Division of Gastroenterology and Hepatology, Creighton University School of Medicine, Omaha, NE, USA.
Division of Digestive Diseases, Emory University, Atlanta, GA, USA.
Indian J Gastroenterol. 2023 Aug;42(4):475-484. doi: 10.1007/s12664-023-01384-2. Epub 2023 Jul 7.
Proton-pump inhibitors (PPIs) are the mainstay of treatment in erosive esophagitis (EE). An alternative to PPIs in EE is Vonoprazan, a potassium competitive acid blocker. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing vonoprazan to lansoprazole.
Multiple databases searched through November 2022. Meta-analysis was performed to assess endoscopic healing at two, four and eight weeks, including for patients with severe EE (Los Angeles C/D). Serious adverse events (SAE) leading to drug discontinuation were assessed. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology.
Four RCTs with 2208 patients were included in the final analysis. Vonoprazan 20 mg once-daily was compared to lansoprazole 30 mg once-daily dosing. Among all patients, at two and eight weeks post-treatment, vonoprazan resulted in significantly higher rates of endoscopic healing as compared to lansoprazole, risk ratios (RR) 1.1, p<0.001 and RR 1.04, p=0.03. The same effect was not observed at four weeks, RR 1.03 (CI 0.99-1.06, I=0%) following therapy. Among patients with severe EE, vonoprazan resulted in higher rates of endoscopic healing at two weeks, RR 1.3 (1.2-1.4, I=47%), p=<0.001, at four weeks, RR 1.2 (1.1-1.3, I=36%), p=<0.001 and at eight weeks post-treatment, RR 1.1 (CI 1.03-1.3, I=79%), p=0.009. We found no significant difference in the overall pooled rate of SAE and pooled rate of adverse events leading to drug discontinuation. Finally, the overall certainty of evidence for our main summary estimates was rated as high (grade A).
Based on limited number of published non-inferiority RCTs, our analysis demonstrates that among patients with EE, vonoprazan 20 mg once-daily dosing achieves comparable and in those with severe EE, higher endoscopic healing rates as compared to lansoprazole 30 mg once-daily dosing. Both drugs have a comparable safety profile.
质子泵抑制剂 (PPI) 是治疗糜烂性食管炎 (EE) 的主要药物。PPI 的替代药物是钾竞争性酸阻滞剂 Vonoprazan。我们对比较 Vonoprazan 和兰索拉唑的随机对照试验 (RCT) 进行了系统评价和荟萃分析。
通过多个数据库检索,截至 2022 年 11 月。进行荟萃分析以评估内镜愈合情况,包括 2 周、4 周和 8 周时的愈合情况,以及洛杉矶 C/D 级重度 EE 患者的愈合情况。评估导致停药的严重不良事件 (SAE)。使用推荐评估、制定与评价 (GRADE) 方法学评估证据质量。
最终分析纳入了四项 RCT 和 2208 名患者。Vonoprazan 20mg 每日一次与兰索拉唑 30mg 每日一次进行比较。在所有患者中,治疗后 2 周和 8 周时,Vonoprazan 内镜愈合率显著高于兰索拉唑,风险比 (RR) 为 1.1,p<0.001 和 RR 为 1.04,p=0.03。在 4 周时未观察到相同的效果,RR 为 1.03(CI 0.99-1.06,I=0%)。在重度 EE 患者中,Vonoprazan 在 2 周时内镜愈合率更高,RR 为 1.3(1.2-1.4,I=47%),p<0.001,在 4 周时,RR 为 1.2(1.1-1.3,I=36%),p<0.001,在治疗后 8 周时,RR 为 1.1(CI 1.03-1.3,I=79%),p=0.009。我们没有发现 SAE 的总体汇总率和导致停药的不良事件的总体汇总率存在显著差异。最后,我们主要汇总估计的总体证据确定性被评为高(A级)。
基于有限数量的已发表的非劣效性 RCT,我们的分析表明,在 EE 患者中,Vonoprazan 20mg 每日一次给药与兰索拉唑 30mg 每日一次给药相比,内镜愈合率相当,在重度 EE 患者中,内镜愈合率更高。两种药物具有相似的安全性。