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Delayed release dexlansoprazole in the treatment of GERD and erosive esophagitis.

Wittbrodt ET, Baum C, Peura DA - Clin Exp Gastroenterol (2009)

Bottom Line: Dexlansoprazole MR is the (R)-enantiomer of lansoprazole contained in a formulation that produces two distinct releases of drug and significantly extends the duration of active plasma concentrations and % time pH > 4 beyond that of conventional single-release PPI.Dexlansoprazole MR 60 mg demonstrated similar efficacy for healing of erosive esophagitis at 8 weeks compared with lansoprazole 30 mg, and dexlansoprazole MR 30 mg was superior to placebo for maintenance of healed erosive esophagitis at 6 months with 99% of nights and 96% of days heartburn-free over 6 months in patients taking dexlansoprazole MR 30 mg.The safety profile of dexlansoprazole MR is similar to that of lansoprazole.

View Article: PubMed Central - PubMed

Affiliation: Takeda Pharmaceuticals North America, Inc.

ABSTRACT
Although proton pump inhibitors (PPI) have a record of remarkable effectiveness and safety in the management of gastroesophageal reflux disease (GERD), several treatment challenges with PPI have emerged. Dexlansoprazole MR is the (R)-enantiomer of lansoprazole contained in a formulation that produces two distinct releases of drug and significantly extends the duration of active plasma concentrations and % time pH > 4 beyond that of conventional single-release PPI. Dexlansoprazole MR can be administered without regard to meals or the timing of meals in most patients. Dexlansoprazole MR 60 mg demonstrated similar efficacy for healing of erosive esophagitis at 8 weeks compared with lansoprazole 30 mg, and dexlansoprazole MR 30 mg was superior to placebo for maintenance of healed erosive esophagitis at 6 months with 99% of nights and 96% of days heartburn-free over 6 months in patients taking dexlansoprazole MR 30 mg. Superior relief of heartburn occurred in patients taking dexlansoprazole MR 30 mg (55% heartburn-free 24-hour periods) vs placebo (14%) for symptomatic nonerosive GERD. The safety profile of dexlansoprazole MR is similar to that of lansoprazole. The extended pharmacodynamic effects, added convenience, and efficacy and safety of dexlansoprazole MR offer a novel approach to gastric pH control in patients with acid-related disorders.

No MeSH data available.


Related in: MedlinePlus

Median percentage of 24-hour heartburn-free days and median percentage of nights without heartburn during treatment.P < 0.0025 vs placebo (Hochberg’s procedure; Wilcoxon rank sum tests).Reproduced with permission from Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. 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. Aliment Pharmacol Ther. 2009;29(7):742–754.34 Copyright © 2009 Wiley-Blackwell.
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f5-ceg-2-117: Median percentage of 24-hour heartburn-free days and median percentage of nights without heartburn during treatment.P < 0.0025 vs placebo (Hochberg’s procedure; Wilcoxon rank sum tests).Reproduced with permission from Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. 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. Aliment Pharmacol Ther. 2009;29(7):742–754.34 Copyright © 2009 Wiley-Blackwell.

Mentions: The enrollment of the study that compared dexlansoprazole MR 30 mg and 60 mg with placebo was 445 subjects, and the withdrawal rate from study medication was 83% for the placebo group and 34% for each dexlansoprazole MR group, mostly due to relapse of erosive esophagitis. Maintenance of healing rates were significantly higher for both dexlansoprazole MR doses compared to placebo, and this finding was consistent for all grades of erosive esophagitis and for moderate-to-severe disease. The median percentage of 24-hour heartburn-free days and median percentage of nights without heartburn was statistically significantly higher for all doses of dexlansoprazole MR than placebo, with 96% of 24-hour periods and 99% of nights being reported as heartburn-free over 6 months for dexlansoprazole MR 30 mg vs 29% of 24-hour periods and 72% of nights for placebo (Figure 5).


Delayed release dexlansoprazole in the treatment of GERD and erosive esophagitis.

Wittbrodt ET, Baum C, Peura DA - Clin Exp Gastroenterol (2009)

Median percentage of 24-hour heartburn-free days and median percentage of nights without heartburn during treatment.P < 0.0025 vs placebo (Hochberg’s procedure; Wilcoxon rank sum tests).Reproduced with permission from Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. 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. Aliment Pharmacol Ther. 2009;29(7):742–754.34 Copyright © 2009 Wiley-Blackwell.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3108635&req=5

f5-ceg-2-117: Median percentage of 24-hour heartburn-free days and median percentage of nights without heartburn during treatment.P < 0.0025 vs placebo (Hochberg’s procedure; Wilcoxon rank sum tests).Reproduced with permission from Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. 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. Aliment Pharmacol Ther. 2009;29(7):742–754.34 Copyright © 2009 Wiley-Blackwell.
Mentions: The enrollment of the study that compared dexlansoprazole MR 30 mg and 60 mg with placebo was 445 subjects, and the withdrawal rate from study medication was 83% for the placebo group and 34% for each dexlansoprazole MR group, mostly due to relapse of erosive esophagitis. Maintenance of healing rates were significantly higher for both dexlansoprazole MR doses compared to placebo, and this finding was consistent for all grades of erosive esophagitis and for moderate-to-severe disease. The median percentage of 24-hour heartburn-free days and median percentage of nights without heartburn was statistically significantly higher for all doses of dexlansoprazole MR than placebo, with 96% of 24-hour periods and 99% of nights being reported as heartburn-free over 6 months for dexlansoprazole MR 30 mg vs 29% of 24-hour periods and 72% of nights for placebo (Figure 5).

Bottom Line: Dexlansoprazole MR is the (R)-enantiomer of lansoprazole contained in a formulation that produces two distinct releases of drug and significantly extends the duration of active plasma concentrations and % time pH > 4 beyond that of conventional single-release PPI.Dexlansoprazole MR 60 mg demonstrated similar efficacy for healing of erosive esophagitis at 8 weeks compared with lansoprazole 30 mg, and dexlansoprazole MR 30 mg was superior to placebo for maintenance of healed erosive esophagitis at 6 months with 99% of nights and 96% of days heartburn-free over 6 months in patients taking dexlansoprazole MR 30 mg.The safety profile of dexlansoprazole MR is similar to that of lansoprazole.

View Article: PubMed Central - PubMed

Affiliation: Takeda Pharmaceuticals North America, Inc.

ABSTRACT
Although proton pump inhibitors (PPI) have a record of remarkable effectiveness and safety in the management of gastroesophageal reflux disease (GERD), several treatment challenges with PPI have emerged. Dexlansoprazole MR is the (R)-enantiomer of lansoprazole contained in a formulation that produces two distinct releases of drug and significantly extends the duration of active plasma concentrations and % time pH > 4 beyond that of conventional single-release PPI. Dexlansoprazole MR can be administered without regard to meals or the timing of meals in most patients. Dexlansoprazole MR 60 mg demonstrated similar efficacy for healing of erosive esophagitis at 8 weeks compared with lansoprazole 30 mg, and dexlansoprazole MR 30 mg was superior to placebo for maintenance of healed erosive esophagitis at 6 months with 99% of nights and 96% of days heartburn-free over 6 months in patients taking dexlansoprazole MR 30 mg. Superior relief of heartburn occurred in patients taking dexlansoprazole MR 30 mg (55% heartburn-free 24-hour periods) vs placebo (14%) for symptomatic nonerosive GERD. The safety profile of dexlansoprazole MR is similar to that of lansoprazole. The extended pharmacodynamic effects, added convenience, and efficacy and safety of dexlansoprazole MR offer a novel approach to gastric pH control in patients with acid-related disorders.

No MeSH data available.


Related in: MedlinePlus