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Biomedical subjects

B Simon

Publications and source records attributed to B Simon.

At least 217 records · Page 12Linked to original sources
PubMed1987

Famotidine once-a-day in the therapy of acute, benign gastric ulcer: a worldwide experience.

Three hundred thirty-six patients with endoscopically diagnosed benign gastric ulcers, randomly allocated to treatment with 40 mg famotidine at night or placebo, were evaluated in a double-blind multicenter trial conducted in 14 countries worldwide. After 4 weeks, 294 patients qualified for a "per protocol" analysis. Complete ulcer healing was observed in 70 of 149 patients (47%) treated with famotidine 40 mg at night and in 45 of 145 patients (31%) receiving placebo. Cumulative healing rates at 6 weeks were 65 and 46%, and at 8 weeks 80 and 54%, respectively. There were statistically significant differences between the healing rates at each time point (p less than 0.01). The famotidine treatment was significantly more effective at rapidly reducing the incidence of ulcer-related symptoms. Adverse side effects reported were minor and equally distributed between the two groups. The results of this trial show that 40 mg famotidine administered at night is significantly superior to placebo in both accelerating the healing of benign gastric ulcers and in relieving ulcer symptoms. Since 40 mg famotidine administered at night suppresses exclusively nocturnal acid secretion, these findings support the hypothesis that this factor is also of particular importance in the pathogenesis of gastric ulcers.

Acute Disease↗
PubMed1987

What are the current possibilities in treating peptic ulcer disease?

There are two major principles of ulcer therapy. Today, the most widely accepted drugs are those which substantially reduce aggressive factors (i.c. acid and pepsin), namely histamine H2-receptor antagonists, antimuscarinics and antacids. Less frequently applied are mucoprotective agents like colloidal bismuth compounds and sucralfate. Prostaglandins both reduce acid secretion substantially and are believed to enhance mucosal resistance. Their anti-ulcer efficacy, however, is solely explicable by their antisecretory activity. Although mucosa-strengthening agents and H2-receptor blockers have nearly identical healing rates, mucosa-strengthening agents have inconvenient dosage regimens (four times or twice daily) and are probably less effective in relieving pain. The same holds true for antacids. Prostaglandins, antimuscarinics and antacids have dose related side effects. In contrast, H2-receptor blockers are characterized by a clear mechanism of action, convenient dosage regimens, good tolerance and a low incidence of side-effects. H2-receptor antagonists are the most effective anti-ulcer drugs presently available.

Anti-Ulcer Agents↗
PubMed1987

Selective inhibition of endothelium-dependent dilation in resistance-sized vessels in vivo.

In vivo experiments were performed in autoperfused hindlimbs of rabbits to investigate the role of endothelium-mediated vasomotion in resistance-sized vessels. The flow responses to the vasodilators acetylcholine (ACh), ATP, and substance P (SP), all of which have been shown to act in an endothelium-dependent manner in large conduit arteries, were studied before and after exposure of the hindleg vasculature to gossypol (a potent inhibitor of endothelium-mediated vasodilation in vitro). The flow responses to adenosine (ADO), nitroglycerin (GTN), and prostaglandin E2 (PGE2), which induce relaxation by a direct effect on vascular smooth muscle, were tested in the same manner. All vasodilators induced dose-dependent increases in femoral flow up to two- to threefold when administered intra-arterially. After gossypol, the flow responses to the endothelium-dependent compounds (ACh, ATP, and SP) were severely reduced (by 88 +/- 3%, P less than 0.01) or sometimes were converted to constrictions (ATP). The flow increases induced by ADO, PGE2, and GTN remained largely unaffected. Sham treatment (gossypol solute only), exposure to indomethacin (10 microM), and ganglionic blockade had no differential effect on the flow responses. The selective action of gossypol in suppressing the flow responses to the endothelium-dependent compounds ACh, ATP, and SP is consistent with a vasomotor role for endothelial cells in resistance-sized vessels in vivo.

Adrenergic beta-Antagonists↗
PubMed1987

Famotidine: proven once-a-day treatment for gastric ulcer.

An 8-week, double-blind, randomized, placebo-controlled, multinational (n = 14), multicenter (n = 44) trial was conducted to determine whether famotidine speeds healing and relief of symptoms in patients with benign gastric ulcer. Of the 336 patients who entered the trial, 167 received 40 mg of famotidine in the evening, and 169 received placebo. At 4, 6, and 8 weeks after entry, ulcers had healed in a significantly (P less than 0.01) higher percentage of famotidine-treated patients than in those treated with placebo (47%, 65%, 80% versus 31%, 46%, 54%, respectively). Famotidine was also superior to placebo in relieving ulcer symptoms; the proportion of patients receiving additional antacid therapy was significantly lower in the famotidine group. The findings show that the new H2-receptor antagonist famotidine, administered as a single evening dose, significantly speeds the healing of benign gastric ulcers and that it is a safe and highly effective treatment of gastric ulceration. The convenient dosage regimen of famotidine (one tablet in the evening) should improve patient compliance, which, in turn, may result in faster healing of ulcers and a lower incidence of ulcer complications.

Adult↗
PubMed1987

The 24-hour acid suppression profile of nizatidine.

To determine the antisecretory potency of bedtime doses of the new thiazole H2-receptor antagonist nizatidine in the suppression of nocturnal acid secretion, this randomized, cross-over, single-blind study was performed in 10 healthy male subjects. The actions of a single bedtime (2100 h) dose of the H2-receptor antagonist nizatidine (150 mg and 300 mg), ranitidine (300 mg), cimetidine (800 mg), and famotidine (40 mg), as well as placebo on nocturnal gastric acid and volume secretion (2400 to 0600 h) and on overall 24 h H+-ion concentration were studied. Compared with placebo, night-time (2300 to 0700 h) H+ ion concentration was reduced by 70, 79, 95, 75, and 89% (p less than 0.05 to p less than 0.01). Nocturnal acid secretion, too, was significantly lower for the H2-blockers than for placebo (p less than 0.01). A significant reduction in total night-time gastric volume secretion was observed (p less than 0.01). Nizatidine 300 mg nocte, ranitidine, cimetidine and famotidine had no significant carry-over effects on daytime acidity (0800 to 1800 h). No significant pharmacodynamic differences between nizatidine 300 mg nocte, ranitidine 300 mg nocte, cimetidine 800 mg nocte and famotidine 40 mg nocte were observed. Thus, it may be concluded that these four H2-blockers will be equally effective in accelerating peptic ulcer healing and pain relief.

Adult↗
PubMed1987

300 mg nizatidine at night versus 300 mg ranitidine at night in patients with duodenal ulcer. A multicentre trial in Europe.

Patients (859) from six countries were randomized into an endoscopically controlled double-blind trial. The objective of this study was to compare the efficacy and safety of nizatidine 300 mg nocte with ranitidine 300 mg nocte in the therapy of duodenal ulceration. Patients fulfilling the entry criteria and completing the protocol numbered 777 (388 nizatidine, 389 ranitidine). Endoscopy was performed on entry and at 4-week intervals (up to 8 weeks) until the ulcer healed, except in Germany where endoscopy was also performed after 14 days. Both groups appeared well matched for population demographics, duodenal ulcer history, previous therapy and pre-study symptomatology. Overall healing rates in the nizatidine group compared favourably with the ranitidine group at 4 weeks (nizatidine 81%, ranitidine 80%) and 8 weeks (nizatidine 92%, ranitidine 93%). Data from Germany alone showed similar ulcer healing rates after 2 weeks therapy (nizatidine 60%, ranitidine 64%). Although there were no differences between or within the treatment groups, overall ulcer healing was significantly impaired (p less than 0.05 or less) in patients with a large ulcer (greater than 15 mm), a family history of peptic ulcer disease, verified disease or greater than 5 years duration, or heavy smokers (greater than 20 cigarettes/day). Age did not influence healing. Overall healing rates were significantly influenced by country of patient origin, being higher in Germany, and lower in Belgium (p less than 0.001). After 2 weeks therapy, about 60% of the nizatidine and ranitidine treated patients were pain free, while 4 weeks therapy was associated with relief of all symptoms in 72% of patients and relief of night pain in more than 90%. Antacid consumption reduced at a similar rapid rate during the study. Events were reported equally in both treatment groups, events compatible with peptic ulcer disease predominating. Events associated with study termination appeared related to documented disease or protocol violations. Monitoring of laboratory data suggested no significant haematological or biochemical abnormalities in the nizatidine group. Nizatidine 300 mg nocte appears to be as effective as ranitidine 300 mg nocte in both ulcer healing and symptomatic response.

Adult↗
PubMed1987

Nizatidine versus ranitidine in gastric ulcer disease. A European multicentre trial.

Two hundred and seventy five patients from six countries were randomized into an endoscopically controlled, eight-week, double-blind, study. The objective of this investigation was to compare the efficacy and safety of nizatidine, administered as either a single (300 mg nocte) or twice daily (150 mg B.D.) dose, with ranitidine 150 mg twice daily, in the therapy of benign gastric ulceration. Two hundred and fifty-two patients fulfilled entry criteria and completed the protocol (80 nizatidine 150 mg B.D.; 89 nizatidine 300 mg nocte; 83 ranitidine 150 mg B.D.). Endoscopy was performed on entry and at four-week intervals until the ulcer healed. The diagnosis of benign ulceration was always supported by endoscopic histology and/or cytology. On entry into the study, both groups appeared well matched (i.e. for population demographics, duodenal ulcer history, previous therapy and pre-study symptomatology), except for epigastric day pain which was significantly less in the ranitidine group (p = 0.020). Overall gastric ulcer healing rates were similar in the three groups at four weeks (nizatidine B.D. 66.2%: nizatidine nocte 65.2%: ranitidine B.D. 63%) and at eight weeks (nizatidine B.D. 90%: nizatidine nocte 86.5%: ranitidine B.D. 86.7%). Healing was not consistently influenced by country of origin or smoking. After four weeks of therapy, 66% (nocte dose) to 68% (B.D. dose) of nizatidine treated patients were symptom free, while 93% (nocte dose) to 95% (B.D. dose) were free of night pain. Events were similar in the three treatment groups, and the majority were gastro-intestinal.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1987

[H2 receptor antagonists in the therapy of peptic ulcer disease].

Today histamine-H2-receptor antagonists are the most intensively investigated drugs in the therapy of acid related diseases. They are characterized by a clear mechanism of action, a convenient application form, a high tolerability, a low incidence of side effects, and a large therapeutic window. The single nocturnal dosage regimen of H2-blockers follows the concept to reduce substantially night time acidity only, which is believed to play a decisive pathogenetic role in peptic ulcer disease, while during day time physiological acid secretion remains unaffected. The clinical efficacy of this application form has been well documented in the healing and symptomatic relief of acute peptic ulcers. However, about 30% of patients still suffer from ulcer pain after a 2 weeks treatment period. A more flexible dosage regimen, which is more adapted to the ulcer symptoms of the patient will probably lead to even better clinical results.

Anti-Ulcer Agents↗
PubMed1987

[Omeprazole in the therapy of acid-induced diseases].

Omeprazole is a substituted benzimidazole which inhibits profoundly and long-lasting human acid secretion. The maximum inhibition effect of omeprazole begins after 3-5 days treatment. Even after 28 days application no significant rebound effects were seen after withdrawal from the medication. Omeprazole was clinically tested on several thousand patients. The daily doses of 20 mg to 60 mg in cases of duodenal ulcer led to healing rates of 60-100% after 14 days. In direct comparative studies omeprazole was superior in cases of duodenal ulcers to cimetidine and ranitidine. With regard to gastric ulcers identical successful results were seen with 20 mg omeprazole daily as with 2 X 150 mg ranitidine daily. Omeprazole was also superior to H2-blockers in the treatment of erosive reflux-oesophagitis. Results from long-term therapy with the exception of Zollinger-Ellison syndrome are not yet available. In the clinical studies, omeprazole proved to be well tolerated. Its definite place in the management of peptic ulcer disease, however, remains to clearly established.

Clinical Trials as Topic↗
PubMed1987

[Drug therapy of peptic ulcer. What is coming up?].

Prostaglandin-E analogues inhibit gastric acid secretion after oral administration. Therefore, these drugs are tested in clinical trials and one of them--Misoprostol--has recently been registered. With regard to healing rate of peptic ulcers and improvement of clinical signs and symptoms the prostaglandin analogues are superior to placebo but only equally effective or even slightly inferior to H2-receptor blockers. Side effects such as diarrhea or uterotropic actions will probably limit their broad application. The exact therapeutic effectiveness of prostaglandin analogues in treatment of peptic ulcer remains to be evaluated in greater detail. The substituted benzimidazole omeprazole is the first drug which exerts a long lasting and almost complete suppressive effect on gastric acid secretion in humans. This unique inhibition leads to a significant and more rapid healing rate of duodenal ulcers compared to treatment with H2-blockers. Additionally, peptic ulcers resistant to H2-blocker therapy can be treated effectively with omeprazole. In spite of these promising results the exact therapeutic effectiveness of this drug requires further evaluation.

Alprostadil↗
PubMed1987

[Therapy and prevention of peptic lesions by prostaglandins].

Prostaglandin-E-analogues inhibit gastric acid secretion after oral administration. Therefore, these drugs are tested in clinical trials and two of them- misoprostol and rosaprostol-has recently been registered. With regard to healing rate of peptic ulcer and improvement of clinical signs and symptoms the prostaglandin analogues are superior to placebo but only equally effective or even slightly inferior to H2-receptor blockers. The relapse rates following successful therapy with prostaglandin analogues are similar to that with H2-blockers. Side effects such as diarrhea or uterotropic actions will probably limit their broad application. The exact therapeutic effectiveness of prostaglandin analogues in treatment of peptic ulcer remains to be evaluated in greater detail. As in the treatment of peptic ulcer disease prostaglandin-analogues are only effective in preventing NOSAC-induced peptic lesions when given in antisecretory doses.

Alprostadil↗
PubMed1987

An alprostadil analogue and human gastric secretion. A double-blind placebo-controlled study of the effects of a tablet and lyovial formulation.

The effects of single doses of 800 micrograms and 1200 micrograms of the new alprostadil analogue (prostaglandin E1 16-methyl-16-methoxy derivative) MDL 646, presented as tablet and lyovial formulations, on basal and pentagastrin-stimulated gastric acid secretion, were studied in 10 normal male volunteers using a randomised, double-blind placebo-controlled cross-over design. Compared to placebo, both doses of MDL 646 significantly decreased acid output during the basal and pentagastrin-stimulated periods. No difference between the tablet and lyovial formulations was found. Total basal output (tablet and lyovial data pooled) was reduced by 58% and 68% following 800 micrograms and 1200 micrograms MDL 646, respectively. Stimulated output was reduced to a lesser degree (15% and 27%). Inhibition of the stimulated acid secretion was observed up to 1.5 to 1.75 h after drug administration. Tolerance was good with only one subject reporting nocturnal abdominal pain following each dose of the drug and placebo.

Adult↗