Journal Mobile Options
Table of Contents
Vol. 70, No. 1, 2004
Issue release date: 2004

Efficacy and Safety of Pantoprazole versus Ranitidine in the Treatment of Patients with Symptomatic Gastroesophageal Reflux Disease

van Zyl J. · van Rensburg C. · Vieweg W. · Fischer R.
To view the fulltext, log in and/or choose pay-per-view option

Individual Users: Register with Karger Login Information

Please create your User ID & Password

Contact Information

I have read the Karger Terms and Conditions and agree.

To view the fulltext, please log in

To view the pdf, please log in


Background/Aim: Gastroesophageal reflux disease (GERD) is a prevalent disease associated with a high symptom burden and a reduced quality of life. This multicenter, randomized, double-blind study compared relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) and from other gastrointestinal symptoms (epigastric pain, vomiting, nausea, flatulence, retching, and retrosternal feeling of tightness) and safety profiles of the proton pump inhibitor pantoprazole and the H2 antagonist ranitidine in patients suffering from symptomatic GERD. Methods: The patients [338 intention-to-treat (ITT) population; 284 per-protocol (PP) population] received 20 mg pantoprazole (once daily in the morning) plus ranitidine placebo (once daily in the evening; ITT n = 167, PP n = 136) or pantoprazole placebo (once daily in the morning) plus 300 mg ranitidine (once daily in the evening; ITT n = 171, PP n = 148) for 28 days. The primary efficacy criterion (ITT and PP populations) was relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) after 28 days of treatment. Secondary criteria (PP) included relief from key GERD symptoms on day 14, relief from all gastrointestinal symptoms on days 14 and 28, and relief from key GERD symptoms on days 14 and 28. Safety evaluations included adverse events and laboratory assessments. Results: Significantly more pantoprazole-treated patients were free from key GERD symptoms at day 28 (68.3%, n = 114) as compared with ranitidine-treated patients (43.3%, n = 74; 95% confidence interval for odds ratio 1.84–4.51). Pantoprazole was also significantly more efficacious in controlling all gastrointestinal symptoms of GERD. By day 28, 51.5% (n = 70) of the pantoprazole-treated patients were completely symptom free versus 31.1% (n = 46) of the ranitidine-treated patients (95% confidence interval for odds ratio1.45–3.83). Both treatments were well tolerated. Conclusion: Pantoprazole is significantly superior to ranitidine in the treatment of key and associated gastrointestinal symptoms of GERD and is well tolerated.

Copyright / Drug Dosage

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.


  1. Ollyo JB, Monnier P, Fontolliet C, Savary M: The natural history, prevalence and incidence of reflux oesophagitis. Gullet 1993;3(suppl):3–10.
  2. Wienbeck M, Barnert J: Epidemiology of reflux disease and reflux esophagitis. Scand J Gastroenterol Suppl 1989;156:7–13.
  3. Glise H, Hallerback B, Johansson B: Quality of life assessments in the evaluation of gastroesophageal reflux and peptic ulcer disease before, during and after treatment. Scand J Gastroenterol Suppl 1995;208:133–135.
  4. Revicki DA, Wood M, Maton PN, Sörensen S: The impact of gastroesophageal reflux disease on health-related quality of life. Am J Med 1998;104:252–258.
  5. Revicki DA, Crawley JA, Zodet MW, Levine DS, Joelsson BO: Complete resolution of heartburn symptoms and health-related quality of life in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther 1999;13:1621–1630.
  6. Kaplan-Machlis B, Spiegler GE, Revicki DA: Health-related quality of life in primary care patients with gastroesophageal reflux disease. Ann Pharmacother 1999;33:1032–1036.
  7. Jones R: Gastro-oesophageal reflux disease in general practice. Scand J Gastroenterol Suppl 1995;211:35–38.
  8. Jones RH, Lydeard SE, Hobbs FD, Kenkre JE, Williams EI, Jones SJ, Repper JA, Caldow JL, Dunwoodie WM, Bottomley JM: Dyspepsia in England and Scotland. Gut 1990;31:401–405.
  9. Fennerty MB, Castell D, Fendrick AM, Halpern M, Johnson D, Kahrilas PJ, Leiberman D, Richter JE, Sampliner RE: The diagnosis and treatment of gastroesophageal reflux disease in a managed care environment: Suggested disease management guidelines. Arch Intern Med 1996;156:477–484.
  10. Dent J, Jones R, Kahrilas P, Talley NJ: Management of gastro-oesophageal reflux disease in general practice. BMJ 2001;322:344–347.
  11. van Zyl JH, de K Grundling H, van Rensburg CJ, Retief FJ, O’Keefe SJ, Theron I, Fischer R, Bethke T: Efficacy and tolerability of 20 mg pantoprazole versus 300 mg ranitidine in patients with mild reflux-oesophagitis: A randomized, double-blind, parallel, and multicentre study. Eur J Gastroenterol Hepatol 2000;12:197–202.
  12. Schenk BE, Kuipers EJ, Klinkenberg-Knol EC, Festen HP, Jansen EH, Tuynman HA, Schrijver M, Dieleman LA, Meuwissen SG: Omeprazole as a diagnostic tool in gastroesophageal reflux disease. Am J Gastroenterol 1997;92:1997–2000.
  13. 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;112:1798–1810.
  14. Klok RM, Postma MJ, Van Hout BA, Brouvers JR: Meta-analysis: Comparing the efficacy of proton pump inhibitors in short-term use. Aliment Pharmacol Ther 2003;17:1237–1245.
  15. Yacyshyn BR, Thomson AB: The clinical importance of proton pump inhibitor pharmacokinetics. Digestion 2002;66:67–78.
  16. Moss SF, Armstrong D, Arnold R, Ferenci P, Fock KM, Holtmann G, McCarthy DM, Moraes-Filho JP, Mutschler E, Playford R, Spechler SJ, Stanghellini V, Modlin IM: GERD 2003 – a consensus on the way ahead. Digestion 2003;67:111–117.
  17. Katz PO: Gastroesophageal reflux disease – state of the art. Rev Gastroenterol Disord 2001;1:128–138.
  18. Cheer SM, Prakash A, Faulds D, Lamb HM: Pantoprazole: An update of its pharmacological properties and therapeutic use in the management of acid-related disorders. Drugs 2003;63:101–133.
  19. 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.
  20. Gillessen A, Beil W, Modlin IM, Gatz G, Hole U: 40 mg pantoprazole and 40 mg esomeprazole are equivalent in the healing of esophageal lesions and relief from gastroesophageal reflux disease-related symptoms. J Clin Gastroenterol 2004;38:332–340.
  21. Cada DJ, Levien T, Baker DE: Pantoprazole. IV. Hosp Pharm 2001;36:846–854.
  22. Dettmer A, Vogt R, Sielaff F, Luhmann R, Schneider A, Fischer R: Pantoprazole 20 mg is effective for relief of symptoms and healing of lesions in mild reflux oesophagitis. Aliment Pharmacol Ther 1998;12:865–872.
  23. Kaspari S, Biedermann A, Mey J: Comparison of pantoprazole 20 mg to ranitidine 150 mg b.i.d. in the treatment of mild gastroesophageal reflux disease. Digestion 2001;63:163–170.
  24. Richter JE, Kahrilas PJ, Johanson J, Maton P, Breiter JR, Hwang C, Marino V, Hamelin B, Levine JG; Esomeprazole Study Investigators: Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: A randomized controlled trial. Am J Gastroenterol 2001;96:656–665.
  25. Körner T, Schütze K, van Leendert RJ, Fumagalli I, Costa Neves B, Gatz G, Bohuschke M: Interim analysis of POETrial, the pantoprazole/omeprazole equivalence trial: Healing of lesions in patients with gastroesophageal reflux disease II/III after 4 weeks of treatment with pantoprazole 40 mg or omeprazole 40 mg once daily (abstract). Gastroenterology 2001;120 (suppl):438.

    External Resources

  26. Körner T, Schütze K, van Leendert RJ, Fumagalli I, Costa Neves B, Bohuschke M, Gatz G: Comparable efficacy of pantoprazole and omeprazole in patients with moderate to severe reflux esophagitis: Results of a multinational study. Digestion 2003;67:6–13.
  27. Dent J, Watts R, Riley S, Scheikh R, de Groot G, van Oudvorst A, Hatlebakk JG, Haug K, Carlsson R, Dalvag A, Junghard O, Wiklund I: Omeprazole improves quality of life in patients with gastroesophageal reflux disease (abstract). Gastroenterology 1996;110(suppl):94.

Pay-per-View Options
Direct payment This item at the regular price: USD 38.00
Payment from account With a Karger Pay-per-View account (down payment USD 150) you profit from a special rate for this and other single items.
This item at the discounted price: USD 26.50