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Biomedical subjects

B Simon

Publications and source records attributed to B Simon.

At least 235 records · Page 13Linked to original sources
PubMed1986

Comparative clinical trial of enprostil and ranitidine in the treatment of gastric ulcer.

In a randomized, double-bind, parallel, multi-clinic study, the safety and efficacy of enprostil (35 micrograms twice daily) and ranitidine (150 mg twice daily) were compared in the treatment of active gastric ulcer in 93 outpatients (47 enprostil-treated patients and 46 ranitidine). The two treatment groups were well matched for demographic characteristics. The healing rates in the enprostil group were 22, 58, 80, and 86 percent at two, four, six, and eight weeks, respectively. The corresponding rates in the ranitidine group were 22, 66, 84, and 89 percent. None of these differences was statistically significant. The area of the ulcer at baseline and smoking status did not appear to influence healing rates. There were no significant differences between treatment groups in time to relief of ulcer symptoms, frequency of daytime or nighttime ulcer pain, or antacid use. Side effects attributable to enprostil treatment were diarrhea (10 percent versus 6 percent with ranitidine), gastrointestinal pain, and vomiting. These side effects, however, did not influence the patients' assessments of their overall response to enprostil and ranitidine therapy. Six enprostil-treated patients and one ranitidine-treated patient withdrew from the trial prematurely because of adverse experiences. Monitoring of clinical laboratory test results showed no significant changes in the two treatment groups. This study demonstrates that a prostaglandin E2 analogue, enprostil, in a dose of 35 micrograms twice daily, is similarly safe and effective as ranitidine in the treatment of active gastric ulcer.

Adolescent↗
PubMed1986

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↗
PubMed1986

Effects of 800 mg cimetidine once daily on gastric acid secretion.

Today, the reduction of nocturnal acid secretion is believed to be the most important point in duodenal ulcer therapy. This is supported by the fact that during the day gastric acid secretion is largely buffered by meals. Moreover, independently of food intake the intragastric H+ activity during the day is lower than during the night. During nighttime (2300-0700 h) there was a mean hourly H+ activity of 38 mmol/l--that is, a 65% increase compared with daytime H+ activity with meals--and still a 30% increase without meals. Nocturnal acidity can be suppressed best by single large bedtime doses of H2-receptor antagonists. Cimetidine, 800 mg at night, reduces nocturnal intragastric acidity by 85%; 300 mg ranitidine at night and 40 mg famotidine at night reduce it by 95%. The first clinical trials show that a single nighttime dose of cimetidine or ranitidine is at least as effective in promoting ulcer healing as is twice daily administration.

Administration, Oral↗
PubMed1986

Nocturnal acid suppression with a new H2 receptor antagonist--nizatidine.

To determine the potential efficacy of bedtime doses of the new furan H2 receptor antagonist nizatidine in the suppression of nocturnal acid secretion, this randomized, crossover, single-blind study was performed in 10 healthy male subjects. The actions of a single bedtime (21:00 hour) dose of the H2 receptor antagonists nizatidine (150 mg and 300 mg), ranitidine (300 mg) and cimetidine (800 mg), as well as placebo on nocturnal gastric acid and volume secretion (01:00 to 07:00 hours, and on overall 24 hour H+ ion concentration were studied. Compared with placebo, night-time (23:00 to 07:00 hours) H+ ion concentration was reduced by 70, 79, 95, and 76% (p less than 0.05-p less than 0.01). Nocturnal acid secretion, too, was significantly lower for the H2 blockers than for placebo (p less than 0.05-p less than 0.01). A significant reduction in night-time gastric volume secretion was observed in the hourly intervals from 04:00 to 07:00 hours and in total volume in the whole 6 hours period (p less than 0.05-p less than 0.01). Nizatidine 300 mg nocte, ranitidine and cimetidine significantly decreased H+ concentration for only 1 hour (08:00 to 09:00 hours, p less than 0.05-p less than 0.01) during the subsequent daytime period (08:00 to 13:00 hours). Since no significant pharmacodynamic differences between nizatidine 300 mg nocte, cimetidine 800 mg nocte and ranitidine 300 mg nocte were observed, it may be concluded that at the doses employed, these three H2-blockers will all be similarly effective in the acute therapy of peptic ulcer disease.

Adult↗
PubMed1986

[The action of various doses of the new imidazole H2-receptor antagonist etintidine on intragastric acidity in man].

The chemical structure of etintidine differs from that of cimetidine by the addition of an ethinyl group to the terminal methyl group of the side chain. We investigated the influence of etintidine 300 or 400 mg b.d. and of etintidine 300 or 600 mg nocte, cimetidine 800 mg nocte versus placebo in two different double-blind randomized cross-over studies on 24-h intragastric acidity and nocturnal volume and acid secretion (12:00 midnight to 6:00 a.m.) in 12 and 8 healthy male volunteers, respectively. 5-10 ml of gastric contents were aspirated hourly via a nasogastric tube. The pH of the samples was determined using a glass electrode. The results were expressed in terms of H+-activity (mmol/l). Etintidine 300 or 400 mg b.d. reduced day- and nighttime acidity by 53 and 60% or 41 and 41%, respectively. Nocturnal acid secretion (mmol/l) was inhibited by 38 and 42%, resp. Etintidine 300 or 600 mg nocte and cimetidine 800 mg nocte (9:00 p.m.) lowered nocturnal intragastric acidity by 69, 84 and 79%, resp. Daytime inhibition was not observed. Our results suggest, that 1. etintidine 300 and 400 mg b.d. are equipotent in promoting peptic ulcer healing and 2. that this new imidazole H2-receptor antagonist is also effective in a single bedtime dose.

Adult↗
PubMed1986

[Acute injury to the gastric mucosa by acetylsalicylic acid. A comparative endoscopic study in man with oral prostaglandin analogs, omeprazole and ranitidine].

The deleterious effects of acetylsalicylic acid (ASA) on gastric mucosa have been well documented in experimental and clinical studies. With a direct endoscopic assay system we evaluated in healthy volunteers whether pretreatment with prostaglandin analogues (misoprostol, rioprostil), omeprazole and ranitidine prevented ASA-induced gastric mucosal injuries. Ranitidine (2 X 150 mg/d) in large antisecretory doses almost completely abolished these changes (p less than 0.05). By contrast, misoprostol (4 X 50 micrograms/d and 4 X 200 micrograms/d), rioprostil (3 X 100 micrograms/d), omeprazole (5 mg and 10 mg/d) as well as ranitidine in non-antisecretory doses (2 X 25 mg/d) did not reduce gastric mucosal injury after single-dose ASA administration. The results of this trial indicate that socalled cytoprotective doses of prostaglandins, omeprazole and ranitidine in contrast to animal findings are not effective in preventing acute ASA-induced mucosal damage.

Adult↗
PubMed1986

[Rioprostil 600 micrograms at night: marked inhibition of nocturnal intragastric acidity in man].

Antisecretory doses of prostaglandin analogues of the E1 and E2 series have been shown to promote peptic ulcer healing. In this double blind randomized cross-over study we investigated the effect of oral Rioprostil 300 micrograms b.i.d., 600 micrograms hs and placebo on 24 h intragastric H+ activity in 9 healthy male volunteers (age 20-37 years). 5-10 ml of gastric contents were aspirated hourly via a nasogastric tube. The pH of the samples was determined using a glass electrode . The results were expressed in terms of H+ activity (mmol/l). Night acidity (AUC/h, 2400-0800) is decreased by rioprostil in a dose related fashion (300 micrograms: 52%, 600 micrograms: 74%). The effect on day-time (0900-1800) H+ activity is much less. Rioprostil 300 micrograms given at breakfast reduce day-time acidity by 33%. Our results suggest that 600 micrograms Rioprostil in a single bedtime dose is effective in peptic ulcer treatment.

Adult↗
PubMed1986

[Enprostil in the acute treatment of duodenal ulcer: direct comparative study with pirenzepin].

In a randomized, endoscopically controlled double-blind trial the effectiveness of a twice daily dose of the prostaglandin E2-analogue enprostil was compared with pirenzepine given to 97 ambulatory patients with duodenal ulcers. Under 35 micrograms b.i.d. enprostil the ulcer healing rates after 2, 4 and 6 weeks averaged 41%, 82% and 92%. The corresponding values for pirenzepine were 44%, 72% and 89%. The differences were not statistically significant. Both drugs had a similar influence on the ulcer symptoms.

Acute Disease↗
PubMed1986

Prostaglandins and peptic ulcer disease: nocturnal administration of rioprostil vs ranitidine in duodenal ulcer healing.

Hypochlorhydria induced by potent antisecretory drugs is followed by a marked elevation of serum gastrin levels which leads to changes in ECL cell density in rats. "Soft" antiulcer drugs like prostaglandins do not increase gastrin levels. Their use in peptic ulcer disease seems to be mainly limited by a relatively high incidence of diarrhea and abdominal cramps. Rioprostil is a new prostaglandin E1 analogue. We compared the potency and duration of action of rioprosil 600 micrograms nocte with 300 micrograms bid on human gastric secretion in a placebo-controlled double-blind study. We further evaluated the clinical effectiveness of rioprostil 600 micrograms nocte in the acute treatment of duodenal ulcer. Nocturnal gastric acidity (24:00 to 08:00) was inhibited from 54.5 +/- 1.7 mmol H+/L (placebo experiments; n =9) to 26.7 +/- 3.5 mmol H+/L (52%) by rioprostil 300 micrograms bid (p less than 0.05) and to 14.4 +/- 3.8 mmol H+/L (74%) by rioprostil 600 micrograms nocte (p less than 0.05). During the daytime (09:00 to 18:00), H+ activity was reduced by 33% and 15% respectively (n.s.). Two hundred and three patients with endoscopically proven duodenal ulcers were randomly allocated to treatment with either rioprostil 600 micrograms nocte or ranitidine 300 mg nocte for 4 weeks in a prospective double-blind study. The two groups were similar. After 2 and 4 weeks treatment respectively, about 55% and 85% of patients healed on rioprostil 600 micrograms nocte and 55% and 90% on ranitidine 300 mg nocte. There were no differences between the treatment groups in ulcer pain relief.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1986

[Intragastric acidity under the prostaglandin E2 analog trimoprostil. Increased inhibitory effect through administration after meals].

In this double-blind cross-over study the effect of trimoprostil (trimethyldesoxyprostaglandin E2), an orally effective prostaglandin E2 analogue, on 24-h intragastric H+-activity, nocturnal acid output, nocturnal volume secretion and meal stimulated gastrin secretion was determined in 12 healthy male volunteers. On three different days the subjects received four times a day either placebo or 1.5 mg trimoprostil 30 min before or 30 min after meals. Trimoprostil administered before or after meals reduced 24-h intragastric acidity by 27.0 and 53.9%. Nocturnal acid output was inhibited by 32.7 and 55.6%. Nocturnal volume secretion and meal stimulated gastrin secretion remained unaffected. The study shows that the antisecretory activity is significantly increased when trimoprostil is given after meals.

Administration, Oral↗
PubMed1986

[A comparative gastroscopic study of lonazolac and indomethacin in healthy subjects].

In 9 healthy volunteers the effects of a 14-day treatment with lonazolac 300 mg b.i.d. on gastric and duodenal mucosa have been endoscopically compared with those of indomethacin 75 mg b.i.d. in a double-blind placebo-controlled trial. Lonazolac and indomethacin induced significantly more gastric and duodenal mucosal injuries (1.9 +/- 0.4 and 1.7 +/- 0.3) compared to placebo (0.9 +/- 1.0) (p less than 0.05). The validity of different procedures in predicting the deleterious effects of nonsteroidal antiinflammatory drugs on the human upper gastrointestinal epithelium is discussed.

Adult↗
PubMed1986

[Dose-dependent telenzepine inhibition of the secretion of human gastric acid stimulated by sham feeding and saliva].

The effect of graded doses of the new antimuscarinic agent telenzepine on human gastric secretion has been studied in a double-blind placebo-controlled trial in nine healthy volunteers. Over a period of 60 minutes basal acid output as well as acid response to sham feeding was examined. Telenzepine reduced dose-dependently basal acid secretion: This parameter was inhibited with 1 mg by 2%, with 2 mg by 37%, with 3 mg by 53% and with 5 mg by 76%, respectively. The corresponding values for stimulated acid secretion were 16%, 34%, 40% and 57%, respectively. The reduction of basal and stimulated acid secretion was statistically significant (p less than 0.05) following the two larger telenzepine doses. Production of saliva was inhibited by 9%, 21%, 28% and 48%, respectively. The latter reaching statistical significance (p less than 0.05).

Adult↗
PubMed1986

[Effect of FCE 20,700, an effective oral prostaglandin E2 analog on the human gastric mucosa epithelium].

In randomised double-blind crossover studies the effect of FCE 20700, an oral effective PG E2-analogue, has been evaluated on human gastric secretion, on the behaviour of transmucosal gastric potential difference against acetylsalicylic acid as well as on indomethacin-evoked mucosal lesions of stomach and duodenum in healthy volunteers. Single doses of 500 micrograms and 1500 micrograms FCE 20700 inhibited basal acid output without affecting pentagastrin maximally stimulated acid secretion. Both doses of this prostaglandin analogue prevented completely the drop in gastric potential difference brought about by 1000 mg acetylsalicylic acid. Concomitant administration of 250 micrograms t.i.d. and 750 micrograms t.i.d. FCE 20700 did not reduce the lesion score induced by 50 mg t.i.d. indomethacin over 6 days.

Administration, Oral↗
PubMed1986

[Gastroduodenal tolerability of indomethacin and acetaminophen. A comparative endoscopic study in healthy subjects].

The effect of a 5- and 10-day treatment with indometacin and acemetacin (Rantudil) on the gastroduodenal mucosa was endoscopically evaluated in 16 healthy volunteers. In a randomised double-blind cross-over fashion the volunteers received 50 mg t.i.d. indometacin as well as 60 mg t.i.d. acemetacin. Acemetacin evoked after 5 and 10 days significantly less gastroduodenal lesions than indometacin. Possible reasons for this apparently better tolerability of acemetacin in man are discussed.

Acetaminophen↗