May 18, 2017
Recent research from two phase 3 clinical trails, presented at Digestive Disease Week 2017, showed that Trulance (plecanatide, Synergy) is safe and effective at reducing symptom severity in patients with irritable bowel syndrome (IBS) with constipation.
“IBS is a chronic gastrointestinal disorder characterized by recurrent abdominal pain and changes in stool frequency or consistency,” Ronald Fogel, MD, of the Clinical Research Institute of Michigan, and colleagues, wrote in their presentation. “Many patients suffer from the subtype of IBS with constipation. Plecanatide is an orally-active peptide. It replicates the function of uroguanylin, a guanylate cyclase-C agonist that stimulates fluid secretion and promotes stool consistency necessary for normal bowel function. The current two trials evaluate the efficacy and safety of once-daily plecanatide in IBS with constipation patients.”
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The researchers conducted two identical phase 3, double-blind, placebo-controlled, trails to determine the impact of Trulance on symptoms related to IBS with constipation. Study one included 1055 patients, and study two included 1135 patients. Patients were assigned to receive a once daily dose of Trulance 3 mg, Trulance 6mg, or placebo for 12 weeks.
The primary endpoints of both studies were at least a 30% reduction in abdominal pain and an increase of at least 1 complete spontaneous bowel movement. The researchers also evaluated incidences of adverse events for safety and tolerability.
Study results showed that there was a significant difference in symptom reduction between the Trulance groups and the placebo group. They found that 30.2% of patients in the 3 mg group in study one met the study endpoints, and 29.5% of patients in the 6 mg group compared with 17.8% in the placebo group (P = .001). Results in study two were comparable, with 21.5% of patients in the 3 mg group and 24% of patients in the 6 mg group compared with 14.2% in the placebo group.
“These clinical studies indicate plecanatide may offer a promising new treatment for patients with IBS with constipation,” Dr Fogel and colleagues concluded.