Efficacy and safety of omeprazole in Japanese patients with nonerosive reflux disease.
J Gastroenterol
; 43(9): 670-8, 2008.
Article
em En
| MEDLINE
| ID: mdl-18807128
ABSTRACT
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Omeprazol
/
Refluxo Gastroesofágico
/
Antiulcerosos
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Aged80
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Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
J Gastroenterol
Ano de publicação:
2008
Tipo de documento:
Article