PWE-025 Assessing the Percent of Days Linaclotide Improved Abdominal Symptoms and Stool Frequency in Patients with Irritable Bowel Syndrome with Constipation (IBS-C): Pooled Analysis of 2 Phase 3 Trials: Abstract PWE-025 Table
Authors: S S Rao, L Chang, X Hao, B Lavins, S J Shiff, X Cao, H Schneier, M Currie, J Johnston
Journal: Gut (2013)

<h3>Introduction</h3> Linaclotide (LIN), a minimally absorbed guanylate cyclase C agonist (GCCA), improved abdominal symptoms and bowel movement (BM) frequency in patients (pts) with IBS-C in 2 Phase 3 trials. This post-hoc analysis determined the % of days pts reported improvements in abdominal symptoms and BMs with LIN or placebo (PBO) treatment. <h3>Methods</h3> In 2 Phase 3 trials, pts with IBS-C (Rome II criteria) were randomised to LIN 290 -μg qd po or PBO. Using pooled intent-to-treat (ITT) data from the 1st 12 wks of both trials, we determined (for pts with an average baseline score ≥3 out of 10 for each respective parameter) 1) % of days with ≥30% improvement in either abdominal pain, discomfort, bloating, cramping or fullness and 2) % of days with a spontaneous BM (SBM) or a complete SBM (CSBM). <h3>Results</h3> The pooled ITT population included 797 PBO- and 805 LIN-treated pts. During the 2-wk Baseline Period, pts had an SBM on a mean of 24% of days and a CSBM on a mean of 3% of days. Pts in subgroups with an average baseline abdominal symptom score ≥3 experienced ≥30% improvement in the specific abdominal symptom on a significantly greater % of days for LIN vs PBO (Table). LIN-treated pts had ≥30% improvement in abdominal pain for 55% of days vs 41% for PBO (p &lt; 0.0001). Results were similar for other abdominal symptoms, with LIN-treated pts achieving ≥30% improvement for ~50% of days during the Treatment Period; PBO pts met the threshold on 33–42% of days. LIN also significantly increased the % of days with SBM/CSBM vs PBO (Table). <h3>Conclusion</h3> LIN improved abdominal symptoms (pain, discomfort, bloating, fullness and cramping) by ≥30% on ~50% of treatment days and significantly increased the % of days with SBM/CSBM. Thus, LIN relieved key IBS-C symptoms and increased the % of days with symptom improvement. These data provide estimates for results of treatment with LIN that clinicians and pts may anticipate. <i>Supported by Ironwood Pharmaceuticals Inc and by Forest Laboratories, Inc. Editing assistance was provided by Complete Medical Communications, funded by Almirall</i> <h3>Disclosure of Interest</h3> S. Rao Grant/Research Support from: SmartPill Corporation, Forest Laboratories and Ironwood Pharmaceuticals, Conflict with: Advisory board for Forest Laboratories and Ironwood Pharmaceuticals. Sits on Advisory Board Smart Pill Corporation, AMS, AstraZeneca and Asubio Pharmaceuticals, L. Chang Grant/Research Support from: Ironwood Pharmaceuticals and Forest Laboratories, Consultant for: Ironwood Pharmaceuticals and Forest Laboratories, X. Hao Shareholder of: Ironwood Pharmaceuticals, Employee of: Ironwood Pharmaceuticals, B. Lavins Shareholder of: Ironwood Pharmaceuticals, Employee of: Ironwood Pharmaceuticals, S. Shiff Shareholder of: Forest Laboratories, Employee of: Forest Laboratories, X. Cao Employee of: Forest Laboratories, H. Schneier Shareholder of: Forest Laboratories, Employee of: Forest Laboratories, M. Currie Shareholder of: Ironwood Pharmaceuticals, Employee of: Ironwood Pharmaceuticals, J. Johnston Shareholder of: Ironwood Pharmaceuticals, Employee of: Ironwood Pharmaceuticals