LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).1
Abdominal scores at baseline: 6.4 for LINZESS and 6.5 for placebo. Least squares 12-week mean change from baseline: -1.9 for LINZESS and -1.2 for placebo.
*As measured by the composite abdominal score.
Based on responses to the following questions: How would you rate your worst abdominal bloating, your worst abdominal pain, and your worst abdominal discomfort in the past 24 hours?
The adverse event profile was consistent with the pivotal trials.
STUDY DESIGN: A randomized, double-blind, placebo-controlled, parallel-group study (N=614) to evaluate the efficacy on overall combined abdominal symptoms (abdominal bloating, abdominal pain, and abdominal discomfort) and safety of linaclotide 290 mcg administered orally to adult patients with irritable bowel syndrome with predominant constipation (IBS-C). The study comprised a 12-week treatment period and a 4-week randomized withdrawal period (post-treatment). The primary endpoint was the change from baseline in the multicomponent abdominal score throughout the treatment period, which is based on the mean abdominal score across treatment weeks obtained using the average daily assessments of abdominal bloating, abdominal pain, and abdominal discomfort. Each abdominal symptom was rated on a 0-to-10-point numeric rating scale (NRS) where 0=no [symptom] and 10=worst possible [symptom].
||Secondary endpoint. A responder showed at least a 2.5-point improvement in the abdominal score from baseline for at least 6 out of 12 weeks.1