Department of Internal Medicine, Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan.
INSERM U1312, University of Bordeaux, Bordeaux, France.
Gastroenterology. 2022 Sep;163(3):608-619. doi: 10.1053/j.gastro.2022.05.055. Epub 2022 Jun 6.
BACKGROUND & AIMS: Novel, effective treatments for Helicobacter pylori infection are needed. This study evaluated the efficacy of vonoprazan, a potassium-competitive acid blocker, vs standard treatment on H pylori eradication in the United States and Europe. METHODS: In a randomized, controlled, phase 3 trial, treatment-naïve adults with H pylori infection were randomized 1:1:1 to open-label vonoprazan dual therapy (20 mg vonoprazan twice daily; 1 g amoxicillin 3 times daily), or double-blind triple therapy twice a day (vonoprazan 20 mg or lansoprazole 30 mg; amoxicillin 1 g; clarithromycin 500 mg) for 14 days. The primary outcome was noninferiority in eradication rates in patients without clarithromycin- and amoxicillin-resistant strains (noninferiority margin = 10%). Secondary outcomes assessed superiority in eradication rates in clarithromycin-resistant infections, and in all patients. RESULTS: A total of 1046 patients were randomized. Primary outcome eradication rates (nonresistant strains): vonoprazan triple therapy 84.7%, dual therapy 78.5%, vs lansoprazole triple therapy 78.8% (both noninferior; difference 5.9%; 95% confidence interval [CI], -0.8 to 12.6; P < .001; difference -0.3%; 95% CI, -7.4 to 6.8; P = .007, respectively). Eradication rates in clarithromycin-resistant infections: vonoprazan triple therapy 65.8%, dual therapy 69.6%, vs lansoprazole triple therapy 31.9% (both superior; difference 33.9%; 95% CI, 17.7-48.1; P < .001; difference 37.7%; 95% CI, 20.5-52.6; P < .001, respectively). In all patients, vonoprazan triple and dual therapy were superior to lansoprazole triple therapy (80.8% and 77.2%, respectively, vs 68.5%, difference 12.3%; 95% CI, 5.7-18.8; P < .001; difference 8.7%; 95% CI, 1.9-15.4; P = .013). Overall frequency of treatment-emergent adverse events was similar between vonoprazan and lansoprazole regimens (P > .05). CONCLUSION: Both vonoprazan-based regimens were superior to proton pump inhibitor-based triple therapy in clarithromycin-resistant strains and in the overall study population. CLINICALTRIALS: gov; NCT04167670.
背景与目的：需要新的、有效的幽门螺杆菌感染治疗方法。本研究评估了钾竞争性酸阻滞剂沃诺拉赞在治疗美国和欧洲幽门螺杆菌感染方面的疗效，与标准治疗相比。 方法：在一项随机、对照、3 期试验中，未经治疗的幽门螺杆菌感染成年人按 1:1:1 随机分配接受开放性标签沃诺拉赞双联疗法（每日 2 次 20 毫克沃诺拉赞；每日 3 次 1 克阿莫西林）或每日 2 次双盲三联疗法（每日 20 毫克沃诺拉赞或兰索拉唑 30 毫克；每日 1 克阿莫西林；每日 500 毫克克拉霉素）治疗 14 天。主要结局是无克拉霉素和阿莫西林耐药菌株患者的根除率非劣效性（非劣效性边界为 10%）。次要结局评估克拉霉素耐药感染和所有患者的根除率的优越性。 结果：共有 1046 名患者被随机分配。主要结局（无耐药菌株）根除率：沃诺拉赞三联疗法 84.7%，双联疗法 78.5%，兰索拉唑三联疗法 78.8%（均非劣效；差异 5.9%；95%置信区间[CI]，-0.8 至 12.6；P <.001；差异-0.3%；95%CI，-7.4 至 6.8；P =.007）。克拉霉素耐药感染的根除率：沃诺拉赞三联疗法 65.8%，双联疗法 69.6%，兰索拉唑三联疗法 31.9%（均为优效；差异 33.9%；95%CI，17.7-48.1；P <.001；差异 37.7%；95%CI，20.5-52.6；P <.001）。在所有患者中，沃诺拉赞三联和双联疗法均优于兰索拉唑三联疗法（分别为 80.8%和 77.2%，68.5%，差异 12.3%；95%CI，5.7-18.8；P <.001；差异 8.7%；95%CI，1.9-15.4；P =.013）。沃诺拉赞和兰索拉唑方案的治疗中出现的不良事件总体频率相似（P >.05）。 结论：基于沃诺拉赞的两种方案在克拉霉素耐药菌株和整个研究人群中均优于质子泵抑制剂三联疗法。 临床试验：gov；NCT04167670。
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