Je Min Jeong, Go Jeong Min, Kim Shin Yeong, Kim Min-Gul, Lee Hankil, Jeon Ha-Lim, Kim Jae Hyun
School of Pharmacy and Institute of New Drug Development, Jeonbuk National University, Jeonju, Republic of Korea.
Nanum Space Co., Ltd, Jeonju, Republic of Korea.
Therap Adv Gastroenterol. 2025 Jul 15;18:17562848251356406. doi: 10.1177/17562848251356406. eCollection 2025.
Recent changes in the acid-related disease market, particularly the emergence of potassium-competitive acid blockers (P-CABs), require an updated analysis of trends in gastric acid suppressant utilization.
As the use of P-CAB expands globally, a cross-sectional study is needed to assess its association with potential adverse events from a pharmacovigilance perspective.
Cross-sectional study.
We analyzed gastric acid suppressant use at prescription and patient levels using the Health Insurance Review and Assessment National Patient Sample database (2014-2020). Prescription-level analysis included the annual prescriptions for histamine-2 receptor antagonists (H2RAs), proton pump inhibitors (PPIs), and P-CABs, and proportion of visits by acid-related indications. Patient-level analysis examined annual trends in drug use and clinical characteristics. Logistic regression was used to estimate prevalence odds ratios (ORs) for potential adverse events among drug users and non-users according to the drug class.
In 2020, H2RAs were primarily prescribed for gastritis and duodenitis (64.5%), whereas PPIs (55.4%) and P-CABs (58.6%) were primarily used to treat gastroesophageal reflux disease. H2RA prescriptions declined in 2019, whereas the use of P-CAB increased following the approval of tegoprazan in 2018. Patients aged 40-64 years and female users were predominant across all classes of gastric acid suppressants. P-CAB use was significantly associated with osteoporosis (OR = 1.17; 95% confidence interval (CI): 1.13-1.20), pneumonia (OR = 1.65, 95% CI: 1.55-1.75), and acute kidney injury (OR = 1.39, 95% CI: 1.20-1.61).
P-CABs have reshaped the prescription landscape of gastric acid suppressants. Further longitudinal cohort studies are required to evaluate long-term safety in routine clinical practice.
酸相关性疾病市场最近发生了变化，尤其是钾竞争性酸阻滞剂（P-CABs）的出现，这需要对胃酸抑制剂的使用趋势进行更新分析。
随着P-CAB在全球范围内的使用不断扩大，需要开展一项横断面研究，从药物警戒的角度评估其与潜在不良事件的关联。
横断面研究。
我们使用健康保险审查与评估国家患者样本数据库（2014 - 2020年），在处方和患者层面分析了胃酸抑制剂的使用情况。处方层面的分析包括组胺-2受体拮抗剂（H2RAs）、质子泵抑制剂（PPIs）和P-CABs的年度处方量，以及酸相关性适应症就诊的比例。患者层面的分析研究了药物使用的年度趋势和临床特征。采用逻辑回归分析，根据药物类别估计药物使用者和非使用者发生潜在不良事件的患病率比值比（ORs）。
2020年，H2RAs主要用于治疗胃炎和十二指肠炎（64.5%），而PPIs（55.4%）和P-CABs（58.6%）主要用于治疗胃食管反流病。2019年H2RA的处方量下降，而2018年替戈拉赞获批后P-CAB的使用增加。40 - 64岁的患者和女性使用者在所有类别的胃酸抑制剂使用者中占主导地位。使用P-CAB与骨质疏松症（OR = 1.17；95%置信区间（CI）：1.13 - 1.20）、肺炎（OR = 1.65，95% CI：1.55 - 1.75）和急性肾损伤（OR = 1.39，95% CI：1.20 - 1.61）显著相关。
P-CABs重塑了胃酸抑制剂的处方格局。需要进一步开展纵向队列研究，以评估其在常规临床实践中的长期安全性。
