CHICAGO—The oral potassium-competitive acid blocker vonoprazan was found to provide the same protection against rebleeding of peptic ulcer hemorrhage after endoscopic treatment as an IV proton pump inhibitor in a non-inferiority trial.
In this randomized, multicenter, open-label trial, patients with upper gastrointestinal bleeding were randomized to receive 20 mg of vonoprazan (Phathom) twice daily or 80 mg of pantoprazole followed by an infusion of 8 mg per hour. After 72 hours, those receiving the P-CAB were switched to a 20-mg once-daily dosage, and those receiving a PPI were switched to 20 mg of oral omeprazole twice daily. All patients remained on the assigned acid-lowering therapies for 28 days.
Of the 174 patients recruited, 166 patients completed the study. The groups were well matched for age, use of antithrombotic agents, severity of bleeding, comorbidities and stage of ulcers, noted Tanawat Geeratragool, MD, from Mahidol University Faculty of Medicine, in Bangkok, at Digestive Disease Week 2023 (abstract 614).
On the primary outcome of rebleeding within 30 days, the rates were 4.5% versus 9.3% for the P-CAB and the IV PPI, respectively. Non-inferiority was confirmed at a level of high statistical significance (P=0.0005), Dr. Geeratragool reported.
More favorable outcomes for the P-CAB, leading to highly significant confirmation of non-inferiority, were also met for the secondary end points of bleeding rates within three days (1.14% vs. 5.81%; P=0.0001) and seven days (3.41% vs. 6.98%; P=0.0006).
No patients in either group required surgical rescue, but one patient in the IV PPI group and none in the P-CAB arm required a rescue embolization. There were no cases of bleeding-related mortality in either group, but the all-cause mortality rates at 30 days were 5.68% in the P-CAB and 9.30% IV PPI groups.
Although the most recent guidelines allow high-dose oral PPIs as an alternative, John R. Saltzman, MD, the director of endoscopy at Brigham and Women’s Hospital, in Boston, commented that one strength of this study is that vonoprazan was compared with an established standard. There are, however, potential differences between acid-lowering therapies for Asian and non-Asian populations. “In interpreting these results,” Dr. Saltzman said, “it is important to note that Western populations may require higher doses of PPIs, reportedly due to lesser pharmacodynamic and clinical effects of PPIs.”
—Ted Bosworth
Drs. Geeratragool and Saltzman reported no relevant financial disclosures. The trial received funding from Phathom, which manufactures vonoprazan.
