The efficacy of the third pump inhibitor--pantoprazole--in the short-term treatment of Chinese patients with duodenal ulcer.

BACKGROUND/AIMS: To study the efficacy and tolerability of pantoprazole 40 mg once daily before breakfast compared with ranitidine 300 mg once daily at bedtime in Chinese patients with duodenal ulcer, and to evaluate the relationship between Helicobacter pylori (H. pylori) clearance and ulcer healing rate. METHODOLOGY: A total of 160 patients (80 in each group) with endoscopically diagnosed, active duodenal ulcers were studied in this randomized double-blind trial. Endoscopy was performed after 2 weeks of treatment. If unhealed, then the patients were re-endoscoped after an additional 2 weeks of similar treatment. RESULTS: The healing rates after 2 and 4 weeks were 61.3% and 97.3%, respectively in the pantoprazole group, and 50.7% and 76.9% in the ranitidine group. The difference between the two groups was significant at 4 weeks (p < 0.01, per protocol analysis). The rate of pain free ulcer was higher in the pantoprazole group than in the ranitidine group at 2 weeks (84.2% vs. 59.6%, p < 0.01). Higher clearance of H. pylori was also observed in the pantoprazole group compared with the ranitidine group at 4 weeks (20% vs. 0%, p = 0.05). The healing rate tended to be higher in patients who were H. pylori-cleared at 2 weeks (p = 0.07) in the pantoprazole group. Both medications were well tolerated without any serious adverse effects. CONCLUSIONS: Pantoprazole 40 mg daily is superior to ranitidine 300 mg daily in the short-term treatment of acute duodenal ulcer in Chinese patients, in terms of ulcer healing and pain relief, and appears to be well-tolerated.     

A double-blind study of pantoprazole and ranitidine in treatment of acute duodenal ulcer

Pantoprazole is a new substituted benzimidazole, which is a potent inhibitor of gastric acid secretion by its inhibition of H⁺,K⁺-ATPase. Pantoprazole, 40 mg, was compared with the H₂-receptor antagonist ranitidine, 300 mg, in the healing of acute duodenal ulcer. Two hundred seventy-six patients with endoscopically diagnosed duodenal ulcer were studied in this multicenter double-blind study. Patients were reendoscopied after two weeks of treatment, and those patients whose ulcers remained unhealed were also endoscoped after an additional two weeks of treatment. The primary end point was the complete healing of the ulcer. Demographic characteristics were comparable in both treatment groups. After two weeks of treatment, 90/124 (73%) patients in the pantoprazole group had healed ulcers compared with 57/126 (45%) patients in the ranitidine group (P<0.001, per-protocol analysis). After four weeks, the cumulative healing rates were 92% and 84% in the pantoprazole and ranitidine groups, respectively (P=0.073). Symptoms were also improved at week 2, with 84% and 72% of patients in the pantoprazole and ranitidine groups, respectively, reporting no ulcer pain (P<0.05, per-protocol analysis). Both treatments were well tolerated. This study has confirmed the superiority of pantoprazole compared with ranitidine in the healing of duodenal ulcers and pain relief after two weeks of treatment and has shown pantoprazole to be well tolerated in this indication.This study was sponsored by Byk Gulden, D-78467 Konstanz, Germany.Members of the European Pantoprazole Study Group: Belgium—J. Belaiche, M. Cremer, G, Devis, and A. Elewaut; France—M. Amouretti, M.-A. Bigard, G. Bommelaer, J.-A. Chayvialle, J. Escourrou, Y. Le Quintrec, J.-C. Paris, P. Rampal, J. Sahel, and J.-P. Weill; Italy—F. De Berardinis, G. Delle Fave, M. Frezza, G. Marenco, F. Mazzeo, G. Minoli, A. Saggioro, and S. Vigneri; and The Netherlands—J. Beker, W. Driessen, C. Lamers, and D. Versluis.This work was presented as a poster at the symposium: Management of Acid-Related Diseases: Focus on Pantoprazole, held in Berlin, May 1993.     

潘托拉唑治疗消化性溃疡临床疗效观察

目的：研究潘托拉唑治疗消化性溃疡的疗效及安全性。方法：将经胃镜证实的消化性溃疡患者随机分成潘托拉唑组（治疗组,简称潘组）和奥美拉唑组（对照组,简称奥组）,其中潘组60例,应用潘托拉唑40mg,1次／d;奥组58例;应用败类美拉唑20mg,1次／d。十二指肠溃疡患者疗程4周,胃溃疡6周。停药后均复查胃镜观察溃疡愈合情况。治疗期间每周随访1次。并记录症状改善情况及不良反应。结果：十二指肠溃疡的愈合率两组分别为91．7％和94．7％,胃溃疡的愈合率两组分别为91．7％反应。结果十二指肠溃疡的愈合率两组分别为91．7％和94．7％,胃溃疡的愈合率两组分别为91．7％和90．0％,P值均＞0．05。各项症状的改善情况两组相仿（P＞0．05）。治疗期间,两组均有良好的耐受性。结论潘托拉唑对消化性溃疡有较高的治愈率和症状改善率。疗效与奥美拉唑相当,其不良反应很少,患者耐受性好,是一种有应用前景的质子泵抑制剂。     

Oral pantoprazole for erosive esophagitis: a placebo-controlled, randomized clinical trial. Pantoprazole US GERD Study Group

OBJECTIVES: The aim of this dose-response study was to compare the effectiveness of 10 mg, 20 mg, and 40 mg of pantoprazole with that of placebo tablets in the healing and symptom relief of gastroesophageal reflux disease associated with erosive esophagitis, and to determine the optimal dose. METHODS: A total of 603 patients with endoscopically confirmed (Hetzel-Dent scale) erosive esophagitis of grade 2 (64.5%) or grades 3 or 4 (35.3%) were enrolled in a double-blind, multicenter study and randomly assigned to receive pantoprazole (10 mg, 20 mg, or 40 mg) or placebo, administered once daily in the morning, for 4 or 8 wk depending on healing. RESULTS: The healing rates after 4 wk for placebo and pantoprazole 10 mg, 20 mg, and 40 mg/day were 14%, 42%, 55%, and 72%, respectively (p < 0.001 for all doses of pantoprazole vs placebo). Cumulative healing rates after 8 wk for placebo and pantoprazole 10 mg, 20 mg, and 40 mg/day were 33%, 59%, 78%, and 88%, respectively (p < 0.001 for all doses of pantoprazole vs placebo). The 40-mg pantoprazole dose produced greater rates of healing and earlier healing of esophagitis than either the 10- or 20-mg dose, regardless of severity. Pantoprazole, at any dose, was significantly more effective than placebo in relieving reflux symptoms. Patients on pantoprazole 40 mg experienced relief of symptoms on day 1 of treatment. No serious treatment-related adverse events occurred. CONCLUSIONS: Pantoprazole was safe and effective for healing erosive esophagitis and provided rapid symptomatic relief. These results indicate that pantoprazole offers a new option for treatment of erosive esophagitis. Among the three doses studied, the 40-mg dose was the most effective.     

40 mg pantoprazole and 40 mg esomeprazole are equivalent in the healing of esophageal lesions and relief from gastroesophageal reflux disease-related symptoms

BACKGROUND: Proton pump inhibitors are regarded as the most effective class of acid suppressive medication for gastroesophageal reflux disease treatment. There is considerable interest regarding the dose equivalence between various proton pump inhibitors. GOALS: To compare the efficacy of pantoprazole and esomeprazole with regard to healing and relief from gastroesophageal reflux disease-related symptoms. STUDY: Multicenter, randomized, double-blind study. Patients with gastroesophageal reflux disease grades B/C (Los Angeles classification) received 40 mg pantoprazole daily (n = 113) or 40 mg esomeprazole daily (n = 114). Healing (endoscopy) and relief from gastroesophageal reflux disease-related symptoms (direct questioning) were assessed at first and final visit (after 4, 6, 8, or 10 weeks of treatment). RESULTS: Overall healing in both treatment groups was 88% of patients (intention-to-treat population), 95% (pantoprazole), and 90% (esomeprazole) (per-protocol population); statistically, this indicates "at least equivalence" between treatments. Overall relief from gastroesophageal reflux disease-related symptoms was similar for pantoprazole (55%) and esomeprazole (51%, per-protoco). No correlation between healing and symptom relief was seen. The majority of reported adverse events were assessed as "not related" to the study drug. Pantoprazole and esomeprazole have comparably good safety and tolerability. CONCLUSION: In patients with gastroesophageal reflux disease, 40 mg pantoprazole daily and 40 mg esomeprazole daily are equally effective for healing of esophageal lesions and relieving gastroesophageal reflux disease-related symptoms.     

A double-blind,randomized comparison of omeprazole Multiple Unit Pellet System (MUPS) 20 mg,lansoprazole 30 mg and pantoprazole 40 mg in symptomatic reflux oesophagitis followed by 3 months of omeprazole MUPS maintenance treatment: a Dutch multicentre trial

BACKGROUND: Proton pump inhibitors (PPIs) have proved to be effective in treating reflux oesophagitis. Until now, no study had compared the PPIs omeprazole Multiple Unit Pellet System (MUPS), lansoprazole and pantoprazole in patients with reflux oesophagitis. AIM: To compare omeprazole MUPS 20 mg, lansoprazole 30 mg and pantoprazole 40 mg for treatment effect in symptomatic reflux oesophagitis. METHOD: Patients with grade I-IV symptomatic reflux oesophagitis were randomized to double-blind omeprazole 20 mg once morning, lansoprazole 30 mg o.m. or pantoprazole 40 mg o.m. Patient satisfaction and symptoms were evaluated after 4 and 8 weeks. Patients not satisfied after 8 weeks were treated for another 4 weeks with omeprazole 40 mg MUPS (open). Successful treatment was followed by 3 months' maintenance treatment with omeprazole MUPS 20 mg (patients satisfied after 4 or 8 weeks) or omeprazole MUPS 40 mg (patients satisfied after 12 weeks). RESULTS: On intention-to-treat (ITT) analysis (n = 461) at 4 and 8 weeks, respectively, 84% and 87% (omeprazole MUPS), 78% and 81% (lansoprazole), and 84% and 89% (pantoprazole) were free of heartburn. Equivalence was found between omeprazole MUPS and pantoprazole (heartburn relief), but not with lansoprazole. Patient satisfaction after 4 and 8 weeks, respectively, was 79% and 89% (omeprazole MUPS), 76% and 86% (lansoprazole), and 79% and 91% (pantoprazole). Patient satisfaction was similar in all treatment groups. During maintenance, 87% in the omeprazole MUPS 20 mg group and 81% in the omeprazole MUPS 40 mg group were satisfied after 3 months. CONCLUSIONS: Omeprazole MUPS 20 mg and pantoprazole 40 mg have equivalent efficacy in the treatment of reflux oesophagitis. Based on patient satisfaction, omeprazole MUPS 20 mg, lansoprazole 30 mg and pantoprazole 40 mg are equally effective.     

康复新液联合潘托拉唑治疗消化性溃疡疗效分析

目的研究康复新液与潘托拉唑联合治疗消化性溃疡（PU）的疗效。方法将经胃镜检查确诊的128例PU患者随机分为两组,治疗组65例,口服康复新液10ml每日3次,潘托拉唑40mg每日1次口服;对照组63例,口服潘托拉唑40mg每日1次。治疗期间每周1次随防,记录症状转归情况。疗程结束后,胃镜复查评估溃疡愈合情况。结果各项临床症状的改善和疼痛消失情况两组相比差异无显著性（P〉0.05）。PU的愈合率和总有效率治疗组为95.4%和98.5%。对照组为82.5%和87.3%,两组相比差异有显著性（P〈0.05）。两组在用药期间,不良反应少,均有良好的耐受性。结论康复新液联合潘托拉唑治疗PU可提高溃疡的愈合率和总有效率,缩短溃疡的愈合时间。     

Pantoprazole versus ranitidine in the treatment of duodenal ulcer: a multicenter study in Brazil

OBJECTIVE: The aim of this study was to compare the effectiveness and tolerance of pantoprazole versus ranitidine in the treatment of duodenal ulcers in the Brazilian population. METHODS: A total of 222 patients with active duodenal ulcers (DU) were randomly allocated to a double dummy blind treatment, either with ranitidine (RAN) 300 mg (111, aged from 20-68 yr old, 56 female) or with pantoprazole (PANT) 40 mg (111 patients, 18-70 yr old, 45 female). After a 2-wk course of treatment, each patient was clinically and endoscopically assessed for ulcer healing. Failure to heal required a further 2-wk course of treatment and a new evaluation thereafter. RESULTS: In all, 77 of the 103 patients in the PANT group (74.8%) and 42 of the 94 patients in the RAN group (44.7%) who completed the study had ulcer healing after one 2-wk treatment course, and an additional 23 in the PANT group (22.3%) and 28 in the RAN group (29.8%) after the second 2-wk treatment course, totaling 100 (97.1%) and 70 (74.5%), respectively. Therapeutic gain in favor of pantoprazole was significant both at the end of the first and the second 2-wk treatment course (p<0.001). At 2 wk, symptoms remission was significantly higher in the PANT group (97.6%) than with the RAN group (77.5%) (p<0.001). The Intention-to-treat analysis showed results statistically similar to those observed in the per-protocol analysis. Minor adverse events were reported by four patients in the PANT group and three in the RAN group. No relevant laboratory abnormalities were seen. No patient withdrew from the study due to adverse events. CONCLUSIONS: Our results show that pantoprazole is more effective than ranitidine in the treatment of duodenal ulcer providing faster ulcer healing in most patients (97.1%), in 4 wk. Adverse events were rare and were similar in both groups, and had no influence on the therapeutic outcome.     

Comparison of pantoprazole 20 mg to ranitidine 150 mg b.i.d. in the treatment of mild gastroesophageal reflux disease

BACKGROUND: Despite a high prevalence of mild gastroesophageal reflux disease (GERD), few studies investigated efficacy and safety of proton pump inhibitors in this indication. This randomized double-blind study compares pantoprazole to ranitidine in GERD 0 and I, i.e. reflux without esophagitis or with confined lesions only. METHODS: Patients received either pantoprazole 20 mg o.a.d. or ranitidine 150 mg b.i.d. Outcome was assessed after 2 and 4 weeks. Primary criterion was relief of leading symptoms, i.e. heartburn, acid eructation and pain on swallowing, after 4 weeks of treatment. RESULTS: According to the per-protocol (PP) analysis, 69% (100/144) and 80% (115/144) of patients in the pantoprazole group were relieved of leading symptoms after 2 and 4 weeks, respectively. The rates in the ranitidine group were 47% (62/133) and 65% (86/133). Thus, superiority of pantoprazole could be proven. Quality-of-life parameters improved more in the pantoprazole group and patients' assessment of treatment was more favorable. Analysis for Helicobacter pylori status showed infection to lead to higher symptom relief rates. Both study medications were well tolerated. CONCLUSION: Pantoprazole 20 mg demonstrated superior efficacy with faster relief of reflux symptoms and similar tolerability compared to ranitidine 150 mg in the treatment of mild GERD.     

泮托拉唑钠粉针剂治疗上消化道出血疗效观察

目的　评价泮托拉唑钠 (诺森 )粉针剂对消化性溃疡所致的上消化道出血的疗效和安全性 ,并与奥美拉唑 (洛赛克 )粉针剂作对照。方法　选择消化性溃疡出血患者 90例 ,泮托拉唑治疗组 60例 ,其中胃溃疡 (GU) 2 4例 ,十二指肠球部溃疡 (DU) 33例 ,糜烂性胃炎 3例。奥美拉唑对照组 30例 ,其中GU 9例 ,DU 1 6例 ,糜烂性胃炎 5例。治疗方法 :分别用泮托拉唑或奥美拉唑 80mg加入 5 %葡萄糖液 2 50ml内 ,静脉滴注 (30～ 60min) ,1次 /d ,共 5d。观察生命体征与出血情况的改变。结果　两组出血情况差异无显著性 (P >0 .0 5)。治疗后 3d内泮托拉唑组有 51例止血 (85 % ) ,奥美拉唑组有 2 4例止血 (80 % ) ;4～ 5d内止血分别为 7例 (1 1 .7% )和 5例 (1 6 .7% )。止血显效率 ,泮托拉唑组为 85 % ,奥美拉唑组为 80 % ,治疗总有效率两组均为 96 .7%。两组各有 1例出现恶心症状 ,不良反应发生率分别为1 .7%和 3 .4%。结论　泮托拉唑钠粉针剂是治疗消化性溃疡出血安全、有效的药物     

Cimetidine vs placebo in duodenal ulcer therapy

We studied the healing efficacy of cimetidine or placebo in 23 endoscopically proven duodenal ulcer outpatients in a randomized, controlled, prospective, double-blind trial. There were 11 patients in the cimetidine (1200 mg daily) treatment group and 12 patients in the placebo-treated group. No antacid was allowed, but a placebo antacid with no neutralizing capacity was given as needed for pain. The incidence of complete endoscopic healing at 2, 4, and 6 weeks was 54%, 63%, and 72% in the cimetidine-treated patients and 8%, 50%, and 67% in the placebo-treated patients. There was a statistically significant difference (P<0.05) in complete duodenal ulcer healing between both treatment groups after 2 weeks of therapy, but there was no significant difference at the 4- and 6-week observation periods. The incidence of complete pain relief at 2 and 4 weeks was 64% and 82% in the cimetidine-treated patients and 67% and 75% in the placebo-treated patients. At 6 weeks of treatment there was no increase in the number of patients with complete pain relief in either group. There was no significant difference between the two groups in the incidence of ulcer pain relief at any of the three observation periods. Duodenal ulcer healing rates and duodenal ulcer pain relief were compared at 2, 4, and 6 weeks. There was no statistical association between ulcer healing and complete pain relief in the placebo treatment group at the 2-week evaluation period, but there was statistical association (P<0.05) in the cimetidine treatment group at 2 weeks and both treatment groups at the 4- and 6-week evaluation periods. The results of this study demonstrate that in duodenal ulcer outpatients treated for 6 weeks: (1) cimetidine increases the incidence of duodenal ulcer healing during the first 2 weeks of treatment; (2) more than 50% of duodenal ulcers will spontaneously heal during a 4 to 6-week observation period which is not statistically modified by cimetidine treatment; (3) the complete relief of duodenal ulcer pain is not influenced by treatment with cimetidine when compared to placebo.     

Pantoprazole versus lansoprazole in French patients with reflux esophagitis

OBJECTIVES: The aim of this study was to compare the efficacy of pantoprazole 40 mg and lansoprazole 30 mg given for 4 to 8 weeks on endoscopic healing and symptom relief in grade II-III reflux esophagitis patients (according to Savary-Miller classification).METHODS: Four hundred and sixty one patients were included (pantoprazole n=226, lansoprazole n=235) in this prospective, randomized, multicenter double-blind study. Endoscopic control was performed at 4 weeks and at 8 weeks if esophagitis was not healed. RESULTS: In the intention-to-treat analysis, the healing rates at 4 weeks were 81 and 80% in the pantoprazole and lansoprazole groups, respectively (NS), 90 and 86% at 8 weeks (NS). In the per-protocol analysis, the healing rates at 4 weeks were 86% in the 2 groups and at 8 weeks 97% in the pantoprazole group and 93% in the lansoprazole group (NS). The heartburn relief rates at day 14 were 88% and 86% in the pantoprazole and lansoprazole groups, respectively. Only esophagitis grade at entry was shown to be a predictive factor for healing at 4 weeks (P<0.0001). CONCLUSION: This study showed that pantoprazole 40 mg once daily is as effective and well tolerated as lansoprazole 30 mg once daily in the treatment of grade II-III acute reflux esophagitis.     

Efficacy and tolerability of 20 mg pantoprazole versus 300 mg ranitidine in patients with mild reflux-oesophagitis: a randomized, double-blind, parallel, and multicentre study

BACKGROUND AND AIM: The aim of this study was to compare the efficacy and tolerability of low dose pantoprazole (20 mg) (a gastric proton pump inhibitor) with standard dose ranitidine (300 mg) (a histamine-receptor antagonist), in their ability to relieve symptoms and heal oesophageal lesions associated with gastrooesophageal reflux disease (GORD). METHODS: Patients with endoscopically established mild GORD (stage I, modified Savary-Miller classification) were enrolled into a multicentre, randomized, double-blind, parallel-group comparison study (intention-to-treat population, n = 201; age range, 18-82 years). Patients took either oral pantoprazole 20 mg in the morning (n = 101) or ranitidine 300 mg in the evening (n = 100) once daily for 4 weeks or, if the healing was not complete, 8 weeks. Relief from key symptoms (heartburn, acid regurgitation, pain on swallowing) was assessed after 2, 4, and if applicable, 8 weeks. Healing of lesions was confirmed endoscopically after 4 and, if applicable, 8 weeks. RESULTS: Complete relief from key symptoms was noted after 2 weeks in 70/88 (80%) patients treated with pantoprazole vs 45/89 (51%) patients treated with ranitidine ('per-protocol and key-point available' populations, P < 0.001); the corresponding results after 4 weeks were 77/88 (88%) vs 51/88 (58%) (P < 0.001). Complete healing of lesions after 4 weeks of treatment was seen in 74/88 (84%) vs 49/89 (55%) in the pantoprazole and ranitidine group, respectively (P < 0.001, per-protocol); by week 8 the cumulative healing rates were 84/88 (95%) vs 69/89 (78%) in the pantoprazole and ranitidine group, respectively (P < 0.001). For the intention-to-treat populations, the corresponding values for healing after 4 and 8 weeks were 73% vs 49% (P < 0.001) and 83% vs 69% (P < 0.05), respectively. Both study medications were well tolerated. CONCLUSION: Compared to ranitidine 300 mg, the regimen with pantoprazole 20 mg provides faster relief from symptoms and is significantly more effective in healing of oesophageal lesions in patients with mild reflux-oesophagitis. Thus, the low dose of pantoprazole offers a treatment approach which minimizes drug exposure and costs while retaining high efficacy.     

Improved symptom relief and duodenal ulcer healing with lansoprazole, a new proton pump inhibitor, compared with ranitidine.

The purpose of this study was to compare duodenal ulcer healing, symptom relief, and safety of lansoprazole (a new proton pump inhibitor) given at doses of 30 mg and 60 mg, in the morning with ranitidine 300 mg at bedtime. Two hundred and eighty nine patients were enrolled over a 20 month period in a double blind randomised parallel group comparative study set in outpatient endoscopy units of six United Kingdom medical centres. Patients were randomised to receive lansoprazole 30 mg in the morning (n = 95), 60 mg in the morning (n = 96), or ranitidine 300 mg at bedtime (n = 98) for four weeks. Efficacy was assessed by gastroscopy at study entry and after two and four weeks of treatment. Symptom relief was monitored by patient diaries and physician review at two and four weeks. Both doses of lansoprazole resulted in significantly greater ulcer healing than ranitidine after two and four weeks. Respective healing rates on lansoprazole 30 mg, 60 mg, and ranitidine 300 mg were 78%, 80%, and 60% after two weeks and 93%, 97%, and 81% after four weeks. Patients on lansoprazole 30 mg (p = 0.002) and lansoprazole 60 mg (p = 0.026) also recorded greater relief of night time pain in the diary cards during the first seven days of treatment than those on ranitidine. Patients on lansoprazole 60 mg reported significantly better pain relief at their two week visit compared with those receiving ranitidine (p = 0.007). There were no differences between treatment groups in the occurrence or pattern of adverse drug reactions during the trial. It is concluded that for patients with duodenal ulcer, lansoprazole 30 mg or 60 mg is associated with faster ulcer healing and better symptom relief than ranitidine 300 mg at bedtime. There were no significant differences between lansoprazole 30 mg and 60 mg. These data indicate that lansoprazole should be used at a once daily dose of 30 mg for the treatment of duodenal ulcer.     

Omeprazole heals duodenal, but not gastric ulcers more rapidly than ranitidine. Results of two German multicentre trials

In two double-blind, randomized German multicentre trials the effects of omeprazole 20 mg mane and ranitidine 150 mg b.i.d. were compared for the first time in 334 outpatients with duodenal ulcer and 184 outpatients with gastric ulcer. In patients with duodenal ulcer endoscopically controlled healing rates after two weeks were 72% with omeprazole and 59% with ranitidine (p = 0.012); after 4 weeks 96 and 92%, resp. were healed (n.s.). In patients with gastric ulcer the healing rates after two, four, and eight weeks were 43, 81, and 95%, respectively, with omeprazole and 45, 80, and 90%, respectively, with ranitidine (n.s.). Smoking impaired healing in duodenal, but not in gastric ulcer. Symptom relief was comparable with both drugs. Serious side effects or clinically relevant changes in laboratory screening results were not detected. - Our results demonstrate for the first time that omeprazole 20 mg mane is superior to ranitidine 150 mg b.i.d. in the short-term treatment of duodenal, but not gastric ulcer.     

No clinical benefit of adding cisapride to pantoprazole for treatment of gastro-oesophageal reflux disease

OBJECTIVE: Although a proton pump inhibitor (PPI) and a prokinetic drug are often combined for the medical treatment of gastro-oesophageal reflux disease (GORD), there are few well-conducted clinical studies on the efficacy and tolerability of this therapy. This study investigates whether pantoprazole plus cisapride leads to an additional benefit in comparison to pantoprazole alone. DESIGN AND SETTING: Randomized double-blind prospective multicentre study conducted in patients of 33 hospitals in Ireland, South Africa and the UK. PARTICIPANTS: A total of 350 intention-to-treat (ITT) patients aged 18 years or older with GORD of grade II and III were included in the study. The per-protocol (PP) population comprised 152 patients in the pantoprazole group and 136 in the pantoprazole plus cisapride group. INTERVENTIONS: Patients received either pantoprazole 40 mg once daily or pantoprazole 40 mg once daily plus cisapride 20 mg twice daily. Treatment outcome was assessed after 4 and 8 weeks. The primary criterion was endoscopically confirmed healing after 4 weeks. Additionally, relief of leading symptoms was studied. MAIN OUTCOME MEASURES: The prior null hypothesis was no difference in healing rates between both treatment groups. RESULTS: After 4 weeks of treatment 81% and 82%, and after 8 weeks 89% and 90%, of PP patients treated with pantoprazole or pantoprazole plus cisapride were healed, respectively. Thus, equivalence of the two treatment strategies could be proven. Additionally, improvement of symptom relief showed no significant difference between the two regimens. In contrast to disease grade at baseline, Helicobacter pylori status did not influence the healing rates in our study. Both study medications were tolerated well. CONCLUSION: Addition of cisapride to pantoprazole provides no further benefit in the treatment of GORD.     

Effects of pantoprazole, a novel H+/K+-ATPase inhibitor, on duodenal ulcerogenic and healing responses in rats: a comparative study with omeprazole and lansoprazole

BACKGROUND: Pantoprazole, 2-[(2-pyridylmethyl) sulphinyl] benzimidazole, is a new substituted benzimidazole that inhibits the parietal cell H+/K+-ATPase. METHODS: In the present study, the anti-secretory and anti-ulcer activities of pantoprazole were compared with those of omeprazole and lansoprazole in rats. RESULTS: Pantoprazole (0.3-3 mg/kg, p.o.) as well as omeprazole (1-10 mg/kg, p.o.) and lansoprazole (1-10 mg/kg, p.o.) dose-dependently decreased both basal acid secretion in pylorus-ligated rats and the stimulated acid secretion induced by mepirizole in acute fistula rats, and the effects of pantoprazole were more potent than those of omeprazole and lansoprazole, the ED50 values for the stimulated acid secretion being 0.8, 2.0 and 1.2 mg/kg, respectively. Neither of these drugs had any effect on duodenal HCO3- secretion. These pump inhibitors prevented the development of duodenal lesions in response to mepirizole in a dose-related manner, the ED50 values for pantoprazole, omeprazole and lansoprazole being 0.4, 2.0 and 1.3 mg/kg, respectively. Likewise, pantoprazole showed the healing promoting action on chronic duodenal ulcers induced by acetic acid, and this effect was also more potent when compared to omeprazole or lansoprazole. CONCLUSIONS: We conclude that pantoprazole exhibited both anti-ulcer and healing promoting effects on duodenal ulcers in rats, and the effects may be attributable to its potent anti-secretory action. Other pump inhibitors such as omeprazole and lansoprazole were almost equally effective as pantoprazole, yet this drug was most potent on the basis of ED50 values.     

国产泮托拉唑治疗非甾体消炎药相关性溃疡出血的疗效分析

目的 比较泮托拉唑(商品名:泮立苏)与奥美拉唑(商品名:洛赛克)治疗非甾体消炎药相关消化性溃疡伴出血的疗效、不良反应及成本-效果比.方法 选择符合非甾体消炎药相关性溃疡伴出血诊断标准的住院患者58例,按随机数字表分为泮托拉唑组(31例)和奥美拉唑组(27例).泮托拉唑组予以国产泮托拉唑40 mg加入0.9%氯化钠溶液100 ml中静脉滴注,每12小时1次;奥美拉唑组予以进口奥美拉唑40 mg加入0.9%氯化钠溶液100 ml中静脉滴注,每12小时1次,两组疗程均为7 d.观察两组疗效及不良反应,并运用药物经济学方法分析二者成本-效果比.结果 泮托拉唑组总有效率为93.5%,奥美拉唑组总有效率为96.3%,两组药物均能有效止血,差异无统计学意义(P=1.00);两组不良反应发生率分别为3.2%和7.4%;成本-效果比(C/E)分别为7.76、20.73;奥美拉唑相对于泮托拉唑的增量成本-效果比(△C/△E)为454.结论 国产泮托拉唑是治疗非甾体消炎药相关性溃疡出血有效、安全、经济的药物.

Abstract：

Objective To compare the efficacy, adverse reactions and cost-effectiveness between domestic pantoprazole (Pan Li Su) and imported omeprazole (Losec) in the treatment of non-steroidal anti-inflammatory drugs (NSAID) associated ulcer bleeding.Methods Fifty-eight hospitalized patients with NSAID associated ulcer bleeding were randomly divided into pantoprazole group (n=31)and omeprazole group (n= 27) according to random number table.Pantoprazole group was given 40 mg domestic pantoprazole dissolved 100 ml 0.9% sodium chloride solution intravenously every 12 hours.Omeprazde group was given 40 mg omeprazole dissolved in 100 ml 0.9% sodium chloride solution intravenously every 12 hours.The two groups were both treated for seven days.Finally, the efficacy and adverse effect were observed, and cost-effectiveness was analyzed with pharmacoeconomics.Results The total effective rate of pantoprazole group was 93.5%, omeprazole group was 96.3% .The drugs of the two groups could effectively stop bleeding, the difference was not statistically significant (P= 1.00).The rate of adverse effect was 3.2 % and 7.4 % in the two groups accordingly.The cost-effectiveness ratio (C/E) was 7.76 and 20.73 respectively.Compared with pantoprazole group, the incremental cost-effectiveness ratio of omeprazole group was 454.Conclusions Domesic pantoprazole is an effective, safety and economical medicine for NSAID associated ulcer bleeding.     

Efficacy and tolerability of pantoprazole compared with misoprostol for the prevention of NSAID-related gastrointestinal lesions and symptoms in rheumatic patients

AIM: To compare the efficacy and tolerability of pantoprazole 20 mg once daily (o.d.) with misoprostol 200 microg twice daily (b.i.d.), administered for 6 months to rheumatic patients who required long-term therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) and who were at increased risk of developing gastrointestinal lesions. METHODS: This randomized, double-blind, multicenter, parallel group comparison study was performed with rheumatic patients (n = 515) who were likely to take NSAIDs continuously for at least 6 months. Patients were 55 years or older, at risk to develop gastrointestinal lesions, had less than five erosions/petechiae in the stomach and duodenum, no ulcers, no reflux esophagitis (endoscopy-proven), and gastrointestinal symptoms of at most moderate intensity. A minimum daily dose was defined for NSAIDs (COX-2 inhibitors were not available at the time). Patients were randomized to take either pantoprazole 20 mg o.d. (n = 257) or misoprostol 200 microg b.i.d. (n = 258) for 6 months while continuing NSAID therapy. Endoscopy was performed at baseline, 3, and 6 months. RESULTS: Pantoprazole was superior to misoprostol (p < 0.001) with regard to 'therapeutic failure' (occurrence of a peptic ulcer, ten or more erosions/petechiae in the stomach/duodenum, reflux esophagitis, severe gastrointestinal symptoms, and/or 'likely' or 'definitely' related adverse event leading to study termination). Estimated remission rates at 3 and 6 months (Kaplan-Meier life-table analysis) were, respectively, 93 and 89% (pantoprazole) and 79 and 70% (misoprostol). Pantoprazole was superior to misoprostol (p = 0.005) with regard to 'endoscopic failure' (occurrence of a peptic ulcer, ten or more erosions/petechiae in the stomach/duodenum, or reflux esophagitis) after 6 months. Estimated remission rates at 3 and 6 months were, respectively, 98 and 95% (pantoprazole) and 95 and 86% (misoprostol). Patients discontinuing the study early due to adverse events 'likely' or 'definitely' related to the study drug accounted for 13/257 (5%) in the pantoprazole and 33/258 (13%) in the misoprostol treatment groups. CONCLUSION: Pantoprazole 20 mg o.d. is superior to misoprostol 200 microg b.i.d. in the prevention of NSAID-induced gastrointestinal lesions and symptoms in patients on continuous long-term treatment with NSAIDs due to rheumatic diseases and at risk to develop such lesions or symptoms.     

艾普拉唑肠溶片治疗十二指肠溃疡的多中心、随机、双盲、阳性平行对照临床研究

目的 初步评价艾普拉唑肠溶片治疗十二指肠溃疡的疗效和安全性,探讨剂量-疗效关系.方法 采用多中心、随机、双盲双模拟、阳性药物平行对照设计.将胃镜检查证实为活动性十二指肠溃疡患者235例随机分为艾普拉唑低(5 mg/d)、中(10 mg/d)、高(20 mg/d)剂量组和奥美拉唑组(20 mg/d),各组连续服药4周.观察治疗后溃疡愈合及临床症状的改善情况.结果 不同剂量艾普拉唑和奥美拉唑均可快速缓解患者腹痛、烧灼感、反酸、恶心呕吐、嗳气、腹胀等临床症状,4周末综合症状改善显效率和有效率、单一症状改善有效率在各组间差异均无统计学意义(P值均>0.05).2周和4周溃疡愈合率在艾普拉唑低剂量组分别为72.88%和86.44%,中剂量组分别为86.21%和93.10%,高剂量组分别为76.27%和86.44%,奥美拉唑组分别为72.88%和89.83%,各组间差异无统计学意义(P>0.05).不良反应主要为腹泻、微量蛋白尿、头痛、头晕、转氨酶升高等,四组均未发生严重不良反应.结论 三种剂量艾普拉唑肠溶片均能快速缓解十二指肠溃疡患者的临床症状,促进溃疡愈合,且安全有效,但疗效与剂量无明显相关性.