Clinical trial: Dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagitis

D. C. Metz, Colin Howden, M. C. Perez, L. Larsen, J. O'Neil, S. N. Atkinson

Research output: Contribution to journalArticle

51 Citations (Scopus)

Abstract

Background Dexlansoprazole MR heals all grades of erosive oesophagitis (EO). Aim To assess efficacy and safety of dexlansoprazole MR in maintaining healed EO and heartburn relief. Methods In this randomized, double-blind trial, 445 patients with healed EO received dexlansoprazole MR 30 mg or 60 mg or placebo once daily for 6 months. This trial assessed maintenance of endoscopic healing (primary endpoint) and continued symptom relief based on daily diaries (secondary endpoints). Results Dexlansoprazole MR 30 mg and 60 mg were superior to placebo for maintaining healed EO (P < 0.0025; Hochberg's). By life-table analysis, maintenance rates were 75%, 83% and 27% for dexlansoprazole MR 30 mg, 60 mg and placebo respectively. Crude maintenance rates were 66% for both dexlansoprazole MR doses and 14% for placebo. Dexlansoprazole MR controlled heartburn (medians of 91-96% for 24-h heartburn-free days, 96-99% for heartburn-free nights). The only more common adverse event occurring at a significantly higher rate in dexlansoprazole MR groups than placebo when analysed per patient-months of exposure was upper respiratory tract infection. Conclusions Dexlansoprazole MR effectively maintained EO healing and symptom relief; most patients were heartburn-free for >90% of days. Both doses were well tolerated.

Original languageEnglish (US)
Pages (from-to)742-754
Number of pages13
JournalAlimentary Pharmacology and Therapeutics
Volume29
Issue number7
DOIs
StatePublished - Apr 1 2009

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Dexlansoprazole
Esophagitis
Proton Pump Inhibitors
Clinical Trials
Technology
Recurrence
Placebos
Heartburn
Maintenance
Safety

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

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Clinical trial : Dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagitis. / Metz, D. C.; Howden, Colin; Perez, M. C.; Larsen, L.; O'Neil, J.; Atkinson, S. N.

In: Alimentary Pharmacology and Therapeutics, Vol. 29, No. 7, 01.04.2009, p. 742-754.

Research output: Contribution to journalArticle

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abstract = "Background Dexlansoprazole MR heals all grades of erosive oesophagitis (EO). Aim To assess efficacy and safety of dexlansoprazole MR in maintaining healed EO and heartburn relief. Methods In this randomized, double-blind trial, 445 patients with healed EO received dexlansoprazole MR 30 mg or 60 mg or placebo once daily for 6 months. This trial assessed maintenance of endoscopic healing (primary endpoint) and continued symptom relief based on daily diaries (secondary endpoints). Results Dexlansoprazole MR 30 mg and 60 mg were superior to placebo for maintaining healed EO (P < 0.0025; Hochberg's). By life-table analysis, maintenance rates were 75{\%}, 83{\%} and 27{\%} for dexlansoprazole MR 30 mg, 60 mg and placebo respectively. Crude maintenance rates were 66{\%} for both dexlansoprazole MR doses and 14{\%} for placebo. Dexlansoprazole MR controlled heartburn (medians of 91-96{\%} for 24-h heartburn-free days, 96-99{\%} for heartburn-free nights). The only more common adverse event occurring at a significantly higher rate in dexlansoprazole MR groups than placebo when analysed per patient-months of exposure was upper respiratory tract infection. Conclusions Dexlansoprazole MR effectively maintained EO healing and symptom relief; most patients were heartburn-free for >90{\%} of days. Both doses were well tolerated.",
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N2 - Background Dexlansoprazole MR heals all grades of erosive oesophagitis (EO). Aim To assess efficacy and safety of dexlansoprazole MR in maintaining healed EO and heartburn relief. Methods In this randomized, double-blind trial, 445 patients with healed EO received dexlansoprazole MR 30 mg or 60 mg or placebo once daily for 6 months. This trial assessed maintenance of endoscopic healing (primary endpoint) and continued symptom relief based on daily diaries (secondary endpoints). Results Dexlansoprazole MR 30 mg and 60 mg were superior to placebo for maintaining healed EO (P < 0.0025; Hochberg's). By life-table analysis, maintenance rates were 75%, 83% and 27% for dexlansoprazole MR 30 mg, 60 mg and placebo respectively. Crude maintenance rates were 66% for both dexlansoprazole MR doses and 14% for placebo. Dexlansoprazole MR controlled heartburn (medians of 91-96% for 24-h heartburn-free days, 96-99% for heartburn-free nights). The only more common adverse event occurring at a significantly higher rate in dexlansoprazole MR groups than placebo when analysed per patient-months of exposure was upper respiratory tract infection. Conclusions Dexlansoprazole MR effectively maintained EO healing and symptom relief; most patients were heartburn-free for >90% of days. Both doses were well tolerated.

AB - Background Dexlansoprazole MR heals all grades of erosive oesophagitis (EO). Aim To assess efficacy and safety of dexlansoprazole MR in maintaining healed EO and heartburn relief. Methods In this randomized, double-blind trial, 445 patients with healed EO received dexlansoprazole MR 30 mg or 60 mg or placebo once daily for 6 months. This trial assessed maintenance of endoscopic healing (primary endpoint) and continued symptom relief based on daily diaries (secondary endpoints). Results Dexlansoprazole MR 30 mg and 60 mg were superior to placebo for maintaining healed EO (P < 0.0025; Hochberg's). By life-table analysis, maintenance rates were 75%, 83% and 27% for dexlansoprazole MR 30 mg, 60 mg and placebo respectively. Crude maintenance rates were 66% for both dexlansoprazole MR doses and 14% for placebo. Dexlansoprazole MR controlled heartburn (medians of 91-96% for 24-h heartburn-free days, 96-99% for heartburn-free nights). The only more common adverse event occurring at a significantly higher rate in dexlansoprazole MR groups than placebo when analysed per patient-months of exposure was upper respiratory tract infection. Conclusions Dexlansoprazole MR effectively maintained EO healing and symptom relief; most patients were heartburn-free for >90% of days. Both doses were well tolerated.

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