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Biomedical subjects

M Petrillo

Publications and source records attributed to M Petrillo.

At least 37 records · Page 2Linked to original sources

A double-blind gastroscopic evaluation of the effects of etodolac and naproxen on the gastrointestinal mucosa of rheumatic patients.

The aim of this clinical, endoscopical study was to evaluate the therapeutic efficacy and the gastric tolerability of etodolac, a new anti-inflammatory, non-steroidal drug, compared with naproxen. The study was conducted on 48 patients suffering from rheumatoid arthritis. 44 of whom completed the trial. After an initial oesophagogastroduodenoscopy to exclude the presence of gastric mucosal lesions, patients were randomly allocated to double-blind treatment with either etodolac 200 mg b.i.d. or naproxen 500 mg b.i.d. for a period of 4 weeks. Endoscopic control followed this treatment period. Both drugs proved effective in relieving clinical symptoms, without a statistically significant difference. Gastric mucosal lesions were observed in 15% of etodolac-treated patients and in 46% of patients treated with naproxen (P less than 0.05) (95% CI 0.01-0.60). Painful dyspepsia was observed in 15% of patients treated with etodolac vs. 38% of patients on naproxen therapy. This study demonstrates that etodolac is at least as active as naproxen in relieving rheumatic symptoms, and its administration results in a significantly lower degree of gastric damage.

Anti-Inflammatory Agents, Non-Steroidal

Treatment of refractory peptic ulcer with omeprazole or continued H2 receptor antagonists: a controlled clinical trial.

We tested the hypothesis that the gastric H+/K+ adenosine triphosphatase inhibitor, omeprazole, because of its different mode of action and pronounced inhibitory effect on gastric acid secretion, may be more effective in peptic ulcer that is refractory to histamine H2 receptor antagonist treatment than continuing the same therapy. Altogether 107 patients (duodenal ulcer, n = 88; prepyloric ulcer, n = 14; gastric ulcer, n = 3; mixed sites, n = 2) with refractory peptic ulcer - that is ulcer unhealed after at least two months' treatment with cimetidine 0.8 g or 1 g daily or with ranitidine 0.3 g daily - were randomly allocated to receive either omeprazole 40 mg daily (n = 54) or to continue treatment with the same H2 receptor antagonist and at the same dose (n = 53) for up to eight weeks. The patients in the two treatment groups were well matched demographically. Healing by 'intent to treat' analysis was as follows: at four weeks, omeprazole 46 of 54 (85%), H2 receptor antagonist 18 of 53 (34%) (p less than 0.0001); and at eight weeks, 52 of 54 (96%) and 30 of 53 (57%) respectively (p less than 0.0001). One patient was lost to follow up but of the 22 patients whose ulcers were shown to be unhealed at endoscopy after receiving continued H2 receptor antagonist treatment, 21 healed in four to eight weeks when changed to omeprazole. Daytime epigastric pain cleared at four weeks in 43 of 47 (91%) patients on omeprazole and in 32 of 46 (70%) on H2 receptor antagonists (p=0.01) and relief of all dyspeptic symptoms occurred in 39 of 47 (83%) and 23 of 45 (51%) (p=0.0009) patients respectively. Adverse events occurred in 11 of 54 (20%) patients on omeprazole and in 12 of 35 (34%) on cimetidine but in none on ranitidine. The events were mild and none required treatment withdrawal. The commonest event in patients on omeprazole was loose stools or diarrhoea (n=5). Omeprazole was significantly better than continued H2 receptor antagonist treatment for the short term management of refractory peptic ulcer as judged by healing rate and pain relief, and it was safe.

Cimetidine

Comparative study of mifentidine and ranitidine in the short-term treatment of duodenal ulcer.

The efficacy and safety of mifentidine 20 mg at night, a new, potent, long-acting H2-receptor antagonist, has been compared with ranitidine 300 mg at night in 60 patients with acute duodenal ulcer, in a randomized double-blind study. Antacid tablets were allowed as additional treatment for pain relief. The treatment lasted for 4 weeks. After 4 weeks of treatment the healing rate was similar; amongst the patients who completed the treatment, healing was 68% for mifentidine, 63% for ranitidine, and on intention-to-treat analysis, healing in both groups was 63%. Pain relief and antacid consumption were similar in both groups. Clinically significant adverse effects were not detected and any changes in laboratory values were minimal, clinically insignificant and reversible. Mifentidine appears to be an effective and safe once-a-day treatment for acute duodenal ulcer disease.

Adult

Imidazole salicylate versus piroxicam in the treatment of arthrosis in elderly patients. A double-blind clinical and endoscopic trial.

The clinical efficacy and gastroduodenal tolerability of imidazole salicylate (imidazole 2-hydroxybenzoate, ITF 182), a new synthetic drug with an anti-inflammatory action, was evaluated endoscopically in comparison with those of piroxicam in elderly patients suffering from osteoarthrosis. Of the 41 patients entering the trial, only 38 completed the protocol (6 men and 32 women; mean age, 71; range, 65-80 years). After upper gastrointestinal endoscopy for the purpose of excluding gastric and duodenal mucosal lesions, the patients were allocated at random, according to a double-blind, double-dummy protocol, to treatment either with imidazole salicylate 750 mg three times daily or with piroxicam 20 mg once daily for a period of 4 weeks. Imidazole salicylate proved active in controlling a number of the pain symptoms caused by arthrosis, although its efficacy was inferior to that of piroxicam. Grade 2 gastric mucosal lesions were detected in 1 of 20 patients (5%) treated with imidazole salicylate; lesions corresponding to grades 2, 3, and 4 were found in 6 of 18 (33%) of those treated with piroxicam (P = .034). Painful dyspepsia was reported by 15% of the patients in the imidazole salicylate group and by 28% of those in the piroxicam group. On the basis of these results and under the experimental conditions adopted in this trial, the authors concluded that imidazole salicylate is characterized by good gastric tolerability and can thus be used in the treatment of rheumatic diseases in the elderly.(ABSTRACT TRUNCATED AT 250 WORDS)

Activities of Daily Living

Comparison of qid and bd administration of De-Nol in the short term treatment of duodenal ulcer.

One hundred and twelve patients (80 males, 32 females) with endoscopically proven gastroduodenal ulcer participated in a clinical trial to compare the ulcer-healing effect of colloidal bismuth subcitrate (CBS) at standard dosage, administered either twice daily (Group A) or four times a day (Group B). Endoscopic control was programmed at Week 4 and Week 8, in case of delayed healing. With an 'intention to treat' analysis, the healing percentage at four weeks was 69.6 for Group A and 82.1 for Group B (IC95 of percentage difference: -0.049 to 2.29). At Week 8, the healing percentage for Groups A and B was 87.5 and 94.6 per cent respectively (IC95: -0.05 to 0.19). The mean steady-state values of bismuth levels in plasma were well below the threshold value of 50 micrograms/l. The data confirm the efficacy and acceptability of CBS swallowing formulation tablets and suggest that administration twice daily is an acceptable alternative to the qid schedule.

Adult

Gastric antisecretory and cytoprotective activity of MDL 646, a 16-methyl-16-methoxy prostaglandin E1 analog in man.

MDL 646 is a 16-methyl-16-methoxy PGE analog with gastric antisecretory and cytoprotective activity in rats following oral administration. The efficacy of MDL 646 in inhibiting pentagastrin-stimulated acid secretion in man was investigated in a pilot crossover study in 10 male subjects given single oral doses of 500-1,000 mcg of the compound or placebo in randomized order. The doses showing consistent antisecretory effects in all subjects were 800 and 1,000 mcg, which caused a reduction in acid output of at least 25% over the whole test period (2.5 h), with greater inhibition in the first hour. The cytoprotective activity of MDL 646 was investigated by measuring the ability of single oral doses of 500 mcg of compound to prevent the drop in gastric potential difference (PD) induced by aspirin. The study was carried out in 8 male subjects given MDL 646 or placebo in randomized order in accordance with a single-blind crossover design. MDL 646 prevented the aspirin-induced drop in PD: No adverse reactions or changes in bowel habits were reported in either study. The compound is worth investigating further as a potential anti-ulcer agent.

Administration, Oral

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 natural history of peptic ulcer disease: the influence of H2-antagonist treatment.

Little is known about the natural history of peptic ulcer disease. Its active phase tends to last about 15 years with a high frequency of complications (in 20-25% of cases) and recurrences after initial healing, although subsequently these problems are reduced. Until the advent of the H2 blockers, therapy (whether medical or surgical) failed to alter the course of the disease. Peptic ulcer disease, however, appears to respond positively to therapy with H2 blockers, inasmuch as these drugs at relatively low doses induce rapid healing of the ulcer in a high percentage of patients, while subsequent maintenance treatment at lower doses helps prevent recurrences and complications throughout the entire administration period. In so doing, H2 blockers improve the patients' quality of life.

Cimetidine

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 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

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