THURSDAY, Sept. 20 (HealthDay News) -- Over 26 weeks of treatment, the peptide guanylate cyclase-C agonist linaclotide significantly improves abdominal pain and bowel symptoms in patients with irritable bowel syndrome with constipation (IBS-C), according to research published online Sept. 18 in the American Journal of Gastroenterology.
To evaluate the efficacy and safety of oral linaclotide treatment (290 µg once daily), William D. Chey, M.D., of the University of Michigan Health System in Ann Arbor, and colleagues conducted a 26-week, randomized, double-blind, placebo-controlled trial involving 804 patients (mean age, 44 years; 90 percent female) with IBS-C.
Using the U.S. Food and Drug Administration end point (improvement in pain and increase in complete spontaneous bowel movement [CSBM]), the researchers found that significantly more linaclotide- versus placebo-treated patients were responders (33.7 versus 13.9 percent). The pain responder criterion of the FDA end point was met by 48.9 and 34.5 percent of linaclotide- and placebo-treated patients, respectively, while the CSBM criterion was met by 47.6 and 22.6 percent of patients, respectively. There was a significant improvement in all other primary and secondary end points for linaclotide versus placebo, including abdominal pain/bloating and bowel symptoms. The incidence of adverse events was similar between the groups, except for diarrhea, which caused discontinuation for 4.5 percent of linaclotide-treated and 0.2 percent of placebo-treated patients.
"Linaclotide has the potential to offer relief for the multiple symptoms from which patients with IBS-C suffer," the authors write.
Several authors disclosed financial ties to Forest Research Institute and Ironwood Pharmaceuticals, both of which funded the study and manufacture linaclotide.
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