This article is more than 5 years old. Information may no longer be current.
Linaclotide improved severe abdominal symptoms, QoL in IBS patients with constipation
Click Here to Manage Email Alerts
Linaclotide, a guanylate cyclase-C agonist, improved symptoms, quality of life and global measures in irritable bowel syndrome patients with constipation and severe abdominal symptoms in two recent clinical trials.
To evaluate the efficacy of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C) who experienced severe abdominal symptoms, researchers performed a post hoc analysis of data from two phase 3 clinical trials. Patients were randomly assigned 290 mcg linaclotide or placebo once daily for 12 weeks during the trials, and they rated abdominal pain, discomfort, bloating, fullness and cramping daily on a scale of zero to 10.
This subsequent study evaluated the intent-to-treat (ITT) subpopulation of IBS-C patients who reported severe symptoms (≥7 at baseline) for efficacy of linaclotide in treating these symptoms, global measures of improvement and IBS-related quality of life (QoL).
Among 1,602 ITT patients (placebo, n=797; linaclotide, n=805), 44% reported severe fullness and bloating, 32%, severe discomfort; 23%, severe pain; and 22%, severe cramping.
Linaclotide reduced all severe symptoms with average change in baseline severity scores ranging from –2.7 to –3.4 vs. –1.4 to –1.9 for placebo (P<.0001). Linaclotide also aided global measures with 59% to 61% of patients reporting adequate relief of IBS symptoms compared with 28% to 32% assigned placebo (P<.0001). Improvements in IBS-QoL ranged from 62% to 68% among the linaclotide group vs. 45% to 47% in the placebo patients (P<.01). Diarrhea, the most common AE, occurred in 18.8% to 21% of the linaclotide cohort and 1.6% to 2.1% of placebo patients.
“Linaclotide not only improves severe abdominal and bowel symptoms but also improves patient-perceived global relief of IBS symptoms and QoL in these patients with severe abdominal symptoms,” the researchers concluded. “Thus, linaclotide offers an effective treatment for the overall management of IBS-C patients with severe abdominal symptoms.”
Disclosure: See the study for a full list of relevant financial disclosures.
Click Here to Manage Email Alerts