Tradipitant improves nausea, vomiting in gastroparesis
Tradipitant correlated with statistically and clinically meaningful improvements in nausea and decreased vomiting in patients with idiopathic or diabetic gastroparesis, according to results from Gastroenterology.
“Tradipitant was demonstrated to be well-tolerated with an adverse event profile similar to placebo,” Jesse L. Carlin, PhD, lead clinical scientist from Vanda Pharmaceuticals Inc., the drug’s manufacturer, in Washington, D.C., and colleagues wrote. “The overall benefit risk profile, if confirmed, is likely to offer advantages over both approved and off label treatments currently utilized.”
Carlin and colleagues performed a double-blind trial of 152 adult patients with gastroparesis from 47 sites in the United States between 2016 and December 2018. The researchers assigned patients to either oral tradipitant 85 mg (n = 77) or placebo (n = 75) twice daily for 4 weeks. They used daily symptom dairy, gastroparesis cardinal symptoms index scores and other patient-reported questionnaires to evaluate symptoms. The primary outcome from the intent to treat analysis was change in average nausea severity from baseline to week 4, measured by the gastroparesis core symptom daily diary.
Researchers observed a decrease in nausea score at week 4 in patients who received tradipitant, compared with placebo (reduction of 1.2 vs. 0.7; P = .0099). At week 4, investigators noted an increase in nausea-free days for both tradipitant and placebo (28.8% vs. 15%; P = .016). At baseline, patients with nausea and vomiting experienced a greater decrease in nausea when they received tradipitant vs. placebo (reduction of 1.4 vs. 0.4; P < .0001). These patients also experienced an increase in nausea-free days (32.3% with tradipitant vs. 7.6%; P = .003).
At week 4, the average nausea score was 1 or less in 32.9% of patients who received tradipitant vs. 11.8% of patients who received placebo (P = .0013). Patients who received tradipitant had a greater than 1-point improvement in gastroparesis cardinal symptom index score, compared with placebo (46.6% vs. 23.5%; P = .0053).
“The effect of tradipitant in achieving complete response in nausea but also improving overall symptoms may suggest a disease modifying effect through an action to the local neuromuscular network as well as the central nervous system centers for nausea and vomiting,” the researchers wrote.