G. Brandstatter et al., COMPARISON OF ROXATIDINE ACETATE AND RANITIDINE IN THE TREATMENT OF REFLUX ESOPHAGITIS, Clinical therapeutics, 15(2), 1993, pp. 283-293
The 408 patients with symptomatic and endoscopic evidence of reflux es
ophagitis were enrolled in a double-blind, multicenter study. For 6 we
eks, 201 patients (median age, 51 years; 59 women) were randomly assig
ned to receive 75 mg of roxatidine acetate twice daily and 207 (median
age, 51 years; 62 women) received 150 mg of ranitidine twice daily. B
aseline and final endoscopic findings were available for 158 of the ro
xatidine group and 156 of the ranitidine group who completed the study
. After treatment, completely healed or residual erythema of the mucos
a (conventional healing rate) was found in 68% of the roxatidine group
and in 69% of the ranitidine group, complete healing of the mucosa, i
n 32% and 38%, and improvement in 83% and 84%. According to a reflux s
ymptom index, at 6 weeks, 28% of 161 evaluable roxatidine-treated pati
ents and 36% of 158 evaluable ranitidine-treated patients were asympto
matic during both the day and night. The conventional healing rates in
this study were similar to those in nine previous studies of ranitidi
ne; 3 roxatidine-treated patients and 4 ranitidine-treated patients dr
opped out of the study because of side effects. It is concluded that 7
5 mg of roxatidine acetate twice daily is as safe and effective as 150
mg of ranitidine twice daily in the treatment of reflux esophagitis.