Pirenzepine versus Cimetidine in Duodenal Ulcer
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Abstract:
90 patients with active duodenal ulcer were admitted to a double-blind trial to compare the effects of pirenzepine (150 mg/daily), cimetidine (1 g/daily) and placebo on the healing of duodenal ulcer. 5 patients did not complete the trial. In 21 of 29 patients (72%) receiving pirenzepine and in 21 of 28 (75%) of those receiving cimetidine, the ulcers had healed after 4 weeks of treatment compared with 10 of 28 (36%) patients receiving placebo (p < 0.01). Symptomatic improvement and reduction of antacid consumption were significantly more marked in the pirenzepine- and cimetidine-treated groups than in the placebo group. Tolerability of drugs was good. The results show that pirenzepine is as effective as cimetidine for the treatment of duodenal ulcer.Keywords:
Cimetidine
Tolerability
Antacid
Previous research has suggested that concurrent administration of antacid and cimetidine results in lower than expected plasma levels of cimetidine. Because these studies were all of single-dose design, this study was undertaken to determine the nature of the interaction after repeated administration of both drugs. There was no statistically significant difference demonstrated for any of the pharmacokinetic parameters evaluated in the study. Based on these findings, the previous recommendation that administration of antacid and cimetidine be separated in time may not be necessary.
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Intragastric pH was monitored during 24 hours in eight volunteers with duodenal ulcer disease in remission, while on placebo, cimetidine 400 mg bd, pirenzepine 50 mg bd, cimetidine 400 mg bd + pirenzepine 50 mg bd, cimetidine 200 mg bd + pirenzepine 25 mg bd. The control of intragastric acidity during the 24 hour period by the combination of low dose cimetidine and pirenzepine was significantly better than with cimetidine, or pirenzepine alone in full dosage. This difference was most apparent after breakfast but was still present after lunch when cimetidine had no significant effect. Combination treatment is a logical approach when continuous control of intragastric acidity is needed, but a three times daily regimen will be necessary to cover the 24 hours.
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The effect of pirenzepine and cimetidine on healing, symptoms and relapse rate of duodenal ulcer was studied in a placebo-controlled double-blind trial. Cimetidine (1 g daily) was superior at the beginning of therapy to a low dose of pirenzepine (75 mg daily) and placebo with regard to symptoms. No significant differences in ulcer healing were found between the 3 groups of treatment. The relapse rate after treatment with pirenzepine was lower than after treatment with cimetidine.
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The effect of pirenzepine and cimetidine on healing, symptoms, and relapse rate of duodenal ulcer was studied in a placebo controlled double blind trial. With regard to symptoms, cimetidine (1 g daily) was superior at the beginning of therapy to a low dose of pirenzepine (75 mg daily) and to placebo. No significant differences in ulcer healing were found between the 3 treatment groups. The relapse rate after treatment with pirenzepine was lower than after treatment with cimetidine.
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The rationale of ulcer therapy with cimetidine or antacids is to block or neutralize gastric acid secretion intragastrically. 5 tablets of cimetidine can inhibit gastric acid secretion in duodenal ulcer patients by more than 50% over a 24-hour period. Approximately 250 ml per day of a highly active antacid is necessary to achieve a similar effect. The effect of cimetidine on night secretion is superior. In acute ulcer attack cimetidine brings about healing of the ulcer in duodenal ulcer disease in about 80% of all patients in about 4-6 weeks, and a maintenance dose of 200 mg in the evening may prevent a recurrence within a year in about 50% of all patients. According to American studies, antacid therapy in the above-mentioned dosage may achieve a similar healing rate in duodenal ulcer patients in acute attack. However, it is unknown whether high antacid therapy prevents ulcer recurrences. If acceptability of the treatment by the patient, side effects and costs are taken into account, cimetidine appears to be superior to high doses of antacid. However, it must be considered that in many European countries, including Switzerland, the spontaneous healing rate is up to 60% in placebo studies. It is thus legitimate to continue treating uncomplicated ulcers with the small antacid doses customary in Europe.
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37 patients with endoscopically confirmed gastric ulcers received either cimetidine (19 patients) or pirenzepine (18 patients) in a double-blind trial. At 4 weeks, 53% of the patients treated with cimetidine and 44% of those treated with pirenzepine had endoscopically healed ulcers. At 8 weeks, complete healing had occurred in 83% of the patients taking cimetidine and 71% of those taking pirenzepine. These differences are not statistically significant.
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Although cimetidine is more effective than a placebo for the prophylaxis of stress-induced ulcers, it has no advantage over titrated antacid dosing. Several comparative studies even suggest that combining cimetidine with antacid is no more effective than use of full-dose antacid. Therefore, we recommend prophylatic use of cimetidine' only when very large dosages of antacid are required, in order to minimize acid-base disturbances.
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