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.
Walt
R P
RP
Queen Elizabeth Hospital, Edgbaston, Birmingham, UK.
Logan
R F
RF
Hawkey
C J
CJ
Daneshmend
T K
TK
Long
R G
RG
Cooper
B T
BT
Langman
M J
MJ
Collins
M
M
Street
R
R
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