OBJECTIVES To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848). METHODS This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety. RESULTS Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity. DISCUSSION Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.

中文翻译：

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沃诺拉赞对非糜烂性胃食管反流病患者的疗效和安全性：一项随机、安慰剂对照的 3 期研究。


目的 评估沃诺拉赞对非糜烂性反流病 (NERD) 患者胃灼热症状的疗效和安全性（ClinicalTrials.gov：NCT02954848）。方法 这项 3 期、双盲、安慰剂对照研究纳入了 20 岁及以上患有 N/M NERD 和复发性胃灼热的日本患者。患者接受安慰剂 (n = 245) 或沃诺拉赞 10 mg (n = 238) 治疗 4 周。主要疗效结果是患者在治疗期间经历胃灼热的频率（没有胃灼热的天数比例）。其他结果包括胃灼热的累积改善率、治疗第四周胃灼热完全缓解的患者比例以及安全性。结果 与安慰剂相比，在完整分析中，沃诺拉赞组无胃灼热的天数比例并未显着更高（主要终点，沃诺拉赞对比安慰剂为 72.55% vs 61.50%，P = 0.0643），但在每组中显着更高。方案集敏感性分析（P = 0.0341）。沃诺拉赞组观察到较早出现反应，并且胃灼热的累积改善率显着更高（P = 0.0003）。在事后分析中，沃诺拉赞组报告在治疗第四周内胃灼热完全缓解的患者比例较高（P = 0.0023）。治疗组之间治疗引起的不良事件的发生率相似（23.5% vs 23.3%）；大多数治疗中出现的不良事件的严重程度都很轻微。讨论 尽管沃诺拉赞 10 mg 在日本 NERD 患者中无胃灼热天数比例方面并不优于安慰剂，但沃诺拉赞的胃灼热缓解累积率显着较高，且耐受性良好。