Icatibant in ACEi-induced angioedema
Trial question
What is the role of icatibant in patients who had ACE-inhibitor-induced angioedema?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 27
27 patients (10 female, 17 male).
Inclusion criteria: patients who had ACE-inhibitor-induced angioedema of the upper aerodigestive tract.
Key exclusion criteria: causes other than ACE inhibitors, history of angioedema before the initiation of ACE-inhibitor therapy, acute urticaria, unstable angina, acute myocardial ischemia, acute HF with a NYHA class of III or IV, pregnancy, and lactation.
Interventions
N=13 icatibant (at a dose of 30 mg SC).
N=14 standard therapy (intravenous 500 mg prednisolone plus 2 mg clemastine).
Primary outcome
Median time to complete resolution of edema
8 hours
27.1 hours
27.1 hours
20.3 hours
13.6 hours
6.8 hours
0.0 hours
Icatibant
Standard
therapy
Significant
decrease ▼
Significantly shorter median time to complete resolution of edema (8 hours vs. 27.1 hours; AD -19.1 hours, 95% CI -31.18 to -7.02).
Secondary outcomes
Significant increase in complete resolution within 4 hours (38% vs. 0%; AD 38%, 95% CI 5.95 to 70.05).
Significantly shorter median time to the onset of symptom relief (2 hours vs. 11.7 hours; AD -9.7 hours, 95% CI -18.47 to -0.93).
Safety outcomes
No significant difference in drug-related adverse event.
Significant differences in adverse events (7% vs. 27%), redness at injection site (80% vs. 27%), swelling at injection site (53% vs. 20%), pain at injection site (47% vs. 13%).
Conclusion
In patients who had ACE-inhibitor-induced angioedema of the upper aerodigestive tract, icatibant was superior to standard therapy with respect to median time to complete resolution of edema.
Reference
Bas M, Greve J, Stelter K et al. A randomized trial of icatibant in ACE-inhibitor-induced angioedema. N Engl J Med. 2015 Jan 29;372(5):418-25.
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