A comparison of roxatidine and ranitidine for the acute treatment of duodenal ulcer.
Roxatidine acetate is a new histamine H2-antagonist of about twice the potency of ranitidine on a weight-for-weight basis. Two hundred and thirty-two patients participated in a double-blind randomized trial of duodenal ulcer healing comparing 300 mg ranitidine nocte with 150 mg roxatidine nocte. Endoscopy was repeated fortnightly to 4 weeks in each of four participating centres. Usual exclusion criteria applied but NSAID users were allowed. There were no important demographic differences between treatment recipients. Three analyses were used: protocol (dropouts and violators not included), intention-to-treat I (dropouts considered failures), and intention-to-treat II (dropouts considered failures, but violators outcome included). Healing rates differed markedly (but not significantly) with each analysis. After 2 weeks of treatment ulcers had healed in 51% versus 45% using the intention to treat I analysis with roxatidine and ranitidine, respectively; by the protocol analysis the healing proportions were 60% and 55%. These differences between treatments were not significant. After 4 weeks of treatment healing rates ranged from 71% to 83% on roxatidine and between 69% and 84% on ranitidine depending on the analysis. Differential healing proportions of smokers and non-smokers were non-significant (83% vs. 79%). Both drugs were well tolerated and adverse events were similar with each agent. Roxatidine should prove as effective as ranitidine for acute duodenal ulcer treatment.
Queen Elizabeth Hospital, Edgbaston, Birmingham, UK.
R P
RP
Walt
R F
RF
Logan
C J
CJ
Hawkey
T K
TK
Daneshmend
R G
RG
Long
B T
BT
Cooper
M J
MJ
Langman
M
M
Collins
R
R
Street
D000328:Adult; D000368:Aged; D004381:Duodenal Ulcer / Q000188:drug therapy*; D005260:Female; D006635:Histamine H2 Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage / Q000627:therapeutic use*; D011899:Ranitidine / Q000008:administration & dosage / Q000627:therapeutic use*
D006635:Histamine H2 Antagonists; D010880:Piperidines; D011899:Ranitidine; C053742:roxatidine acetate