Abstract
3 phase 3 studies. In all studies, eligible patients were ≥10 years old who presented with an HAE attack considered to be moderate (affected activities of daily living) or severe (prevented activities of daily living). All patients provided written informed consent and the appropriate IRB approved the studies at each site. Pre-treatment information collected in some or all of the studies included affected anatomic location, accompanying symptoms, relevant medical history, physical examination, laboratory evaluations, and pain assessments—using the McGill Short Form Pain Questionnaire and a Visual Analog Scale (VAS) pain score. Results: Across all studies, 310 patients (40 patients 9-17 years old; 270 patients ≥18 years old) were treated for 1249 HAE attacks affecting any anatomic location; abdominal symptoms were reported in 698 attacks (56%). Approximately 51% of these attacks only affected the abdomen. Data on accompanying symptoms were available for 166 attacks with abdominal symptoms. Distention (74% of attacks), cramping (72%), and nausea (65%) were reported most frequently; vomiting (20%) and diarrhea (13%) were less common. Based on available data from the McGill Pain Questionnaire (N=502 abdominal attacks), patients were most likely to describe their abdominal pain as tender, aching, or cramping. In 23% of 569 abdominal attacks, white blood cell (WBC) counts were elevated (mean ± standard deviation: 15.1 ± 11.27 X 109/L); WBC elevations were more likely to be associated with severe attacks (64% of severe abdominal attacks had elevated WBC vs 34% of moderate attacks). In 183 patients with abdominal attacks, 23% had a surgical history of appendectomy and 16% had a history of cholecystectomy. Conclusions: During HAE attacks, patients often experience gastrointestinal symptoms in the absence of peripheral signs of angioedema. Gastroenterologists should consider HAE in the differential diagnosis for patients with recurrent, unexplained crampy abdominal pain associated with nausea with or without an elevated WBC.
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