Efficacy and Tolerability of 14-Day Tegoprazan-based Triple Therapy for Eradication of Helicobacter Pylori Eradication: A Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- H. pylori eradication rates
研究概览
简要总结
In 2015, vonoprazan, a potassium-competitive blocker (P-CAB), was launched in Japan and used as an alternative for proton pump inhibitors (PPIs) for eradicating Helicobacter pylori. In recent studies, vonoprazan-based triple therapy significantly increased the eradication rate from 72.8% to 87.9%, compared to PPI treatment group. Accordingly, the Japanese Helicobacter treatment guidelines recommend prescribing P-CAB for eradication treatment. In 2018, a new P-CAB, tegoprazan, was developed in Korea and approved for gastric ulcer treatment. Subsequently, it was proven effective in the treatment of reflux esophagitis compared to PPIs in a non-inferiority clinical trial. P-CAB can increase the gastric pH to 6 or higher within 7 hours after taking tegoprazan. Because tegoprazan can be taken after meals, it can improve patient compliance for H. pylori eradication. Unlike vonoprazan in Japan, however, tegoprazan-based eradication in Korean population was similar to conventional PPI-based treatment. To date, the eradication success rates of PPI and tegoprazan-based triple therapy were 76.4-84.2% and 77.3-84.3%, respectively, and there was no significant difference between the two treatment groups.
Bismuth has long been used as a semi-metal in the dyspepsia and traveler's diarrhea. In H. pylori eradication therapy, several guidelines recommended the addition of bismuth to treatment regimens. Recently, bismuth was added to the 2-week triple regimen to increase the first-line H. pylori eradication rate in countries with high antibiotic resistance. The H. pylori eradication significantly increased from 87.5-88.1% to 95.8-97.3% in a recent study. The odds ratio was 1.63-2.18 in bismuth-added treatment group, compared to no use of bismuth group. In subgroup analysis, odd ratio was 1.66-2.22 in high clarithromycin-resistant areas. However, there was no comparative analysis of PPIs and tegoprazan in a bismuth-added triple therapy.
详细描述
The investigators aim to evaluate the eradication success rate and treatment compliance between PPI and tegoprazan in first-line H. pylori treatment with adding bismuth.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastroscopy can be performed
- •H. pylori test and pathological analysis can be performed
排除标准
- •Age < 20 or > 80 years
- •Anemia (serum hemoglobin level < 10 g/dL)
- •Severe systemic disease
- •Advanced chronic liver disease
- •Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
- •History of H. pylori eradication
- •Drug allergy to antibiotics
- •History of gastric surgery
- •Recent history of upper gastrointestinal bleeding
研究组 & 干预措施
PPI-BID group
Standard dose of PPI bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid 14 days
Tegoprazan-BID group
Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days
PPI-QID group
Standard dose of PPI bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid 14 days
Tegoprazan-QID group
Tegoprazan 50 mg bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid,tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days
结局指标
主要结局
H. pylori eradication rates
时间窗: 6 weeks
Urea breath test after completing H. pylori eradication regimen
次要结局
- Treatment compliance(6 weeks)
- Drug-related adverse event rate(6 weeks)
研究者
Jun-Hyung Cho
Professor
Soonchunhyang University Hospital
