Comparative study of nizatidine and famotidine for maintenance therapy of erosive esophagitis.
BACKGROUND
The therapeutic effect of combined administration of prokinetics and histamine H2 receptor antagonists (H2RA) in gastroesophageal reflux disease is reported to be superior to that of monotherapy with H2RA alone. In addition to its acid-suppressing effect, the H2RA nizatidine also has a prokinetic action by suppressing acetylcholine esterase. The present multicenter, randomized controlled study was performed to investigate whether nizatidine is superior to famotidine, which does not suppress acetylcholine esterase activity, in maintenance therapy for erosive esophagitis. In addition, the question as to whether the grade of erosive esophagitis affects the non-recurrence rate during the maintenance therapy with H2RA was also investigated.


METHODS
Seventy-two patients with endoscopically healed erosive esophagitis after 8 weeks of initial treatment with proton pump inhibitors were randomly divided into two groups. Patients in the nizatidine group were treated with 150 mg nizatidine twice a day (b.i.d.), while patients in the famotidine group were treated with 20 mg famotidine b.i.d. for 6 months. At the end of therapy, and at the time when patients complained of symptoms, endoscopic investigations were repeated to find out whether the esophagitis had recurred.


RESULTS
Nizatidine produced a significantly higher non-recurrence rate than famotidine (P = 0.049 in intention-to-treat [ITT] analysis). This difference of remission rate between nizatidine and famotidine was observed mainly in grade B esophagitis (P = 0.016 in ITT analysis).


CONCLUSIONS
Nizatidine is a more effective H2RA than famotidine in the maintenance therapy of patients with reflux esophagitis.
Hamamoto
Naoharu
N
Department of Gastroenterology and Hepatology, Shimane University, School of Medicine, 89-1 Enya-cho, Izumo-shi, Shimane 693-8501, Japan.
Hashimoto
Tomoyuki
T
Adachi
Kyoichi
K
Hirakawa
Kazuya
K
Ishihara
Shunji
S
Inoue
Harue
H
Taniura
Hiroyuki
H
Niigaki
Masatoshi
M
Sato
Shuichi
S
Kushiyama
Yoshinori
Y
Suetsugu
Hiroshi
H
Miyake
Tatsuya
T
Kinoshita
Yoshikazu
Y
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D004945:Esophagoscopy; D015738:Famotidine / Q000627:therapeutic use*; D005260:Female; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016567:Nizatidine / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
D006635:Histamine H2 Antagonists; D015738:Famotidine; D016567:Nizatidine