To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Icatibant Safe and Effective in Treating Symptoms of Hereditary Angioedema: Presented at AAAAI URL: http://www.pslgroup.com/dg/21E9BA.htm Doctor's Guide March 20, 2008
By Maggie Schwarz PHILADELPHIA -- March 20, 2008 -- Icatibant provides rapid relief of the symptoms of hereditary angioedema (HAE) and shortens the length of pain episodes, researchers reported here at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Marc Riedl, MD, Division Chief, Allergy and Immunology Division, David Geffen School of Medicine, University of California, Los Angeles, presented results of 2 randomized, multicenter, double-blind, phase 3 studies of icatibant in the treatment of moderate to severe cutaneous and/or abdominal HAE attacks. HAE is a rare disease that affects 1 in 10,000 in the general population. The disease most commonly affects the skin, gastrointestinal tract, or genitals, causing pain, but also can affect the larynx and uvula. Swelling can be severe, and can lead to death when airways swell; when this occurs, patients may need to be intubated. In the studies -- For Angioedema Subcutaneous Treatment (FAST-1 and -2) -- patients were randomized to icatibant 10 mg subcutaneously (SC) or placebo (FAST-1; n = 56) and icatibant 30 mg SC or oral tranexamic acid 1000 mg (FAST-2; n = 74). Time to onset of clinically significant symptom relief was shorter with icatibant (median 2.0 hours; n = 61) than tranexamic acid (median 11.1 hours; P < .001; n = 34) and placebo (4.2 hours; P = .04; n = 27). Overall, 74% of patients treated with icatibant experienced the onset of symptom relief within 4 hours versus 31% of tranexamic-acid patients (P < .001) and 46% of placebo patients (P = .012). Median time to almost complete symptom relief was 5.3 hours with icatibant, 28.5 hours with tranexamic acid (P < .001 vs icatibant), and 21.1 hours with placebo (P = .011 vs icatibant). Most adverse effects were mild or moderate in intensity. During the double-blind phase, 49.2%, 65.5%, and 42.1% patients reported at least 1 adverse effect in the icatibant, placebo, and tranexamic acid groups, respectively. Dr. Riedl noted that icatibant prevents edema by blocking the bradykinin receptor. "Once injected, [icatibant] goes right to the blood vessels and you see fast relief," Dr. Riedl explained in his presentation on March 18. Without the drug, he noted, it can take hours or days for an attack to subside. Dr. Riedl expressed hope that icatibant will be developed for autoinjection into the skin so that patients will be able to use it at home "to prevent life-threatening attacks as well as pain." This study was funded by Jerini AG, Berlin, Germany. [Presentation title: Icatibant, a Selective Bradykinin B2 Receptor Antagonist Proves Effective and Safe in Treating the Symptoms of Hereditary Angioedema (HAE) Attacks. Abstract 398] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.