Vonoprazan noninferior to PPIs in preventing 30-day rebleeding in high-risk peptic ulcers
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Key takeaways:
- Incidence of 30-day rebleeding was 7.1% in the vonoprazan group and 10.4% in the proton pump inhibitor group.
- Results corresponded with a risk difference of –3.3% and a noninferiority margin of 10%.
Vonoprazan was noninferior to high-dose IV proton pump inhibitor therapy in preventing 30-day rebleeding among patients with high-risk peptic ulcer bleeding who had achieved endoscopic hemostasis, according to data.
“Efficacy of vonoprazan has been demonstrated as noninferior to PPIs in various acid-related diseases, including erosive esophagitis, Helicobacter pylori eradication therapy, peptic ulcer disease, secondary prevention of ulcers caused by low-dose aspirin or NSAIDs and artificial ulcer after gastric endoscopic submucosal dissection,” Tanawat Geeratragool, MD, of the division of gastroenterology at Mahidol University in Bangkok, and colleagues wrote in Gastroenterology. “However, the efficacy of vonoprazan for preventing high-risk peptic ulcer rebleeding has not been studied to date.”
In a multicenter, randomized, open-label noninferiority trial, researchers compared the efficacy of vonoprazan vs. high-dose PPIs in preventing rebleeding among 194 adult patients (mean age, 66 years; 69% men) with high-risk peptic ulcer bleeding who had achieved hemostasis. Ninety-eight patients received vonoprazan 20 mg twice daily for 3 days, then 20 mg once daily for 28 days, and 96 patients received pantoprazole IV infusion at 8 mg per hour for 3 days, then omeprazole 20 mg twice daily for 28 days.
The primary studied outcome was rebleeding rate at 30 days; secondary outcomes included the rate of rebleeding at days 3 and 7, all-cause and bleeding-related mortality, rate of rescue therapy, blood transfusion, length of hospital stay and safety.
Researchers noted the majority of patients had Forrest IIa ulcers — 84.7% in the vonoprazan group and 78.1% in the PPI group. All participants received a combination of adrenaline injection and mechanical or thermal therapy for hemostasis.
According to results, incidence of rebleeding within 30 days was 7.1% in the vonoprazan group and 10.4% in the PPI group — a risk difference of –3.3% (95% CI, –11.2 to 4.7) and a noninferiority margin of 10%, which remained in per-protocol and post hoc sensitivity analyses.
Researchers also reported the time to rebleeding was similar between groups (HR = 0.67; 95% CI, 0.25-1.75), which remained comparable after adjusting for baseline differences (HR = 0.68; 95% CI, 0.26-1.79).
The 3- and 7-day rebleeding rates were 3.1% and 6.3% and 5.1% and 8.3%, respectively, in the vonoprazan and PPI groups, with a noninferiority margin of 10%. Mortality rates were 6.1% and 9.4%, respectively.
Further, total blood transfusion requirements were similar between groups (2 units vs. 3 units), as were post-endoscopy blood transfusion requirements (1 unit vs. 1 unit) and length of hospital stay (5.5 days vs. 6 days).
Overall, 23.5% of patients in the vonoprazan group and 27.1% in the PPI group experienced mild adverse events.
“Our open-label study offers robust evidence substantiating the noninferiority of vonoprazan to intravenous PPI for the prevention of 30-day rebleeding in high-risk peptic ulcer bleeding patients with comparable adverse events,” Geeratragool and colleagues wrote. “Further research is needed to determine the generalizability of our findings to multiethnic populations and to assess the cost-effectiveness.”
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