A multicenter parallel-group double-blind randomized placebo-controlled phase III clinical trial of generic aprepitant QLG2174 for the prevention of postoperative nausea and vomiting.

Summary

In this multicenter, double-blind, placebo-controlled phase III trial, 515 high-risk Chinese patients undergoing elective laparoscopic surgery were randomized to intravenous generic aprepitant or placebo. QLG2174 increased the 24-hour complete response rate to 70.7% versus 44.0% with placebo, an adjusted absolute difference of 26.6 percentage points, supporting clinically meaningful efficacy for postoperative nausea and vomiting prevention.

Key Findings

• The trial enrolled 515 patients undergoing elective laparoscopic gynecologic or abdominal surgery with at least two postoperative nausea and vomiting risk factors.
• The 24-hour complete response rate was 70.7% with QLG2174 versus 44.0% with placebo.
• The adjusted absolute treatment difference was 26.6 percentage points, with a 95% confidence interval of 18.4 to 34.7 percentage points.

Clinical Implications

Intravenous generic aprepitant administered shortly before induction may be considered as part of prophylaxis for patients with at least two risk factors for postoperative nausea and vomiting undergoing elective laparoscopic abdominal or gynecologic surgery. Local formulary, cost, safety, and combination-prophylaxis considerations remain necessary.

Limitations

• The study population was limited to Chinese patients undergoing selected elective laparoscopic procedures, which may limit generalizability.
• The provided abstract does not report the complete adverse-event profile or longer-term outcomes.
• The results address a specific QLG2174 dose and peri-induction administration strategy and may not establish superiority over all other antiemetic regimens.

Future Directions

Future trials should compare generic aprepitant directly with established neurokinin-1 receptor antagonists and multimodal prophylaxis strategies, evaluate cost-effectiveness, and assess effectiveness across diverse surgical populations and health systems.