A randomized, double-blind trial assessing the efficacy and safety of sublingual metopimazine and ondansetron in the prophylaxis of chemotherapy-induced delayed emesis

Abstract

The prevention of delayed emesis following chemotherapy remains an important challenge. This randomized, double-blind, double-dummy, multicenter study was designed to compare the efficacy and tolerance of metopimazine and ondansetron at preventing nausea and emesis in patients receiving chemotherapy. Two hundred patients were evaluated for efficacy: 103 patients received metopimazine (7.5 mg x 2 t.i.d.) and 97 received ondansetron (8 mg b.i.d.) for 5 days. Patients were asked to report episodes of nausea and emesis in a diary, and quality of life (QoL) was evaluated using the Functional Living Index--Emesis questionnaire. The incidence of complete response (defined as no nausea and emesis for 5 days) did not differ between the two treatment arms (53.4% for metopimazine versus 49.5% for ondansetron; P=0.58). No significant difference was found for the incidence of emesis (23.3% for metopimazine versus 30.9% for ondansetron) or QoL. Tolerance was as expected for both drugs and comparable, except for the incidence of gastrointestinal disorders, which was significantly lower in the metopimazine group (19.4 versus 32.7%; P=0.03). We conclude that metopimazine is an alternative to ondansetron that is better tolerated for the prevention of delayed emesis in patients receiving chemotherapy.