Clinical trial: efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis – maintenance of healing and symptom relief

• Published in: Alimentary pharmacology & therapeutics Vol. 30; no. 9; pp. 895 - 907
• Main Authors: HOWDEN, C. W., LARSEN, L. M., PEREZ, M. C., PALMER, R., ATKINSON, S. N.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-11-2009; Blackwell
• Subjects: 2-Pyridinylmethylsulfinylbenzimidazoles - administration & dosage; 2-Pyridinylmethylsulfinylbenzimidazoles - adverse effects; Adult; Aged; Anti-Ulcer Agents - administration & dosage; Anti-Ulcer Agents - adverse effects; Biological and medical sciences; Dexlansoprazole; Digestive system; Dose-Response Relationship, Drug; Double-Blind Method; Esophagitis - drug therapy; Esophagus; Female; Gastroenterology. Liver. Pancreas. Abdomen; Heartburn - prevention & control; Humans; Lansoprazole; Male; Medical sciences; Middle Aged; Other diseases. Semiology; Pharmacology. Drug treatments; Proton Pump Inhibitors - administration & dosage; Proton Pump Inhibitors - adverse effects; Treatment Outcome; Human; Dexlansoprazole; Toxicity; Treatment efficiency; Esophageal disease; Esophagitis; Antiulcer agent; Symptomatology; Benzimidazole derivatives; Healing agent; Digestive diseases; Clinical trial; Safety; Cicatrization
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2009.04119.x

Summary
Background  Dexlansoprazole MR, a modified‐release formulation of dexlansoprazole, an enantiomer of lansoprazole, effectively heals erosive oesophagitis.
Aim  To assess dexlansoprazole MR in maintaining healed erosive oesophagitis.
Methods  Patients (n = 451) with erosive oesophagitis healed in either of two dexlansoprazole MR healing trials randomly received dexlansoprazole MR 60 or 90 mg or placebo once daily in this double‐blind trial. The percentage of patients who maintained healing at month 6 was analysed using life table and crude rate methods. Secondary endpoints were percentages of nights and of 24‐h days without heartburn based on daily diaries.
Results  Dexlansoprazole MR 60 and 90 mg were superior to placebo for maintaining healing (P < 0.0025). Maintenance rates were 87% and 82% for the 60 and 90 mg doses, respectively, vs. 26% for placebo (life table), and 66% and 65% vs. 14%, respectively (crude rate). Both doses were superior to placebo for the percentage of 24‐h heartburn‐free days (60 mg, 96%; 90 mg, 94%; placebo, 19%) and nights (98%, 97%, and 50%, respectively). Diarrhoea, flatulence, gastritis (symptoms) and abdominal pain occurred more frequently with dexlansoprazole MR than placebo, but were not dose‐related.
Conclusion  Dexlansoprazole MR effectively maintained healed erosive oesophagitis and symptom relief compared with placebo, and was well tolerated.