A multicenter parallel-group double-blind randomized placebo-controlled phase III clinical trial of generic...

Postoperative nausea and vomiting (PONV), a common gastrointestinal disorder following surgery, primarily occurs within 6-24 hours postoperatively, with an incidence rate of approximately 30% in general surgical patients. QLG2174 (generic aprepitant) is a neurokinin-1 (NK-1) receptor antagonist exerting antiemetic effects by blocking the binding of substance P to NK-1 receptors. This study aimed to evaluate the efficacy and safety of QLG2174 for preventing PONV in Chinese patients.

This was a multi-center, parallel-group, double-blind, randomized, placebo-controlled, phase 3 clinical trial. Patients with ≥2 PONV risk factors and scheduled for elective laparoscopic gynecologic or abdominal surgery under general anesthesia were randomized 1:1 to receive either QLG2174 32 mg or placebo via intravenous injection within 30 seconds before anesthesia induction. The primary efficacy endpoint was the proportion of patients achieving complete response (CR, defined as no vomiting and no rescue therapy use) within 24 hours postoperatively.

A total of 515 patients were enrolled. The CR rate within 24 hours postoperatively was significantly higher in the QLG2174 group compared with that in the placebo group [70.7% (181/256) versus 44.0% (114/259); adjusted rate difference 26.6% (95% confidence interval, 18.4-34.7), P < 0.0001]. The incidence of treatment-emergent adverse events (TEAEs) were similar between the QLG2174 group (80.5%) and the placebo group (76.8%). The incidences of grade ≥3 TEAEs and serious TEAEs were similar between the two groups.

QLG2174 significantly increased CR rate compared with placebo and demonstrated promising efficacy in preventing PONV in patients scheduled for elective laparoscopic surgery under general anesthesia.