Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand; Siriraj GI Endoscopy Center, Siriraj Hospital, Bangkok, Thailand.
Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand; Siriraj GI Endoscopy Center, Siriraj Hospital, Bangkok, Thailand.
Gastroenterology. 2024 Sep;167(4):778-787.e3. doi: 10.1053/j.gastro.2024.03.036. Epub 2024 Apr 5.
BACKGROUND & AIMS: High-dose proton pump inhibitor (PPI) therapy has been recommended to prevent rebleeding of high-risk peptic ulcer (PU) after hemostasis. Vonoprazan has been proven to be noninferior to PPIs in various acid-related diseases. This study aimed to compare the efficacy of vonoprazan vs PPI for preventing high-risk PU rebleeding after hemostasis.
A multicenter, randomized, noninferiority study was conducted in 6 centers. Pre-endoscopic and endoscopic therapy were performed according to standard protocol. After successful hemostasis, patients with high-risk PU bleeding (Forrest class Ia/Ib, IIa/IIb) were randomized into 1:1 to receive vonoprazan (20 mg twice a day for 3 days, then 20 mg once a day for 28 days) or high-dose PPI (pantoprazole intravenous infusion 8 mg/h for 3 days, then omeprazole 20 mg twice a day for 28 days). The primary outcome was a 30-day rebleeding rate. Secondary outcomes included 3- and 7-day rebleeding rate, all-cause and bleeding-related mortality, rate of rescue therapy, blood transfusion, length of hospital stay, and safety.
Of 194 patients, baseline characteristics, severity of bleeding, and stage of ulcers were comparable between the 2 groups. The 30-day rebleeding rates in vonoprazan and PPI groups were 7.1% (7 of 98) and 10.4% (10 of 96), respectively; noninferiority (within 10% margin) of vonoprazan to PPI was confirmed (%risk difference, -3.3; 95% confidence interval, -11.2 to 4.7; P < .001). The 3-day and 7-day rebleeding rates in the vonoprazan group remained noninferior to PPI (P < .001 by Farrington and Manning test). All secondary outcomes were also comparable between the 2 groups.
In patients with high-risk PU bleeding, the efficacy of vonoprazan in preventing 30-day rebleeding was noninferior to intravenous PPI. (ClinicalTrials.gov, Number: NCT05005910).
高剂量质子泵抑制剂（PPI）疗法已被推荐用于预防止血后高危消化性溃疡（PU）再出血。沃诺拉赞已被证明在各种酸相关疾病中不劣于 PPIs。本研究旨在比较沃诺拉赞与 PPI 预防止血后高危 PU 再出血的疗效。
在 6 个中心进行了一项多中心、随机、非劣效性研究。在进行内镜检查前和内镜检查时，根据标准方案进行了治疗。在成功止血后，将高危 PU 出血患者（Forrest 分级 Ia/Ib、IIa/IIb）随机分为 1:1 组，分别接受沃诺拉赞（20 mg，每日 2 次，连用 3 天，然后每日 1 次，连用 28 天）或高剂量 PPI（泮托拉唑静脉输注 8 mg/h，连用 3 天，然后奥美拉唑 20 mg，每日 2 次，连用 28 天）治疗。主要结局是 30 天再出血率。次要结局包括 3 天和 7 天再出血率、全因死亡率和出血相关死亡率、挽救性治疗率、输血率、住院时间和安全性。
在 194 例患者中，两组的基线特征、出血严重程度和溃疡分期无统计学差异。沃诺拉赞组和 PPI 组的 30 天再出血率分别为 7.1%（98 例中的 7 例）和 10.4%（96 例中的 10 例）；沃诺拉赞不劣于 PPI（差值在 10%范围内，风险差异为-3.3%；95%置信区间为-11.2%至 4.7%；P <.001）。沃诺拉赞组的 3 天和 7 天再出血率仍不劣于 PPI（经 Farrington 和 Manning 检验，P <.001）。两组的所有次要结局也无统计学差异。
在高危 PU 出血患者中，沃诺拉赞预防 30 天再出血的疗效不劣于静脉 PPI。（ClinicalTrials.gov，注册号：NCT05005910）
