title: Preprocedural administration of nanofiltered C1 esterase inhibitor to prevent hereditary angioedema attacks.
abstract: Patients with hereditary angioedema (HAE) may have attacks triggered by dental, medical, or surgical procedures. This analysis evaluated the efficacy and safety of preprocedural administration of nanofiltered C1 esterase inhibitor (C1 INH-nf; human) for the prevention of HAE attacks during and after dental, medical, or surgical procedures. Data were reviewed retrospectively from two acute treatment trials in which at least 1000 U of C1 INH-nf was administered i.v. within 24 hours before an emergency or noncosmetic medical, surgical, or dental procedure. Dosing data, HAE attacks reported within 72 hours, and adverse events (AEs) reported within 7 days after a preprocedural dose of C1 INH-nf were analyzed to assess efficacy and safety. Forty-one unique subjects (8 children and 33 adults) received C1 INH-nf for 91 procedures (40 in children and 51 in adults). The majority of procedures (56%) involved dental work and 44% involved a variety of surgical or medical procedures. A single 1000-U dose of C1 INH-nf was administered for 96% of procedures. An HAE attack did not occur within 72 hours after C1 INH-nf dosing for 98% (89/91) of procedures. Two HAE attacks were reported after the procedure, and both were treated with C1 INH-nf and achieved relief. None of the reported AEs were judged to be related to C1 INH-nf or were associated with an HAE attack. This analysis supports the efficacy and safety of preprocedural administration of C1 INH-nf for the prevention of HAE attacks.
authors.affiliation: Department of Internal Medicine, University of Texas Medical Branch, Galveston, USA. jagrant@utmb.edu
authors.forename: J Andrew
authors.initials: JA
authors.lastname: Grant
authors.forename: Martha V
authors.initials: MV
authors.lastname: White
authors.forename: H Henry
authors.initials: HH
authors.lastname: Li
authors.forename: David
authors.initials: D
authors.lastname: Fitts
authors.forename: Ira N
authors.initials: IN
authors.lastname: Kalfus
authors.forename: Marc E
authors.initials: ME
authors.lastname: Uknis
authors.forename: William R
authors.initials: WR
authors.lastname: Lumry
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D054179:Angioedemas, Hereditary / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*; D002648:Child; D050718:Complement C1 Inhibitor Protein / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005374:Filtration / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D036103:Nanotechnology / Q000379:methods; D011292:Premedication; D013514:Surgical Procedures, Operative / Q000009:adverse effects*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D050718:Complement C1 Inhibitor Protein