A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor.

Astermark, Jan (author): Lund University,Lunds universitet,Institutionen för kliniska vetenskaper, Malmö,Medicinska fakulteten,Klinisk koagulationsmedicin, Malmö,Forskargrupper vid Lunds universitet,Department of Clinical Sciences, Malmö,Faculty of Medicine,Clinical Coagulation, Malmö,Lund University Research Groups

Donfield, Sharyne M (author)

Dimichele, Donna M (author)

Gringeri, Alessandro (author)

Gilbert, Steven A (author)

Waters, Jennifer (author)

Berntorp, Erik (author): Lund University,Lunds universitet,Klinisk koagulationsmedicin, Malmö,Forskargrupper vid Lunds universitet,Clinical Coagulation, Malmö,Lund University Research Groups

(creator_code:org_t)

2006-09-21
2007
English.
In: Blood. - : American Society of Hematology. - 1528-0020 .- 0006-4971. ; 109:Sep 21, s. 546-551

Related links:: http://www.ncbi.nlm.... (free); show more...; http://dx.doi.org/10... (free); https://lup.lub.lu.s...; https://doi.org/10.1...; show less...

Abstract Subject headings

The development of inhibitory antibodies to factor VIII is a serious complication of hemophilia. FEIBA (factor VIII inhibitor-bypassing activity), an activated prothrombin complex concentrate (aPCC), and NovoSeven, recombinant factor Vila (rFVIIa), are used as hemostatic bypassing agents in treating patients with inhibitors. The FENOC study was designed to test equivalence of the products in the treatment of ankle, knee, and elbow joint bleeding. A prospective, open-label, randomized, crossover, equivalency design was used. The parameters of interest were the percentage of patients who reported efficacy in response to FEIBA and the percentage that reported efficacy in response to NovoSeven. A difference in these percentages of no more than 15% was determined to be a clinically acceptable magnitude for equivalence of the 2 products. The primary outcome was evaluation 6 hours after treatment. Data for 96 bleeding episodes contributed by 48 participants were analyzed. The criterion for declaring the 2 products equivalent at 6 hours was not met; however, the confidence interval of the difference in percentages of efficacy reported for each product only slightly exceeded the 15% boundary (-11.4%-15.7%), P=.059. FEIBA and NovoSeven appear to exhibit a similar effect on joint bleeds, although the efficacy between products is rated differently by a substantial proportion of patients. This trial was registered at www.clinicaltrials.gov as #NCT00166309.

By the author/editor: Astermark, Jan; Donfield, Sharyn ...; Dimichele, Donna ...; Gringeri, Alessa ...; Gilbert, Steven ...; Waters, Jennifer; show more...; Berntorp, Erik; show less...

About the subject

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Hematology

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