Larazotide acetate 0.5 mg found beneficial in celiac disease

(HealthDay)—Larazotide acetate 0.5 mg is associated with improvement in symptoms of celiac disease (CeD), according to a study published in the June issue of Gastroenterology.

Daniel A. Leffler, Ph.D., from Beth Israel Deaconess Medical Center in Boston, and colleagues conducted a multicenter, randomized trial assessing larazotide acetate 0.5, 1, or 2 mg three times daily to relieve symptoms of CeD. Three hundred forty-two adults with CeD who had been on a gluten-free diet for 12 months or longer were included in the study. The difference in average on-treatment Celiac Disease Gastrointestinal Symptom Rating Scale score was assessed as the primary end point.

The researchers found that the primary end point was met with the 0.5-mg dose of larazotide acetate, with fewer symptoms versus placebo in modified intent-to-treat analysis (340 patients). The 0.5-mg dose affected exploratory end points such as a decrease in CeD patient-reported outcome symptomatic days (26 percent decrease; P = 0.017); increase in improved symptom days (31 percent increase; P = 0.034); 50 percent or greater reduction from baseline of the weekly average abdominal pain score for six or more of 12 weeks of treatment (P = 0.022); and reduction in nongastrointestinal symptoms of headache and tiredness (P = 0.010). No differences were seen for 1- and 2-mg doses versus placebo.

"Larazotide acetate 0.5 mg reduced signs and symptoms in CeD patients on a gluten-free diet better than a gluten-free diet alone," the authors write.

Several authors disclosed financial ties to pharmaceutical and biotechnology companies, including Alba Therapeutics Corporation and Cephalon/Teva, both of which provided funding for the study.