Clinical trial

Efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis - Maintenance of healing and symptom relief

Colin Howden, L. M. Larsen, M. C. Perez, R. Palmer, S. N. Atkinson

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)895-907
Number of pages13
JournalAlimentary Pharmacology and Therapeutics
Volume30
Issue number9
DOIs
StatePublished - Nov 1 2009
Externally publishedYes

Fingerprint

Dexlansoprazole
Esophagitis
Maintenance
Clinical Trials
Safety
Placebos
Heartburn
Life Tables
Lansoprazole
Flatulence
Gastritis
Abdominal Pain
Diarrhea

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

Cite this

Clinical trial : Efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis - Maintenance of healing and symptom relief. / Howden, Colin; Larsen, L. M.; Perez, M. C.; Palmer, R.; Atkinson, S. N.

In: Alimentary Pharmacology and Therapeutics, Vol. 30, No. 9, 01.11.2009, p. 895-907.

Research output: Contribution to journalArticle

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abstract = "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.",
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N2 - 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.

AB - 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.

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