Methodology Score: 1.5/5 Usefulness Score: 1/5
Baş M, Greve J, Stelter K, et al. N Engl J Med. 2015 Jan 29;372(5):418-25
Full Article
This small phase 2, multicenter, double blind randomized trial of 30 ED patients found a shorter time to complete resolution of ACE-I induced angioedema with a bradykinin antagonist, icatibant, compared with standard therapy (glucocorticoids and antihistamines). While the premise showed promise, JC attendees were disappointed by the lack of allocation concealment, no intention to treat analysis, loss to follow-up and wide confidence intervals. Further high quality study is required before considering this therapy for this challenging population. By: Dr. Ian Taylor
Epi Lesson: Intention to Treat vs. Per Protocol Analyses
Baş M, Greve J, Stelter K, et al. N Engl J Med. 2015 Jan 29;372(5):418-25
Full Article
This small phase 2, multicenter, double blind randomized trial of 30 ED patients found a shorter time to complete resolution of ACE-I induced angioedema with a bradykinin antagonist, icatibant, compared with standard therapy (glucocorticoids and antihistamines). While the premise showed promise, JC attendees were disappointed by the lack of allocation concealment, no intention to treat analysis, loss to follow-up and wide confidence intervals. Further high quality study is required before considering this therapy for this challenging population. By: Dr. Ian Taylor
Epi Lesson: Intention to Treat vs. Per Protocol Analyses