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.
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.
Sugai
Susumu
S
Kanazawa Medical University, Ishikawa, Japan. sussugai@helen.ocn.ne.jp
Takahashi
Hiroki
H
Ohta
Shuji
S
Nishinarita
Makoto
M
Takei
Masami
M
Sawada
Shigemasa
S
Yamaji
Ken
K
Oka
Hiroshi
H
Umehara
Hisanori
H
Koni
Ichiro
I
Sugiyama
Eiji
E
Nishiyama
Susumu
S
Kawakami
Atsushi
A
D000368:Aged; D000409:Alanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004435:Eating / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009055:Mouth / Q000187:drug effects; D011453:Prostaglandins / Q000096:biosynthesis; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D012463:Saliva / Q000187:drug effects / Q000378:metabolism; D012859:Sjogren's Syndrome / Q000188:drug therapy*; D012890:Sleep / Q000187:drug effects; D016896:Treatment Outcome; D014987:Xerostomia / Q000188:drug therapy*
D000893:Anti-Inflammatory Agents; D011453:Prostaglandins; D015363:Quinolones; C052785:rebamipide; D000409:Alanine