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Biomedical subjects

M Lazzaroni

Publications and source records attributed to M Lazzaroni.

At least 91 records · Page 5Linked to original sources

Long-term low-dose antacid versus cimetidine therapy in the treatment of duodenal ulcer recurrence.

The effect of cimetidine (400 mg at night) and of low-dose antacid (400 mg of aluminum hydroxide plus 400 mg of magnesium hydroxide four times a day) given alone or in combination was assessed in a double-blind double-dummy endoscopic trial on prevention of duodenal ulcer (DU). Seventy-five outpatients with healed DU were followed up clinically for 1 year and were checked endoscopically after 6 and 12 months of therapy or in case of symptomatic relapse. After 6 and 12 months, 25% and 41%, respectively, of patients treated with cimetidine alone experienced a relapse, compared with 42% and 54% of those treated with antacid alone and 25% and 43% of patients treated with the combination therapy. The differences are not statistically significant. No relevant side effects were observed in patients of any group. It is concluded that long-term prophylactic treatment of DU with low-dose antacid is as safe and effective as cimetidine treatment, whereas a combination of the two drugs does not achieve a therapeutic gain.

Antacids↗

The influence of colloidal bismuth subcitrate on duodenal ulcer relapse.

Antisecretory drugs, although able to promote ulcer healing, have been shown to be unable to modify the course of ulcer disease. Relapse rates after short-term cures and after prophylactic long-term therapy are equivalent to those observed during placebo treatment. Conversely, evidence shows that colloidal bismuth subcitrate (CBS)--by means of a mechanism as yet unclear--reduces the risk of ulcer relapse after a short cure for acute disease. This has been shown in several controlled trials and in two studies on duodenal ulcer patients undertaken by our group. Our experience has shown that 12 months after treatment the relapse rate in patients treated with CBS only during the acute phase was: a) equivalent to that observed in patients whose acute ulcers had healed with cimetidine and had thereafter been treated prophylactically with cimetidine 400 mg at night (69% versus 68%), and b) significantly lower than that of patients whose ulcers had healed with ranitidine and who were subsequently placed under medical observation (67% versus 84%; P less than 0.05). It is concluded that CBS is a valid alternative in the prophylactic treatment of duodenal ulcer.

Bismuth↗

Colloidal bismuth subcitrate and two different dosages of cimetidine in the treatment of resistant duodenal ulcer. Preliminary results.

The use of colloidal bismuth subcitrate (CBS) has been recently suggested for cimetidine-resistant duodenal ulcers. We have therefore compared the activity of CBS with that of two different doses of cimetidine in patients whose duodenal ulcers had not healed after 8 weeks of therapy with cimetidine, 1.2 g, or ranitidine, 300 mg/day. Forty-three patients (35 men and 8 women) were randomly allocated to one of the following oral regimens: CBS, 120 mg 4 times a day, or cimetidine (C), 400 mg 3 times a day, or cimetidine, 400 mg at meals plus 800 mg at bedtime, for 4-8 weeks. The interim analysis after 4 weeks of treatment showed similar percentages of healing in the two cimetidine schedules (46.7% with C, 1.2 g, and 42.9% with C, 2 g, respectively); conversely, CBS treatment resulted in a significantly higher healing rate as compared with both C, 1.2 g, and C, 2 g (P less than 0.05). These findings suggest that resistant duodenal ulcers are more responsive to cytoprotective agents than to antisecretory compounds.

Adult↗

Colloidal bismuth subcitrate and ranitidine in the short-term treatment of benign gastric ulcer. An endoscopically controlled trial.

Colloidal bismuth subcitrate (CBS) in the form of a chewable tablet has been compared with ranitidine in the short-term treatment of benign gastric ulcers. Eighty patients were admitted to this randomised single blind study. Endoscopic control was carried out after 4 weeks, and after 8 weeks when healing was incomplete or had not occurred at the 4-week examination. After 1 month of therapy the healing rates were 70% with CBS and 62.5% with ranitidine (P = not significant). At two months the corresponding cure rates were 87.5% and 79%, respectively (P = not significant). Antacid consumption was higher in the group treated with ranitidine, but the difference was not statistically significant. Patient cooperation was good and similar in the two groups. These findings confirm that CBS, in tablet form, is at least as effective as ranitidine in the acute treatment of benign gastric ulcers.

Adult↗

Colloidal bismuth subcitrate as coated tablets: four times versus twice daily dosage in duodenal ulcer.

Forty patients with endoscopically proven duodenal ulceration have cooperated in a clinical trial to compare the ulcer healing effect of colloidal bismuth subcitrate (CBS) at standard dosage administered either twice or four times a day. No statistically significant difference was found to exist between ulcer healing in the two groups after 4 weeks (70% and 95%, respectively), and it is concluded that twice daily CBS is an effective treatment for duodenal ulcer with clear advantages as regards patient cooperation.

Adult↗

Somatostatin and cimetidine in the control of acute upper gastrointestinal bleeding. A controlled multicenter study.

Acute upper gastrointestinal bleeding remains a difficult emergency problem, and, despite recent pharmacological advances, the choice and results of medical treatment are the subject of debate. To determine the effectiveness of two potent inhibitors of gastric acid secretion, somatostatin and cimetidine, in the control of upper gastrointestinal bleeding of non-variceal origin, we initiated a multicentric, randomized, prospective therapeutic trial in 56 patients presenting with acute hemorrhage due to gastric and duodenal ulcers and erosions defined by uniform and precise criteria. The two drugs were administered i.v. for 48 hours at a dose of 250 mcg/h (somatostatin) and 1,600 mg/24 h (cimetidine). Vital signs, laboratory values, and gastric aspirate were checked frequently in accordance with a strict schedule; the number of blood transfusions was also noted. Endoscopy for the assessment of bleeding before admission to the trial and the end of treatment was performed in every patient. Bleeding stopped in 28 of the 30 (93.3%) patients treated with somatostatin, and in 16 of the 26 (61.5%) of those receiving cimetidine (p less than 0.01). The blood requirement of the patients treated with somatostatin and cimetidine was, on average, 1.10 +/- 1.16 and 2.46 +/- 4.03 units per patient, respectively (p less than 0.05). Somatostatin was also significantly superior - in the patients in whom the treatments were successful - with respect to the time taken to achieve this result. In conclusion, our results, together with those already published, point to a definite therapeutic effectiveness of somatostatin in upper gastrointestinal bleeding as here defined, and would appear to justify a more extensive clinical use under controlled conditions.

Acute Disease↗

Effect of nifedipine on gastric acid secretion and gastrin release in man.

The role of nifedipine in inducing the blockage of calcium slow channels in the smooth muscle cell of the esophagus is well known. The aim of our study was to evaluate the action nifedipine exerts upon acid secretion and gastrin release stimulated by intragastric titration with a peptone meal (pH 5.5) in 7 healthy adult males. Percentage gastrin variations were constantly lower after oral administration of 20 mg nifedipine than with placebo. However, IGO values were shown to be not significantly different (9.3 +/- 1.8 vs 8.4 +/- 2.1 ng. min/ml). No variations in acid output were observed throughout the entire examination period (120 min). In our experience, therefore, nifedipine - under experimental conditions - proved unable to interfere with gastric secretion, probably due to the absence of specific receptors on the parietal and antral cell.

Adult↗

Inhibition of food stimulated acid secretion by association of pirenzepine and ranitidine in duodenal ulcer patients.

The effects of pirenzepine and ranitidine alone and combined, on gastric acid secretion and gastrin release stimulated by liquid peptone meal were evaluated in 12 duodenal ulcer patients. Six patients received placebo and ranitidine 150 mg per os and the other six patients were given placebo, pirenzepine 50 mg and pirenzepine 50 mg plus ranitidine 150 mg per os, according to randomized sequences. In the first experiment ranitidine markedly inhibited (69%) gastric acid secretion for entire two hours period (p less than 0.01). In the second experiment acid secretion after pirenzepine, was reduced by 39% while the combination of pirenzepine plus ranitidine almost completely inhibited the meal stimulated acid secretion (99%). Mean integrated gastrin responses after pirenzepine and ranitidine alone as well as pirenzepine plus ranitidine were not significantly different from placebo. The results of these studies show that in duodenal ulcer patients, the simultaneous block of muscarinic and H2-receptors, suppresses meal stimulated gastric acid secretion, without affecting gastrin release. This therapeutic combination might be used in clinical situations (non-responders, Zollinger-Ellison syndrome) in which complete inhibition of gastric acid secretion is needed.

Adult↗

Cigarette smoking, gastric acid secretion, and serum pepsinogen I concentrations in duodenal ulcer patients.

Cigarette smoking has been linked with duodenal ulcer disease although the mechanism of this association is unclear. This study assessed basal gastric secretory response to acute smoking of smokers with an active duodenal ulcer; in addition the possible effects of chronic smoking on gastric secretory capacity, as expressed by pentagastrin stimulated gastric acid secretion and fasting serum pepsinogen I (PG I) concentrations, were investigated in patients with active duodenal ulcer, or non-ulcer dyspepsia. In 10 smokers with duodenal ulcer smoking four cigarettes during 40 minutes did not influence basal gastric secretion of acid and pepsin, or serum PG I and gastrin concentrations. In 136 patients with duodenal ulcer and 90 controls with non-ulcer dyspepsia, pentagastrin stimulated acid secretion and fasting serum PG I concentrations were significantly higher among habitual heavy smokers than among non-smokers. These findings suggest that in heavy smokers with duodenal ulcer acid- and pepsin-secreting cell function is not affected by acute cigarette smoking. By contrast, chronic cigarette smoking seems to be associated either with an increase of parietal- and chief-cell mass, or with an enhancement of their secretory capacity.

Adult↗

Effect of pirenzepine and atropine on peptone meal-stimulated gastric secretion and plasma gastrin in healthy volunteers, patients with duodenal ulcer and vagotomized patients.

The aim of this study was to compare the effects of atropine with those of placebo and pirenzepine on food-induced gastrin release, and gastric and acid secretion. Three groups of subjects were studied: 8 healthy volunteers; 8 duodenal ulcer patients, and 6 vagotomized patients. Gastric acid secretion and serum gastrin were studied in each subject on 3 different days, after placebo, atropine or pirenzepine, given in random order. In each group, acid secretion was significantly depressed by atropine and pirenzepine. Unlike pirenzepine, atropine induced a significantly increase in serum gastrin in both healthy volunteers and duodenal ulcer patients. None of the treatments caused differences in gastrin response in vagotomized patients.

Adult↗

Famotidine in the management of duodenal ulcer: experience in Italy.

A multicenter study that involved 15 Italian institutions was carried out to compare the efficacy and safety of famotidine 40 mg at bedtime, famotidine 20 mg b.i.d., famotidine 40 mg b.i.d., and ranitidine 150 mg b.i.d. in promoting the healing of acute duodenal ulcer. Two hundred and twenty-four patients with endoscopically proven duodenal ulcer were randomly allocated into four treatment groups. Efficacy results for the four groups were similar at weeks 2, 4, and 8 of therapy. At week 8, the percentage of patients healed in each group was as follows: 92% in the famotidine 40-mg bedtime group, 97% with 20 mg b.i.d., 93% with 40 mg b.i.d., and 90% with ranitidine 150 mg b.i.d. Day pain and night pain were markedly reduced in all four groups, antacid consumption fell considerably, and therapy was generally well tolerated. The adverse experiences evaluated by the investigator as possibly, probably, or definitely related to test medication were rare and moderate.

Adult↗

Famotidine (MK-208) in the treatment of gastric ulcer. Results of a multicenter double-blind controlled study.

The aim of the present investigation was to study the efficacy and safety of famotidine (MK-208), a new, potent, histamine H2 receptor antagonist, in promoting the healing of active gastric ulcer when compared to placebo. Of the 71 patients who took part in this multicenter double-blind study in Italy, 37 were administered famotidine 40 mg once daily and 34 placebo. Treatment duration was for up to 8 weeks, and endoscopic and clinical studies were performed at onset and week 4 and, if necessary, at weeks 6 and 8. All patients were carefully evaluated at regular intervals for adverse drug reactions by clinical and laboratory examinations. By the end of the study, 97% of the ulcers were healed in the famotidine group compared to 66% in the placebo group (p less than 0.01). Day and night pain decreased significantly more in the famotidine group than in the placebo group. Both treatments were well tolerated, and no alterations in laboratory tests were observed. Famotidine, therefore, proved effective in the treatment of gastric ulcer and was well tolerated on a short-term basis.

Adolescent↗

The use of cimetropii bromidum as premedication for endoscopy of the upper gastro-intestinal tract: a double-blind controlled clinical trial.

The effectiveness of cimetropii bromidum (10 or 20 mg i.v.) as premedication for upper gastro-intestinal tract endoscopy was examined and compared with that of placebo in a double-blind crossover study involving 160 patients. The drug effects were assessed from the degree of opening of the pyloric sphincter and the endoscopist's rating of drug performance. The study showed that the effects of cimetropii bromidum differed highly significantly (p less than 0.0001) from those of placebo, on either count. No adverse effects were noted.

Adolescent↗

Effect of maprotiline on pentagastrin-stimulated acid secretion in man.

We have studied the effect of maprotiline, an antidepressant with a strong pronoradrenergic effect, on human gastric secretion. Twelve subjects (nine men and three women) entered the study; six had an active duodenal ulcer, and six were healthy volunteers. Each patient underwent two experiments with an interval of at least 48 h. In a randomized double-blind order, each patient received maprotiline or placebo intravenously during intravenous stimulation with pentagastrin (2 micrograms/kg/h). Thirty minutes after basal collection, pentagastrin was administered for 180 min by constant intravenous infusion. After 60 min placebo or maprotiline (1 mg/kg/h) was added to the intravenous infusion from the 60th to 120th min; thereafter 2 mg/kg/h were infused until the 180th min. Maprotiline infusion (2 mg/kg/h) inhibited significantly stimulated acid secretion in comparison with placebo in duodenal ulcer patients but not in healthy volunteers.

Adult↗

Comparison of pirenzepine and carbenoxolone in the treatment of chronic gastric ulcer. A double-blind endoscopic trial.

The purpose of the present study was to compare the effectiveness of pirenzepine and carbenoxolone in accelerating the healing of chronic gastric ulcer. Sixty-six out-patients with endoscopically proven gastric ulcer, without major systemic diseases, were admitted to the study. Patients were randomly allocated to either pirenzepine, 50 mg three times a day for 6 weeks, or carbenoxolone, 100 mg three times a day for one week followed by 50 mg three times a day for the remaining five weeks. At 6 weeks, the ulcers had healed in 20 out of 34 patients (59%) treated with pirenzepine, and in 15 out of 29 patients (52%) treated with carbenoxolone. Symptomatic improvement was similar with both drugs. Some major side effects (oedema, hypokalaemia and hypertension) occurred in approximately 30% of patients treated with carbenoxolone; of those receiving pirenzepine 25% complained of minor symptoms (e.g. dry mouth, headache, tachycardia). It is concluded that pirenzepine and carbenoxolone are of similar, but rather limited, efficacy in speeding the healing of chronic gastric ulcer, but show important differences with respect to tolerability.

Anti-Ulcer Agents↗

A double-blind endoscopic study with De-Nol tablets and cimetidine for duodenal ulcer.

In a double-blind, double-dummy comparison of short-term ulcer healing, involving 50 patients treated with either De-Nol tablets (four times daily) or cimetidine tablets (400 mg, twice daily), no statistical difference in healing rates was observed after 8 weeks' treatment. There was, however, a numerical trend in favour of De-Nol (De-Nol, 100% healed; cimetidine, 88% healed). Statistical significance in favour of De-Nol was observed, however, in the reduction of antacid tablet consumption and relief of ulcer pain. No unwanted side effects were observed with either drug. This trial indicates that De-Nol and cimetidine are equally effective and useful in the short-term treatment of duodenal ulcer.

Adult↗