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学科主题: 临床医学
题名:
Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial
作者: 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
发表日期: 2012
DOI: 10.1185/03007995.2011.639353
卷: 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
项目资助者: Livzon Pharmaceutical Group Inc. (China)
WOS记录号: WOS:000299284800012
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/57869
Appears in Collections:北京大学第三临床医学院_消化科_期刊论文

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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

Recommended Citation:
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.
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