Ecallantide was no more effective than placebo in this phase II study.
Ecallantide, a kallikrein inhibitor, is FDA-approved for treatment of hereditary angioedema. To evaluate its effectiveness for angiotensin-converting enzyme (ACE) inhibitor–induced angioedema (ACEIIA), investigators conducted a multicenter, double-blind, randomized, controlled phase II trial funded by the manufacturer. All patients received conventional therapy; those in the ecallantide group received doses of 10, 30, or 60 mg.
Of 76 patients, most had mild (45%) or moderate (42%) ACEIIA. The proportion of patients stable and ready for discharge 6 hours after treatment did not differ significantly between the placebo and ecallantide groups (72% and 88%).
Reviewing Author
DisclosuresConsultant/Advisory BoardPortola Pharmaceuticals, Inc.
Speaker’s BureauPeerView Institute for Medical Education
Grant/Research SupportAgency for Healthcare Research and Quality; CDC; NIH–National Center for Advancing Translational Sciences; NIH–National Institute of Allergy and Infectious Diseases (NIAID); NIH–NIAID–Antibacterial Resistance Leadership Group; Merck; Pfizer; Boehringer-Ingelheim; Shire; Portola Pharmaceuticals, Inc.; Novartis; bioMérieux; Siemens; Rapid Pathogen Screening; Magnolia; Stago; Innovative Biosensors; Molecular Detection, Inc.; Dyax Corp.; Trius Pharmaceuticals
DisclosuresConsultant/Advisory BoardPortola Pharmaceuticals, Inc.
Speaker’s BureauPeerView Institute for Medical Education
Grant/Research SupportAgency for Healthcare Research and Quality; CDC; NIH–National Center for Advancing Translational Sciences; NIH–National Institute of Allergy and Infectious Diseases (NIAID); NIH–NIAID–Antibacterial Resistance Leadership Group; Merck; Pfizer; Boehringer-Ingelheim; Shire; Portola Pharmaceuticals, Inc.; Novartis; bioMérieux; Siemens; Rapid Pathogen Screening; Magnolia; Stago; Innovative Biosensors; Molecular Detection, Inc.; Dyax Corp.; Trius Pharmaceuticals