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PubMedDate not supplied

Inhibition of peptic ulcer relapse by ranitidine and ecabet independently of eradication of Helicobacter pylori: a prospective, controlled study versus ranitidine.

BACKGROUND/AIMS: The recent increase in resistant strains of Helicobacter pylori has become a serious problem. Ecabet is a novel anti-ulcer agent that acts directly on the gastric mucosa, has bactericidal activity, and inhibits adhesion of Helicobacter pylori to the gastric mucosa. These actions result from inhibition of urease and ATPase in Helicobacter pylori, a mechanism distinct from that of antibiotics. METHODOLOGY: Sixty-three patients positive for Helicobacter pylori who had been cured of gastric ulcers and duodenal ulcers were randomly assigned to receive maintenance therapy with ranitidine alone or a combination of ranitidine and ecabet. Ulcer relapse was studied in these patients. RESULTS: The cumulative relapse rates in the ranitidine group and the ecabet plus ranitidine group were respectively, 29.6% and 4.4% after 1 year of treatment and 66.1% and 13.0%, after 2 years. These differences were significant (p = 0.006). Multivariate analysis of factors potentially related to relapse showed that outcome was significantly related only to treatment (p = 0.020) and not to other characteristics, such as age, diagnosis, or sex. CONCLUSIONS: We conclude that maintenance therapy with a combination of ranitidine and ecabet prevents ulcer relapse in Helicobacter pylori-positive patients. Controlled studies comparing ulcer relapse rates between eradication treatment and maintenance therapy with ranitidine and ecabet are awaited.

Abietanes↗
PubMed1989

[Nizatidine versus ranitidine in the treatment of acute duodenal ulcer. Comparison of 300 mg nizatidine and 300 mg ranitidine in a single evening dose].

In a double-blind, endoscopically controlled study on 367 duodenal ulcer patients, we compared the clinical efficacy of 300 mg ranitidine nocte with that of 300 mg nizatidine nocte, which is known to reliably provide selective inhibition of nocturnal acid secretion. Nizatidine was administered to 183, ranitidine to 184 patients. Endoscopy was performed at the start of the study, as well as at 2, 4 and 8 weeks. The presence of ulcer was defined as a benign lesion of the gastric mucosa measuring at least 5 mm in diameter; healing was characterized as complete reepithelialization. In the nizatidine group, as many as 76% of our patients were free from night pain at 2 weeks, and 88% at 4 weeks. Identical values were obtained in the group treated with 300 mg ranitidine nocte. The healing rates at 2, 4 and 8 weeks were comparable in the nizatidine and ranitidine groups (nizatidine: 57%, 87%, 92%, respectively; ranitidine: 63%, 90%, 96%, respectively). Clinically significant adverse effects were seen in neither of the two treatment groups. These results demonstrate that selective inhibition of nocturnal acid secretion achieves healing of duodenal ulcer and freedom from pain as rapidly and effectively as protracted inhibition of acid secretion provided by the administration of 300 mg ranitidine nocte.

Adolescent↗
PubMed1986

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↗
PubMed1993

Colloidal bismuth subcitrate, ranitidine, and ranitidine plus metronidazole in the treatment of duodenal ulcer and Helicobacter pylori infection: a controlled and prospective study.

A controlled, prospective clinical trial of colloidal bismuth subcitrate (CBS), ranitidine and ranitidine plus metronidazole for the treatment of duodenal ulcer (DU) is reported here, with evaluation of the possible pathogenic role of Helicobacter pylori (HP) on DU in a six-month follow-up. A total of 42 patients with active DU on endoscopy were randomly selected to receive oral CBS (300 mg 1 hour before each meal, and at bedtime, n = 16), ranitidine (150 mg bid; n = 12) or ranitidine (150mg b.i.d.) plus metronidazole (250 mg t.i.d; n = 14) treatment for one month. Ulcer healing was endoscopically evaluated. Healed patients received another two-week treatment; unhealed subjects received another one-month treatment with the same agents. Healed patients were followed endoscopically at 1, 3, and 6 months after the cessation of medication without maintenance therapy. Unhealed or relapsed subjects were excluded. To assess HP status, during each endoscopy two prepyloric mucosal biopsies were taken for urease testing and culture of HP. The prevalence of HP in patients with DU was 95.2%. Data showed that those treated with CBS had a lower DU healing rate than those treated with ranitidine or ranitidine plus metronidazole after the one-month treatment, but there was no statistical significance in the DU healing rates after the two-month treatment, and at follow-up six months after the cessation of medication. After one month of treatment those treated by CBS showed the highest rates of HP clearance on gastric antral mucosa among the three groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1985

Ranitidine versus ranitidine and prazepam in the short-term treatment of duodenal ulcer--a double-blind controlled trial.

Fifty out-patients with an active, endoscopically proven duodenal ulcer were entered a double-blind trial of ranitidine + prazepam or ranitidine + placebo. Two drop-outs occurred in the prazepam group and 1 in the placebo group. After 28 days of treatment, the ulcer had healed in 95.6% of the patients on ranitidine + prazepam and 75% of the patients on ranitidine + placebo (p = 0.03). Sleepiness was the most frequent side effect, reported by 8 subjects in the prazepam group and by 1 subject in the placebo group. It is concluded that prazepam can be usefully combined with ranitidine in the short-term treatment of duodenal ulcer.

Adult↗
PubMed2002

Development of a sensitive high-performance thin-layer chromatography method for estimation of ranitidine in urine and its application for bioequivalence decision for ranitidine tablet formulations.

A sensitive and simple HPTLC method was developed for estimation of ranitidine in human urine. The drug was extracted from urine after basification using dichloromethane. Dichloromethane extract was spotted on silica gel 60 F254 TLC plate and was developed in a mixture of ethyl acetate-methanol-ammonia (35:10:5 v/v) as the mobile phase and scanned at 320 nm. The RF value obtained for the drug was 0.67 +/- 0.03. The method was validated in terms of linearity (50-400 ng/spot), precision and accuracy. The average recovery of ranitidine from urine was 89.35%. The proposed method was applied to evaluate bioequivalence of two marketed ranitidine tablet formulations (150 mg, Formulation I and Formulation 2) using a crossover design by comparing urinary excretion data for unchanged ranitidine in six healthy volunteers. Various pharmacokinetic parameters like peak excretion rate [(dAU/dt)max], time for peak excretion rate (tmax), AUC0-24, AUC0-infinity, cumulative amount excreted were calculated for both formulations and subjected to statistical analysis. The relative bioavailability of Formulation 2 with respect to Formulation 1 was 93.76 and 95.31% on the basis of AUC0-24 and cumulative amount excreted, respectively. Statistical comparison of various pharmacokinetic parameters indicated that the two ranitidine tablet formulations are bioequivalent.

Area Under Curve↗
PubMed1996

Ranitidine bismuth citrate: a novel anti-ulcer agent with different physico-chemical characteristics and improved biological activity to a bismuth citrate-ranitidine admixture.

BACKGROUND: Ranitidine bismuth citrate (RBC) is a new chemical entity for the treatment of peptic ulcer disease. RESULTS: RBC is freely soluble in water (more than 600 mg/mL at pH 4.6), whereas an equimolar admixture of its component molecules, bismuth citrate and ranitidine, formed an almost totally insoluble suspension. Even at very low pH values (around 2.0), the solubility of bismuth in ranitidine bismuth citrate was at least two-fold better than in the admixture. Comparison of several physico-chemical characteristics indicated that RBC possessed significantly different melting point properties, X-ray powder diffraction patterns, infra-red spectra and 13C-NMR solid-state spectra to the admixture. Ranitidine bismuth citrate inhibited human pepsin isoenzymes 1, 2, 3 and 5 but the admixture was inactive. RBC showed approximately two-fold greater anti-Helicobacter pylori activity in vitro than the admixture (geometric mean minimum inhibitory concentrations of 12.5 and 25.7 mg/L, respectively) and was more rapidly bactericidal. In a mouse model of gastric H. pylori colonization, 200 mg/kg of bismuth, given as RBC, eradicated the organism from all mice while only 10% of infections were eradicated by equivalent levels of bismuth in admixture form. CONCLUSION: It is believed that the significantly greater solubility of RBC, especially at lower pH values, is highly relevant to its better antipepsin and anti-H. pylori action compared to the insoluble admixture of bismuth citrate and ranitidine.

Animals↗
PubMed2000

Ranitidine versus ranitidine plus octreotide in the treatment of acute non-variceal upper gastrointestinal bleeding: a prospective randomised study.

AIM: To compare the efficacy of ranitidine with that of ranitidine plus octreotide in the treatment of non-variceal upper gastrointestinal (UGI) bleeding. DESIGN: Prospective, randomised, open study. PATIENTS AND METHODS: Upper GI endoscopy was carried out during the first 24 hours in all patients with UGI bleeding who had been admitted within a period of 18 months. Patients with variceal bleeding, and those who had undergone any type of gastric operation, were excluded. Eighty-four patients (58 men and 26 women) aged 21-92 years (mean age: 61.2 +/- 15.0 SD) were included. Patients were randomised to receive ranitidine 50 mg tid intravenously alone (Group A: 44 patients, 29 men), or in combination with octreotide 100 micrograms tid subcutaneously, the second drug given for three days only (Group B: 40 patients, 29 men). The study end-points were discharge without operation, emergency surgical intervention or death. The number of blood units given and the days of hospitalization were also recorded. RESULTS: Aspirin and non-aspirin NSAID use before bleeding was reported by 16/44 (36%) patients in Group A and by 19/40 (47.5%) patients in Group B (p = 0.38, OR = 0.63, 95% CI = 0.26-1.51). The endoscopically detected pathology and bleeding stigmata did not differ between the groups (p = 0.86, p = 0.64, OR = 0.78, 95% CI = 0.3-1.99, respectively). Mean use of blood units (p = 0.16) and days of hospitalization (p = 0.25) did not differ. Three patients in Group A (6.8%) and three in Group B (7.5%) required surgical intervention (p = 1.0, OR = 1.1, 95% CI = 0.21-5.84). CONCLUSION: Ranitidine plus subcutaneous octreotide is not superior to ranitidine alone in the management of patients with acute non-variceal UGI bleeding.

Adult↗
PubMed1990

Combined effect of pirenzepine and ranitidine on the nocturnal intragastric pH in non-responders to ranitidine.

Both H2-receptor antagonists and pirenzepine are used in the treatment of peptic ulcer disease. Since we have recently found a higher frequency of non-responders to H2-receptor antagonists among cirrhotics, we tested the effect of the combination of 50 mg pirenzepine and 300 mg ranitidine in 25 patients (12 cirrhotics and 13 controls) in whom a normal 300 mg dose of ranitidine had failed to suppress intragastric acidity. Nocturnal intragastric pH was continuously monitored for 12 hours. A rise in the intragastric pH above 4.0 for more than 6 hours following the oral dose at 18.00 h was considered as response. In all subjects, plasma concentrations of ranitidine and pirenzepine were in the therapeutic range. Coadministration of pirenzepine and ranitidine resulted in sufficient increase of the intragastric pH in only 4 of the 12 patients with cirrhosis, and in 4 of the 13 control patients. This treatment failure in most of our patients does not support the view that excessive vagal drive might play an important role in the non-response to H2-blockers. With regard to the benefit resulting from coadministration of pirenzepine and ranitidine, there seems to be no difference between cirrhotic and control patients.

Adult↗
PubMed1988

Barrett's ulcer: response to standard dose ranitidine, high dose ranitidine, and omeprazole.

Between January 1984 and December 1986, 116 patients were found to have columnar-lined esophagus (Barrett's esophagus) during upper gastrointestinal endoscopy. Twenty-eight patients (16 men and 12 women) were found to have peptic ulcer of the esophagus (Barrett's ulcer). In 17 (60%), standard measures and ranitidine 300 mg daily resulted in healing. Two men with resistant ulcers were treated by surgical repair of their hiatus hernia. Nine (six men, three women) in whom healing failed to occur on this regimen after 3-15 months were treated with high dose ranitidine (300 mg bd). In five, healing was complete after 8 wk and one more healed after an additional 4 wk. The three patients with unhealed ulcers after high dose ranitidine received omeprazole 40 mg in the morning. In two of these, ulcers healed after 4 wk; in the third, one of two ulcers persisted after 8 wk, although the remaining ulcer was smaller and more superficial. Pain relief was good, but minor reflux symptoms persisted in both treatment groups. On completion of the study, patients received 300 mg ranitidine at night. Powerful acid-reducing regimens may be required to heal a proportion of Barrett's ulcers.

Barrett Esophagus↗
PubMed1985

Comparison between ranitidine and ranitidine plus Caved-S in the treatment of gastric ulceration.

In a double blind endoscopically controlled study, 100 patients with gastric ulcers were treated with either ranitidine or ranitidine plus Caved-S. On single therapy, 58% of ulcers were healed at four weeks, 92% at eight weeks and 96% at 12 weeks. Combination therapy did not alter the healing rate, nor improve on the control of dyspeptic symptoms. No difference in healing rate was found between good and poor drug compliance patients. This suggests that ranitidine may be equally effective at lower dosages. Thirty seven patients had developed their ulcer while taking non-steroidal anti-inflammatory drugs. These patients were mainly elderly women who had a higher risk of bleeding (p = 0.006) from a large ulcer (p = 0.009).

Aged↗
PubMed1986

A single-centre study of gastric ulcer healing with 300 mg ranitidine at night versus 150 mg ranitidine twice daily.

In a single-centre study 59 patients with gastric ulcer were treated either with 300 mg ranitidine at night or with 150 mg ranitidine twice daily. After 4 and 8 weeks 73% and 97%, respectively, of those treated with 300 mg at night and 59% and 86% of those treated with 150 mg twice daily had complete ulcer healing. These differences between the two groups were not statistically significant. No serious side effects were seen. Ranitidine, 300 mg at night, appears to be at least as effective as the standard 150 mg twice daily regimen in the treatment of gastric ulcer.

Adult↗
PubMed2004

Comparison of ranitidine bismuth citrate, tetracycline and metronidazole with ranitidine bismuth citrate and azithromycin for the eradication of Helicobacter pylori in patients resistant to PPI based triple therapy.

BACKGROUND/AIMS: Helicobacter pylori is the most common infectious disease all over the world. Ten to twenty percent of the patients remain infected despite treatment with proton pump inhibitors (PPIs), amoxicillin and clarithromycin. We compared PPI, bismuth, tetracycline and metronidazole with ranitidine bismuth citrate, tetracycline and metronidazole in cases resistant to PPIs-based triple therapies. METHODS: The study included 52 patients who underwent a triple therapy with PPI, clarithromycin and amoxicillin for 14 days between September 2001 and December 2002, and were found to be resistant to the therapy. They were randomized to take ranitidine bismuth citrate (Rb) 400 mg twice a day, tetracycline (T) 1 g twice a day and metronidazole (M) 500 mg three times a day for 14 days (RbTM), or ranitidine bismuth citrate (Rb) 400 mg twice a day for 14 days and azithromycin (A) 500 mg once a day for 7 days (RbA). Four weeks after the treatment, endoscopies were repeated, and patients were assessed with respect to changes in symptoms. When H. pylori was negative on histological analysis and urease test, eradication was achieved. RESULTS: A total of 52 patients, 32 females and 20 males with a mean age of 49+/-12 years, were included in the study. Eradication was achieved in 15 (28%) out of 52 patients in total. There was a significant difference between RbA and RbTM groups (p=0.01). In fact, H. pylori was eradicated in 3 (12%) out of 25 patients in the RbA group, whereas it was eradicated in 12 (44.4%) out of 27 patients in the RbTM group. Symptom scores significantly improved in both groups after the treatment, though there was not a significant difference between the groups (p=0.705). CONCLUSIONS: Triple therapy including azithromycin does not seem to be a good choice in cases resistant to the first line therapies; however, a similarly lower rate of eradication was achieved with the quadruple therapy proposed. Therefore, different treatment schemes should be applied in resistant patients, and further studies are needed as well.

Adult↗
PubMed1981

Investigations on the penetration of ranitidine into the cerebrospinal fluid and a comparison of the effects of ranitidine and cimetidine on male sex hormones.

Cerebrospinal fluid (CSF) ranitidine concentrations were measured in 13 normal subjects undergoing routine myelography following either one, or two doses ranitidine 200 mg. Small amounts of the drug were detectable in the CSF. A separate investigation of duodenal ulcer patients compared the effects of ranitidine 150 mg twice-daily and cimetidine 1 g daily on basal and stimulated levels of male reproductive hormones in the plasma. Although cimetidine treatment resulted in a small rise in basal and stimulated testosterone, neither drug was associated with significant changes in basal or stimulated hormone levels.

Adult↗
PubMed1994

[The effect of ranitidine and famotidine on the intragastric pH profile of healthy subjects. Randomized cross-over trial with ranitidine effervescent tablets (300 mg) versus famotidine film tablets (40 mg) ].

Influence of Ranitidine and Famotidine on the Intragastric pH-profile in Healthy Volunteers/Randomised cross-over study of ranitidine effervescent tablets (300 mg) versus famotidine film coated tablets (40 mg). A controlled cross-over trial was carried out to compare the duration of time until the onset of action and its intensity following administration of ranitidine (R, Sostril, CAS 76824-35-6) effervescent tablets (300 mg) and famotidine (F, CAS 76824-35-6) film coated tablets (40 mg). Twelve volunteers (4 female, 8 male) participated in the study. The efficacy of the test medications was assessed by pH-metry during 12 h. The evaluation of the measurements showed that a pH-value 3.5 was reached 100 s after administration of R and 3,392 s (56.5 min) after F (p < 0.01). The median pH-values were significantly higher after R during the first 2 h. The AUC-values (area under the curve; pH-time) for 1, 2 and 4 h were calculated by the trapezoid rule. The intake of R resulted in significantly higher areas than that of F. After reaching the pH-value of 3.5 this value remained stable during the complete period of measurement (R = 12 h, F = 11 h). The faster onset of pH-value elevation could correspond clinically with a faster onset of pain relief.

Adult↗
PubMed1993

Effectiveness of cisapride in gastric ulcer. Results of a double-blind randomized trial versus ranitidine and versus cisapride plus ranitidine.

Among the factors involved in the pathogenesis of gastric ulcer, the reduced clearing capacity of the stomach seems to play an important role. On this basis, cisapride, which improves gastrointestinal motility, enhances gastric emptying, and prevents duodenogastric reflux, may be effective in the treatment of the gastric ulcer. We randomly allocated 60 consecutive patients, with uncomplicated antral gastric ulcer (diameter 5-25 mm), into three groups of treatment: cisapride 20 mg b.i.d. (C), ranitidine 150 mg b.i.d. (R), cisapride 20 mg b.i.d. + ranitidine 150 mg b.i.d. (C+R). Endoscopic examination with biopsy specimens was performed on admission, after 4 weeks and (if ulcer not healed) after 8 weeks of therapy. Three patients were lost to follow-up (two in C and one in C+R), and three were withdrawn, due to malignant ulcer (one case in R) or to side effects (one case of diarrhea in C, one case of headache in C+R). Healing rates at 4 weeks were 41.1% in C, 52.6% in R, and 50.0% in C+R; at 8 weeks they were 88.2% in C, 89.4% in R, and 94.4% in C+R. Though the lack of a placebo arm makes final considerations difficult, the results were similar in all three groups, with no evident differences. In conclusion, therapy with cisapride appears as effective as H2-blocker alone or combined treatments in healing benign gastric ulcer.

Adult↗
PubMed1988

Inhibition by ranitidine of acetaminophen conjugation and its possible role in ranitidine potentiation of acetaminophen-induced hepatotoxicity.

Pretreatment with ranitidine (RA) potentiates the hepatotoxicity of acetaminophen (APAP) in male Fischer 344 rats. The present studies were undertaken to investigate the role of APAP metabolism in this potentiation. Administration of RA (50 mg/kg p.o.) to male Fischer 344 rats 30 min before [3H]APAP (750 mg/kg p.o.) increased the plasma concentrations of acetaminophen at 2 hr (193%) and 4 hr (277%) after APAP. Covalent binding of [3H]APAP-related material to hepatic macromolecules in RA-pretreated animals was similar to APAP alone values up to 12 hr after treatment; however, 24 hr after APAP, binding in the RA-pretreated animals was twice that observed in animals given [3H]APAP alone. Urinary excretion (0-24 hr) of APAP and APAP glucuronide were reduced in ranitidine-pretreated animals to 64 and 66% of control, respectively, indicating that in vivo RA altered APAP conjugation with glucuronic acid. APAP uridine diphosphoglucuronyltransferase activity in rat hepatic microsomes was competitively inhibited by RA (0.1-2 mM). The Ki apparent for RA inhibition of APAP uridine diphosphoglucuronyltransferase was 0.04 mM. In contrast, neither APAP nor 4-nitrophenol sulfotransferase activity in rat hepatic cytosol was inhibited by RA at concentrations up to 5 mM. Together, these results support the suggestion that RA-mediated alterations of APAP conjugation may explain the potentiation of APAP-induced hepatotoxicity by RA in rats.

Acetaminophen↗
PubMed1986

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↗