Dexansoprazole MV in the treatment of gastroesophageal reflux disease
https://doi.org/10.21518/2079-701X-2018-21-132-137
Abstract
Dexlensoprazole MB is the R-enantiomer of lansoprazole and is currently the only proton pump inhibitor with the new Dual Delayed Release delivery technology. The pharmacokinetics of the drug shows two peaks of release in the 12-finger and small intestine; antisecretory effect is shown in doses of 30 mg, 60 mg, and retention of intragastric pH > 4 more than 16.5 hours per day; regardless of the time of administration. Clinical studies have shown that dexlansoprazole MB is highly effective in the healing of erosive esophagitis and symptom control in patients with non-erosive reflux disease; maintains remission with prolonged use. Effective in improving the symptoms of night heartburn associated with GERD, with sleep disturbances. Dexlensoprazole MB has a similar safety profile and side effects with lansoprazole.
About the Authors
М. V. Leonova
Federal State Budgetary Educational Institution of Higher Education “Pirogov Russian National Research Medical University” of the Ministry of Health of Russia
Russian Federation
Russian Federation
Leonova Marina Vasilievna – Dr. of Sci. (Med.), Professor, Corr. Member of RANS, Clinical Pharmacologist, Member of the Interregional Public Organization, Association of Clinical Pharmacologists of Russia
117997, Moscow, 1 Ostrovityanova
E. Е. Alimova
Federal State Budgetary Educational Institution of Higher Education “Pirogov Russian National Research Medical University” of the Ministry of Health of Russia
Russian Federation
Russian Federation
Alimova Elmira Erfanovna – Cand.of Sci. (Med.), Associate Professor, Department of Clinical Pharmacology, Faculty of General Medicine
117997, Moscow, 1 Ostrovityanova
References
1. Moayyedi P., Santana J., Khan M., Preston C., Donnellan C. WITHDRAWN: Medical treatments in the short term management of reflux oesophagitis. Cochrane Database Syst Rev. 2011;2: CD003244.
2. Katz P.O., Scheiman J.M., Barkun A.N. Review article: Acid-related disease – What are the unmet clinical needs? Aliment Pharmacol Ther. 2006; 23(Suppl 2): 9–22.
3. Ruigómez A., Johansson S., Wernersson B., Fernández C.O., García R.L.A.. Gastroesophageal reflux disease in primary care: using changes in proton pump inhibitor therapy as an indicator of partial response. Scand J Gastroenterol. 2012; 47(7): 751-61.
4. Bell N.J., Burget D., Howden C.W., Wilkinson J., Hunt R.H. Appropriate acid suppression for the management of gastro‐oesophageal reflux disease. Digestion. 1992, 51(Suppl. 1): 59–67.
5. Hunt R.H. Review article: the unmet needs in delayed‐release proton‐pump inhibitor therapy in 2005. Aliment Pharmacol Ther. 2005, 22(Suppl. 3): 10–19.
6. Chey W.D., Mody R.R., Izat E. Patient and physician satisfaction with proton pump inhibitors (PPIs): are there opportunities for improvement? Dig Dis Sci. 2010; 55(12): 3415-22.
7. Dean B.B., Gano A.D., Knight K., Ofman J.J., Fass R. Effectiveness of proton pump inhibitors in nonerosive reflux disease. Clin Gastroenterol Hepatol. 2004; 2: 656–64.
8. Zhang J.X., Ji M.Y., Song J., Lei H.B., Qiu S., Wang J. et al. Proton pump inhibitor for non-erosive reflux disease: a meta-analysis. World J Gastroenterol. 2013; 19(45): 8408-19.
9. Sachs G., Shin J.M., Howden C.W. Review article: the clinical pharmacology of proton pump inhibitors. Aliment Pharmacol Ther. 2006; 23(Suppl 2): 2-8.
10. Miner P.J., Katz P.O., Chen Y., Sostek M. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole: a five‐way crossover study. Am J Gastroenterol. 2003; 98: 2616–20.
11. Fass R., Murthy U., Hayden C.W., Malagon I.B., Pulliam G., Wendel C., Kovacs T.O. Omeprazole 40 mg once a day is equally effective as lansoprazole 30 mg twice a day in symptom control of patients with gastro-oesophageal reflux disease (GERD) who are resistant to conventionaldose lansoprazole therapy-a prospective, randomized, multi-centre study. Aliment Pharmacol Ther. 2000; 14(12): 1595-603.
12. Zhang H., Yang Z., Ni Z., Shi Y. A meta-analysis and systematic review of the efficacy of twice daily PPIs versus once daily for treatment of dastroesophageal reflux disease. Gastroenterol Res Pract. 2013; Article ID 9865963.
13. Fujiwara Y., Arakawa T., Fass R. Gastroesophageal reflux disease and sleep disturbances. J Gastroenterol. 2012; 47(7): 760-9.
14. Nzeako U.C., Murray J.A. An evaluation of the clinical implications of acid breakthrough in patients on proton pump inhibitor therapy. Aliment Pharmacol Ther. 2002; 16: 1309–16.
15. Belousov Yu.B., Leonova M.V. Modified release dosage forms and drug delivery systems: pharmacokinetic features and clinical efficacy. M.: Litterra, 2011: 440-444 (In Russ).
16. Frye J.W., Peura D.A. Managing gastroesophageal reflux disease – comparative efficacy and outcomes of dexlansoprazole MR. Ther Clin Risk Manag. 2015; 11: 1649–56.
17. Katsuki H., Yagi H., Arimori K., Nakamura C., Nakano M., Katafuchi S. et al. Determination of R(+)- and S(-)-lansoprazole using chiral stationary-phase liquid chromatography and their enantioselective pharmacokinetics in humans. Pharm Res. 1996, 13: 611–5.
18. Metz D.C., Vakily M., Dixit T., Mulford D. 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.
19. Vakily M., Zhang W., Wu J., Atkinson S., 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.
20. Wu J., Vakily M., Witt G., Mulford D. TAK-390MR 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): S124 (abstract).
21. Lee R.D., Mulford D., Wu J., Atkinson S.N. 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.
22. Sharma P., Shaheen N.J., Perez M.C., Pilmer B.L., Lee M., Atkinson S.N., Peura D. Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel delayed-release formulation – results from two randomized controlled studies. Aliment Pharmacol Ther. 2009; 29: 731-41.
23. Fass R., Chey W.D., Zakko S.F, Andhivarothai N., Palmer R.N., Perez M.C., Atkinson S.N. Clinical trial: the effect 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.
24. Farup C., Kleinman L., Sloan S., Ganoczy D., Chee E., Lee C., Revicki D. The impact of nocturnal symptoms associated with gastroesophageal reflux disease on health-related quality of life. Arch Intern Med. 2001; 161: 45–52 .
25. Mody R., Bolge S.C., Kannan H., Fass R. Effects of gastroesophageal reflux disease on sleep and outcomes. Clin Gastroenterol Hepatol. 2009; 7: 953–9.
26. Fass R., Johnson D.A., Orr W.C., Han C., Mody R., Stern K.N. et al. The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD. Am J Gastroenterol. 2011; 106: 421-31.
27. Fass R., Inadomi J., Han G., Mody R., O’Neil J., Perez M.C. Maintenance of heartburn relief after stepdown from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release. Clin Gastroenterol Hepatol. 2012; 10: 247-63.
28. Dickman R., Maradey-Romero C., Gingold-Belfer R., Fass R.. Unmet needs in the treatment of gastroesophageal reflux disease. J Neurogastroenterol Motil. 2015; 21: 309–19.
29. Metz D.C., Howden C.W., Perez M.C., Larsen L., O’Neil J., Atkinson S.N. 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.
30. Peura D.A., Metz D.C., Dabholkar A.H., Paris M.M., Yu P., Atkinson S.N. Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. Aliment Pharmacol Ther. 2009; 30: 1010-21.
31. Zhang W., Wu J., Atkinson S.N. Effects of dexlansoprazole MR, a novel dual delayed release formulation of a proton pump inhibitor, on plasma gastrin levels in healthy subjects. J Clin Pharmacol. 2009; 49(4): 444–454.
32. Ivashkin V.T., Maev I.V., Trukhmanov A.S., Baranskaya E.K., Dronova O.B., Zayratyants O.V., et al. Clinical guidelines of the Russian Gastroenterological Association for the diagnosis and treatment of gastroesophageal reflux disease. Ros. Zhurn. Gastroenterol. Gepatol. Koloproktol 2017; 27 (4): 75-95 (In Russ).
Review
For citations:
Leonova МV, Alimova EЕ. Dexansoprazole MV in the treatment of gastroesophageal reflux disease. Meditsinskiy sovet = Medical Council. 2018;(21):132-137. (In Russ.) https://doi.org/10.21518/2079-701X-2018-21-132-137
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