What is the role of linaclotide in IBS?
Linaclotide was recently approved by the FDA for adults with IBS-C and chronic idiopathic constipation. It is a minimally absorbed 14-amino-acid peptide that binds to and activates the guanylate cyclase C receptor. In two large, randomized trials, linaclotide resulted in improvement in abdominal pain, bowel function, and global outcomes in patients with IBS-C. The FDA endpoint for IBS-C (an increase from baseline of 1 or more complete SBMs per week and a 30% or more reduction from baseline in the weekly average of daily worst abdominal pain scores for 50% of the treatment weeks) was met by 49% to 50% of linaclotide-treated patients compared with 35% to 38% of placebo-treated patients with a number needed to treat (NNT) of 7. This, combined with a good safety and tolerability profile, suggests that linaclotide is an effective treatment for IBS-C.