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Digestive Diseases and Sciences

, Volume 60, Issue 6, pp 1724–1732 | Cite as

Efficacy of Lafutidine Versus Famotidine in Patients with Reflux Esophagitis: A Multi-Center, Randomized, Double-Blind, Non-inferiority Phase III Trial

  • Eun Hye Kim
  • Yong Chan Lee
  • Young Woon Chang
  • Jong-Jae Park
  • Hoon Jai Chun
  • Hwoon-Yong Jung
  • Hyun-Soo Kim
  • Hyun Yong Jeong
  • Sang-Young Seol
  • Sok Won Han
  • Myung-Gyu Choi
  • Soo-Heon Park
  • Ok-Jae Lee
  • Jin Tae Jung
  • Dong Ho Lee
  • Hyun Chae Jung
  • Soo Teik Lee
  • Jae Gyu Kim
  • Sei Jin Youn
  • Hak Yang Kim
  • Sang Woo Lee
Original Article

Abstract

Background

There has been no study on the efficacy of lafutidine for patients with reflux esophagitis in Korea.

Aim

To evaluate the efficacy of a new-generation histamine-2 receptor antagonist, lafutidine, in comparison with famotidine in patients with reflux esophagitis.

Methods

This was a randomized, double-blind, non-inferiority trial enrolling patients with erosive esophagitis. The efficacy and safety of 20 mg lafutidine (treatment group) were compared with those of 40 mg famotidine (control group) and 20 mg omeprazole (reference group). The primary endpoint was the complete healing rates of reflux esophagitis on endoscopy after 8 weeks of treatment. The non-inferiority margin was assumed to be −15 %.

Results

The healing rates of reflux esophagitis on endoscopy after 8 weeks of treatment were 70.14 % (101/144) in the lafutidine, 63.45 % (92/145) in the famotidine, and 85.71 % (126/147) in the omeprazole group. The difference in healing rates between the lafutidine and famotidine groups was 6.69 % (95 % confidence interval = [−4.14 to 17.52]). In addition, lafutidine was superior to famotidine in clinical improvement (53.73 % vs. 39.55 %, P = 0.0200).

Conclusions

Lafutidine was non-inferior to famotidine in healing of reflux esophagitis. Lafutidine, however, was superior to famotidine in terms of symptom relief of reflux esophagitis.

Keywords

Lafutidine Famotidine Omeprazole Reflux esophagitis 

Notes

Acknowledgments

This study was funded by Boryung Pharmaceutical Co., Ltd.

Conflict of interest

All authors reported no conflicts of interest.

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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Eun Hye Kim
    • 1
  • Yong Chan Lee
    • 1
    • 21
  • Young Woon Chang
    • 1
    • 2
  • Jong-Jae Park
    • 1
    • 3
  • Hoon Jai Chun
    • 1
    • 4
  • Hwoon-Yong Jung
    • 1
    • 5
  • Hyun-Soo Kim
    • 1
    • 6
  • Hyun Yong Jeong
    • 1
    • 7
  • Sang-Young Seol
    • 1
    • 8
  • Sok Won Han
    • 1
    • 9
  • Myung-Gyu Choi
    • 1
    • 10
  • Soo-Heon Park
    • 1
    • 11
  • Ok-Jae Lee
    • 1
    • 12
  • Jin Tae Jung
    • 1
    • 13
  • Dong Ho Lee
    • 1
    • 14
  • Hyun Chae Jung
    • 1
    • 15
  • Soo Teik Lee
    • 1
    • 16
  • Jae Gyu Kim
    • 1
    • 17
  • Sei Jin Youn
    • 1
    • 18
  • Hak Yang Kim
    • 1
    • 19
  • Sang Woo Lee
    • 1
    • 3
    • 20
  1. 1.Department of Internal MedicineYonsei University College of MedicineSeoulKorea
  2. 2.Department of Internal MedicineKyung Hee University School of MedicineSeoulKorea
  3. 3.Department of Internal MedicineKorea University College of MedicineSeoulKorea
  4. 4.Department of Internal MedicineKorea University College of MedicineSeoulKorea
  5. 5.Department of Internal Medicine, Asan Medical CenterUniversity of Ulsan College of MedicineSeoulKorea
  6. 6.Department of Internal MedicineChonnam National University Medical SchoolGwangjuKorea
  7. 7.Department of Internal MedicineChungnam National University School of MedicineDaejeonKorea
  8. 8.Department of Internal MedicineInje University College of MedicineBusanKorea
  9. 9.Department of Internal MedicineThe Catholic University of Korea College of MedicineSeoulKorea
  10. 10.Department of Internal MedicineThe Catholic University of Korea College of MedicineSeoulKorea
  11. 11.Department of Internal MedicineThe Catholic University of Korea College of MedicineSeoulKorea
  12. 12.Department of Internal Medicine, Institute of Health ScienceGyeongsang National University School of MedicineJinjuKorea
  13. 13.Department of Internal MedicineCatholic University of Daegu School of MedicineDaeguKorea
  14. 14.Department of Internal MedicineSeoul National University College of MedicineSeoulKorea
  15. 15.Department of Internal MedicineSeoul National University College of MedicineSeoulKorea
  16. 16.Department of Internal MedicineChonbuk National University Medical SchoolJeonju-SiKorea
  17. 17.Department of Internal MedicineChung-Ang University College of MedicineSeoulKorea
  18. 18.Department of Internal MedicineChungbuk National University College of MedicineCheongju-SiKorea
  19. 19.Department of Internal MedicineHallym University College of MedicineSeoulKorea
  20. 20.Department of Internal MedicineKorea University College of MedicineSeoulKorea
  21. 21.Department of Internal MedicineYonsei University College of MedicineSeoulKorea

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