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Background  US Food and Drug Administration ( FDA ) set a rigorous standard for defining patient responders in irritable bowel syndrome‐C ( IBS ‐C; i.e.,  FDA 's Responder Endpoint) for regulatory approval. However, this endpoint's utility for health‐care practitioners to assess clinical response has not been determined. We analyzed pooled  IBS ‐C linaclotide trial data to evaluate clinically significant responses in linaclotide‐treated patients who did not meet the  FDA  responder definition.    Methods  Percentages of  FDA  non‐responders reporting improvement in abdominal pain, bowel function and/or global relief measures were determined using pooled data from two linaclotide Phase 3  IBS ‐C trials.    Key Results  1602  IBS ‐C patients enrolled; 34% of linaclotide‐treated and 17% of placebo‐treated patients met the  FDA  Responder Endpoint (p < 0.0001). Among  FDA  non‐responders at week 12, 63% of linaclotide‐treated patients reported their abdominal pain was at least somewhat relieved, compared with 48% of placebo‐treated patients. For stool frequency, 62% of linaclotide‐treated patients reported that they were at least somewhat improved at week 12, compared with 46% of placebo‐treated patients. For global  IBS  symptoms, 65% of linaclotide‐treated patients reported at least some  IBS ‐symptom relief, 43% reported adequate relief of  IBS  symptoms, and 57% reported being satisfied with linaclotide treatment, vs placebo rates of 48%, 34%, and 41% respectively.    Conclusions & Inferences  Most linaclotide‐treated  IBS ‐C patients who were  FDA  non‐responders reported some improvement in abdominal pain and stool frequency, and global relief/satisfaction. In addition to the  FDA  Responder Endpoint, differing response thresholds and symptom‐specific change from baseline should be considered by clinicians for a complete understanding of clinical response to linaclotide and other  IBS ‐C therapies.

Responders vs clinical response: a critical analysis of data from linaclotide phase 3 clinical trials in IBS ‐C