Sa1397 Effect of Linaclotide on Patient-Reported Confidence in Bowel Movement Success, Predictability of Bowel Movement Timing, and Treatment Satisfaction in Patients With Chronic Idiopathic Constipation and Prominent Abdominal Bloating

Abstract

Objective: To evaluate the effect of linaclotide treatment on patient confidence in bowel movement (BM) success, completeness, and ease, predictability of BM timing, and on treatment satisfaction in chronic idiopathic constipation (CIC) patients with prominent abdominal bloating.Methods: Post-hoc analyses were performed on data from a phase 3b, randomized, double-blind, placebo-controlled trial of linaclotide in patients who met modified Rome II criteria for CIC and had abdominal bloating ≥5 (0-10-point numerical rating scale). Patients were randomized to linaclotide 145 μg (n=154), 290 μg (n=160), or placebo (n=173) once daily. Assessments of patient confidence included confidence in having a BM at least once every other day, producing stool when going to the bathroom with an urge to have a BM, feeling completely empty after having a BM, and occurrence of BMs without straining, each measured weekly in the two-week pretreatment period and 12-week treatment period using a 3-point Likert scale (1=Not at all; 2=Somewhat; 3=Very). Patients' ability to predict BM timing after taking study medication was measured weekly in the 12-week treatment period using a 3-point Likert scale (1=Not at all; 2=Somewhat; 3=Very). Patient satisfaction with the study medication's ability to relieve constipation symptoms was measured using a 5point Likert scale (1=Not at all; 2=A little; 3=Moderately; 4=Quite; 5=Very). Data were averaged over the pretreatment period and each of the three (4-week) study months. Treatment and time effects were analyzed (for the intent-to-treat population) within a repeatedmeasures linear model. Results: Table 1 displays the study results. No differences were observed between treatment arms for any outcomes during the pretreatment period. Prior to treatment initiation, 79% of patients reported no confidence in having successful, complete BMs without straining. There was an apparent dose-response on improvement over time across all outcomes, with statistically significant differences in improvement observed between linaclotide (both doses) and placebo (all p<0.0001). Linaclotide-treated patients had significantly greater confidence in BM frequency, completeness of evacuation, and the occurrence of BMs without straining than placebo-treated patients. Figure 1 shows results for patient confidence in BM frequency. Patients treated with linaclotide were statistically significantly more likely to be able to predict the timing of their BMs and were more satisfied with treatment than patients on placebo. Conclusions: Linaclotide treatment improves patient confidence in BM success, completeness, and ease as well as patients' ability to predict BM timing. Improvement in specific BM attributes may be an important driver of treatment satisfaction.