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学科主题临床医学
Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial
Wang, Ling1; Zhou, Liya2; Hu, Haitang3; Lin, Sanren2; Xia, Jielai1
关键词Acid Suppression Cyp2c19 Duodenal Ulcer Ilaprazole Non-inferiority Ppi
刊名CURRENT MEDICAL RESEARCH AND OPINION
2012
DOI10.1185/03007995.2011.639353
28期:1页:101-109
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Medicine, General & Internal ; Medicine, Research & Experimental
研究领域[WOS]General & Internal Medicine ; Research & Experimental Medicine
关键词[WOS]PROTON PUMP INHIBITORS ; GASTROESOPHAGEAL-REFLUX DISEASE ; HELICOBACTER-PYLORI INFECTION ; PEPTIC-ULCER ; OMEPRAZOLE ; POLYMORPHISM ; PANTOPRAZOLE ; RABEPRAZOLE ; RANITIDINE ; METABOLISM
英文摘要

Objective:

The new proton pump inhibitor (PPI), ilaprazole performed better at the dose of 10 mg/d relative to 5 or 20 mg/d in a previous phase II trial. A larger phase III trial was carried out to confirm the efficacy and safety of ilaprazole (10 mg/d) compared with omeprazole (20 mg/d) and provide some characteristics of the relationship between ilaprazole metabolism and CYP2C19 for later studies.

Research design and methods:

Patients with at least one endoscopically diagnosed active duodenal ulcer (DU) were enrolled in a multicenter, randomized, double-blind, positive controlled trial and then assigned randomly to the ilaprazole group (10 mg/d) or the omeprazole group (20 mg/d) with a sample allocation ratio 2:1. The course of treatment was 4 weeks.

Clinical trial registration:

ClinicalTrials.gov registration number: NCT00952978.

Main outcome measures:

The primary endpoint was endoscopically diagnosed ulcer healing rate at week 4. Symptom relief was evaluated as a secondary endpoint by graded scores. Safety and tolerability were evaluated on basis of clinical assessments. In addition, blood samples were collected at baseline for CYP2C19 genotypes identification.

Results:

Efficacy analyses were based on 494 patients. At week 4, the ulcer healing rates were 93.0% in ilaprazole group and 90.8% in omeprazole group (rate difference: 2.2%; 95% confidence interval: -2.8% to 7.2%). No obvious variation of healing rate on different CYP2C19 genotypes was found in ilaprazole group. The majority of patients (>80%) became asymptomatic after treatment. Incidences of adverse drug reactions were similar between ilaprazole group and omeprazole group (8.5% vs. 11.5%).

Conclusions:

Ilaprazole (10 mg/d) is as effective as omeprazole (20 mg/d) in the treatment of DU with similar side effects. The efficacy of ilaprazole is not affected by CYP2C19 polymorphisms.

语种英语
WOS记录号WOS:000299284800012
资助机构Livzon Pharmaceutical Group Inc. (China)
引用统计
被引频次:18[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/57869
专题北京大学第三临床医学院_消化科
作者单位1.Livzon Pharmaceut Inst, Zhuhai, Guangdong, Peoples R China
2.Fourth Mil Med Univ, Dept Hlth Stat, Xian 710032, Shaanxi, Peoples R China
3.Peking Univ Third Hosp, Dept Gastroenterol, Beijing, Peoples R China
推荐引用方式
GB/T 7714
Wang, Ling,Zhou, Liya,Hu, Haitang,et al. Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial[J]. CURRENT MEDICAL RESEARCH AND OPINION,2012,28(1):101-109.
APA Wang, Ling,Zhou, Liya,Hu, Haitang,Lin, Sanren,&Xia, Jielai.(2012).Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial.CURRENT MEDICAL RESEARCH AND OPINION,28(1),101-109.
MLA Wang, Ling,et al."Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial".CURRENT MEDICAL RESEARCH AND OPINION 28.1(2012):101-109.
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