PMID- 22856635 OWN - NLM STAT- MEDLINE DCOM- 20121220 LR - 20161020 IS - 1539-6304 (Electronic) IS - 1088-5412 (Linking) VI - 33 IP - 4 DP - 2012 Jul-Aug TI - Preprocedural administration of nanofiltered C1 esterase inhibitor to prevent hereditary angioedema attacks. PG - 348-53 LID - 10.2500/aap.2012.33.3585 [doi] AB - 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. FAU - Grant, J Andrew AU - Grant JA AD - Department of Internal Medicine, University of Texas Medical Branch, Galveston, USA. jagrant@utmb.edu FAU - White, Martha V AU - White MV FAU - Li, H Henry AU - Li HH FAU - Fitts, David AU - Fitts D FAU - Kalfus, Ira N AU - Kalfus IN FAU - Uknis, Marc E AU - Uknis ME FAU - Lumry, William R AU - Lumry WR LA - eng SI - ClinicalTrials.gov/NCT00289211 SI - ClinicalTrials.gov/NCT00438815 PT - Clinical Trial PT - Controlled Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - Allergy Asthma Proc JT - Allergy and asthma proceedings JID - 9603640 RN - 0 (Complement C1 Inhibitor Protein) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Angioedemas, Hereditary/drug therapy/etiology/*prevention & control MH - Child MH - Complement C1 Inhibitor Protein/administration & dosage/adverse effects/*therapeutic use MH - Female MH - Filtration/methods MH - Humans MH - Male MH - Middle Aged MH - Nanotechnology/methods MH - *Premedication MH - Surgical Procedures, Operative/*adverse effects MH - Treatment Outcome MH - Young Adult EDAT- 2012/08/04 06:00 MHDA- 2012/12/21 06:00 CRDT- 2012/08/04 06:00 PHST- 2012/08/04 06:00 [entrez] PHST- 2012/08/04 06:00 [pubmed] PHST- 2012/12/21 06:00 [medline] AID - 10.2500/aap.2012.33.3585 [doi] PST - ppublish SO - Allergy Asthma Proc. 2012 Jul-Aug;33(4):348-53. doi: 10.2500/aap.2012.33.3585.