Comparison of pantoprazole versus omeprazole in the treatment of acute duodenal ulceration—a multicentre study

Methods: In this randomized, double-blind, multicentre study, the proton pump inhibitors pantoprazole and omeprazole were compared in patients with active duodenal ulcers. Two hundred and seventy-six protocol-correct patients received either pantoprazole 40 mg (n= 185) or omeprazole 20 mg (n= 91), once daily for 2 or 4 weeks, depending on the progress of ulcer healing. Results: Rates of complete ulcer healing after 2 weeks were 71% in patients given pantoprazole and 74% in patients given omeprazole. After 4 weeks the figures were 96% and 91%, respectively. These differences were not significant. There was no significant difference in ulcer pain prior to treatment, and 85% of the pantoprazole group and 86% on omeprazole were pain-free after 2 weeks (not significant). The time until complete pain relief with pantoprazole or omeprazole, based on data from diary cards, was not significantly different (P < 0.05, Uleman's U-test). Both treatments were equally well tolerated. Changes in routine laboratory parameters were minimal in both groups. Conclusion: Pantoprazole was shown to be a highly-effective and well-tolerated treatment for acute duodenal ulcer. Pantoprazole 40 mg and omeprazole 20 mg were equally effective with respect to ulcer healing and pain relief, and have similar adverse event profiles.     

Omeprazole versus famotidine in the short-term treatment of duodenal ulcer disease

The efficacy and safety of omeprazole, in 241 patients with active recurrent duodenal ulcer from 21 Italian centres, was studied in a multicentre double-blind randomized trial comparing 20 mg omeprazole o.m. or 40 mg famotidine nocte with endoscopic examination, symptom recording, laboratory screening and gastrin assay. In a per protocol analysis, the duodenal ulcer healing rates for omeprazole and famotidine, documented by endoscopy, were 62% (68/109) and 33% (39/117) after 2 weeks of treatment (P less than 0.001), 92% (96/104) and 80% (86/108) cumulative after 4 weeks (P less than 0.05), and 99% (102/103) and 92% (96/104) after 6 weeks (P less than 0.05), respectively. The results of this trial demonstrate that 20 mg omeprazole o.m. is superior to 40 mg famotidine nocte in duodenal ulcer healing.     

Effective treatment after failure of omeprazole plus amoxycillin to eradicate Helicobacter pylori infection in peptic ulcer disease

Methods: Fifty patients with relapsing or complicated Helicobacter pylori positive duodenal (n= 41) or gastric ulcer disease (n= 9) and failure of a combined treatment with omeprazole plus amoxycillin to eradicate H. pylori infection were re-treated with either oral triple therapy (bismuth subsalicylate, metronidazole, tetracycline) plus ranitidine [group I: n= 22] or high-dose omeprazole (40 mg b.d. to t.d.s.) plus amoxycillin (1 g t.d.s.) [group II: n= 28]. Results: Patients of group I and II had similar demographic and clinical characteristics. The overall proportion of eradication of H. pylori infection was 81.8% in group I and 78.6% in group II (P= N.S.) as judged from negative bacterial findings by means of an urease test, specific culture and histology after modified Giemsa stain. Ulcer healing was observed in all patients after a maximum duration of 10 weeks. Ten patients on triple therapy and only one patient on omeprazole plus amoxycillin (45.5%vs. 3.6%; P < 0.001) complained of side effects without necessity of discontinuation of the study medication in either group. Twenty patients (group I: n= 10: group II: n= 10) with relapsing duodenal ulcer disease and successful cure were prospectively followed for one year without any evidence of ulcer relapse or H. pylori re-infection. Conclusion: Oral triple therapy plus ranitidine or highdose omeprazole plus amoxycillin remain highly effective in eradicating H. pylori infection in patients with peptic ulcer disease and treatment failure of omeprazole/amoxycillin, but the omeprazole enhanced antibiotic monotherapy seems to be superior with regard to side effects. Thus, high-dose omeprazole/amoxycillin is recommended as the treatment of first choice in these selected patients. Triple therapy should be reserved for patients intolerant of amoxycillin     

Does 40 mg omeprazole daily offer additional benefit over 20 mg daily in patients requiring more than 4 weeks of treatment for symptomatic reflux oesophagitis?

This study was designed to establish whether 40 mg omeprazole once daily exhibits sufficient additional efficacy over that of 20 mg omeprazole once daily in patients with symptomatic reflux oesophagitis requiring more than an initial 4-week course of 20 mg omeprazole once daily (o.m.) to warrant routine use of the higher dose. Three hundred and thirteen patients were randomized to receive either 20 mg omeprazole (4 weeks) then 20 mg (second 4 weeks if not both healed and symptom-free after 4 weeks), or 20 mg omeprazole (4 weeks) then 40 mg omeprazole o.m. (second 4 weeks). One hundred and twenty-seven patients were healed and symptom-free after 4 weeks and left the study at that point. Taking the second treatment period in isolation, the healing rate (64%vs. 45%, P < 0.02) and relief of heartburn (72%vs. 60%, P < 0.002) were greater among patients receiving 40 mg omeprazole o.m., demonstrating the existence of a dose–response relationship for omeprazole. However, on completion, there were no significant differences between the patients randomized to the 20/20 mg (healed 65%, asymptomatic 69%) or the 20/40 mg (healed 74%, asymptomatic 74%: both not significant differences compared with 20/20 mg) regimens. The magnitude of the difference in efficacy between 20 and 40 mg omeprazole in symptomatic reflux oesophagitis is insufficient to warrant the routine use of 40 mg in patients requiring more than 4 weeks' treatment with 20 mg omeprazole o.m.; continued treatment with 20 mg omeprazole for 4–8 weeks is the preferred option.     

Lansoprazole: A Comprehensive Review

Lansoprazole is the second member of the substituted benzimidazole class of antisecretory agents approved for use in the United States. These drugs decrease parietal cell acid secretion by inhibiting H⁺,K⁺-adenosine triphosphatase, the final step in the secretion of acid. Lansoprazole has been studied extensively for the short-term treatment of duodenal and gastric ulcers, reflux esophagitis, and Helicobacter pylori-positive peptic ulcer disease; long-term treatment of Zollinger-Ellison syndrome; and maintenance treatment of erosive esophagitis. A dosage of 30 mg/day produced higher healing rates and equivalent or faster relief of ulcer symptoms than ranitidine or famotidine in patients with duodenal or gastric ulcers and reflux esophagitis. Compared with omeprazole 20 mg/day, that dosage provided faster epigastric pain relief in these patients after 1 week, although healing rates for the two agents were equivalent at 4 and 8 weeks. In patients with peptic ulcer refractory to 8-week therapy with histamine₂-receptor antagonists, healing rates were not significantly different between lansoprazole and omeprazole. In patients with Zollinger-Ellison syndrome, lansoprazole was superior to histamine₂-receptor antagonists and was similar in efficacy, safety, and duration of action to omeprazole. Combinations of lansoprazole or omeprazole with one or two antibiotics produced equivalent eradication of H. pylori. In clinical trials, lansoprazole was well tolerated, with frequency of adverse effects similar to that reported with ranitidine, famotidine, and omeprazole.     

Symptomatic and endoscopic duodenal ulcer relapse rates 12 months following Helicobacter pylori eradication treatment with omeprazole and amoxycillin with or without metronidazole

Aim: To determine the effect of Helicobacter pylori eradication with omeprazole and amoxycillin, with or without metronidazole, on the 12-month course of duodenal ulcer disease. Methods: In a randomized, double-blind study, conducted in 19 hospitals, 105 H. pylori positive duodenal ulcer patients were healed and symptom-free following either omeprazole dual therapy (omeprazole 40 mg o.m.+amoxycillin 500 mg t.d.s., OA, eradication rate 46%, n=52) or omeprazole triple therapy (omeprazole 40 mg o.m.+amoxycillin 500 mg t.d.s.+metronidazole 400 mg t.d.s., OAM, eradication rate 92%, n=53) for 2 weeks, followed by 2 weeks of omeprazole 20 mg o.m. and a 12-month untreated follow-up period, after which time all patients were endoscoped. Endoscopic and symptomatic relapse rates, and effect on H. pylori status measured using ¹³C-urea breath test, were determined. Results: During the 12-month untreated follow-up period, the life-table endoscopic relapse rates were 12% (95% CI: 2–22%) and 2% (95% CI: 0–6%) for OA and OAM patients, respectively. By 12 months, life-table symptomatic relapse rates were 22% (95% CI: 13–37%) and 19% (95% CI: 8–30%) for OA and OAM, respectively. In the 12 months untreated follow-up period, 2/69 (3%, 95% CI: 0–7%) patients rendered H. pylori negative had an endoscopic relapse at the end of the 12-month follow-up period, compared with 5/31 (16%, 95% CI: 3–29%) patients remaining H. pylori positive (P=0.03 between H. pylori positive and negative groups). Twelve of 69 (17%, 95% CI: 8–26%) patients rendered H. pylori negative relapsed symptomatically, compared with 9/31 (29%, 95% CI: 13–45%) patients remaining H. pylori positive (P= N.S. between groups). There was a significant improvement in epigastric pain (P=0.0001), nausea and vomiting (P<0.05) between entry to the study and 1, 6 and 12 months post-treatment for both treatment groups. Conclusions: OAM eradicates H. pylori in significantly more patients than OA, but successful H. pylori eradication with either OAM or OA predisposes to low endoscopic and symptomatic relapse rates for duodenal ulcer patients when followed up for 12 months.     

Eradication of Helicobacter pylori and prevention of recurrence of duodenal ulcer: a randomized, double-blind, multi-centre trial of omeprazole with or without clarithromycin

Background: Antimicrobial treatment for Helicobacter pylori eradication is currently recommended for all patients with duodenal ulcer disease, but consensus on the best treatment is lacking. Methods: Patients with active duodenal ulcer and H. pylori were enrolled in a double-blind, randomized, placebo-controlled multi-centre study. Patients received omeprazole 40 mg daily for 28 days and either clarithromycin 500 mg t.d.s. or placebo t.d.s. for the first 14 days. Patients underwent endoscopy before starting treatment, at 2 weeks, immediately after stopping treatment if unhealed at 2 weeks, and at 1, 6 and 12 months after the end of treatment, or at the recurrence of symptoms. Eradication of H. pylori, duodenal ulcer healing and ulcer recurrence were measured. Results: One-hundred and fifty-four patients were recruited and randomized to omeprazole plus clarithromycin (n= 74) or to omeprazole plus placebo (n= 80). One month after treatment, H. pylori was eradicated in 57 of 69 (83%; 95% CI: 72–91%) patients receiving omeprazole plus clarithromycin, compared with 1 of 75 (1%; 95% CI: 0–7%) receiving omeprazole alone (P < 0.001). In patients receiving omeprazole plus clarithromycin the ulcer healed at 2 weeks in 83% (95% CI: 71–91%) and at 4 weeks in 100% (95% CI: 95–100%), compared with 77% (95% CI: 66–86%) and 97% (95% CI: 91–100%) in those given omeprazole plus placebo (N.S.). Ulcers recurred at 12 months in 6% (95% CI: 1–16%) of patients given omeprazole plus clarithromycin, compared with 76% (95% CI: 63–86%) of patients given omeprazole plus placebo (P < 0.001). The incidence of side-effects was similar in both treatment groups (38% with clarithromycin dual therapy and 29% with omeprazole plus placebo; P= 0.304). Ninety per cent of patients took at least 90% of their prescribed medication. Conclusions: Omeprazole plus clarithromycin dual therapy eradicated H. pylori in 83% of patients with duodenal ulcer and significantly decreased 12-month recurrence from 76% to 6%.     

泮托拉唑治疗十二指肠溃疡的系统评价

目的:评价泮托拉唑治疗十二指肠溃疡的临床疗效和安全性。方法:检索泮托拉唑与其他H2受体拮抗剂治疗十二指肠溃疡的临床随机对照研究,筛选符合纳入标准临床研究,应用Juni评分法进行评价,运用RevMan 5.0软件对相关数据进行Meta分析。结果:根据标准筛选出21篇文献,Meta分析结果显示:泮托拉唑与雷尼替丁治疗十二指肠溃疡的2周溃疡愈合率:OR=3.11,95%CI=(2.46,3.94),(P<0.05);4周溃疡愈合率:OR=5.72,95%CI=(4.16,7.85),(P<0.05);泮托拉唑与法莫替丁治疗十二指肠溃疡的4周溃疡愈合率:OR=4.70,95%CI=(1.96,11.28),(P<0.05);泮托拉唑与西咪替丁治疗十二指肠溃疡的4周溃疡愈合率:OR=3.80,95%CI=(1.89,7.65),(P<0.05)。在不良反应发生率方面差异无显著性。结论:与雷尼替丁﹑法莫替丁﹑西咪替丁相比较,泮托拉唑具有起效迅速、临床症状缓解快、溃疡愈合率高等优点,是治疗十二指肠溃疡的优选方案。     

Short report: treatment of Helicobacter pylori-associated duodenal ulcer with omeprazole plus antibiotics

Omeprazole heals most duodenal ulcers after 4 weeks of treatment but relapse is common. Eradication of Helicobacter pylori is associated with reduced rate of ulcer relapse. This study investigates the effect of omeprazole with antibiotics in H. pylori-associated duodenal ulceration. Forty-three patients with endoscopically proven duodenal ulcer and H. pylori entered this study. Treatment consisted of 20 mg omeprazole daily (four weeks) and seven days (first week) treatment with 400 mg metronidazole t.d.s. and 500 mg tetracycline t.d.s. Four weeks after completing the treatment, 81 % (35143) had a healed duodenal ulcer, and 58% (25/43) had H. pylori eradication. In those who healed, at one year 21 remained H. pylori-negative, 12 had persistent H. pylori infection and 2 had re-infection. The ulcer relapse rate at one year was 26%: of the 9 who relapsed, 6 had persistent infection, 2 were re-infected, and only 1 was H. pylori-negative. This combination therapy of antibiotics with omeprazole successfully eradicates Helicobacter pylori and has a lower ulcer replase than omeprazole alone.     

Single night-time doses of 40 mg famotidine or 800 mg cimetidine in the treatment of duodenal ulcer

Famotidine (40 mg) and 800 mg cimetidine as single night-time doses were compared in a randomized, double-blind, multicentre study of acute treatment for duodenal ulceration. Fifteen centres recruited 304 patients into the study. Of these, 274 were included for analysis, with 136 receiving famotidine and 138 receiving cimetidine. After 4 weeks, 75% of the patients who received famotidine and 77% of the patients who received cimetidine were healed. At 6 weeks the cumulative healing rates were 91% with famotidine and 87% with cimetidine. Differences between the groups were not significant at 4 or 6 weeks. No significant difference in healing rates between smokers and non-smokers was found. Day and night pain resolved rapidly in both groups. Both treatments were well-tolerated; adverse events were reported in 17 patients on famotidine and 18 on cimetidine, with headache the most frequent event in both groups. Famotidine is effective and well-tolerated in the short-term treatment of duodenal ulcer.     

奥美拉唑治疗消化性溃疡的剂量与疗程分析

目的分析研究奥美拉唑对消化性溃疡的治疗剂量与疗程和疗效。方法将90例消化性溃疡患者随机分为两组,A组45例,用奥美拉唑20mg/d,治疗十二指肠溃疡4周,胃溃疡6周;B组45例用奥美拉唑40mg/d,治疗十二指肠溃疡2周,胃溃疡3周;两组患者均同时服用甲硝唑400mg,克拉霉素250mg,均2次/d。结果十二指肠溃疡的愈合率两组分别为84%和84%,胃溃疡的愈合率两组分别为85%和85%;十二指肠溃疡的总有效率两组分别为96%和96%,胃溃疡的总有效率两组均为100%,在愈合率与总有效率方面无明显差异。说明用奥美拉唑20mg/d,治疗时间要长,用奥美拉唑40mg/d,治疗时间则短,无论采取哪种方法,该药对消化性溃疡的治疗效果都是令人满意的。结论奥关拉唑对消化性溃疡的治疗效果是显著的,该药是质子泵抑制剂,能很好地抗胃酸分泌,迅速缓解症状,促进消化性溃疡的愈合。     

Does eradication of Helicobacter pylori alone heal duodenal ulcers?

BACKGROUND: Eradication of Helicobacter pylori infection prevents duodenal ulcer (DU) relapse, but it remains uncertain whether eradication of H. pylori alone heals duodenal ulceration. AIM: To test the hypothesis that eradication of H. pylori infection is accompanied by healing of duodenal ulcer. METHODS: A total of 115 consecutive patients with endoscopically confirmed H. pylori-infected duodenal ulcer were randomly assigned to one of two groups. Group BTC patients received a 1-week course of colloidal bismuth subcitrate 220 mg b.d., tinidazole 500 mg b.d., clarithromycin 250 mg b.d. Group OBTC patients received omeprazole 20 mg daily for 4 weeks with the BTC regimen during the first week. Endoscopy with antral biopsies and 13C-urea breath test (UBT) were performed before and 4 weeks after completion of the 7-day triple or quadruple therapy. RESULTS: Eight patients dropped out (four in BTC and four in OBTC). Duodenal ulcer healing rates on an intention-to-treat basis in BTC and OBTC were 86% (95% CI: 77-95%) and 90% (95% CI: 82-98%), respectively. The eradication rates of H. pylori on an intention-to-treat basis in BTC and OBTC were 88% (95% CI: 79-96%) and 91% (95% CI: 84-99%), respectively. There were no statistically significant differences in ulcer healing rates and eradication rates between these two groups (P > 0.05). Epigastric pain resolved more rapidly in patients assigned to OBTC compared with those assigned to BTC. Both of the two regimens were well tolerated with only minor side-effects (3% of the 115 patients) and the compliance was good. CONCLUSIONS: BTC is a very effective H. pylori eradication regimen. Almost all duodenal ulcers heal spontaneously after cure of H. pylori infection using a 1-week low-dose bismuth-based triple therapy. Treating duodenal ulcer with simultaneous administration of omeprazole achieves ulcer pain relief more rapidly.     

Omeprazole and sucralfate in the treatment of NSAID-induced gastric and duodenal ulcer

Aim:

To establish the healing efficacy of two drugs, omeprazole and sucralfate, when given to patients who had developed gastric or duodenal ulcer while undergoing chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs).

Methods:

Ninety-eight patients with arthritis or arthrosis and NSAID-related gastric or duodenal ulcer were admitted to the endoscopic, single-blind study. They were randomized to receive either omeprazole 20 mg o.m. or sucralfate 2 g b.d. for 4–8 weeks. The patients continued to receive the same NSAID during the trial. Upper gastrointestinal endoscopy was performed at entry and after 4 or 8 weeks.

Results:

Eighty-eight patients completed the 4-week study, but only 81 were available for final analysis at 8 weeks. Omeprazole was significantly superior to sucralfate in inducing gastric ulcer healing after both 4 (87 vs. 52%, P = 0.007) and 8 weeks (100 vs. 82%, P = 0.04). No statistically significant difference in duodenal ulcer healing rates emerged between the two groups either at 4 (79 vs. 55%) or 8 weeks (95 vs. 73%). The healing rates in patients with combined gastric and duodenal ulcer were 67 vs. 33% after 4 weeks and 67 vs. 67% after 8 weeks of treatment. The percentages of asymptomatic patients were similar in the two treatment groups both at 4 (70 vs. 73%) and 8 weeks (70 vs. 75%). H. pylori infection did not influence healing rates, but significantly more H. pylori-positive patients healed with omeprazole.

Conclusions:

The results of this study show that omeprazole is superior to sucralfate in healing NSAID-induced gastroduodenal ulcer in patients who continue to take anti-inflammatory drugs. The good results observed were unrelated to H. pylori status.

     

Short report: high-dose omeprazole and amoxycillin in the treatment of Helicobacter pylori-associated duodenal ulcer

Thirteen consecutive patients with active duodenal ulcer disease were assigned to a treatment schedule with high-dose omeprazole and amoxycillin. Duodenal ulcer was diagnosed endoscopically in all patients, at which time antral biopsies were taken for culture and histology. All were positive for Helicobacter pylori and histological gastritis. Treatment was for 2 weeks: 80 mg omeprazole daily plus 500 mg amoxycillin syrup t.d.s. in the first week, followed by 40 mg omeprazole daily in the second week. Repeat gastroscopy was performed 4 weeks after completion of treatment in all patients. Duodenal ulcer healing occurred in 4/13 patients. H. pylori eradication was achieved in 2/4 patients with healed ulcers and in 3/9 patients with persistent ulceration. This study suggests that a short period of treatment with high-dose omeprazole and amoxycillin achieves low rates of ulcer healing and H. pylori eradication.     

奥美拉唑与法莫替丁治疗十二指肠溃疡疗效的荟萃分析

目的:评价奥美拉唑和法莫替丁治疗十二指肠溃疡的临床疗效和安全性。方法:检索中国知网(CNKI)、维普资讯网(VIP)、中国生物医学文献数据库(CBM)、PubMed、EMBase、the Cochrane Library数据库1990-2011年的相关文献,收集奥美拉唑与法莫替丁治疗十二指肠溃疡的随机对照临床研究。筛选符合纳入标准的临床研究,应用Juni评分法进行评价。以RevMan 5.0软件对相关数据进行荟萃(Meta)分析,采用漏斗图分析发表偏倚。结果:根据标准筛选出11篇文献:3篇C级,2篇B级,6篇A级。荟萃分析结果显示:奥美拉唑治疗十二指肠溃疡的2周愈合率OR=4.26,95%CI=(2.87,6.33),P<0.05;4周愈合率OR=2.62,95%CI=(1.87,3.67),P<0.05。两种药物导致的药品不良反应发生率无显著性差异。结论:与法莫替丁相比,奥美拉唑具有起效迅速和溃疡愈合率高的优点,是治疗十二指肠溃疡的优选药物。     

The DU-MACH study: eradication of Helicobacter pylori and ulcer healing in patients with acute duodenal ulcer using omeprazole based triple therapy

AIM: To investigate the efficacy of two omeprazole triple therapies for the eradication of Helicobacter pylori, ulcer healing and ulcer relapse during a 6-month treatment-free period in patients with active duodenal ulcer. METHODS: This was a double-blind, randomized study in 15 centres across Canada. Patients (n = 149) were randomized to omeprazole 20 mg once daily (O) or one of two 1-week b. d. eradication regimens: omeprazole 20 mg, metronidazole 400 mg and clarithromycin 250 mg (OMC) or omeprazole 20 mg, amoxycillin 1000 mg and clarithromycin 500 mg (OAC). All patients were treated for three additional weeks with omeprazole 20 mg once daily. Ulcer healing was assessed by endoscopy after 4 weeks of study therapy. H. pylori eradication was determined by a 13C-urea breath test and histology, performed at pre-entry, at 4 weeks after the end of all therapy and at 6 months. RESULTS: The intention-to-treat (intention-to-treat) analysis contained 146 patients and the per protocol (per protocol) analysis, 114 patients. The eradication rates were (intention-to-treat/per protocol): OMC-85% and 92%, OAC-78% and 87% and O-0% (O). Ulcer healing (intention-to-treat) was greater than 90% in all groups. The differences in the eradication and relapse rates between O vs. OMC and O vs. OAC were statistically significant (all, P < 0.001). Treatment was well tolerated and compliance was high. CONCLUSION: The OMC and OAC 1-week treatment regimens are safe and effective for eradication, healing and the prevention of relapse in duodenal ulcer patients.     

Pantoprazole versus omeprazole in the treatment of acute gastric ulcers

Background: Pantoprazole is a new substituted benzimidazole which is a potent inhibitor of gastric acid secretion by its action upon H⁺,K⁺-ATPase. Methods: The proton pump inhibitors pantoprazole and omeprazole were compared in a randomized, doubleblind study in 219 patients with benign gastric ulcers. Patients received either pantoprazole 40 mg (n= 146) or omeprazole 20 mg (n= 73), once daily before breakfast for 4 weeks. Treatment was extended for a further 4 weeks if the ulcer had not healed. Results: After 4 weeks, complete ulcer healing was seen in 88% of protocol-correct patients given pantoprazole and in 77% given omeprazole (between-group difference P < 0.05). At 8 weeks, the corresponding values were 97% and 96% (not significant). In the comparative intention-to-treat analysis there were no statistical differences between the treatment groups. Among the patients who had ulcer pain prior to treatment, 79% of the pantoprazole group and 68% of the omeprazole group were pain-free after 2 weeks, and after 4 weeks 88% and 81%, respectively (not significant). Pronounced improvement in the other gastrointestinal symptoms was seen in both groups. Only 10% of patients in each group reported adverse events. There were moderate increases in fasting serum gastrin levels with both treatments at 4 and 8 weeks. Conclusion: Pantoprazole, 40 mg once daily in the morning, is a highly effective, well tolerated treatment for acute, benign gastric ulcer. Pantoprazole and omeprazole were equally safe in the therapy of gastric ulcer.     

Pantoprazole and omeprazole in the treatment of reflux oesophagitis: a European multicentre study

Background: Pantoprazole is a new substituted benzimidazole which inhibits gastric H⁺,K⁺-ATPase. Methods: In this double-blind, multicentre study, pantoprazole 40 mg once daily was compared with omeprazole 20 mg once daily in the treatment of grade II and III (Savary–Miller) reflux oesophagitis. Endoscopy was repeated after 4 weeks of treatment, and also after 8 weeks in patients unhealed at 4 weeks. Results: The primary efficacy variable was ulcer healing; after 4 weeks, 81/103 (78.6%) patients in the pantoprazole group and 83/105 (79.0%) patients in the omeprazole group had healed completely. After 8 weeks, the cumulative healing rates were 94.2% and 91.4 % in the pantoprazole and omeprazole groups, respectively (P > 0.05 at 4 weeks and 8 weeks). Both groups experienced rapid relief of the key symptoms: heartburn, acid regurgitation and pain on swallowing. The time course of relief of the individual symptoms was similar in both groups after 2 and 4 weeks (P > 0.05). Both treatments were well tolerated, with only three patients withdrawing owing to adverse events. Conclusion: Pantoprazole has been shown to be as effective as omeprazole in the treatment of reflux oesophagitis.     

Comparison between single morning and bedtime doses of 40 mg famotidine for the treatment of duodenal ulcer

The aim of this study was to compare the duodenal ulcer healing effects of morning (08.00 hours) vs. single bedtime (22.00 hours) doses of 40 mg famotidine, bearing in mind that the known efficacy of bedtime doses of H2-antagonists is regarded as evidence of the predominance of nocturnal gastric acidity in the pathogenesis of duodenal ulcer. This randomized double-blind multicentre trial was conducted in a total of 127 patients with endoscopically proven active duodenal ulcer. Nine patients dropped out and thus 118 were included in the final analysis. The duration of treatment was 4 weeks, and this was extended to 8 weeks in patients whose ulcers failed to heal by week 4. The patients in the two treatment groups were well matched for age and sex. The therapeutic efficacy parameters were endoscopic healing of the ulcer lesion and disappearance of pain. Results were compared using the chi-square method. The 4- and 8-week (cumulative) ulcer healing rates in the patients treated with the morning dose of famotidine were 77.2% and 86%, respectively, compared with 78.6% and 91.8% in those who received the bedtime dose. The differences failed to prove statistically significant either at week 4 (P = 0.85) or at week 8 (P = 0.31). The percentages of patients with ulcer pain, evaluated weekly, were similar in the two treatment groups. The equivalent efficacy of the morning and bedtime famotidine regimens raises doubts concerning the predominance of nocturnal gastric acidity in the pathogenesis of duodenal ulcer.     

A multicentre, randomized, double-blind study comparing nocte famotidine or ranitidine for the treatment of active duodenal ulceration

The efficacy and safety of famotidine and ranitidine in the treatment of active duodenal ulcer were compared in a multicentre, randomized, double-blind study. The study was carried out in five centres which included a total of 143 patients with endoscopically documented active duodenal ulcer. The patients received either famotidine (one tablet of 40 mg at night) or ranitidine (two tablets of 150 mg at night). Endoscopic examinations were performed at 4 and 6 weeks of active treatment. Daytime and nocturnal pain were also monitored, and the laboratory and clinical profiles evaluated. One hundred and thirty-three patients fulfilled the evaluation criteria (66 patients in the famotidine group and 67 in the ranitidine group). Healing rates at 4 or 6 weeks of treatment showed no significant differences between the famotidine and ranitidine groups. The healing rates were 80% at week 4 and 97% at week 6 in the famotidine group, and 77% at week 4 and 96% at week 6 in the ranitidine group. Similar results were observed in both treatment groups with regard to pain resolution, decrease in antacid intake and safety profile.