DDW 2015. Sa1397. Effect of Linaclotide

Digestive Disease Week 2015 

DDW 2015. 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. 

Douglas C. Taylor(1), William M. Spalding(1), Jessica L. Buono(2), David Reasner(1)

1. Ironwood Pharmaceuticals, Inc., Cambridge, Massachusetts, United States; 2. Forest Research Institute, Jersey City, New Jersey, United States

Results: No differences were observed between treatment arms for any outcomes during the pre-treatment period. Prior to treatment initiation, 79% of patients reported no confidence in having successful, complete bowel movements (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.

Figure 1. Change in confidence in having a bowel movement at least once every other day, ITT population

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.

 

CARE Faculty Perspective:

The goal of this study was to evaluate the effect of linaclotide on patient confidence in bowel movement (BM) success, completeness, ease, and predictability of BM timing, as well as treatment satisfaction in CIC with prominent abdominal bloating. Results are positive, showing that linaclotide is able to effectively improve each of these factors. 

Linaclotide is an agonist of the guanylate cyclase C receptor on the luminal surface of intestinal enterocytes. In other phase III trials, linaclotide has also shown to improve abdominal pain and stool frequency and was well tolerated for IBS-C patients. This agent was approved by Health Canada in late 2014 and was included in the recent ACG/AGA guidelines on constipation management and should be incorporated in clinical practice across Canada.

- CARE Gastroenterology Faculty

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