Clinical trial: Efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis - Maintenance of healing and symptom relief

Alimentary Pharmacology and Therapeutics

Volumn 30, Issue 9, 2009, Pages 895-907

  Howden, C W ^b   Larsen, L M ^c   Perez, M C ^a   Palmer, R ^a   Atkinson, S N ^a  

^a TAKEDA PHARMACEUTICALS   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

^c TAP PHARMACEUTICAL PRODUCTS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEXLANSOPRAZOLE; LANSOPRAZOLE; PLACEBO; TAK 390MR; UNCLASSIFIED DRUG;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ABDOMINAL TENDERNESS; ACUTE SINUSITIS; ADULT; ARTICLE; BLOATING; CHRONIC GASTRITIS; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ENDOMETRIOSIS; EROSIVE GASTRITIS; ESOPHAGUS PERFORATION; ESOPHAGUS ULCER; FEMALE; FLATULENCE; GASTRIC DYSMOTILITY; GASTRITIS; GASTROESOPHAGEAL REFLUX; GASTROINTESTINAL MOTILITY DISORDER; GASTROINTESTINAL PAIN; HEADACHE; HEALING; HEARTBURN; HUMAN; INTESTINE METAPLASIA; LARYNGITIS; MAJOR CLINICAL STUDY; MALE; NAUSEA; PHARYNGITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REFLUX ESOPHAGITIS; RETCHING; SINGLE BLIND PROCEDURE; SINUS HEADACHE; SINUSITIS; STOMACH DISEASE; STOMACH PERFORATION; STOMACH ULCER; SYMPTOM; THORAX PAIN; TREATMENT OUTCOME; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; VIRAL GASTROENTERITIS; VIRAL PHARYNGITIS; VIRUS INFECTION; VOMITING;

2-PYRIDINYLMETHYLSULFINYLBENZIMIDAZOLES; ADULT; AGED; ANTI-ULCER AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ESOPHAGITIS; FEMALE; HEARTBURN; HUMANS; MALE; MIDDLE AGED; PROTON PUMP INHIBITORS; TREATMENT OUTCOME;

EID: 70349687374     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2009.04119.x     Document Type: Article

References (29)

1. DeVault KR, Castell DO. Current diagnosis and treatment of gastroesophageal reflux disease. Mayo Clin Proc 1994 69 : 867 876.
2. Rai A, Orlando R. Gastroesophageal reflux disease. Curr Opin Gastroenterol 1998 12 : 326 333.
3. Thomson AB, Chiba N, Armstrong D, Tougas G, Hunt RH. The Second Canadian Gastroesophageal Reflux Disease Consensus: moving forward to new concepts. Can J Gastroenterol 1998 12 : 551 556.
4. Fennerty MB. Medical treatment of gastroesophageal reflux disease in the managed care environment. Semin Gastrointest Dis 1997 8 : 90 9.
5. DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol 2005 100 : 190 200.
6. Kaynard A, Flora K. Gastroesophageal reflux disease. Control of symptoms, prevention of complications. Postgrad Med 2001 110 : 42 4, 47 8, 51 3.
7. Carlsson R, Dent J, Watts R, et al. Gastro-oesophageal reflux disease in primary care: an international study of different treatment strategies with omeprazole. International GORD Study Group. Eur J Gastroenterol Hepatol 1998 10 : 119 124.
8. Chiba N. Proton pump inhibitors in acute healing and maintenance of erosive or worse esophagitis: a systematic overview. Can J Gastroenterol 1997 11 (Suppl B 66B 73B.
9. Dent J, Brun J, Fendrick AM, et al. An evidence-based appraisal of reflux disease management-the Geneva Workshop report. Gut 1999 44 (Suppl 2 S1 16.
10. Donnellan C, Sharma N, Preston C, Moayyedi P. Medical treatments for the maintenance therapy of reflux oesophagitis and endoscopic negative reflux disease. Cochrane Database Syst Rev 2004. Art. No. CD003245 4 : 1 76.
11. Devault KR, Johanson JF, Johnson DA, Liu S, Sostek MB. Maintenance of healed erosive esophagitis: a randomized six-month comparison of esomeprazole twenty milligrams with lansoprazole fifteen milligrams. Clin Gastroenterol Hepatol 2006 4 : 852 859.
12. Labenz J, Armstrong D, Lauritsen K, et al. Esomeprazole 20 mg vs. pantoprazole 20 mg for maintenance therapy of healed erosive oesophagitis: results from the EXPO study. Aliment Pharmacol Ther 2005 22 : 803 811. (Pubitemid 41564360)
13. Lauritsen K, Deviere J, Bigard MA, et al. Esomeprazole 20 mg and lansoprazole 15 mg in maintaining healed reflux oesophagitis: metropole study results. Aliment Pharmacol Ther 2003 17 : 333 341. (Pubitemid 36259395)
14. Mayer MD, Vakily M, Witt G, Mulford DJ. 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 [abstract S1095]. Gastroenterology 2008 134 (4 Suppl 1 A176.
15. 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 : 627 638.
16. Zhang W, Wu J, Atkinson S. 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. Abstract.
17. Sharma P, Shaheen NJ, Perez MC, et al. 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 : 731 741.
18. Johnson DA, Benjamin SB, Vakil NB, et al. Esomeprazole once daily for 6 months is effective therapy for maintaining healed erosive esophagitis and for controlling gastroesophageal reflux disease symptoms: a randomized, double-blind, placebo-controlled study of efficacy and safety. Am J Gastroenterol 2001 96 : 27 34.
19. Vakil NB, Shaker R, Johnson DA, et al. The new proton pump inhibitor esomeprazole is effective as a maintenance therapy in GERD patients with healed erosive oesophagitis: a 6-month, randomized, double-blind, placebo-controlled study of efficacy and safety. Aliment Pharmacol Ther 2001 15 : 927 935.
20. Chey W, Huang B, Jackson R. Lansoprazole and esomeprazole in symptomatic GERD. A double-blind, randomised, multicentre trial in 3000 patients confirms comparable symptom relief. Clin Drug Invest 2003 23 : 69 84.
21. Miner P. Jr., Orr W, Filippone J, Jokubaitis L, Sloan S. Rabeprazole in nonerosive gastroesophageal reflux disease: a randomized placebo-controlled trial. Am J Gastroenterol 2002 97 : 1332 1339. (Pubitemid 34664773)
22. Scholten T, Gatz G, Hole U. Once-daily pantoprazole 40 mg and esomeprazole 40 mg have equivalent overall efficacy in relieving GERD-related symptoms. Aliment Pharmacol Ther 2003 18 : 587 594.
23. De La Loge C, Trudeau E, Marquis P, et al. Responsiveness and interpretation of a quality of life questionnaire specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol 2004 2 : 778 786. (Pubitemid 39200716)
24. de la Loge C, Trudeau E, Marquis P, et al. Cross-cultural development and validation of a patient self-administered questionnaire to assess quality of life in upper gastrointestinal disorders: the PAGI-QOL. Qual Life Res 2004 13 : 1751 1762.
25. Rentz AM, Kahrilas P, Stanghellini V, et al. Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders. Qual Life Res 2004 13 : 1737 1749.
26. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988 75 : 800 802.
27. Freston JW, Rose PA, Heller CA, Haber M, Jennings D. Safety profile of lansoprazole: the US clinical trial experience. Drug Saf 1999 20 : 195 205.
28. Ligumsky M, Lysy J, Siguencia G, Friedlander Y. Effect of long-term, continuous versus alternate-day omeprazole therapy on serum gastrin in patients treated for reflux esophagitis. J Clin Gastroenterol 2001 33 : 32 5.
29. Metz DC, Howden CW, Perez MC, Larsen LM, 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 esophagitis. Aliment Pharmacol Ther 2009 29 : 742 754.