Efficacy and safety of omeprazole in Japanese patients with nonerosive reflux disease

• Published in: Journal of gastroenterology 2008-09, Vol.43 (9), p.670-678
• Main Authors: Uemura, Naomi, Inokuchi, Hideto, Serizawa, Hiroshi, Chikama, Toshiharu, Yamauchi, Masao, Tsuru, Tomomi, Umezu, Toru, Urata, Toshiro, Yurino, Nobuo, Tanabe, Satoshi, Yoshida, Tomoharu, Kawamura, Susumu, Murakami, Atsushi, Yamamoto, Munemitsu, Chiba, Tsutomu
• Format: Article
• Language: English
• Subjects: Abdominal Surgery; Adult; Aged; Aged, 80 and over; Alimmentary Tract; Anti-Ulcer Agents - adverse effects; Anti-Ulcer Agents - therapeutic use; Aryl Hydrocarbon Hydroxylases - analysis; Aryl Hydrocarbon Hydroxylases - genetics; Colorectal Surgery; Cytochrome P-450 CYP2C19; Double-Blind Method; Female; Gastroenterology; Gastroesophageal Reflux - drug therapy; Gastroesophageal Reflux - genetics; Gastroesophageal Reflux - pathology; Genotype; Heartburn - drug therapy; Hepatology; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Omeprazole - adverse effects; Omeprazole - therapeutic use; Surgical Oncology
• ISSN: 0944-1174; 1435-5922
• DOI: 10.1007/s00535-008-2214-5

Background There is increasing awareness of nonerosive reflux disease (NERD) as a disease requiring treatment in Japan. This randomized, double-blind, placebo-controlled, parallel-group study was conducted to investigate the efficacy and safety of omeprazole 10 mg and 20 mg once daily in Japanese patients with NERD. Methods Patients with heartburn for at least 2 days a week during the month before entry into the study and no endoscopic signs of a mucosal break (grade M or N according to Hoshihara’s modification of the Los Angeles classification) were randomly assigned to one of three groups (omeprazole 10 mg or 20 mg, or placebo) once daily for 4 weeks. Results Overall, 355 patients were enrolled, of whom 284 were randomly assigned to one of the three groups (omeprazole 10 mg, n = 96; omeprazole 20 mg, n = 93; placebo, n = 95). The rate of complete resolution of heartburn in week 4 was significantly higher in patients treated with omeprazole 10 mg [32.3%, 95% confidence interval (CI), 22.9%–41.6%] or 20 mg (25.8%, 95% CI, 16.9%–34.7%) than in the placebo group (12.0%, 95% CI, 5.3%–18.6%). No significant difference between the two omeprazole groups was observed. The rate of complete resolution of heartburn by omeprazole was similar between patients with grade M and those with grade N esophagus. Omeprazole also increased the rate of sufficient relief from heartburn. Omeprazole was well tolerated. Conclusions Omeprazole 10 mg or 20 mg once daily is effective and well tolerated in patients with NERD regardless of their endoscopic classification.