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

Autor: Toshiharu Chikama, Susumu Kawamura, Naomi Uemura, Toshiro Urata, Tomoharu Yoshida, Hiroshi Serizawa, Munemitsu Yamamoto, Tomomi Tsuru, Nobuo Yurino, Masao Yamauchi, Toru Umezu, Satoshi Tanabe, Atsushi Murakami, Hideto Inokuchi, Tsutomu Chiba
Rok vydání: 2008
Předmět:
Zdroj: Journal of Gastroenterology. 43:670-678
ISSN: 1435-5922
0944-1174
DOI: 10.1007/s00535-008-2214-5
Popis: 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.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.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.Omeprazole 10 mg or 20 mg once daily is effective and well tolerated in patients with NERD regardless of their endoscopic classification.
Databáze: OpenAIRE
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