|A New PPI, Ilaprazole Compared With Omeprazole in the Treatment of Duodenal Ulcer A Randomized Double-Blind Multicenter Trial|
|Wang, Ling1; Zhou, Liya2; Lin, Sanren2; Hu, Haitang3; Xia, Jielai1|
|关键词||ilaprazole PPI duodenal ulcer acid suppression randomized trial|
|刊名||JOURNAL OF CLINICAL GASTROENTEROLOGY|
|WOS标题词||Science & Technology|
|类目[WOS]||Gastroenterology & Hepatology|
|研究领域[WOS]||Gastroenterology & Hepatology|
|关键词[WOS]||GASTROESOPHAGEAL-REFLUX DISEASE ; HELICOBACTER-PYLORI INFECTION ; PANTOPRAZOLE|
Goals: To investigate the efficacy and safety of a new proton pump inhibitor (PPI), ilaprazole (IY-81149) in the treatment of duodenal ulcers and provide some characteristics of the dose-response relationship for later studies.
Background: PPIs have been used therapeutically for many years, and shown great efficacy in accelerating ulcer healing. Currently researches are focused on more potent PPIs. Some preclinical studies have shown that ilaprazole might be such a new substitute.
Study: 235 patients with at least 1 endoscopically diagnosed active duodenal ulcer were enrolled in a randomized trial. Patients were randomized into 4 groups (5, 10, and 20 mg/d ilaprazole, with 20 mg/d omeprazole as positive control) and treated for up to 4 weeks. Forty patients accepted continuous 24-hour pH measurements after the fifth dose. The primary endpoint was ulcer healing rate at week 4.
Results: The efficacy analyses were based on 235 patients. At week 4, 86.4%, 93.1%, 86.4%, and 89.8% patients treated with 5mg ilaprazole, 10mg ilaprazole, 20 mg ilaprazole, and 20mg omeprazole once daily, respectively had ulcers healed (P=0.59). The majority of patients (> 70%) became asymptomatic after 4 weeks treatment. Both drugs with stipulated dosages exhibited similar efficacy and safety profiles. Gastric acid suppression increased with increasing dose of ilaprazole in pH study.
Conclusions: Ilaprazole is as tolerable, safe, and efficacious as omeprazole in the treatment of duodenal ulcers, especially at a lower dose (10 mg/d ilaprazole vs. 20 mg/d omeprazole). (Clinical-Trials.gov ID: NCT00953381).
|资助机构||Livzon Pharmaceutical Group Inc. (China)|
|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, Hosp 3, Dept Gastroenterol, Beijing 100871, Peoples R China
|Wang, Ling,Zhou, Liya,Lin, Sanren,et al. A New PPI, Ilaprazole Compared With Omeprazole in the Treatment of Duodenal Ulcer A Randomized Double-Blind Multicenter Trial[J]. JOURNAL OF CLINICAL GASTROENTEROLOGY,2011,45(4):322-329.|
|APA||Wang, Ling,Zhou, Liya,Lin, Sanren,Hu, Haitang,&Xia, Jielai.(2011).A New PPI, Ilaprazole Compared With Omeprazole in the Treatment of Duodenal Ulcer A Randomized Double-Blind Multicenter Trial.JOURNAL OF CLINICAL GASTROENTEROLOGY,45(4),322-329.|
|MLA||Wang, Ling,et al."A New PPI, Ilaprazole Compared With Omeprazole in the Treatment of Duodenal Ulcer A Randomized Double-Blind Multicenter Trial".JOURNAL OF CLINICAL GASTROENTEROLOGY 45.4(2011):322-329.|