T. Havelund et al., EFFICACY OF OMEPRAZOLE IN LOWER GRADES OF GASTROESOPHAGEAL REFLUX DISEASE, Scandinavian journal of gastroenterology, 29, 1994, pp. 69-73
Grade I oesophagitis is usually considered to be a less severe form of
gastro-oesophageal reflux disease (GORD). However, with regard to sym
ptom 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 inclu
ded patients with lower grades of the disease. The results show that t
he differences in efficacy between omeprazole and H-2-receptor antagon
ists, which have been established for the treatment of erosive and ulc
erative oesophagitis, also extend to patients with grade I oesophagiti
s (erythema and friability). In these studies, omeprazole provided mor
e rapid symptom resolution and histological improvement than ranitidin
e. In one double-blind comparative trial, complete endoscopic normaliz
ation of the oesophageal mucosa was observed in 90% of patients with g
rade I oesophagitis within 4 weeks of treatment with omeprazole, 40 mg
once daily, compared with 55% of those treated with ranitidine, 150 m
g twice daily; at 8 weeks the mucosa in all patients in the omeprazole
group had completely healed at endoscopy, while oesophagitis was stil
l present in 21% of the patients receiving ranitidine. A separate 6-mo
nth, placebo-controlled maintenance study was performed in patients wh
o had completed a short-term study and who had total relief from the m
ajor symptoms of GORD and complete healing of endoscopic oesophagitis.
All patients given placebo had an endoscopic recurrence (i.e. endosco
pic grade I or more) and this was associated with the return of sympto
ms in 75% of cases. In patients treated long term with omeprazole, 10
mg daily, 45% remained in endoscopic remission at 6 months, and the co
rresponding figure for omeprazole, 20 mg daily, was 65%. Amongst those
patients treated with omeprazole, 10 mg daily, who were not in endosc
opic remission at 6 months, about 50% were nevertheless still asymptom
atic, 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 omeprazol
e in the management of patients with symptomatic GORD without oesophag
itis.