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Biomedical subjects

G Dobrilla

Publications and source records attributed to G Dobrilla.

At least 55 records · Page 3Linked to original sources

Cisapride versus placebo in reflux esophagitis. A multicenter double-blind trial.

In a 6 to 12-week double-blind trial, the effect of cisapride (10 mg q.i.d.) was compared with that of placebo in 63 patients with esophagitis confirmed by endoscopy and/or biopsy. In only one patient (3%) in the cisapride group but in 43% of the placebo patients (p = 0.001), symptoms had not improved after 6 weeks. Forty patients continued treatment until week 12. At that time, control endoscopy showed a significantly (p = 0.005) higher rate of healing (no erosions, ulcers, or bleeding mucosa) in the cisapride patients (63%) than in the placebo patients (12%). At week 12, only three of the 21 cisapride patients still had moderate reflux symptoms, whereas eight of the 19 placebo patients had moderate or severe symptoms (p less than 0.05). Cisapride patients also took significantly (p less than 0.001) less antacids during the trial. These results show that cisapride, 10 mg q.i.d., heals esophagitis lesions and greatly reduces associated symptoms. The treatment was well tolerated.

Adult↗

Influence of ulcer healing agents on ulcer relapse after discontinuation of acute treatment: a pooled estimate of controlled clinical trials.

Whether or not the incidence of ulcer relapse varies according to the drug used to produce initial healing is a controversial matter. We tackled this problem using data from 15 eligible trials from 25 published controlled trials in patients followed up for six to 12 months. Pooled estimates of differences in ulcer relapse incidence between patients initially healed with H2-antagonists and patients initially healed with non-H2-antagonist drugs were calculated. The overall incidence of relapse in patients healed with comparator drugs is 11 percentage units lower at six and 12 months, than that observed in H2-antagonist-healed patients. The confidence intervals are +/- 8% at six months and +/- 7% at 12 months. These data suggest the existence of a different effect on relapse incidence for the entire class of comparator drugs taken as a whole, compared with H2-antagonists. On considering the non-H2-antagonists singly, this conclusion holds good only in the case of tripotassium dicitrato bismuthate.

Anti-Ulcer Agents↗

Comparison of once-daily bedtime administration of famotidine and ranitidine in the short-term treatment of duodenal ulcer. A multicenter, double-blind, controlled study.

A multicenter, double-blind, randomized, controlled study was conducted in 234 duodenal ulcer patients to compare the efficacy and safety of the H2-receptor antagonists famotidine and ranitidine in the treatment of duodenal ulcer. Patients received 40 mg famotidine (119 patients) or 300 mg ranitidine (115 patients) once daily at bedtime for 4 weeks. If ulcer lesions persisted, treatment was extended to 6 weeks. Efficacy was assessed by relief of symptoms and endoscopic findings of ulcer healing. Safety was determined on the basis of reports of side effects, results of laboratory tests, and, in selected patients, changes in plasma levels of hormones. The 4- and 6-week healing rates achieved with famotidine were 76% and 91%, respectively, and with ranitidine they were 76% and 87%, respectively; the differences in healing rates for the two drugs were not statistically significant. Similarly, both drugs provided satisfactory relief of pain and dyspeptic symptoms. However, famotidine produced significantly (P less than 0.05) greater relief of postprandial fullness and heartburn. The incidence of untoward effects was low in both treatment groups, and abnormal results in laboratory tests were observed in only one patient, a chronic alcoholic receiving famotidine, who withdrew from the study because of a slight elevation in serum transaminase levels. One patient in the ranitidine treatment group dropped out of the study because of a generalized urticarial rash; however, a causal relationship between drug and effect could not be established. The authors conclude that famotidine may be regarded as the best alternative to ranitidine in the treatment of duodenal ulcer.

Adolescent↗

Short-term treatment of reflux oesophagitis with ranitidine 300 mg nocte. Italian multicentre study.

A multicentre study involving 9 Italian institutions was carried out to compare the efficacy and safety of ranitidine 150 mg b.i.d. and ranitidine 300 mg nocte in the treatment of reflux oesophagitis. 117 patients with histologically proven oesophagitis were randomly allocated to two comparable treatment groups. Efficacy and reliability were evaluated by clinical and laboratory tests at the beginning of the study, and at 3 and 6 weeks; endoscopy and biopsies were performed at the beginning and at 6 weeks. Treatment with ranitidine for 6 weeks led to total disappearance of gastro-oesophageal reflux symptoms in 60% of patients, with percentages of partial improvement varying between 85% and 95% of cases. Improvement in the results of endoscopic examination was 85%, of which 55% were cured. Microscopic examination revealed an improvement of 36% and 44%, with a cure rate of 18% and 26% respectively. With regard neither to the regression of symptoms nor to the macroscopic and microscopic inflammation of the oesophageal mucosa did statistical examination show significant differences in the therapeutic efficacy of ranitidine 150 mg b.i.d. or 300 mg nocte for treatment of reflux oesophagitis.

Adult↗

Omeprazole vs. ranitidine in the short-term treatment of duodenal ulcer: an Italian multicenter study.

A double-blind, double-dummy, randomized Italian multicenter trial was carried out to compare the efficacy and safety of omeprazole 20 mg in the morning and ranitidine 150 mg b.i.d. in short-term treatment of acute duodenal ulcer. One hundred and twenty-one patients (61 in the omeprazole and 60 in the ranitidine group) with endoscopically proven active duodenal ulcer, completed the study. The healing rates after 2, 4 and 6 weeks were 66, 97 and 100%, respectively, with omeprazole and 53, 85 and 92%, respectively, with ranitidine. The difference was statistically significant (p less than 0.05) at weeks 4 and 6. Night and day pain were markedly reduced during both treatments, as also antacid consumption. Both drugs were well tolerated, and the adverse events were infrequent and moderate. In our experience, omeprazole 20 mg once daily seems to be superior to ranitidine 150 mg b.i.d. in the short-term treatment of duodenal ulcer.

Adult↗

Inhibitory effect of famotidine on cat gastric secretion.

The inhibitory effect of the novel H2 receptor antagonist famotidine was studied in conscious gastric fistula cats against dimaprit-induced hypersecretion, in comparison with ranitidine. On the secretory plateau induced by dimaprit (2 mumol kg-1 h-1) famotidine (0.05-0.2 mumol kg-1 i.v.) exerted a dose-dependent inhibitory effect, being approximately 4.5 times as potent as ranitidine (ID50 values were 0.067 +/- 0.015 and 0.30 +/- 0.025 mumol kg-1 for famotidine and ranitidine, respectively). No significant differences were found between the two drugs, as for the time-course of the inhibitory effect. Famotidine (0.01-0.32 mumol kg-1 h-1) caused a parallel displacement of the dose-response curve to dimaprit to the right, without reducing the maximum response to the stimulant, thus behaving as a competitive antagonist, like ranitidine. pA2 values for famotidine and ranitidine were 7.95 and 6.92, respectively. In the same range of doses famotidine dose-dependently reduced also the secretory response to histamine. From these data it was concluded that famotidine is a potent histamine H2 receptor antagonist in the cat gastric mucosa; moreover, conversely from "in vitro" data, the antagonism was surmountable even at the highest doses tested. In vivo experiment, therefore, did not reveal any particular feature of this compound, apart from the undoubtedly high potency, in comparison with other members of the family.

Animals↗

A single nighttime dose of ranitidine 300 mg versus ranitidine 150 mg twice daily in the acute treatment of duodenal ulcer: a European multicenter trial.

Six hundred and five patients with endoscopically diagnosed duodenal ulcer were randomly allocated to treatment with ranitidine 300 mg at night or ranitidine 150 mg twice daily in a prospective double-blind multicenter trial conducted in nine European countries. Endoscopy at 4 weeks showed complete ulcer healing in 246 of 301 patients (82%) treated with ranitidine 150 mg b.i.d. and 230 of 304 patients (76%) treated with ranitidine 300 mg at night. Cumulative healing rates at 8 weeks were 95 and 94% respectively. Both treatment regimens were equally effective at rapidly reducing the incidence of ulcer-related symptoms. Adverse events were few and consistent with those reported in previous studies with ranitidine 150 mg twice daily. The results of this trial indicate that a single nighttime dose of ranitidine is an effective and safe alternative to the twice daily regimen in the acute treatment of duodenal ulcer.

Adult↗

Prospective evaluation of the diagnostic efficacy of CA 19-9 assay as a marker for gastrointestinal cancers.

Levels of a new carbohydrate antigen, CA 19-9, which is a monosialoganglioside identified by a monoclonal antibody raised against colorectal carcinoma cells, were compared to conventional CEA assays in 615 sera from healthy controls, patients with benign gastrointestinal disorders, and patients with cancers of gastrointestinal or extragastrointestinal origin. Whereas CEA levels were higher in smokers, CA 19-9 values were independent of the smoking history. CA 19-9 was undetectable in lymphoma and myeloma patients, but some patients with extraintestinal epithelial cancers expressed this antigen in serum. For benign and malignant gastrointestinal diseases, CA 19-9 displayed higher sensitivity, specificity, and predictive values than CEA. CA 19-9 was elevated as frequently as CEA in patients with metastatic pancreatic cancer, but in patients with localized disease, CA 19-9 was elevated more often than was CEA. In colorectal cancer, patients with and without metastases were detected at similar rates by both assays. It is concluded that CA 19-9 is a marker of epithelial cancers, does not vary with the smoking status, and is superior to CEA in detecting gastrointestinal malignancies, especially those arising from the pancreatic gland.

Antibodies, Monoclonal↗

CA 19-9 assay in differential diagnosis of pancreatic carcinoma from inflammatory pancreatic diseases.

Levels of a new carbohydrate antigen CA 19-9, which is a monosialoganglioside identified by a monoclonal antibody raised against colorectal carcinoma cells, were compared to carcinoembryonic antigen and tissue polypeptide antigen assays in 250 sera from patients with different pancreatic diseases including acute pancreatitis, chronic pancreatitis, and pancreatic cancer. All three tumoral markers were elevated at the onset of an acute pancreatic attack in a few patients. All but five patients with chronic pancreatitis displayed normal levels with each of the three markers; in two of these five cases an extraintestinal cancer was later discovered. CA 19-9 displayed higher sensitivity and predictive value of a negative result than the other two markers. The best operational characteristic of CA 19-9 was its high predictive value for a positive test which suggests a "ruling in" usage of it for pancreatic cancer diagnosis. CA 19-9 assay was of extreme value in disclosing both localized and metastatic pancreatic cancer while the other two markers were more often positive in the latter case. Of 71 cancer patients with positive markers, only four would have escaped a right diagnosis by assaying CA 19-9 alone.

Acute Disease↗

A double-blind controlled trial of ranitidine 300 mg nocte and ranitidine 150 mg b.i.d. in the short-term treatment of gastric ulcer.

A multi-center study was carried out to compare the healing rates of ranitidine 300 mg nocte and 150 mg b.i.d. in the short-term treatment of gastric ulcers and to assess the side-effect liability of ranitidine 300 mg given in a single daily dose. Forty-five outpatients suffering from endoscopically and bioptically proven uncomplicated benign gastric ulcer were selected for the study. The patients were treated, for 4 weeks, on the basis of a double-blind randomized design. An endoscopic examination was repeated within 4 days after the end of the treatments. The patients who did not demonstrate complete healing were treated for an additional 4-week period. Clinical controls were performed to evaluate symptoms, antacid consumption, compliance with trial tablet consumption; hematological and biochemical tests were also carried out at the end of the 4 and 8-week periods. No differences were observed between the healing rate induced by 300 mg nocte and 150 mg b.i.d., after 4 weeks of treatment (76% and 79% respectively) and after 8 weeks (100% in both groups). Similar results were obtained as far as symptoms, antacid consumption and compliance are concerned. Neither treatment regimen induced appreciable side-effects.

Adult↗

Comparison between ranitidine 150 mg b.d. and ranitidine 300 mg nocte in the treatment of duodenal ulcer.

A multicenter trial was undertaken to assess the clinical usefulness of a single night-time dose of ranitidine in the short-term healing of duodenal ulcer. 384 patients with endoscopically diagnosed duodenal ulcer were randomly allocated to treatment with ranitidine either 150 mg b.d. or 300 mg as a single night-time dose for four weeks. The patients not healed after four weeks were again treated for four weeks. Of the 356 patients who completed the study, according to the protocol, 148 of 176 (84.1%) recovered on ranitidine 150 mg b.d. and 147 of 180 (81.7%) recovered on 300 mg nocte after four weeks. The healing rates increased to 95.8% and 94.8% respectively after four more weeks. Ulcer symptoms were rapidly reduced with no significant differences between the two treatment groups. There were no unwanted effects in either group and no significant abnormal biochemical or hematological changes. The results of this study support the hypothesis that ranitidine 300 mg given as one night-time dose and ranitidine 150 mg b.d. are equally effective. Ranitidine 300 mg once daily in a clinical practice may be advantageous to the patient.

Adult↗

[Acute drug-induced pancreatitis].

93 publications concerning drug-induced pancreatitis are reviewed. A confirmed causal relationship between drug and acute pancreatitis so far exists only for 8 compounds: azathioprine, chlorothiazide, furosemide, sulfonamides, tetracycline, estrogens, valproic acid and L-asparaginase. There is less convincing, but still suggestive, evidence for a causal relationship with 5 other drugs, namely: corticosteroids, chlorthalidone, ethacrynic acid, phenformin and iatrogenic hypercalcemia. Due to inadequate or contradictory evidence, the link between a number of additional drugs and acute pancreatitis is considered possible, conditional or doubtful. Finally, the scant literature concerning the pathogenesis and histological lesions of drug-induced pancreatitis is briefly reviewed.

Acute Disease↗

Short-term treatment of duodenal ulcer with a single nocturnal dose of ranitidine: an up-to-date overview of Italian experience.

The author compares the efficacy of ranitidine 300 mg in a single bedtime dose, and ranitidine 150 mg twice daily, in 509 duodenal ulcer patients treated in two Italian multicentre trials. In the first of these trials the treatment period was 4 weeks plus a further 4 weeks in patients whose ulcers failed to heal, as against 2 plus 4 weeks in the other trial. Given the homogeneity of the patient entry and exclusion criteria, and the fact that identical clinical and endoscopic evaluation criteria were used in the two trials, the results are grouped together for analysis purposes. This permits detailed evaluation of the therapeutic effects of the two ranitidine regimens at two-weekly intervals over a total period of 8 weeks. With the single bedtime dose regimen, healing rates were 47.2% after 2 weeks, 81.7% after 4 weeks, 83.6% after 6 weeks and 94.8% after 8 weeks, while the corresponding rates for the twice-daily regimen were substantially similar (51.9%, 84.1%, 89.5% and 95.8%). The two regimens also produced comparable results in terms of relief of daytime and nocturnal ulcer pain. The Italian experience confirms, in a fairly large patient population, that the simpler ranitidine regimen represented by the single bedtime dose fully preserves its therapeutic efficacy in duodenal ulcer. Moreover, the fact that no differences were noted in responses of patients from the various different regions of Italy with their greatly differing constitutional, environmental and alimentary characteristics, appears to suggest that such factors are not sufficient in themselves to affect the therapeutic results obtained with the drug.

Circadian Rhythm↗