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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

Comparative 8-week crude erosive esophagitis healing rates for dexlansoprazole MR and lansoprazole.33P = 0.004 vs lansoprazole.
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f4-ceg-2-117: Comparative 8-week crude erosive esophagitis healing rates for dexlansoprazole MR and lansoprazole.33P = 0.004 vs lansoprazole.

Mentions: Baseline demographics were not significantly different between any of the groups in either study. Erosive esophagitis healing rates at week 8 for both dexlansoprazole MR doses were superior to lansoprazole in one study (Study 1); 60 mg of dexlansoprazole MR was noninferior and 90 mg was superior to lansoprazole in the other study (Figure 4). Healing at week 4 was >64% for all groups using both crude rate and life-table analysis methods. Healing of moderate-to-severe erosive esophagitis was significantly greater with dexlansoprazole MR 60 mg than lansoprazole in Study 1 and both doses were noninferior to lansoprazole in Study 2. The median percentage of 24-hour heartburn-free days was greater than 80% in patients who received either dose of dexlansoprazole MR; this was comparable to lansoprazole.


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

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

Comparative 8-week crude erosive esophagitis healing rates for dexlansoprazole MR and lansoprazole.33P = 0.004 vs lansoprazole.
© Copyright Policy
Related In: Results  -  Collection

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

f4-ceg-2-117: Comparative 8-week crude erosive esophagitis healing rates for dexlansoprazole MR and lansoprazole.33P = 0.004 vs lansoprazole.
Mentions: Baseline demographics were not significantly different between any of the groups in either study. Erosive esophagitis healing rates at week 8 for both dexlansoprazole MR doses were superior to lansoprazole in one study (Study 1); 60 mg of dexlansoprazole MR was noninferior and 90 mg was superior to lansoprazole in the other study (Figure 4). Healing at week 4 was >64% for all groups using both crude rate and life-table analysis methods. Healing of moderate-to-severe erosive esophagitis was significantly greater with dexlansoprazole MR 60 mg than lansoprazole in Study 1 and both doses were noninferior to lansoprazole in Study 2. The median percentage of 24-hour heartburn-free days was greater than 80% in patients who received either dose of dexlansoprazole MR; this was comparable to lansoprazole.

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