Long-term treatment of duodenal ulcer with pirenzepine; gastric pH values and incidence of relapses: an open pilot study.

Twenty-three endoscopically healed duodenal ulcer patients entered a long-term treatment with pirenzepine for 1 year (two 25-mg tablets at breakfast and two tablets at bedtime). One day before and 7 days after the long-term treatment started, gastric pH and BAO were measured in each patient after fasting. The patients were clinically examined monthly and underwent endoscopy 4, 8 and 12 months after the trial started or when they complained of ulcer symptoms. Blood and urine laboratory tests were carried out before treatment began and 6 and 12 months afterwards. Eighteen of the 22 patients that completed the trial (82%) did not relapse. The statistical analysis tended to show a relationship between absence of pH increase and relapses. No severe side-effects or changes in the results of laboratory tests were observed.

Long-term management of duodenal ulcer with pirenzepine and cimetidine: a double-blind controlled clinical trial.

The effectiveness of pirenzepine in the prevention of duodenal ulcer relapses was assessed by means of a double-blind controlled trial versus cimetidine. Seventy duodenal ulcer out-patients endoscopically healed after a 6-week treatment with either pirenzepine or cimetidine were admitted to the trial. The former pirenzepine patients were treated again with pirenzepine: 1 tablet at breakfast and 2 tablets at bedtime (75 mg daily). The former cimetidine patients were treated again with cimetidine: 2 tablets at bedtime (400 mg daily). They received one placebo tablet at breakfast. Both treatments lasted 12 months. Tablets of a mild antacid were permitted only if necessary to relieve severe ulcer pain and heartburn. Patients underwent clinical and endoscopic assessments after 4, 8 and 12 months of treatment and whenever ulcer symptoms lasted more than 4-5 consecutive days. Only 47 out of the 70 patients that entered the trial underwent all clinical and endoscopic controls. Sixteen out of 23 patients on pirenzepine (70%) and 17 out of 24 patients on cimetidine (71%) did not relapse after 12 months. The difference is not statistically significant. Both treatments were well tolerated. The results show that pirenzepine was as effective as cimetidine in the prevention of duodenal ulcer relapses when administered at a dosage of 75 mg daily (of which 50 mg at bedtime) for one year.

Possible role of pirenzepine on the release of pancreatic polypeptide in duodenal ulcer patients: preliminary results of a randomized cross-over study.

The effects of repeated oral doses of pirenzepine (100 mg daily for 7 days) and antacid (Maalox, 105 ml daily for 7 days) on the test-meal-stimulated release of pancreatic polypeptide (PP) were evaluated in 7 duodenal ulcer outpatients by means of a randomized cross-over study, with a wash-out period of one week between pirenzepine and antacid administration. The effects of pirenzepine (100 mg daily for 7 days) were also evaluated in 5 healthy adult volunteers. The stimulus test was performed on each fasting patient two days before the treatment started and after a 7-day treatment. Venous blood samples were obtained before the test meal (basal) and 3, 10 and 30 minutes after it. Plasma PP levels were estimated by means of a specific RIA. The results obtained showed that pirenzepine significantly inhibits the PP response to the test meal in the duodenal ulcer patients and in the healthy volunteers. The above-mentioned effects suggest that one of the mechanisms of action on the therapeutic activity of pirenzepine on peptic ulcer might be explained by the preservation of pancreatic secretion unimpaired by an increase in PP release after meal stimulus.

Pirenzepine in the treatment of benign gastroduodenal diseases. A double-blind controlled clinical trial.

Pirenzepine (PRZ, 75 mg/day for 10 days followed by 50 mg/day for 20 days) was compared with placebo (PL) in the treatment of endoscopically confirmed active gastroduodenitis or duodenal ulcer and with carbenoxolone (CB, 300 mg/day followed by 200 mg/day) in the treatment of gastric ulcer in a 30-day double-blind clinical trial. Ninety-seven of 112 outpatients completed the trial. The results can be summarized as follows: a) Gastroduodenitis. Complete normalization of the endoscopic picture was observed in 61% of the 28 patients on PRZ and in 30% of the 27 on PL. b) Duodenal ulcer. Complete endoscopic healing was observed in 75% of the 12 patients on PRZ and in 44% of the 9 on PL. In both studied PRZ induced improvement in clinical symptoms in more patients than PL. c) Gastric ulcer. PRZ and CB induced complete healing in a similar percentage of patients (64% of 11 and 70% of 10 patients). Better results in dyspepsia were observed in the PRZ group than the CB group. No major side-effects and no pathological changes in blood and urine analyses were observed in PRZ-treated patients.

Pirenzepine in duodenal ulcer. A multicentre double-blind controlled clinical trial. Second of two parts.

Ninety-six patients with endoscopically proved active duodenal ulcers were admitted to a multicentre double-blind trial with either pirenzepine (100 mg/day, 25 mg in the morning and midday and 50 mg at bed time) or placebo for 4 weeks. Ninety-two patients (46 in each group) completed the trial. After 4 weeks, complete healing had been achieved in 70% of the pirenzepine-treated patients and in 32% of the placebo-treated ones (P less than 0.01). No important side-effects and no abnormal changes in blood values or urinalysis were observed during treatment. The difference in the ulcer healing rates observed in the two parts of this multicentre trial is briefly discussed.

Pirenzepine and carbenozolone in gastric ulcer. Preliminary results of a multicentre double-blind controlled clinical trial.

Pirenzepine (PRZ) 75 mg/day for 1 week followed by 50 mg/day for 3 weeks did not show a good activity in gastric ulcer healing in comparison to carbenoxolone (CB) (300 mg/day for 1 week followed by 200 mg/day for 3 weeks). The tolerability of PRZ seemed to be better than that of CB. The increase in the daily dose of PRZ to 100 mg/day for 4 weeks led to better results in the patients who have completed satisfactorily the treatment up to now. PRZ's tolerability was greater than CB's. The results of this study are preliminary to further trial.

Pirenzepine in duodenal ulcer. A multicentre double-blind controlled clinical trial, First of two parts.

Eighty-four patients with endoscopically-proved active duodenal ulcer were admitted to a multicentre double-blind trial with either pirenzepine tablets (25 mg three times per day for 1 week followed by 25 mg two times per day for 3 weeks) or placebo. Seventy-nine patients completed the trial, 44 treated with pirenzepine and 35 with placebo. After 4 weeks, complete healing had been achieved in 52% of the pirenzepine-treated patients and in 34% of the placebo-treated ones. Symptomatic responses were signigicantly better in those receiving pirenzepine than in those receiving placebo. In addition, the supplementary antacid consumption was significantly lesser in the pirenzepine group than in the placebo group. No important side-effects were observed in the two groups.