Efficacy of human C1 esterase inhibitor concentrate for treatment of ACE-inhibitor induced angioedema

Strassen, Ulrich; Bas, Murat; Wirth, Magdalena; Wirth, Markus; Groeger, Moritz; Stelter, Klaus; Volkenstein, Stefan; Kehl, Victoria; Kojda, Georg; Hoffmann, Thomas K.; Hahn, Janina; Trainotti, Susanne und Greve, Jens (2022): Efficacy of human C1 esterase inhibitor concentrate for treatment of ACE-inhibitor induced angioedema. In: American Journal of Emergency Medicine, Bd. 64: S. 121-128

Abstract

Background: ACE inhibitor (ACEi) induced angioedema predominantly affects the upper aerodigestive tract. As ACEi induced angioedema is mediated by bradykinin, therapeutic response to antihistamines and glucocorticoids remains unsatisfactory. In bradykinin mediated hereditary angioedema, C1-esterase inhibitor (C1INH) is an ef-fective and approved treatment since many years. Our aim was to evaluate the therapeutic effect of C1INH in ACEi induced angioedema.Methods: We performed a double-blind, parallel-group, multicentre randomised placebo-controlled trial be-tween December 2013 and September 2018. Eligible were adults with ACEi induced angioedema with airway ob-struction. Participants were randomised 1:1 to single doses of either C1INH (20 IU/kg) or placebo (0.9% NaCl) i.v in addition to standard care (i.v. 500 mg prednisolone and 2.68 mg clemastine) i.v. Composite symptom scores were assessed at baseline and up to 48 h, at discharge and 1 week after discharge. Physician assessed time to complete oedema resolution (TCER) and time to onset of relief (TOR).Results: 30 patients (16 C1INH, 14 placebo) were randomised and dosed. 25 (9 C1INH, 12 placebo) completed the study. TCER was 29.63 h +/- 15.56 h in the C1INH and 17.29 h +/- 10.40 h in the placebo arm (p = 0.0457). TORs were 4.13 h +/- 3.38 h and 2.86 h +/- 1.29 h for C1INH and placebo, respectively (p = 0.4443). There were no adverse events related to study medication.Conclusions: In the context of baseline application of steroids and antihistamines C1INH was inferior in the treatment of ACEi induced angioedema when compared to placebo with respect to time to complete resolution of symptoms. Eudra-CT Number: 2012-001670-28.(c) 2022 Elsevier Inc. All rights reserved.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 0735-6757
• Sprache: Englisch