Vol.19 No.2

Original Article

Efficacy and safety of rebamipide for the treatment of dry mouth symptoms in patients with Sjögren’s syndrome: a double-blind placebo-controlled multicenter trial

Authors

Susumu Sugai1,14 , Hiroki Takahashi2 , Shuji Ohta3 , Makoto Nishinarita4 , Masami Takei5 , Shigemasa Sawada5,6 , Ken Yamaji7 , Hiroshi Oka8 , Hisanori Umehara9 , Ichiro Koni10 , Eiji Sugiyama11 , Susumu Nishiyama12, Atsushi Kawakami13

  • Kanazawa Medical University, Ishikawa, Japan
  • First Department of Internal Medicine, Sapporo Medical University School of Medicine, Hokkaido, Japan
  • Department of Rheumatology, Taga General Hospital, Ibaraki, Japan
  • Division of Rheumatology, Nishinarita Clinic Office, Ibaraki, Japan
  • Division of Hematology and Rheumatology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan
  • Division of Rheumatology, Department of Medicine, Nihon University Nerima Hikarigaoka Hospital, Tokyo, Japan
  • Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan
  • Institute of Medical Science, St. Marianna University School of Medicine, Kanagawa, Japan
  • Division of Hematology and Immunology, Kanazawa Medical University, Ishikawa, Japan
  • Division of Rheumatology, Department of Internal Medicine, Kanazawa University Graduate School of Medicine, Ishikawa, Japan
  • Department of Internal Medicine 1, Faculty of Medicine, University of Toyama, Toyama, Japan
  • Rheumatic Disease Center, Kurashiki Medical Center, Okayama, Japan
  • Department of Immunology and Rheumatology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan
  • 17 Nagamachi, Daishouji, Kaga Ishikawa, 922-0024, Japan
Received:

9 July 2008

Accepted:

23 October 2008

Published online:

17 December 2008

Full Text

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Abstract

The effects of rebamipide on dry mouth and salivary secretion in Sjögren’s syndrome patients were investigated in a double-blind placebo-controlled study. Rebamipide (100 mg TID) or placebo was administered for eight weeks and patient-assessed improvement of dry mouth and increase in salivary secretion measured by the Saxon test were evaluated. At two, four, and eight weeks, dry mouth improvement rates were, respectively, 26.0, 44.0, and 46.9% for rebamipide and 20.0, 27.1, and 39.1% for placebo, and mean increases in salivary secretion were, respectively, 0.14, 0.24, and 0.35 g for rebamipide and 0.03, 0.09, and 0.17 g for placebo, indicating higher values in the rebamipide group for both parameters at all timepoints but no significant differences between the two groups. Analysis by baseline characteristics suggested a statistically significant salivary secretion increasing effect of rebamipide in cases of primary Sjögren’s syndrome. No difference in the incidence of adverse events was seen between the two groups, confirming the safety of rebamipide. As a salivary secretion increasing effect was strongly suggested in cases of primary Sjögren’s syndrome, further study on the administration of rebamipide for the treatment of dry mouth in patients with Sjögren’s syndrome is required.

Key words

Dry mouth - Rebamipide - Saxon test - Sjögren’s syndrome