Ecallantide for the Treatment of Acute Attacks in Hereditary Angioedema
| Autor: | Marco Cicardi, William E. Pullman, Marilyn Campion, Donald L. McNeil, Patrick T. Horn, Robyn J. Levy, H. Henry Li, Albert L. Sheffer |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
medicine.medical_specialty
Intention-to-treat analysis Angioedema business.industry General Medicine Placebo medicine.disease law.invention Surgery Clinical trial Ecallantide Randomized controlled trial law Internal medicine Edema Hereditary angioedema medicine medicine.symptom skin and connective tissue diseases business medicine.drug |
| Zdroj: | New England Journal of Medicine. 363:523-531 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa0905079 |
| Popis: | Background Hereditary angioedema is a rare genetic disorder characterized by acute, intermittent, and potentially life-threatening attacks of edema of the skin and mucosa. We evaluated ecallantide, a newly developed recombinant plasma kallikrein inhibitor, for the treatment of acute attacks of angioedema. Methods In this double-blind, placebo-controlled trial, patients with hereditary angioedema presenting with an acute attack were randomly assigned, in a 1:1 ratio, to receive subcutaneous ecallantide, at a dose of 30 mg, or placebo. Two measures of patient-reported outcomes were used to assess the response: treatment outcome scores, which range from +100 (designated in the protocol as significant improvement in symptoms) to −100 (significant worsening of symptoms), and the change from baseline in the mean symptom complex severity score, which range from +2 (representing a change from mild symptoms at baseline to severe symptoms after) to –3 (representing a change from severe symptoms at baseline to no sy... |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|