have inhibitors to factor VIII (FVIII). FEIBA-VH, a second-generation complex, is vapor-heated for 10 hours at a temperature of 60 degrees C and a pressure of 1190 millibar (mbar) and for 1 additional hour at 80 degrees C and 1375 mbar. The current study was performed because of concern that this vapor-heating process would reduce the efficacy of FEIBA-VH as compared with non-heat-treated FEIBA (FEIBA). Forty-one patients received FEIBA-VH for 106 evaluable bleeding episodes. Ninety-three (88%) episodes were controlled, and 13 (12%) were not. Eighty-three (79%) episodes were controlled within 36 hours of the first infusion. No significant toxicity was seen. These results were compared with those of an earlier study with FEIBA. FEIBA-VH was at least as effective as FEIBA in controlling bleeding episodes and can be compared favorably to any reported treatment of bleeding episodes in hemophiliacs with inhibitors to FVIII.
Hilgartner
M
M
Department of Pediatrics, New York Hospital-Cornell Medical Center, New York.
Aledort
L
L
Andes
A
A
Gill
J
J
D001779:Blood Coagulation Factors / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D006467:Hemophilia A / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D013696:Temperature; D014835:Volatilization
D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates; C065655:anti-inhibitor coagulant complex