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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

Mean % time intragastric pH > 4 and mean 24-hour intragastric pH with dexlansoprazole MR 60 mg vs lansoprazole 30 mg on Day 5.19*P < 0.01, **P < 0.001.Note: P-values are from the tests of the differences in least square means between a given dexlansoprazole MR and the LAN regimen.
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f2-ceg-2-117: Mean % time intragastric pH > 4 and mean 24-hour intragastric pH with dexlansoprazole MR 60 mg vs lansoprazole 30 mg on Day 5.19*P < 0.01, **P < 0.001.Note: P-values are from the tests of the differences in least square means between a given dexlansoprazole MR and the LAN regimen.

Mentions: The pharmacokinetics, pharmacodynamics, and safety of three dosing regimens of dexlansoprazole MR (60, 90, and 120 mg) and lansoprazole 30 mg were assessed in an open-label, multiple-dose, single-center, four-period, crossover study in 40 subjects.22 After 5 days of once daily administration dexlansoprazole MR 60 mg produced statistically significantly greater mean 24-hour intragastric pH compared to lansoprazole 30 mg (4.55 vs 4.13, respectively, P < 0.001); a statistically significant increase in % time 24-hour intragastric pH > 4 was also observed (71% vs 60%, respectively, P < 0.01) (Figure 2). The 90 mg dose of dexlansoprazole MR produced 24-hour intragastric pH > 4 for 70% of the time. The pharmacodynamic effect of dexlansoprazole MR 120 mg was similar to that of the 90 mg dose. As a result, the 120 mg dose was not pursued for clinical development. The clinical significance of these differences remains unknown, but the DDRâ„¢ formulation of dexlansoprazole MR appears to provide pharmacodynamic benefit beyond that of lansoprazole most likely due to the extended duration of effective plasma concentration.


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

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

Mean % time intragastric pH > 4 and mean 24-hour intragastric pH with dexlansoprazole MR 60 mg vs lansoprazole 30 mg on Day 5.19*P < 0.01, **P < 0.001.Note: P-values are from the tests of the differences in least square means between a given dexlansoprazole MR and the LAN regimen.
© Copyright Policy
Related In: Results  -  Collection

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

f2-ceg-2-117: Mean % time intragastric pH > 4 and mean 24-hour intragastric pH with dexlansoprazole MR 60 mg vs lansoprazole 30 mg on Day 5.19*P < 0.01, **P < 0.001.Note: P-values are from the tests of the differences in least square means between a given dexlansoprazole MR and the LAN regimen.
Mentions: The pharmacokinetics, pharmacodynamics, and safety of three dosing regimens of dexlansoprazole MR (60, 90, and 120 mg) and lansoprazole 30 mg were assessed in an open-label, multiple-dose, single-center, four-period, crossover study in 40 subjects.22 After 5 days of once daily administration dexlansoprazole MR 60 mg produced statistically significantly greater mean 24-hour intragastric pH compared to lansoprazole 30 mg (4.55 vs 4.13, respectively, P < 0.001); a statistically significant increase in % time 24-hour intragastric pH > 4 was also observed (71% vs 60%, respectively, P < 0.01) (Figure 2). The 90 mg dose of dexlansoprazole MR produced 24-hour intragastric pH > 4 for 70% of the time. The pharmacodynamic effect of dexlansoprazole MR 120 mg was similar to that of the 90 mg dose. As a result, the 120 mg dose was not pursued for clinical development. The clinical significance of these differences remains unknown, but the DDRâ„¢ formulation of dexlansoprazole MR appears to provide pharmacodynamic benefit beyond that of lansoprazole most likely due to the extended duration of effective plasma concentration.

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