Statistical Analysis All efficacy analyses were performed in the altered intention-to-treat population, which consisted of all patients who underwent randomization, received at least 1 dose of a scholarly research drug, and underwent the index PCI. All safety-related analyses had been performed on the safety population, including all patients who received at least one dose of a scholarly study drug. Patients in the safety analyses were designated to a study group on the basis of the treatment they actually received, not as randomized. Intention-to-deal with analyses are presented for complete disclosure of outcomes also. The between-group evaluation of the primary end point was performed by calculating an chances ratio with accompanying 95 percent confidence intervals by using logistic regression..
Marco Cicardi, M.D., Robyn J. Levy, M.D., Donald L. McNeil, M.D., H. Henry Li, M.D., Ph.D., Albert L. Sheffer, M.D., Marilyn Campion, M.S., Patrick T. Horn, M.D., Ph.D., and William E. Pullman, M.B., B.S., Ph.D., F.R.A.C.P.: Ecallantide for the Treatment of Acute Episodes in Hereditary Angioedema Hereditary angioedema can be an autosomal dominant disorder with around prevalence ranging from 1 case in 10,000 to at least one 1 case in 50,000 persons.1-3 Patients with hereditary angioedema have intermittent severe attacks of edema relating to the larynx, oropharynx, encounter, gastrointestinal mucosa, extremities, or genitalia.4 Attacks occur and may persist for 2 to 5 days unpredictably.5,6 Gastrointestinal attacks can cause incapacitating colic, vomiting, and diarrhea and may result in unnecessary abdominal surgery.