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.
Department of Pediatrics, New York Hospital-Cornell Medical Center, New York.
M
M
Hilgartner
L
L
Aledort
A
A
Andes
J
J
Gill
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