Biomedical subjects

I Fumagalli

Publications and source records attributed to I Fumagalli.

At least 19 recordsLinked to original sources

PubMed2003

Comparable efficacy of pantoprazole and omeprazole in patients with moderate to severe reflux esophagitis. Results of a multinational study.

AIM: To compare the efficacy and tolerability of pantoprazole 40 mg and omeprazole MUPS 40 mg in patients with moderate to severe gastroesophageal reflux disease (GERD). METHODS: In this randomized, double-blind, parallel-group, multicenter study conducted in Austria, Germany, Portugal, Switzerland and The Netherlands, patients with endoscopically confirmed moderate to severe GERD (Savary/Miller esophagitis grade II/III) were enrolled. They received a once-daily dose of either 40 mg pantoprazole or 40 mg omeprazole MUPS. Healing was determined by endoscopy after 4 weeks of treatment. If patients were not healed, treatment was extended for another 4 weeks. An additional endoscopy was performed in these cases after 8 weeks of treatment. Healing was determined by endoscopy after 4 and 8 weeks. In addition, treatment effect on symptoms was evaluated by the investigator using a questionnaire assessing heartburn, reflux regurgitation and pain on swallowing at each visit, as well as by a self-administered questionnaire comprising further 24 gastrointestinal symptoms. Analyses were performed for the intention-to-treat (ITT) and the per-protocol (PP) population. In addition, patients with high compliance (HC: 90% </=110%) were considered in a separate group. Adverse events and the influence of the Helicobacter pylori status were investigated. RESULTS: A total of 669 outpatients were enrolled in the study, with 337 patients receiving pantoprazole and 332 omeprazole MUPS. The PP population consisted of 552 patients, 282 treated with pantoprazole and 270 with omeprazole MUPS. The healing rates in both treatment groups were shown to be equivalent and were higher in patients who adhered closely to the administration protocol (HC). According to ITT (ITT(HC)) analyses, healing rates were 65.3% (77.4%) in the pantoprazole and 66.3% (74.7%) in the omeprazole group after 4 weeks. Furthermore, patients infected with H. pylori had slightly but not significantly higher healing rates than those with a negative test result. The safety profile of both treatments was comparable. CONCLUSION: Pantoprazole 40 mg and omeprazole MUPS 40 mg were equivalent with respect to healing after 4 and 8 weeks of treatment in patients with reflux esophagitis grade II/III. Overall, HC patients had higher healing rates than the regular compliant patients. Both drugs were well tolerated and safe.

2-Pyridinylmethylsulfinylbenzimidazoles↗

PubMed2001

Tegaserod, a 5-HT(4) receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation.

AIM: To investigate the efficacy and safety of tegaserod, a novel 5-HT(4) receptor partial agonist, in a randomized, double-blind, placebo-controlled, 12-week treatment, multicentre study. METHODS: Eight hundred and eighty-one patients with irritable bowel syndrome, characterized by abdominal pain, bloating and constipation, received tegaserod, 2 mg b.d. or 6 mg b.d., or placebo for 12 weeks. RESULTS: Tegaserod, 2 mg b.d. and 6 mg b.d., showed a statistically significant relief of overall irritable bowel syndrome symptoms, measured by a weekly, self-administered questionnaire. At end-point, treatment differences from placebo were 12.7% and 11.8% for 2 mg b.d. and 6 mg b.d., respectively. The effect of tegaserod was noted as early as week 1, and was sustained over the 12-week treatment period. Individual irritable bowel syndrome symptoms assessed daily also showed a statistically significant improvement of abdominal discomfort/pain, number of bowel movements and stool consistency, and a favourable trend for reducing days with significant bloating. Adverse events were similar in all groups, with transient diarrhoea being the only adverse event seen more frequently with tegaserod than placebo. CONCLUSIONS: Based upon the results of this study, tegaserod offers rapid and sustained relief of the abdominal pain and constipation associated with irritable bowel syndrome. Tegaserod is also well tolerated.

Abdominal Pain↗

PubMed2000

Failure of a motilin receptor agonist (ABT-229) to relieve the symptoms of functional dyspepsia in patients with and without delayed gastric emptying: a randomized double-blind placebo-controlled trial.

INTRODUCTION: Motilin-receptor agonists are prokinetics; whether they relieve the symptoms of functional dyspepsia is unknown. We aimed to test the efficacy of the motilin agonist ABT-229 in functional dyspepsia patients with and without delayed gastric emptying. METHODS: Patients were randomized with postprandial symptoms and documented functional dyspepsia by endoscopy (n=589 in intention-to-treat analysis). Patients were assigned to either the delayed or normal gastric emptying strata, based on a validated 13C octanoic acid breath test. Patients were then further randomized within each strata, to receive one of four doses of ABT-229 (1.25, 2. 5, 5 or 10 mg b.d. before breakfast and dinner) or placebo for 4 weeks, following a 2-week baseline. The primary outcome was the assessment of change in symptom severity over the 2 weeks from baseline to final visit, based on a self-report questionnaire measuring severity on visual analogue scales. RESULTS: Baseline characteristics across the treatment arms were very similar. No significant differences in the upper abdominal discomfort severity score (maximum 800 mm) were observed for any active treatment arm vs. placebo (mean change from baseline -139, -141, -145, -160 and -134 mm for placebo, 1.25, 2.5, 5, and 10 mg, respectively, at 4 weeks by intention-to-treat). More patients on placebo reported a good or excellent global response than patients on 1.25 or 5 mg of active therapy (both P < 0.05). The results were very similar in those with and without delayed gastric emptying. Helicobacter pylori status did not predict response. Excluding patients with any baseline heartburn (total remaining n=240), ABT-229 10 mg was inferior to placebo in relief of upper abdominal discomfort. CONCLUSIONS: ABT-229 was of no value for relief of symptoms in functional dyspepsia, compared with placebo.

Adult↗

PubMed2000

Pantoprazole 20 mg is an effective maintenance therapy for patients with gastro-oesophageal reflux disease.

OBJECTIVES: To compare the efficacy of 20 mg with 40 mg pantoprazole in maintaining symptomatic and endoscopic remission in patients with gastro-oesophageal reflux disease (GORD). STUDY DESIGN: Patients (18-84 years old; n = 433) with healed GORD II or III were included in this prospective multi-centre, randomized, parallel, double-blind study. Pantoprazole was administered once daily for up to 1 year as either a 20 mg or 40 mg enteric-coated tablet to 221 and 212 patients, respectively. Symptoms of GORD were assessed every 3 months. Endoscopy was performed at entry, after 6 and 12 months, or when symptoms of GORD were perceived on at least three consecutive days. The primary efficacy parameter was the time until endoscopically proven relapse of GORD occurred (stage I or greater); the secondary parameters included tolerability, safety, and time until symptomatic relapse occurred. RESULTS: In the 20 mg treatment group, 87% and 75% of patients were in endoscopic remission after 6 and 12 months, respectively; the corresponding rates in the 40 mg treatment group were 91% and 78%. In both treatment groups, GORD stage I accounted for about 50% of endoscopic relapses. The symptomatic remission rates in the 20 mg group were estimated as 85% and 77% after 6 and 12 months, respectively; the corresponding values in the 40 mg group were 87% and 76%. No correlation was seen either between the endoscopically proven relapse and perception of symptoms, or between the severity of the pre-treatment stage of GORD and the maintenance dose of pantoprazole. Both doses were well tolerated. CONCLUSIONS: Both the 20 mg and 40 mg doses of pantoprazole are safe and effective in maintaining patients with healed reflux oesophagitis in remission. Moreover, for the majority of patients, the 20 mg dose provides adequate long-term therapeutic efficacy at a minimal drug exposure and lower costs.

2-Pyridinylmethylsulfinylbenzimidazoles↗

PubMed1999

Apoptosis and oxidative status in peripheral blood mononuclear cells of diabetic patients.

We have compared the concentrations of intracellular glutathione (GSH), glutathione-dependent antioxidative enzymes, the cell death rate and immunophenotype profile of peripheral blood mononuclear cells (PBMC) from healthy donors and from patients with insulin-dependent type II (NIDDM) diabetes mellitus. The IDDM and NIDDM patients had above-normal absolute lymphocyte counts, whereas the percentages of CD3, CD4 adn CD8 T lymphocytes were significantly reduced. In contrast, the absolute number and percentage of B lymphocytes was higher in diabetic patients than in healthy donors. The low intracellular reduced glutathione(GSH) and the unbalanced profile of key enzymes involved in GSH metabolism, gamma-glutamyltransferase (gamma-GT) and glutathione-S-transferase (GST), account for the increased oxidative status of PBMC from diabetic patients. The plasma membranes of PBMC for diabetic patients were less permeable to propidium iodide than those of PBMC from healthy donors, indicating that the apoptotic cell death rate was lower in the cells from diabetic patients. These differences are potentially useful markers of pathogenic metabolic changes which occur during clinical diabetes and if they are confirmed could be use dot identify the onset of diabetes.

Journal Article↗

PubMed1994

Cisapride versus metoclopramide in the treatment of functional dyspepsia. A double-blind comparative trial.

The efficacy and tolerability of cisapride (5 mg three times daily) and metoclopramide (10 mg three times daily) were evaluated in a randomized double-blind trial in patients with functional dyspepsia. Sixty patients, equally distributed in the two groups, entered the trial. After 4 weeks of treatment there was a significant improvement of symptom severity versus base line (p < 0.001) in both groups. The percentage of responders (with no or only mild symptoms) was 87% in the cisapride group and 77% in the metoclopramide group (no statistically significant intergroup difference). At the follow-up visit 2 weeks after completion of the trial this response rate was significantly higher in the cisapride group (73%) than in the metoclopramide group (47%) (p < 0.05). Four of the patients receiving cisapride and 2 of the patients receiving metoclopramide reported adverse events. On assessment of extrapyrimidal symptoms, relevant clinical values were found in one patient receiving metoclopramide. Increased prolactin concentrations were observed in seven patients of the metoclopramide group versus only 1 of the cisapride group (p < 0.05). The present data indicate that during the 2 weeks after completion of treatment in patients with functional dyspepsia, cisapride may result in a better, more sustained overall response when compared with metoclopramide.

Adult↗

PubMed1993

Effect of cisapride on relapse of esophagitis. A multinational, placebo-controlled trial in patients healed with an antisecretory drug. The Italian Eurocis Trialists.

The effect of a prokinetic agent, cisapride, on the relapse of reflux esophagitis was investigated in a randomized, double-blind trial conducted in 443 patients whose esophagitis had previously been healed with an acid antisecretory drug. Patients received cisapride, 20 mg at night, cisapride 10 mg twice daily, or placebo for 12 months or until endoscopic relapse was confirmed endoscopically. In 88% of all patients (respectively 133, 132, and 124), endoscopic data were available at discontinuation of treatment. In comparison with placebo, the two cisapride regimens prolonged both the time to endoscopically confirmed relapse (Kaplan-Meier analysis; P = 0.001) and the time to symptomatic relapse (P = 0.012). The life-table endoscopic relapse rates at 12 months were 51% for placebo, 32% for cisapride 20 mg at night (P = 0.005), and 34% for cisapride 10 mg twice daily (P = 0.02). Patients with more severe esophagitis before healing relapsed more rapidly during maintenance therapy, regardless of the treatment regimen. Adverse events were infrequent in all three groups. These findings indicate that maintenance treatment with the prokinetic drug cisapride prevents the relapse of esophagitis after it has been healed by acid antisecretory therapy.

Cisapride↗

PubMed1989

Rioprostil, a new prostaglandin E1 analogue, in the once-daily treatment for the prevention of duodenal ulcer recurrence: a comparison with ranitidine.

The efficacy of Rioprostil (a new prostaglandin E1 analogue) is compared with that of ranitidine in the recurrence prevention of duodenal ulcer(s). Duration of treatment is 6 months. Ninety-seven patients received rioprostil, 600 micrograms once-daily orally, and 110 patients received ranitidine, 150 mg once-daily orally. On rioprostil, 14.9% of patients showed a relapse after 6 months compared to 10.1% on ranitidine. Diarrhoea occurred in 7 patients on rioprostil and 3 patients on ranitidine. Rioprostil given 600 micrograms daily in the evening is a highly effective treatment for the prevention of duodenal ulcer relapse, the efficacy not being significantly different from ranitidine 150 mg.

Adult↗

PubMed1987

Presenting characteristics of patients with duodenal ulcer and outcome of medical treatment in controlled clinical trials using cimetidine and diethylamine persilate to treat ulcer attack and diethylamine persilate and placebo to prevent relapses.

A double-blind controlled clinical trial on the medical treatment of the acute episode of duodenal ulcer and the prevention of symptomatic relapses was performed. A total of 164 patients with active duodenal ulcer were either treated with cimetidine 1 g/day (70 patients), diethylaminepersilate (DAP) 1.5 g/day (64 patients) or DAP 2.5 g/day (30 patients). DAP is an allegedly protective agent stimulating mucosal prostaglandin synthesis. Cumulative healing rates after 4 weeks in the 3 groups were 66, 28 and 28% and after 8 weeks 94, 70 and 63%, respectively. One hundred and five patients with healed duodenal ulcer received, in a second double-blind study, either DAP 0.5 g/day or placebo. Thus, ulcer healing was more rapid with cimetidine than with DAP. DAP did not prevent relapses. No presenting characteristic was associated with slow healing. Three presenting characteristics--smoking, teetotalling and bleeding episode in the past--were associated with early symptomatic relapse. The present study was compared with a previous study performed by the same group of investigators using a similar study protocol. In both trials, an early relapse was associated with smoking. No other presenting characteristic was identified which in both trials was associated with slow healing or early symptomatic relapse. Thus, smoking appears to be the only one of the commonly available presenting characteristics which allows a prediction of the course of duodenal ulcer disease.

Adult↗

PubMed1987

Gastric ulcer: a double blind comparison of 800 mcg misoprostol versus 300 mg ranitidine.

Seventy-nine patients with endoscopically confirmed gastric ulcers received either ranitidine (37 patients) or misoprostol (42 patients) in a randomized double-blind manner. Fifty-six percent of the patients treated with ranitidine, and 38% of those treated with misoprostol presented with endoscopically healed ulcers after four weeks of treatment. After eight weeks complete healing had occurred in 86% of the patients receiving ranitidine, and 74% of those on misoprostol. These differences were not statistically significant. In smokers, ranitidine was superior to misoprostol, leading to a higher healing rate at four weeks (73% versus 20%). Thus there was no evidence that in patients with gastric ulcer misoprostol overcomes the negative effect of cigarette smoking.

Adult↗

PubMed1986

[Ranitidine therapy of duodenal ulcer: comparison of once-a-day and twice-a-day administration. A Swiss multicenter double-blind study].

In a Swiss multicenter double-blind trial ranitidine was given in doses of 300 mg nocte and 150 mg b.d. for the treatment of duodenal ulcer. Ninety-seven patients with endoscopically proven ulcer were treated for four, and in cases of non-healing for eight, weeks. Cumulative healing rates with 300 mg and 2 X 150 mg were 77% and 78% after four weeks and 90% and 94% after eight weeks respectively. 60 and 65% of the patients were asymptomatic after four weeks. Smoking did not adversely affect healing. Thus, ranitidine in a dose of 300 mg nocte is as effective as ranitidine in a dose of 150 mg b.d. in the treatment of duodenal ulcer.

Adolescent↗

PubMed1986

Healing and relapse of reflux esophagitis during treatment with ranitidine.

In 108 patients the healing and relapse of reflux esophagitis, defined endoscopically by the presence of epithelial defects (erosions and ulcerations) of the esophageal mucosa, were studied. In the first study, with open treatment of ranitidine, the healing rate after 6 wk was 50%. The most important factor that negatively influenced healing was the extent of esophageal erosions. Patients with isolated erosions had a 6-wk healing rate of 78%; the healing rate was 38% in patients with longitudinally confluent lesions and 23% in those with circumferential erosions of the distal esophagus. Smoking also had an unfavorable effect. Age, sex, duration of history, body weight, and alcohol consumption were not related to outcome. Symptoms improved during treatment with ranitidine, but the correlation between symptoms and endoscopic findings at 6 wk was weak. In the second study, relapse was investigated in 61 patients with healed esophagitis in a randomized, double-blind trial comparing placebo and ranitidine (150 mg at bedtime for 6 mo). In both groups, relapse occurred in more than one-third of the patients, with no significant difference between ranitidine and placebo treatment. Patients with worse daytime symptoms at the time of previous healing had a higher relapse rate. The initial severity of esophagitis and smoking did not influence recurrence. Thus, the initial endoscopic findings are of prognostic value in reflux esophagitis. Smoking retards healing. Low-dose maintenance treatment with ranitidine does not prevent relapse.

Adolescent↗

PubMed1985

[Misoprostol and cimetidine in the treatment of duodenal ulcer. A multicenter Swiss double-blind study].

The efficacy and tolerance of misoprostol a synthetic prostaglandin E1 analogue-and of cimetidine were evaluated in the treatment of duodenal ulcer following a double blind multicenter design. A group of Swiss gastroenterologists recruited 119 patients with endoscopically proven acute duodenal ulcer. They were enrolled and treated according to a uniform protocol either with misoprostol 4 X 50 micrograms daily, with misoprostol 4 X 200 micrograms daily or with cimetidine 4 X 300 mg daily. Patients who were healed after 4 or 8 weeks were followed during 6 months. Cumulative healing rates at 4 weeks in groups receiving misoprostol 200 micrograms, misoprostol 800 micrograms or cimetidine 1200 mg daily were 42%, 58% and 71% respectively. Patients treated with cimetidine showed a more rapid improvement of symptoms than patients treated with misoprostol. Symptomatic recurrences after ulcer healing occurred in almost 40% of the patients within 6 months, irrespective of the type of acute ulcer treatment. Risk factors for slowed healing and increased rate of recurrence were evaluated in the present study, and the results were compared with the results of two previous trials performed according to a similar protocol. Smoking appeared to slow healing and to favor relapses. Moderate consumption of alcohol appeared to decrease the relapse rate. In the present trial, ulcer size was associated with ulcer pain but not with ulcer healing.

Adult↗

PubMed1974