A Prospective Triple-blind Randomized Trial on Safety and Efficacy of Abitant in the Prevention of Chemotherapy-Induced Nausea and Vomiting

Abstract

Background: Oral Aprepitant, a neurokinin-1 receptor antagonist, is suggested in combination with other antiemetic agents in preventing chemotherapy-induced nausea and vomiting(CINV) associated with emetogenic chemotherapeutic regimens in adolescents, but its efficacy and safety in pediatric patients more than six months are unknown. in this study, we used abitant drug (a generic name of Aprepitant produced by Exir pharmaceutical company) for preventing CINV in children. Methods: In this triple-blind clinical trial, patients aged between 6 months to 15 years were randomly assigned to receive 3 mg/kg (maximum of 120 mg per dose) Abitant 60 minutes before receiving moderate to highly emetogenic chemotherapy and 2 mg/kg (maximum 80 mg per dose) in days 2 and 3 or placebo plus ondansetron. The primary efficacy endpoint was the percentage of patients who obtained complete response (stated as no retching, no vomiting, and no urge for rescue medication) during 25–120 hours (delayed phase) after initiation of emetogenic chemotherapy. The secondary endpoint was the proportion of children who attained complete response throughout the acute (0–24 h) and the total phase(0-120 h). Efficacy and safety analyses were done with randomly assigned patients who received at least one study treatment dose. Results: twelve patients of the Abitant group (66/7%) and 11 patients of the placebo group (64/7%) showed complete response (P=0.186). There was no significant adverse effect observed in both groups. Complete response on day 5 was 83.3% in the Abitant group and 86/7% in the placebo group. Conclusion: The efficacy of a combination of abitant along with ondansetron in controlling CINV was not inferior to the ondansetron alone in our pediatric population study group.