Tegaserod (T) Is Superior to Placebo (P) in Patients Suffering from Concomitant Bothersome Abdominal Discomfort (A), Bloating (B), and Constipation (C): 1233

Purpose: We investigated how T improved the bothersomeness of ABC vs P in pts suffering from all three symptoms at baseline (BL) from two chronic constipation (CC) trials. Methods: Data from 2 T double-blind, randomized, placebo-controlled pivotal studies1,2 were pooled for analysis. Results were presented by treatment group. The patient was asked to answer the question on how bothersome each of the three symptoms were over the past week using the scale 0 = not at all, 1 = hardly, 2 = moderately, 3 = a good deal, 4 = a very great deal. A subgroup with at least a “good deal bothersome” symptoms was defined as patients who had BL values of at least 3 for all symptoms. Symptom improvement was defined based on changes from BL for the average of weeks 1–4 and weeks 1–12. A patient was considered to have improvement if the following was fulfilled: • There was no deterioration for any symptom AND • Reduction in bothersomeness (for at least 50% of symptoms): – of at least 0.5 (= at least 12.5% improvement) – of at least 1 (= at least 25% improvement) The thresholds of improvement were selected to reflect changes above the minimum clinically meaningful threshold of improvement (10%: improvement of 0.5 point on a 5-point scale). Results: Out of 882 T patients and 863 P patients, 859 and 845 patients, respectively, were available for classification. 397 (46.2%) T patients and 426 (50.4%) P patients were classified with “at least good deal bothersome” symptoms.TableConclusions: T was significantly superior to P and clinically relevant at relieving the ABC symptoms. These results were sustained over 12 weeks. 1. Johanson et al. Clinical Gastroenterology and Hepatology 2004;2:796–805 2. Kamm et al. AJG 2005;100:362–72 This research was funded by Novartis.