Dexlansoprazole MR – A review

References

• Dent J, El-Serag HB, Wallander MA, Johansson S. Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2005;54:710–7.
   PubMed Web of Science ®Google Scholar
• Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997;112:1448–56.
   PubMed Web of Science ®Google Scholar
• Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976;21:953–6.
   PubMedGoogle Scholar
• Hershcovici T, Fass R. Nonerosive reflux disease (NERD)—an update. J Neurogastroenterol Motil. 2010;16:8–21.
   PubMedGoogle Scholar
• Sandler RS, Everhart JE, Donowitz M, Adams E, Cronin K, Goodman C, . The burden of selected digestive diseases in the United States. Gastroenterology. 2002;122:1500–11.
   PubMed Web of Science ®Google Scholar
• Irvine EJ. Quality of life assessment in gastro-oesophageal reflux disease. Gut. 2004; 53 Suppl 4:iv35–9.
   PubMedGoogle Scholar
• Bytzer P. Goals of therapy and guidelines for treatment success in symptomatic gastroesophageal reflux disease patients. Am J Gastroenterol. 2003;98(3 Suppl):S31–9.
   Google Scholar
• Chiba N, De Gara CJ, Wilkinson JM, Hunt RH. Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: a meta-analysis. Gastroenterology. 1997;112:1798–810.
   PubMed Web of Science ®Google Scholar
• Fass R, Shapiro M, Dekel R, Sewell J. Systematic review: proton-pump inhibitor failure in gastro-oesophageal reflux disease—where next? Aliment Pharmacol Ther. 2005;22: 79–94.
   PubMed Web of Science ®Google Scholar
• Moore JM, Vaezi MF. Extraesophageal manifestations of gastroesophageal reflux disease: real or imagined? Curr Opin Gastroenterol. 2010;26:389–94.
   PubMed Web of Science ®Google Scholar
• Sachs G, Shin JM, Briving C, Wallmark B, Hersey S. The pharmacology of the gastric acid pump: the H+,K+ ATPase. Annu Rev Pharmacol Toxicol. 1995;35:277–305.
   PubMed Web of Science ®Google Scholar
• Sachs G, Shin JM, Howden CW. Review article: the clinical pharmacology of proton pump inhibitors. Aliment Pharmacol Ther. 2006;23 Suppl 2:2–8.
   PubMed Web of Science ®Google Scholar
• Shin JM, Sachs G. Gastric H, K-ATPase as a drug target. Dig Dis Sci. 2006;51:823–33.
   PubMed Web of Science ®Google Scholar
• Hunt RH. Review article: the unmet needs in delayed- release proton-pump inhibitor therapy in 2005. Aliment Pharmacol Ther. 2005;22 Suppl 3:10–19.
   PubMedGoogle Scholar
• Hershcovici T, Fass R. Management of gastroesophageal reflux disease that does not respond well to proton pump inhibitors. Curr Opin Gastroenterol. 2010;26:367–78.
   PubMed Web of Science ®Google Scholar
• Horn JR, Howden CW. Review article: similarities and differences among delayedrelease proton-pump inhibitor formulations. Aliment Pharmacol Ther. 2005;22 Suppl 3:20–4.
   PubMedGoogle Scholar
• Stedman CA, Barclay ML. Review article: comparison of the pharmacokinetics, acid suppression and efficacy of proton pump inhibitors. Aliment Pharmacol Ther. 2000;14:963–78.
   PubMed Web of Science ®Google Scholar
• Metz DC, Vakily M, Dixit T, Mulford D. Review article: dual delayed release formulation of dexlansoprazole MR, a novel approach to overcome the limitations of conventional single release proton pump inhibitor therapy. Aliment Pharmacol Ther. 2009;29:928–37.
   PubMed Web of Science ®Google Scholar
• Katsuki H, Yagi H, Arimori K, Nakamura C, Nakano M, Katafuchi S, . Determination of R(+)- and S(−)-lansoprazole using chiral stationary-phase liquid chromatography and their enantioselective pharmacokinetics in humans. Pharm Res. 1996;13:611–5.
   PubMed Web of Science ®Google Scholar
• Vakily M, Zhang W, Wu J, Atkinson SN, Mulford D. Pharmacokinetics and pharmacodynamics of a known active PPI with a novel dual delayed release technology, dexlansoprazole MR: a combined analysis of randomized controlled clinical trials. Curr Med Res Opin. 2009;25: 627–38.
   PubMed Web of Science ®Google Scholar
• 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;29:742–54.
   PubMed Web of Science ®Google Scholar
• Zhang W, Wu J, Atkinson SN. Pharmacokinetics, pharmacodynamics, and safety evaluation of a single and multiple 60 mg, 90 mg, and 120 mg oral doses of modified-release TAK-390 (TAK-390MR) and 30 mg oral doses of lansoprazole in healthy subjects. Gastroenterology. 2007;132(suppl 52):A487.
   Google Scholar
• Vakily M, Wu J, Atkinson SN, Mulford D. Population pharmacokinetics (PK) of TAK- 390MR in subjects with symptomatic non-erosive gastroesophageal reflux disease (GERD). J Clin Pharmacol. 2008;48:1103.
   Google Scholar
• Bell NJ, Burget D, Howden CW, Wilkinson J, Hunt RH. Appropriate acid suppression for the management of gastro-oesophageal reflux disease. Digestion. 1992;51 Suppl 1: 59–67.
   PubMed Web of Science ®Google Scholar
• Wu J, Vakily M, Witt G, Mulford D. TAK-390 MR vs. Lansoprazole (LAN) for maintenance of drug concentration above a threshold which corresponds to higher%-time pH > 4. Am J Gastroenterol. 2007;102(Suppl 2):124.
   Google Scholar
• Lee RD, Vakily M, Mulford D, Wu J, Atkinson SN. Clinical trial: the effect and timing of food on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR, a novel dual delayed release formulation of a proton pump inhibitor—evidence for dosing flexibility. Aliment Pharmacol Ther. 2009;29:824–33.
   PubMed Web of Science ®Google Scholar
• Lee RD, Mulford D, Wu J, Atkinson SN. The effect of time-of-day dosing on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR: evidence for dosing flexibility with a dual delayed release proton pump inhibitor. Aliment Pharmacol Ther. 2010;31:1001–11.
   PubMed Web of Science ®Google Scholar
• Vakily M, Lee RD, Wu J, Gunawardhana L, Mulford D. Drug interaction studies with dexlansoprazole modified release (TAK-390MR), a proton pump inhibitor with a dual delayedrelease formulation: results of four randomized, double-blind, crossover, placebo-controlled, single-centre studies. Clin Drug Investig. 2009;29:35–50.
   PubMed Web of Science ®Google Scholar
• Vakily M, Zhang W, Wu J, Mulford D. Effect of age and gender on the pharmacokinetics of a single oral dose of TAK-390MR (modified release) [abstract]. Clin Pharmacol Ther. 2008;83 Suppl 1:S96.
   Google Scholar
• Lee RD, Wu J, Vakily M, Mulford D. Effect of hepatic impairment on the pharmacokinetics of TAK-390MR (modified release) [abstract]. Clin Pharmacol Ther. 2008;2008(83 Suppl 1):S95.
   Google Scholar
• Sharma P, Shaheen NJ, Perez MC, Pilmer BL, Lee M, Atkinson SN, . Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation—results from two randomized controlled studies. Aliment Pharmacol Ther. 2009;29:731–41.
   PubMed Web of Science ®Google Scholar
• Howden CW, Larsen LM, Perez MC, Palmer R, Atkinson SN. Clinical trial: efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis—maintenance of healing and symptom relief. Aliment Pharmacol Ther. 2009;30:895–907.
   PubMed Web of Science ®Google Scholar
• Fass R, Chey WD, Zakko SF, Andhivarothai N, Palmer RN, Perez MC, . Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with non-erosive reflux disease. Aliment Pharmacol Ther. 2009;29:1261–72.
   PubMed Web of Science ®Google Scholar
• Mayer MD, Vakily M, Witt G, Mulford D. The pharmacokinetics of TAK-390MR 60 mg, a dual delayed release formulation of the proton pump inhibitor TAK-390, and lansoprazole 60 mg: a retrospective analysis. Gastroenterology. 2008;134(4 Suppl1).
   Google Scholar
• Vakily M, Wu J, Atkinson S. Effect of single oral doses (90 and 300 mg) of TAK-390MR on QT intervals [abstract]. Clin Pharmacol Ther. 2007;81(Suppl1).
   Google Scholar