Nexium® Injection Approved in China for Prevention of Stress-Related Upper Gastrointestinal Bleeding in Critically Ill Patients

Shanghai, July 30, 2020 /PRNewswire/ -- AstraZeneca today announced that the National Medical Products Administration (NMPA) has officially approved NEXIUM® for Injection (esomeprazole sodium for injection) for the prevention of stress ulcer bleeding in critically ill patients. As the originator proton pump inhibitor, the approval of this new indication for esomeprazole sodium for injection provides another option for the prevention of stress-related gastrointestinal bleeding in China.

Stress-related mucosal disease (SRMD) is a collective term for acute gastrointestinal mucosal lesions, such as erosion, ulceration, and hemorrhage, that occur in the human body under severe stress conditions, including severe trauma, complex surgery, and critical illness. In severe cases, it can lead to gastrointestinal perforation, further deteriorating the patient's systemic condition. In China, stress-related mucosal disease is a common complication in critically ill patients. Studies have shown that the mortality rate associated with stress ulcer bleeding in critically ill patients is as high as 50%.^[1][2], therefore, preventing the occurrence of this complication is crucial.

The approval of this indication is based on the results of a randomized, double-blind, parallel-group, multicenter, independent Phase III clinical trial conducted in China. This study evaluated the efficacy and safety of intravenous esomeprazole sodium 40 mg twice daily compared with continuous intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill patients in China. The results of this randomized clinical trial, which used cimetidine as an active control, showed that during the treatment evaluation period, the incidence of upper gastrointestinal bleeding was lower in the esomeprazole group than in the cimetidine group (2.7% in the esomeprazole group vs. 4.6% in the cimetidine group). Esomeprazole 40 mg administered twice daily can effectively prevent upper gastrointestinal bleeding in critically ill patients.^[3]. The safety profile of the esomeprazole group was similar to that of the cimetidine group, with good overall tolerability in critically ill patients in China and no new safety concerns identified.^[4]。

Professor Qin Xinyu, the principal investigator of this study, Vice Chairman of the Surgical Branch of the Chinese Medical Association, and Head of the Gastrointestinal Surgery Group, stated, “As an original proton pump inhibitor, Nexium is characterized by rapid onset and sustained acid suppression. It has been supporting Chinese physicians for over a decade, with its efficacy and safety fully established. Accumulating evidence-based data through scientific research to expand indications for marketed drugs can help guide clinical prevention and treatment in accordance with the product labeling, ensuring that drug use is evidence-based and promoting rational medication practices.”

Mr. Lai Minglong, General Manager of AstraZeneca China, stated, “AstraZeneca has previously launched omeprazole, the world’s first proton pump inhibitor (PPI), and its second-generation product, esomeprazole. In the field of digestive diseases, our scientific exploration to address patients’ treatment needs has never ceased. We are pleased to see that intravenous esomeprazole sodium has become the next product in the Chinese market, following intravenous omeprazole, to be indicated for both the prevention and treatment of gastrointestinal ulcer bleeding. We hope to continue providing comprehensive gastrointestinal protection to more patients in China.”

[1] Bardou M, et al. Nat Rev Gastroenterol Hepatol 2015; 12(2):98-107.

[2] Choung RS, Talley NJ.  Current Molecular Medicine, 2008, 8 (4): 253-257.

[3][4] Lou W, et al. Curr Med Res Opin. 2018 Aug;34(8)1449-1455.