YOU ARE NOW CONNECTED TO THE MEDLINE (1994 - 97) FILE. ==ZANTAC ALTERNATIVES== 1 AUTHOR Mills JG AUTHOR Koch KM AUTHOR Webster C AUTHOR Sirgo MA AUTHOR Fitzgerald K AUTHOR Wood JR TITLE The safety of ranitidine in over a decade of use. SOURCE Aliment Pharmacol Ther 1997 Feb;11(1):129-37 ABSTRACT BACKGROUND: Ranitidine hydrochloride (Zantac) is one of the most extensively studied and widely used drugs of all time. This has provided an excellent opportunity to define its safety profile. METHODS: Data from 189 controlled clinical trials in which more than 26,000 patients received daily doses of ranitidine for 4 weeks or more were reviewed. More than 80% of patients were treated with up to 300 mg ranitidine daily; the remaining patients received doses of up to 1200 mg daily. Eighty-seven trials were placebo controlled. Analyses of post-marketing surveillance and a database of all spontaneously reported adverse events were also evaluated. RESULTS: Overall in the clinical trial programme adverse events were reported by 20% of those receiving ranitidine compared with 27% of those receiving placebo. The pattern of events was similar in all treatment groups with no evidence of dose-related toxicity in regimens encompassing an eightfold range of therapeutic doses. Similarly in a programme of studies designed to evaluate a dose of ranitidine of 75 mg for non-prescription (over-the-counter) use in the treatment of heartburn, ranitidine was not associated with an adverse event profile distinct from that of placebo. Analysis of spontaneously reported adverse event data allowed identification of rare idiosyncratic events. CONCLUSIONS: Review of data from a large population of controlled clinical trials with analyses of postmarketing surveillance studies and spontaneously reported adverse events confirmed the excellent safety profile of ranitidine. 3 AUTHOR Stacey JH AUTHOR Miocevich ML AUTHOR Sacks GE TITLE The effect of ranitidine (as effervescent tablets) on the quality of life of GORD patients. SOURCE Br J Clin Pract 1996 Jun;50(4):190-4, 196 ABSTRACT Patients diagnosed as suffering from symptomatic reflux disease were entered into this comparative, multicentre study based in UK general practice. The study was designed to investigate the symptomatic response and quality of life of these GORD sufferers as they received ranitidine (Zantac effervescent tablets) over a four-week period. All patients initially received ranitidine 150 mg bd for two weeks. Subsequent treatment was allocated according to symptomatic response: responders remained on the initial dose for the remaining two weeks of the study, non-responders had their dosage increased to qds. Quality of life was assessed using the short-form 36 questionnaire (SF-36) both before and two and four weeks after treatment. The GORD sufferers had a significantly worse quality of life than a representative sample of the general population before treatment. After just four weeks of treatment with ranitidine, however, substantial improvements were observed in all domains of the SF-36, to the extent that the quality of life profile of the GORD sufferers became very similar to that of the general population and no significant differences were observed between the groups. 1 AUTHOR Conchillo A AUTHOR Mola C AUTHOR Navarro C AUTHOR Bravo L AUTHOR Bulbena O TITLE Cytoprotective and antisecretory activity of a ranitidine-zinc complex. SOURCE Prostaglandins Leukot Essent Fatty Acids 1995 Jun;52(6):393-7 ABSTRACT The effects of a ranitidine-zinc complex and ranitidine alone were compared in three different experimental models (pyloric ligation, ethanol and indomethacin) of gastric ulceration in the rat. In the pyloric ligation model, the ranitidine-zinc complex (50, 100 and 150 mg/kg p.o.) showed antiulcerogenic activity similar to that observed with equimolar doses of ranitidine (35, 70 and 105 mg/kg p.o.). Both the ranitidine-zinc complex and ranitidine significantly reduced (p < 0.05) gastric acid secretion in a dose-dependent manner. The protective effect of the ranitidine-zinc complex (100 and 150 mg/kg p.o.) against gastric damage developing after p.o. administration of absolute ethanol or indomethacin was enhanced (p < 0.05) with respect to that obtained with equimolar doses of ranitidine (70 and 105 mg/kg p.o.). The presence of zinc in the ranitidine-zinc complex does not interfere with the antisecretory effects of ranitidine on the gastric mucosa, while it confers an additional cytoprotective action to the final compound. YOU ARE NOW CONNECTED TO THE TOXLINE (1981 FORWARD, NON-ROYALTY) FILE. 6 AUTHOR Lorenzo MJV TITLE Zinc acexamate and ranitidine in the short- and mid-term management of gastroduodenal ulcers SOURCE Curr. Ther. Res.; VOL 39 ISS Jan 1986, P19-29, (REF 27) ABSTRACT IPA COPYRIGHT: ASHP A 3-phase study, with 100 initial patients, was undertaken to compare the effectiveness of zinc acexamate (I) to that of ranitidine (II) in the short- and mid-term treatment of gastroduodenal ulcers. In phase one, patients were randomly given either II 300 mg/day, or I in increasing dosages up to 1800 mg/day during 30 days. Endoscopically healed patients entered phase 2 and received 600 mg/day of I or 150 mg/day of II, respectively, for 6 months. Phase 3 is a 6 month follow up with no medication. A 59.5% healing rate was observed in the II group compared to 62% in the I group. These differences are not significant. Among the 14 patients from each group who have completed phase 3, 2 relapses occurred in the II group as opposed to one in the I group. After the 6 month follow up period, 6 more relapses were detected in the II group and 2 more in the I group. It was concluded that the study demonstrated an analogous effectiveness for II and I in the treatment of the acute gastroduodenal ulcer and in the maintenance therapy with a tendency in favor of I relative to relapse rates after treatment. 5 AUTHOR Johnsson F AUTHOR Roth Y AUTHOR Damgaard Pedersen NE AUTHOR Joelsson B TITLE Cimetidine improves GERD symptoms in patients selected by a validated GERD questionnaire. SOURCE Aliment Pharmacol Ther; VOL 7, ISS 1, 1993, P81-6 ABSTRACT A questionnaire was constructed and validated to improve the accuracy of symptom assessment in diagnosing gastro-oesophageal reflux disease (GERD). The GERD questionnaire consisted of four questions describing an upward moving, uncomfortable feeling in the chest frequently accompanied by retrosternal burning that is improved with antacids. It was found that if a patient answered yes to all four questions the likelihood was 85% that erosive oesophagitis would be detected on endoscopy or that pathological gastro-oesophageal reflux on 24-hour pH-monitoring would be documented, or both. The GERD questionnaire was used to identify 269 patients with probable GERD who after one week on placebo entered a 2-week double-blind placebo-controlled study which was completed by 251 patients. Cimetidine (400 mg) b.d. was given to 124 patients and placebo to 127 patients. On diary cards the patients noted the number, the mean duration and the mean severity of GERD symptoms episodes. Cimetidine was significantly superior to placebo in increasing the percentage of symptom-free days, and in reducing the median number of daily symptom episodes. This trial demonstrates that 400 mg cimetidine b.d. is effective in improving GERD symptoms in patients identified by a descriptive, validated GERD questionnaire. 6 AUTHOR Robinsen M AUTHOR Decktor DL AUTHOR Stone RC AUTHOR Pevelery M AUTHOR Barden P AUTHOR Moyer R AUTHOR Holt S AUTHOR Root J AUTHOR Hufnagel K AUTHOR Humphries TJ AUTHOR et al TITLE Famotidine (20 mg) b.d. relieves gastrooesophageal reflux symptoms in patients without erosive oesophagitis. Famotidine/GERD Investigation Group. SOURCE Aliment Pharmacol Ther; VOL 5, ISS 6, 1991, P631-43 ABSTRACT Previous clinical trials have evaluated a large number of symptomatic individuals with heartburn. Most studies have documented the need for multiple daily dosing with H2-antagonists to achieve clinical and statistical efficacy for symptom relief. The purpose of this study was to compare the safety profile and efficacy of famotidine oral dosing regimens, 40 mg nocte and 20 mg b.d. with placebo in the relief of symptoms in patients suffering from frequent heartburn found to have endoscopically normal oesophageal mucosa or mild non-erosive oesophagitis. Famotidine (20 mg) b.d. reduced and eventually completely relieved gastro-oesophageal reflux disease symptoms in most patients during the 6-week trial. Global assessment of improvement at 2 and 6 weeks indicated significantly greater improvement with a b.d. treatment regimen than with either a 40 mg nocte or placebo treatment. No statistically significant differences between famotidine and placebo in the number of patients who experienced clinical adverse experiences were noted and no serious adverse events attributable to famotidine occurred. Based upon these findings, patients with gastro-oesophageal reflux symptoms experience good relief of their complaints with twice daily famotidine in standard doses. 6 AUTHOR Brunner G AUTHOR Arnold R AUTHOR Hennig U AUTHOR Fuchs W TITLE An open trial of long-term therapy with lansoprazole in patients with peptic ulceration resistant to extended high-dose ranitidine treatment. SOURCE Aliment Pharmacol Ther; VOL 7 Suppl 1, 1993, P51-5, discussion 61-6 ABSTRACT Forty-two patients with peptic ulceration of the duodenum, stomach or oesophagus, who had not responded to 3 or more months of high-dose treatment with ranitidine (450 or 600 mg/day), were treated with oral lansoprazole at 30-60 mg daily. In 40 patients (95.2%) the ulcers healed within 2-12 weeks. In the remaining 2 patients healing took several months but eventually all ulcers healed. After healing, 40 patients underwent long-term maintenance treatment with 30-60 mg lansoprazole daily for 1-3 years (continuing). During maintenance therapy with lansoprazole, no endoscopically verified relapses occurred when the drug was taken regularly. In 1 patient treatment had to be discontinued because of a drug-related colitis that disappeared soon after treatment had been stopped. There were no significant changes in routine laboratory tests in any patient. Basal serum gastrin concentrations, which were already elevated by the previous high-dose ranitidine treatment (125 +/- 25 pg/ml), rose to four times the normal values after 4 weeks of treatment with lansoprazole (255 +/- 65 pg/ml). Thereafter no further increases in basal serum gastrin concentrations were observed, even after 3 years of administration. The volume density of argyrophilic cells in the oxyntic mucosa increased slightly during lansoprazole treatment; until now no dysplasia of the enterochromaffin-like cells has been observed. In conclusion, 30-60 mg lansoprazole daily healed ranitidine-resistant peptic ulcers, and subsequent maintenance therapy with 30-60 mg lansoprazole daily was found to be highly effective and safe over the time observed. 7 AUTHOR Scobie IN AUTHOR Saunders J AUTHOR Barnes GD AUTHOR Hoad J AUTHOR Riley AJ AUTHOR et al TITLE Comparative study of the effects of ranitidine and cimetidine on carbohydrate tolerance, growth hormone secretion and the hypothalamic-pituitary-gonadal axis in man SOURCE Curr. Med. Res. Opin.; VOL 10 ISS 5 1986, P285-290, (REF 24) ABSTRACT IPA COPYRIGHT: ASHP The effect of chronic oral administration of 1.0 g/day cimetidine (I) and 300 mg/day ranitidine (II) on plasma levels of prolactin, testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, sex hormone binding globulin and human growth hormone was compared in 2 groups of male patients with dyspeptic symptoms. Eight patients were treated with II and 9 with I for 4 wk. Cimetidine therapy resulted in a significant increase in plasma testosterone levels which was not found in the II group. No significant change occurred in the other hormones. There was no evidence of a significant alteration in carbohydrate metabolism. 11 AUTHOR Savarino V AUTHOR Giusti M AUTHOR Mansi C AUTHOR Marugo M AUTHOR Delitala G AUTHOR et al TITLE Ranitidine and testosterone secretion in man SOURCE Br. J. Clin. Pharmacol.; VOL 15 ISS May 1983, P578-579, (REF 7) ABSTRACT IPA COPYRIGHT: ASHP The effect of ranitidine, 150 mg twice daily for 4 weeks, on testosterone levels, was studied in 28 male duodenal ulcer patients. No effects on testosterone levels were observed. 7 AUTHOR Scobie IN AUTHOR Saunders J AUTHOR Barnes GD AUTHOR Hoad J AUTHOR Riley AJ AUTHOR et al TITLE Comparative study of the effects of ranitidine and cimetidine on carbohydrate tolerance, growth hormone secretion and the hypothalamic-pituitary-gonadal axis in man SOURCE Curr. Med. Res. Opin.; VOL 10 ISS 5 1986, P285-290, (REF 24) ABSTRACT IPA COPYRIGHT: ASHP The effect of chronic oral administration of 1.0 g/day cimetidine (I) and 300 mg/day ranitidine (II) on plasma levels of prolactin, testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, sex hormone binding globulin and human growth hormone was compared in 2 groups of male patients with dyspeptic symptoms. Eight patients were treated with II and 9 with I for 4 wk. Cimetidine therapy resulted in a significant increase in plasma testosterone levels which was not found in the II group. No significant change occurred in the other hormones. There was no evidence of a significant alteration in carbohydrate metabolism. 10 AUTHOR Wang C AUTHOR Wong KL AUTHOR Lam KC AUTHOR Lai CL TITLE Ranitidine does not affect gonadal function in man SOURCE Br. J. Clin. Pharmacol.; VOL 16 ISS Oct 1983, P430-432, (REF 11) ABSTRACT IPA COPYRIGHT: ASHP The effects of ranitidine (I), 150 mg twice daily for 3 months and 150 mg nightly for 9 months, and placebo on gonadal function were compared in 20 men with chronic duodenal ulcer. Similar to placebo, treatment with I did not influence basal serum concentrations of testosterone, luteinizing hormone, follicle stimulating hormone and prolactin. No significant changes were found in sperm concentration, motility or morphology. It was determined that I does not affect gonadal function in man. ABSTRACT We studied the effect of ranitidine on gonadal function in 20 male subjects with chronic duodenal ulcer. Eleven were treated with ranitidine 150 mg twice daily for 3 months and 150 mg at night for 9 months, nine with placebo for 3 months. Similar to placebo, treatment with ranitidine did not influence basal serum concentrations of testosterone (T), luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin (PRL). No significant changes were found in sperm concentration, motility or morphology. Ranitidine does not affect gonadal function in man.