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Pharmacological and Safety Profile of Dexlansoprazole: A New Proton Pump Inhibitor - Implications for Treatment of Gastroesophageal Reflux Disease in the Asia Pacific Region.

Goh KL, Choi MG, Hsu PI, Chun HJ, Mahachai V, Kachintorn U, Leelakusolvong S, Kim N, Rani AA, Wong BC, Wu J, Chiu CT, Shetty V, Bocobo JC, Chan MM, Lin JT - J Neurogastroenterol Motil (2016)

Bottom Line: Dexlansoprazole is the first PPI with a dual delayed release formulation designed to provide 2 separate releases of medication to extend the duration of effective plasma drug concentration.Dexlansoprazole has been shown to be effective for healing of erosive esophagitis, and to improve subjective well-being by controlling 24-hour symptoms.Studies in healthy volunteers showed no clinically important effects on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition, with no dose adjustment of clopidogrel necessary when coprescribed.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.

ABSTRACT
Although gastroesophageal reflux disease is not as common in Asia as in western countries, the prevalence has increased substantially during the past decade. Gastroesophageal reflux disease is associated with considerable reductions in subjective well-being and work productivity, as well as increased healthcare use. Proton pump inhibitors (PPIs) are currently the most effective treatment for gastroesophageal reflux disease. However, there are limitations associated with these drugs in terms of partial and non-response. Dexlansoprazole is the first PPI with a dual delayed release formulation designed to provide 2 separate releases of medication to extend the duration of effective plasma drug concentration. Dexlansoprazole has been shown to be effective for healing of erosive esophagitis, and to improve subjective well-being by controlling 24-hour symptoms. Dexlansoprazole has also been shown to achieve good plasma concentration regardless of administration with food, providing flexible dosing. Studies in healthy volunteers showed no clinically important effects on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition, with no dose adjustment of clopidogrel necessary when coprescribed. This review discusses the role of the new generation PPI, dexlansoprazole, in the treatment of gastroesophageal reflux disease in Asia.

No MeSH data available.


Related in: MedlinePlus

Control of heartburn over 24 hours by dexlansoprazole versus placebo in patients with healed erosive esophagitis (intent to treat population). *P < 0.0025 vs placebo. Adapted from Metz et al46 With permission from John Wiley & Sons, Inc. © 2009 Takeda Global Research & Development Center, Inc.
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f5-jnm-22-355: Control of heartburn over 24 hours by dexlansoprazole versus placebo in patients with healed erosive esophagitis (intent to treat population). *P < 0.0025 vs placebo. Adapted from Metz et al46 With permission from John Wiley & Sons, Inc. © 2009 Takeda Global Research & Development Center, Inc.

Mentions: Metz et al46 found that dexlansoprazole controlled heartburn (91–96% for 24-hour heartburn-free days and 96–99% for heartburn-free nights) (Fig. 5) and was superior to placebo for maintaining healed EE over 6 months at doses of 30 mg and 60 mg (life-table analysis: 74.9% and 82.5%, respectively, versus 27.2% for placebo; P < 0.00001; crude rate analysis: 66.4% for 30 mg and 60 mg versus 14.3% for placebo; P < 0.00001).46 Importantly, results from the PAGI-QOL and PAGI-SYM questionnaires were consistent with the efficacy results. Results from the PAGI-QOL questionnaire showed that both dexlansoprazole doses achieved significant improvement in the diet and food habits subscale versus placebo, and significantly improved the heartburn/regurgitation subscale and total scores of the PAGI-SYM questionnaire, with no significant differences between the 2 doses. These findings are particularly notable because relief of symptoms for 24 hours is more difficult to achieve than relief of either daytime or night-time symptoms alone.


Pharmacological and Safety Profile of Dexlansoprazole: A New Proton Pump Inhibitor - Implications for Treatment of Gastroesophageal Reflux Disease in the Asia Pacific Region.

Goh KL, Choi MG, Hsu PI, Chun HJ, Mahachai V, Kachintorn U, Leelakusolvong S, Kim N, Rani AA, Wong BC, Wu J, Chiu CT, Shetty V, Bocobo JC, Chan MM, Lin JT - J Neurogastroenterol Motil (2016)

Control of heartburn over 24 hours by dexlansoprazole versus placebo in patients with healed erosive esophagitis (intent to treat population). *P < 0.0025 vs placebo. Adapted from Metz et al46 With permission from John Wiley & Sons, Inc. © 2009 Takeda Global Research & Development Center, Inc.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4930293&req=5

f5-jnm-22-355: Control of heartburn over 24 hours by dexlansoprazole versus placebo in patients with healed erosive esophagitis (intent to treat population). *P < 0.0025 vs placebo. Adapted from Metz et al46 With permission from John Wiley & Sons, Inc. © 2009 Takeda Global Research & Development Center, Inc.
Mentions: Metz et al46 found that dexlansoprazole controlled heartburn (91–96% for 24-hour heartburn-free days and 96–99% for heartburn-free nights) (Fig. 5) and was superior to placebo for maintaining healed EE over 6 months at doses of 30 mg and 60 mg (life-table analysis: 74.9% and 82.5%, respectively, versus 27.2% for placebo; P < 0.00001; crude rate analysis: 66.4% for 30 mg and 60 mg versus 14.3% for placebo; P < 0.00001).46 Importantly, results from the PAGI-QOL and PAGI-SYM questionnaires were consistent with the efficacy results. Results from the PAGI-QOL questionnaire showed that both dexlansoprazole doses achieved significant improvement in the diet and food habits subscale versus placebo, and significantly improved the heartburn/regurgitation subscale and total scores of the PAGI-SYM questionnaire, with no significant differences between the 2 doses. These findings are particularly notable because relief of symptoms for 24 hours is more difficult to achieve than relief of either daytime or night-time symptoms alone.

Bottom Line: Dexlansoprazole is the first PPI with a dual delayed release formulation designed to provide 2 separate releases of medication to extend the duration of effective plasma drug concentration.Dexlansoprazole has been shown to be effective for healing of erosive esophagitis, and to improve subjective well-being by controlling 24-hour symptoms.Studies in healthy volunteers showed no clinically important effects on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition, with no dose adjustment of clopidogrel necessary when coprescribed.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.

ABSTRACT
Although gastroesophageal reflux disease is not as common in Asia as in western countries, the prevalence has increased substantially during the past decade. Gastroesophageal reflux disease is associated with considerable reductions in subjective well-being and work productivity, as well as increased healthcare use. Proton pump inhibitors (PPIs) are currently the most effective treatment for gastroesophageal reflux disease. However, there are limitations associated with these drugs in terms of partial and non-response. Dexlansoprazole is the first PPI with a dual delayed release formulation designed to provide 2 separate releases of medication to extend the duration of effective plasma drug concentration. Dexlansoprazole has been shown to be effective for healing of erosive esophagitis, and to improve subjective well-being by controlling 24-hour symptoms. Dexlansoprazole has also been shown to achieve good plasma concentration regardless of administration with food, providing flexible dosing. Studies in healthy volunteers showed no clinically important effects on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition, with no dose adjustment of clopidogrel necessary when coprescribed. This review discusses the role of the new generation PPI, dexlansoprazole, in the treatment of gastroesophageal reflux disease in Asia.

No MeSH data available.


Related in: MedlinePlus