Trulance Reduced Symptom Severity in Patients With Irritable Bowel Syndrome

Recent research from two phase 3 clinical trials, 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. 

The study, entitled “Efficacy and Safety of Placenatide in Patients with Irritable Bowel Syndrome with Constipation: Results From 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trials ,” was conducted by researchers at the Clinical Research Institute of Michigan and the University of North Carolina Chapel Hill. 

“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.”

The researchers conducted two identical phase 3, double-blind, placebo-controlled, trials 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 6 mg, 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 one 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 primary 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. 

The most common adverse event associated with the study was diarrhea. They noted that withdrawal rates associated with adverse events were low, while
discontinuations of Trulance or placebo due to diarrhea were infrequent. In study one, 1.7% of patients in the 3-mg group discontinued, 1.2% in the 6-mg group, and 0% in the placebo group. In study two, 0.8% of patients in the 3-mg group discontinued, 1.6% in the 6-mg group, and 0% 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. —David Costill