Open Study of the Clinical Effects of Lansoprazole in the Treatment of Reflux Oesophagitis

Summary

The clinical efficacy and safety of lansoprazole, administered in a dose of 30mg once daily after breakfast, were studied in an open trial with 38 patients with erosive/ulcerative reflux oesophagitis. In 3 of these patients, the effect on gastro-oesophageal reflux and gastroduodenal motility was also investigated by 24-hour pH and motility monitoring, performed before and 1 week after starting lansoprazole therapy.

Lansoprazole almost completely reduced the total reflux (pH < 4) time and the number of reflux episodes lasting ⩾ 5 minutes, while it did not affect the induction of interdigestive migrating complex. The cumulative disappearance rate of overall subjective and objective symptoms was 66% after 1 week and 91% after 2 weeks. For individual symptoms the disappearance rate for heartburn was 79% after 1 week and 100% after 2 weeks of treatment. An endoscopic healing rate of 76% was achieved after 2 weeks, 97% after 4 weeks, and 97% after 8 weeks of lansoprazole treatment, and in poor responders to histamine H₂-receptor antagonist therapy, the healing rate was 83% after 2 weeks and 100% after 4 weeks. Global improvement evaluation, as assessed by endoscopic findings and changes in symptoms and signs, showed ‘marked improvement’ in 94% and ‘moderate improvement’ in 6% of the patients.

In the overall safety evaluation, no problems occurred in 33 (86.8%) of the 38 patients. Three patients had mild cases of dry mouth. No serious abnormal changes in laboratory values were detected. Lansoprazole was deemed to be ‘extremely useful’ in 31 (89%) and ‘considerably useful’ in 3 (9%) of the 35 patients.

These results indicate that lansoprazole, administered in a dose of 30mg once daily after breakfast, inhibits gastro-oesophageal acid reflux almost completely, and it should prove to be a very useful therapeutic agent for reflux oesophagitis.