Clinical trial: The treatment of gastro-oesophageal reflux disease in primary care - Prospective randomized comparison of rabeprazole 20 mg with esomeprazole 20 and 40 mg

Alimentary Pharmacology and Therapeutics

Volumn 29, Issue 9, 2009, Pages 967-978

  Eggleston, A ^a   Katelaris, P H ^b   Nandurkar, S ^c   Thorpe, P ^d   Holtmann, G ^e,f  

^a JANSSEN RESEARCH FOUNDATION   (Belgium)

^b UNIVERSITY OF SYDNEY   (Australia)

^c BOX HILL HOSPITAL   (Australia)

^d Primary Old Port Road Medical and Dental Centre ^*  (Australia)

^e UNIVERSITY OF ADELAIDE   (Australia)

^f UNIVERSITY HOSPITAL ESSEN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ESOMEPRAZOLE; RABEPRAZOLE;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEFECATION DISORDER; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GASTROESOPHAGEAL REFLUX; GASTROINTESTINAL MOTILITY DISORDER; GASTROINTESTINAL SYMPTOM; HEADACHE; HEARTBURN; HUMAN; INFECTION; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; MULTICENTER STUDY; PATIENT ASSESSMENT; PATIENT SATISFACTION; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; UNSPECIFIED SIDE EFFECT;

2-PYRIDINYLMETHYLSULFINYLBENZIMIDAZOLES; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-ULCER AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; GASTROESOPHAGEAL REFLUX; HEARTBURN; HELICOBACTER INFECTIONS; HELICOBACTER PYLORI; HUMANS; MALE; MIDDLE AGED; OMEPRAZOLE; PRIMARY HEALTH CARE; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 63849322408     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2009.03948.x     Document Type: Article

References (35)

1. Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol 2006 101 : 1900 20. quiz 43.
2. Britt H, Miller G, Charles J, et al. General Practice Activity in Australia 2007-8. General practice series no. 22. Cat. no. GEP 22. page 127. Canberra : Australian Institute of Health and Welfare [cited 2008 October]; Available from: http://www.aihw.gov.au/publications/gep/gpaia07-08/gpaia07-08. pdf.
3. Peura DA, Gudmundson J, Siepman N, Pilmer BL, Freston J. Proton pump inhibitors: effective first-line treatment for management of dyspepsia. Dig Dis Sci 2007 52 : 983 7.
4. Arts J, Eisendrath P, Deviere J, Tack J. Empirical therapy for symptomatic gastroesophageal reflux disease in primary care: determinants of efficacy. Digestion 2007 76 : 207 14.
5. Vakil N. Proton pump inhibitors for dyspepsia. Dig Dis 2008 26 : 215 7.
6. van Pinxteren B, Numans M, Bonis P, Lau J. Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease. Cochrane Database Syst Rev 2006 3 : CD002095.
7. Barton P, Moayyedi P, Talley N, Vakil N, Delaney B. A second-order simulation model of the cost-effectiveness of managing dyspepsia in the United States. Med Decis Making 2008 28 : 44 55.
8. Kjeldsen HC, Bech M, Christensen B. Cost-effectiveness analysis of two management strategies for dyspepsia. Int J Technol Assess Health Care 2007 23 : 376 84.
9. Katelaris P, Holloway R, Talley NJ, Gotley D, Williams S, Dent J. Gastro-oesophageal reflux disease in adults: guidelines for clinicians. J Gastroenterol Hepatol 2002 17 : 825 33.
10. Pace F, Pallotta S, Casalini S, Porro GB. A review of rabeprazole in the treatment of acid-related diseases. Ther Clin Risk Manag 2007 3 : 363 79.
11. Kalaitzakis E, Bjornsson E. A review of esomeprazole in the treatment of gastroesophageal reflux disease (GERD). Ther Clin Risk Manag 2007 3 : 653 63.
12. Norris V, Baisley K, Dunn K, Warrington S, Morocutti A. Combined analysis of three crossover clinical pharmacology studies of effects of rabeprazole and esomeprazole on 24-h intragastric pH in healthy volunteers. Aliment Pharmacol Ther 2007 25 : 501 10.
13. Fock KM, Teo EK, Ang TL, Chua TS, Ng TM, Tan YL. Rabeprazole vs esomeprazole in non-erosive gastro-esophageal reflux disease: a randomized, double-blind study in urban Asia. World J Gastroenterol 2005 11 : 3091 8.
14. Khoury V, Staniek V. Patient Assessment of Gastrointestinal Symptom Severity Index Information Booklet, 1st edn. Lyon : MAPI Research Trust, 2007.
15. 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 49.
16. Lloyd J, Andrews G, Eggleston A. The science of compliance. Good Clin Practice Journal 2008 15 : 19 20.
17. Ware JE, Kosinski M, Gandek B. SF36® Health Survey: Manual & Interpretation Guide. Lincoln, RI : QualityMetric Inc, 2005.
18. Sanson-Fisher RW, Perkins JJ. Adaptation and validation of the SF-36 health survey for use in Australia. J Clin Epidemiol 1998 51 : 961 7.
19. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006 295 : 1152 60.
20. De Vault KR. Review article: the role of acid suppression in patients with non-erosive reflux disease or functional heartburn. Aliment Pharmacol Ther 2006 23 (Suppl. 1 33 9.
21. Fass R. Epidemiology and pathophysiology of symptomatic gastroesophageal reflux disease. Am J Gastroenterol 2003 98 (Suppl. 3 S2 7.
22. Kirby CN, Piterman L, Nelson MR, Dent J. Gastro-oesophageal reflux disease - impact of guidelines on GP management. Aust Fam Physician 2008 37 : 73 7.
23. Talley NJ. What the physician needs to know for correct management of gastro-oesophageal reflux disease and dyspepsia. Aliment Pharmacol Ther 2004 20 (Suppl. 2 23 30.
24. Jones RH, Bytzer P. Review article: acid suppression in the management of gastro-oesophageal reflux disease - an appraisal of treatment options in primary care. Aliment Pharmacol Ther 2001 15 : 765 72.
25. Talley NJ, Moore MG, Sprogis A, Katelaris P. Randomsied controlled trial of pantoprazole versus ranitidine for the treatment of uninvestigated heartburn in primary care. Med J Aust 2002 177 : 415 9.
26. Armstrong D, Veldhuyzen van Zanten S, Barkun AN, et al. Heartburn-dominant, uninvestigated dyspepsia: a comparison of 'PPI-start' and 'H2-RA-start' management strategies in primary care - the CADET-HR study. Aliment Pharmacol Ther 2005 21 : 1189 202.
27. Veldhuyzen van Zanten S, Chiba N, Armstrong D, et al. A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in helicobacter pylori negative, primary care patients with dyspepsia: the CADET-HN study. Am J Gastroenterol 2005 100 : 1477 88.
28. Baisley K, Warrington S, Tejura B, Morocutti A, Miller N. Raberprazole 20mg compared with esomeprazole 40mg in the control of intragastric pH in healthy volunteers. Am J Gastroenterol 2001 96 (Suppl. 9 S48.
29. Baisley KT, Morocutti B, Rabeprazole A. 10 mg is equivalent to esomeprazole 20 mg in control of gastric pH in healthy volunteers. Am J Gastroenterol 2001 96 (Suppl. S48.
30. Miner P Jr., Katz PO, 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.
31. Rohss K, Lind T, Wilder-Smith C. Esomeprazole 40 mg provides more effective intragastric acid control than lansoprazole 30 mg, omeprazole 20 mg, pantoprazole 40 mg and rabeprazole 20 mg in patients with gastro-oesophageal reflux symptoms. Eur J Clin Pharmacol 2004 60 : 531 9.
32. Dent J, Kahrilas PJ, Vakil N, et al. Clinical trial design in adult reflux disease: a methodological workshop. Aliment Pharmacol Ther 2008 28 : 107 26.
33. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD). AstraZeneca; 2004 [cited 2008 November 26th]; Available from: http://www.astrazenecaclinicaltrials.com/clinicaltrials/ nexium/.
34. A 4-Week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium. AstraZeneca; 2006 [cited 2008 November 24th]; Available from: http://www.astrazenecaclinicaltrials.com/clinicaltrials/nexium/.
35. Armstrong D, Talley NJ, Lauritsen K, et al. The role of acid suppression in patients with endoscopy-negative reflux disease: the effect of treatment with esomeprazole or omeprazole. Aliment Pharmacol Ther 2004 20 : 413 21.