EFFICACY OF OMEPRAZOLE IN LOWER GRADES OF GASTROESOPHAGEAL REFLUX DISEASE

Grade I oesophagitis is usually considered to be a less severe form of gastro-oesophageal reflux disease (GORD). However, with regard to symptom severity, patients without macroscopic mucosal lesions have been shown not to differ from those with more severe oesophagitis. A number of controlled trials on the efficacy of omeprazole in GORD have included patients with lower grades of the disease. The results show that the differences in efficacy between omeprazole and H-2-receptor antagonists, which have been established for the treatment of erosive and ulcerative oesophagitis, also extend to patients with grade I oesophagitis (erythema and friability). In these studies, omeprazole provided more rapid symptom resolution and histological improvement than ranitidine. In one double-blind comparative trial, complete endoscopic normalization of the oesophageal mucosa was observed in 90% of patients with grade I oesophagitis within 4 weeks of treatment with omeprazole, 40 mg once daily, compared with 55% of those treated with ranitidine, 150 mg twice daily; at 8 weeks the mucosa in all patients in the omeprazole group had completely healed at endoscopy, while oesophagitis was still present in 21% of the patients receiving ranitidine. A separate 6-month, placebo-controlled maintenance study was performed in patients who had completed a short-term study and who had total relief from the major symptoms of GORD and complete healing of endoscopic oesophagitis. All patients given placebo had an endoscopic recurrence (i.e. endoscopic grade I or more) and this was associated with the return of symptoms in 75% of cases. In patients treated long term with omeprazole, 10 mg daily, 45% remained in endoscopic remission at 6 months, and the corresponding figure for omeprazole, 20 mg daily, was 65%. Amongst those patients treated with omeprazole, 10 mg daily, who were not in endoscopic remission at 6 months, about 50% were nevertheless still asymptomatic, which indicates that omeprazole, 10 mg daily, is sufficient for the control of symptoms in most patients presenting with mild forms of disease. Further studies are required to define the role of omeprazole in the management of patients with symptomatic GORD without oesophagitis.