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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

Percentage of patients with 24-hour heartburn-free days by each study day in nonerosive GERD.Notes: There was no comparison made for each study day and hence no statistical significance is reported.Reproduced with permission from Fass R, Chey WD, Zakko SF, et al. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with nonerosive reflux disease. Aliment Pharmacol Ther. 2009;29(12):1261–1272.36 Copyright © 2009 Wiley-Blackwell.
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f7-ceg-2-117: Percentage of patients with 24-hour heartburn-free days by each study day in nonerosive GERD.Notes: There was no comparison made for each study day and hence no statistical significance is reported.Reproduced with permission from Fass R, Chey WD, Zakko SF, et al. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with nonerosive reflux disease. Aliment Pharmacol Ther. 2009;29(12):1261–1272.36 Copyright © 2009 Wiley-Blackwell.

Mentions: The control of nonerosive GERD symptoms remains a therapeutic challenge for practitioners, because the true etiology of the symptoms may or may not be due to acid or may be unknown. A clinical trial compared two different doses of dexlansoprazole MR (30 and 60 mg) with placebo in subjects with normal esophageal mucosa on EGD.36 This study identified patients with heartburn-predominant complaints for at least 6 months and for 4 of the 7 days prior to screening for enrollment, but no minimal severity of symptoms was required. Besides EGD, no objective assessments of esophageal disease such as pH-metry were conducted and no attempts were made to identify or exclude patients with functional heartburn. Study medication was administered in a blinded fashion once daily in the morning for 28 days. Subjects recorded heartburn symptom assessments twice daily as described for the erosive esophagitis healing and maintenance studies, and investigator assessments occurred at baseline and at 2 and 4 weeks of the study. The primary endpoint was the percentage of 24-hour periods that were free of heartburn symptoms over 28 days, and the secondary endpoint was the percentage of daytime periods and nighttime periods without heartburn. The results demonstrated that a majority of the 24-hour periods were heartburn-free in the groups that received dexlansoprazole MR (median percentage 54.9% for the 30 mg group) compared with 18.5% for the placebo group (Figure 6). The dexlansoprazole MR 30 mg group also experienced significantly greater nighttime periods (median percentage of nights 80.8% vs 51.7% for placebo) and daytime periods (median percentage of days 63.0% vs 26.9% for placebo) that were symptom-free. It is important to note that no nighttime symptom requirement was necessary for enrollment into the study; this may partially explain the relatively large placebo response for this endpoint. The percentage of patients during the study who experienced 24-hour heartburn-free days over the first 3 days of treatment was significantly greater for dexlansoprazole MR treatment groups than placebo. The percentage of patients with 24-hour heartburn-free days by each study day is presented in Figure 7.


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

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

Percentage of patients with 24-hour heartburn-free days by each study day in nonerosive GERD.Notes: There was no comparison made for each study day and hence no statistical significance is reported.Reproduced with permission from Fass R, Chey WD, Zakko SF, et al. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with nonerosive reflux disease. Aliment Pharmacol Ther. 2009;29(12):1261–1272.36 Copyright © 2009 Wiley-Blackwell.
© Copyright Policy
Related In: Results  -  Collection

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

f7-ceg-2-117: Percentage of patients with 24-hour heartburn-free days by each study day in nonerosive GERD.Notes: There was no comparison made for each study day and hence no statistical significance is reported.Reproduced with permission from Fass R, Chey WD, Zakko SF, et al. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with nonerosive reflux disease. Aliment Pharmacol Ther. 2009;29(12):1261–1272.36 Copyright © 2009 Wiley-Blackwell.
Mentions: The control of nonerosive GERD symptoms remains a therapeutic challenge for practitioners, because the true etiology of the symptoms may or may not be due to acid or may be unknown. A clinical trial compared two different doses of dexlansoprazole MR (30 and 60 mg) with placebo in subjects with normal esophageal mucosa on EGD.36 This study identified patients with heartburn-predominant complaints for at least 6 months and for 4 of the 7 days prior to screening for enrollment, but no minimal severity of symptoms was required. Besides EGD, no objective assessments of esophageal disease such as pH-metry were conducted and no attempts were made to identify or exclude patients with functional heartburn. Study medication was administered in a blinded fashion once daily in the morning for 28 days. Subjects recorded heartburn symptom assessments twice daily as described for the erosive esophagitis healing and maintenance studies, and investigator assessments occurred at baseline and at 2 and 4 weeks of the study. The primary endpoint was the percentage of 24-hour periods that were free of heartburn symptoms over 28 days, and the secondary endpoint was the percentage of daytime periods and nighttime periods without heartburn. The results demonstrated that a majority of the 24-hour periods were heartburn-free in the groups that received dexlansoprazole MR (median percentage 54.9% for the 30 mg group) compared with 18.5% for the placebo group (Figure 6). The dexlansoprazole MR 30 mg group also experienced significantly greater nighttime periods (median percentage of nights 80.8% vs 51.7% for placebo) and daytime periods (median percentage of days 63.0% vs 26.9% for placebo) that were symptom-free. It is important to note that no nighttime symptom requirement was necessary for enrollment into the study; this may partially explain the relatively large placebo response for this endpoint. The percentage of patients during the study who experienced 24-hour heartburn-free days over the first 3 days of treatment was significantly greater for dexlansoprazole MR treatment groups than placebo. The percentage of patients with 24-hour heartburn-free days by each study day is presented in Figure 7.

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