An evaluation of cimetidine and ranitidine in the pain relief and acute healing of duodenal ulcer disease.
In a multicenter, single-blind, randomized trial, the effectiveness in pain relief and healing of three regimens of H2-receptor antagonists was compared in 338 patients with endoscopically confirmed active duodenal ulcers, 112 receiving cimetidine 300 mg four times daily (QID), 110 receiving cimetidine 800 mg at bedtime (HS), and 116 receiving ranitidine 300 mg HS. Evaluation of the immediate symptomatic response during the first 24 hours of therapy showed that a greater proportion of patients with nighttime pain were improved on HS regimen and a greater portion of patients with daytime pain were improved on QID regimen. With continued treatment the differences between a once-daily and a four-times-daily regimen disappeared and the HS regimen provided as much daytime pain relief as the QID regimen. For the two once-daily regimens where ranitidine and cimetidine were directly compared, a greater proportion of patients on cimetidine 800 mg HS had an immediate symptomatic improvement than on ranitidine 300 mg HS. When those who smoked were evaluated separately this difference was also evident. During the first 24 hours, a total of 68% of the smokers in the cimetidine HS treatment groups had improvement in daytime pain versus 44% of patients in the ranitidine group at day one. Nighttime pain relief in smokers on day one was apparent in 78% of the patients receiving the cimetidine HS regimen, in contrast to 67% of ranitidine-HS-treated patients. At the completion of a four-week course of treatment, both physicians' and patients' global assessments of the reduction in the severity and frequency of ulcer-related symptoms significantly favored cimetidine HS over ranitidine HS. These results after four weeks of treatment were corroborated by the endoscopy data, which showed 71% of patients in the cimetidine HS group were healed, compared with 63% in the ranitidine HS group. The 300 mg QID cimetidine regimen produced a 69% healing rate. For those patients whose ulcers were unhealed by the end of four weeks of treatment, a further course of treatment produced almost 9C% healing in all treatment groups and symptomatic relief in virtually all patients. None of the regimens was associated with unexpected adverse effects and all patients tolerated the treatments well. The results of this study confirm the efficacy and safety of single bedtime doses of cimetidine or ranitidine, as well as the four-times-daily cimetidine regimen, in the acute treatment of duodenal ulcers.(ABSTRACT TRUNCATED AT 400 WORDS)
Young
M D
MD
Smith Kline & French Laboratories, Philadelphia, Pennsylvania.
Lottes
S R
SR
Webb
L A
LA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002927:Cimetidine / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004381:Duodenal Ulcer / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D011899:Ranitidine / Q000009:adverse effects / Q000627:therapeutic use*; D016037:Single-Blind Method
D002927:Cimetidine; D011899:Ranitidine