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

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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.

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Acknowledgments

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

Conflict of interest

All authors reported no conflicts of interest.

Author information

Authors and Affiliations

  1. Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, Korea

    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

  2. Department of Internal Medicine, Kyung Hee University School of Medicine, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-872, Korea

    Young Woon Chang

  3. Department of Internal Medicine, Korea University College of Medicine, 148 Gurodong-ro, Guro-gu, Seoul, 152-703, Korea

    Jong-Jae Park & Sang Woo Lee

  4. Department of Internal Medicine, Korea University College of Medicine, 73 Inchon-ro, Seongbuk-gu, Seoul, 136-705, Korea

    Hoon Jai Chun

  5. Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 138-736, Korea

    Hwoon-Yong Jung

  6. Department of Internal Medicine, Chonnam National University Medical School, 42 Jebong-ro, Donggu, Gwangju, 501-757, Korea

    Hyun-Soo Kim

  7. Department of Internal Medicine, Chungnam National University School of Medicine, 282 Munhwa-ro, Jung-gu, Daejeon, 301-721, Korea

    Hyun Yong Jeong

  8. Department of Internal Medicine, Inje University College of Medicine, Bokji-ro 75, Busanjin-gu, Busan, 614-735, Korea

    Sang-Young Seol

  9. Department of Internal Medicine, The Catholic University of Korea College of Medicine, 327 Sosa-ro, Wonmi-gu, Gyeonggi-do, Seoul, 420-717, Korea

    Sok Won Han

  10. Department of Internal Medicine, The Catholic University of Korea College of Medicine, 222 Banpo-daero, Seocho-gu, Seoul, 137-701, Korea

    Myung-Gyu Choi

  11. Department of Internal Medicine, The Catholic University of Korea College of Medicine, 10, 63-Ro, Yeongdeungpo-gu, Seoul, 150-600, Korea

    Soo-Heon Park

  12. Department of Internal Medicine, Institute of Health Science, Gyeongsang National University School of Medicine, 79 Gangnam-ro, Gyeongsangnam-do, Jinju, 660-702, Korea

    Ok-Jae Lee

  13. Department of Internal Medicine, Catholic University of Daegu School of Medicine, 33 Duryugongwon-ro 17-gil, Nam-gu, Daegu, 705-718, Korea

    Jin Tae Jung

  14. Department of Internal Medicine, Seoul National University College of Medicine, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Gyeonggi-do, Seoul, 463-707, Korea

    Dong Ho Lee

  15. Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, Korea

    Hyun Chae Jung

  16. Department of Internal Medicine, Chonbuk National University Medical School, 20, Geonji-ro, Deokjin-gu, Jeonju-Si, Jeollabuk-do, 561-712, Korea

    Soo Teik Lee

  17. Department of Internal Medicine, Chung-Ang University College of Medicine, 102, Heukseok-ro, Dongjak-gu, Seoul, 156-755, Korea

    Jae Gyu Kim

  18. Department of Internal Medicine, Chungbuk National University College of Medicine, 766, 1 Sunhwan-ro, Seowon-gu, Cheongju-Si, Chungcheongbuk-do, 361-711, Korea

    Sei Jin Youn

  19. Department of Internal Medicine, Hallym University College of Medicine, 150, Sungan-ro, Gangdong-gu, Seoul, 134-701, Korea

    Hak Yang Kim

  20. Department of Internal Medicine, Korea University College of Medicine, 123 Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Seoul, 425-707, Korea

    Sang Woo Lee

  21. Department of Internal Medicine, Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu, Seoul, 120-752, Korea

    Yong Chan Lee

Authors
  1. Eun Hye Kim
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  2. Yong Chan Lee
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  3. Young Woon Chang
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  4. Jong-Jae Park
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  5. Hoon Jai Chun
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  7. Hyun-Soo Kim
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  8. Hyun Yong Jeong
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  9. Sang-Young Seol
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  10. Sok Won Han
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  11. Myung-Gyu Choi
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  12. Soo-Heon Park
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  13. Ok-Jae Lee
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  14. Jin Tae Jung
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  15. Dong Ho Lee
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  16. Hyun Chae Jung
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  17. Soo Teik Lee
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  18. Jae Gyu Kim
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  19. Sei Jin Youn
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  20. Hak Yang Kim
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  21. Sang Woo Lee
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Corresponding authors

Correspondence to Yong Chan Lee or Sang Woo Lee.

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Kim, E.H., Lee, Y.C., Chang, Y.W. et al. Efficacy of Lafutidine Versus Famotidine in Patients with Reflux Esophagitis: A Multi-Center, Randomized, Double-Blind, Non-inferiority Phase III Trial. Dig Dis Sci 60, 1724–1732 (2015). https://doi.org/10.1007/s10620-014-3489-4

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  • DOI: https://doi.org/10.1007/s10620-014-3489-4

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