Efficacy and safety of omeprazole in Japanese patients with nonerosive reflux disease.
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.
Uemura
Naomi
N
Department of Gastroenterology, International Medical Center of Japan, 1-21-1 Toyama, Shinjuku-ku, Tokyo 162-0052, Japan.
Inokuchi
Hideto
H
Serizawa
Hiroshi
H
Chikama
Toshiharu
T
Yamauchi
Masao
M
Tsuru
Tomomi
T
Umezu
Toru
T
Urata
Toshiro
T
Yurino
Nobuo
N
Tanabe
Satoshi
S
Yoshida
Tomoharu
T
Kawamura
Susumu
S
Murakami
Atsushi
A
Yamamoto
Munemitsu
M
Chiba
Tsutomu
T
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001189:Aryl Hydrocarbon Hydroxylases / Q000032:analysis / Q000235:genetics; D065731:Cytochrome P-450 CYP2C19; D004311:Double-Blind Method; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D005838:Genotype; D006356:Heartburn / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use*
D000897:Anti-Ulcer Agents; D001189:Aryl Hydrocarbon Hydroxylases; C045793:CYP2C19 protein, human; D065731:Cytochrome P-450 CYP2C19; D009853:Omeprazole