To compare the efficacy and safety of lansoprazole 30 mg daily (LAN30) and omeprazole 40 mg daily (OME40) in the treatment of moderate (Savary-Miller grade II) as well as severe reflux oesophagitis (grade III/IVa).
A double-blind, randomized, multicentre study, involving 211 patients at 29 Dutch hospitals.
Healing was assessed by endoscopy, performed on admission, after 4 weeks and after 8 weeks if the patient was not healed after 4 weeks. Symptom relief was determined by symptom assessments at the same time points. Safety was evaluated by determining the incidence of adverse events.
There was no significant difference in intention-to-treat (ITT) healing rates after 4 weeks (LAN30 87.5%, OME40 80.6%; 95% CI (-4.0; +17.8)) and in the ITT overall healing (LAN30 96.1%, OME40 93.1%; 95% CI (-4.2; +10.2)) rates between the LAN30 and the OME40 group. Relief of reflux-related symptoms at 4 weeks as well as 8 weeks did not differ significantly between the treatment groups. No difference in the incidence of adverse events was observed between the groups.
Treatment of patients with reflux oesophagitis grade II, III or IVa with LAN30 was as effective as with OME40 with respect to healing as well as symptom relief.