Dexlansoprazole modified release (MR) uses a dual delayed-release delivery system that extends drug exposure and prolongs pH control.
Proton pump inhibitors (PPIs) are the most effective treatments for healing erosive oesophagitis (EO) and have become the mainstay of pharmacological therapy for acid-related disorders. Despite the widespread use of PPIs as first-line therapy for acid-related disorders, about 30% of patients with gastro-oesophageal reflux disease (GERD) fail to obtain complete healing and ⁄ or symptom relief after a course of conventional PPI therapy.
Failure to effectively control acid reflux in patients with EO has been associated with increased morbidity and complications, such as oesophageal strictures, bleeding and development of Barrett’s oesophagus, with or without dysplasia.
Sharma et al (2009) assessed the efficacy and safety of dexlansoprazole MR in healing erosive EO in patients in two identical double-blind, randomised controlled trials, who received dexlansoprazole MR 60mg or 90mg, or lansoprazole 30mg once daily.
Dexlansoprazole MR achieved non-inferiority to lansoprazole, allowing testing for superiority. Using life-table analysis, dexlansoprazole MR healed 92%-95% of patients in individual studies vs 86%-92% for lansoprazole. Dexlansoprazole MR 90mg was superior to lansoprazole in both studies and 60mg was superior in one study. Week four healing was >64% with all treatments in both studies. In an integrated analysis of eight-week healing in patients with moderate-to-severe EO, dexlansoprazole MR 90mg was superior to lansoprazole. All treatments effectively relieved symptoms and were well tolerated.
They concluded that dexlansoprazole MR is highly effective in healing EO and offers benefits over lansoprazole, particularly in moderate-to-severe disease.
Efficacy, safety of dexlansoprazole MR in maintenance of healed EO
Between 80% and 90% of patients with healed EO will relapse within 6-12 months of discontinuation of their PPI.
Therefore, long-term PPI therapy is recommended for maintenance of healed EO, continued relief of symptoms and preservation of quality of life. Howden et al (2009) assessed dexlansoprazole MR 60mg or 90mg in maintaining healed EO in 451 patients. This double-blind trial showed that both dexlansoprazole doses were superior to placebo for maintaining healing.
Maintenance rates were 87% and 82% for the 60mg and 90mg 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 heartburn-free days (60mg, 96%; 90mg, 94%; placebo, 19%) and nights (98%, 97%, and 50%, respectively). Diarrhoea, flatulence, gastritis and abdominal pain occurred more frequently with dexlansoprazole MR than placebo but were not dose related.
Dexlansoprazole MR is highly effective in healing EO and offers benefits over lansoprazole, particularly in moderate-to-severe disease. Howden et al showed that it also effectively maintained healed EO, and symptom relief compared with placebo and was well tolerated. Similarly, Metz et al (2009) found that both doses of dexlansoprazole MR effectively maintained EO healing and symptom relief. Their study concluded that most patients were heartburn-free for >90% of days, and that both doses were well tolerated.
References available on request.