Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)

BMC Gastroenterology

Ken Haruma^1,12  Yoshikazu Kinoshita⁸  Kazuma Fujimoto^1,16  Hiroto Miwa^1,10  Jun Miwa^1,11  Tsuneyo Oumi⁹  Nobuyuki Shigeto^1,18  Toshikatsu Fujimura^1,19  Yasuhiko Fujioka⁷  Masayasu Kusaka^1,13  Nobuo Tano^2,20  Ryosaku Harada²  Haruhiko Nagami⁴  Katsuaki Satoh^1,15  Tsuyoshi Suzuki^2,22  Akihiro Araki¹  Yasuki Habu^2,23  Junichi Suzuki⁶  Katsuhiro Mabe^1,14  Junichi Akiyama^1,17  Kazuhiko Inoue^2,21  Akihito Nagahara⁵  Kouichi Sakurai³ 

[1] Department of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan;Gastrointestinal Division, Harada Internal Medicine, Tosu, Japan;Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Kumamoto, 860-8556, Japan;Nagami Clinic, Unnan, Japan;Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan;Department of Gastroenterology, KKR Sapporo Medical Center, Sapporo, Japan;Fujioka Hospital, Saga, Japan;Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan;Ooumi Clinic, Tsuyama, Japan;Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan;Department of Internal Medicine, Toshiba Hospital, Tokyo, Japan;Division of Gastroenterology, Department of Internal Medicine, Kawasaki Medical School, Kurashiki, Japan;Kusaka Hospital, Bizen, Japan;Department of Internal Medicine, Yamagata Prefectural Central Hospital, Yamagata, Japan;Satoh Gastrointestinal Surgical Hospital, Kurashiki, Japan;Department of Internal Medicine, Gastrointestinal Endoscopy, Saga Medical School, Saga, Japan;Department of Gastroenterology, International Medical Centre, Tokyo, Japan;Department of Internal Medicine, Tamano City Hospital, Tamano, Japan;Yamaguchi Hospital, Imari, Japan;Department of Internal Medicine, Kyoritsu Hospital, Kawanishi, Japan;Internal Medicine, Matsue Red Cross Hospital, Matsue, Japan;Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan;Department of Gastroenterology, Saiseikai Noe Hospital, Osaka, Japan

关键词: Uninvestigated upper gastrointestinal symptoms;    Teprenone;    Mosapride;    Famotidine;    Omeprazole;   

Others  :  1113085
DOI  :  10.1186/1471-230X-12-42

 received in 2011-03-11, accepted in 2012-05-01,  发布年份 2012

【 摘 要 】

Background

In Japan, treatment guidelines are lacking for patients with upper gastrointestinal symptoms. We aimed to compare the efficacy of different drugs for the treatment of uninvestigated upper gastrointestinal symptoms.

Methods

This was a randomized, open-label, parallel-group multicenter study. Helicobacter pylori-negative, endoscopically uninvestigated patients ≥ 20 years of age with upper gastrointestinal symptoms of at least moderate severity (Global Overall Symptom score [GOS] ≥ 4 on a 7-point Likert scale) were randomized to treatment with omeprazole (10 mg once daily), famotidine (10 mg twice daily), mosapride (5 mg three times daily) or teprenone (50 mg three times daily). The primary endpoint was sufficient relief of upper gastrointestinal symptoms after 4 weeks of treatment (GOS ≤ 2). UMIN clinical trial registration number: UMIN000005399.

Results

Of 471 randomized patients, 454 were included in the full analysis set. After 4 weeks of treatment, sufficient symptom relief was achieved by 66.9% of patients in the omeprazole group, compared with 41.0%, 36.3% and 32.3% in the famotidine, mosapride and teprenone groups, respectively (all, p < 0.001 vs omeprazole). There were no treatment-related adverse events.

Conclusions

The favorable efficacy and safety profiles of omeprazole in relieving uninvestigated upper gastrointestinal symptoms support its use as first-line treatment in this patient group in Japan. Patients who show no improvement in symptoms despite PPI use, and those with alarm symptoms (such as vomiting, GI bleeding or acute weight loss) should receive further investigation, including prompt referral for endoscopy.

Trial registration

UMIN000005399.

【 授权许可】

   
2012 Sakurai et al; licensee BioMed Central Ltd.

【 图 表 】

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