Nizatidine versus placebo in gastroesophageal reflux disease

In a randomized, multicenter trial, nizatidine 150 mg or 300 mg, or placebo, was administered twice daily for six weeks to 515 patients with gastroesophageal reflux disease (GERD). Gelusil antacid tablets were taken as needed for pain. Significantly superior rates of endoscopically proven complete healing (normal-appearing mucosa) versus placebo occurred after three weeks with nizatidine 150 mg, and after six weeks with nizatidine 300 mg. Six-week healing rates were 38.5% for nizatidine 300 mg, 41.1% for nizatidine 150 mg, and 25.8% for placebo. The nizatidine 150 mg treatment group had significantly greater improvement in daytime and nighttime heartburn severity after one day of therapy versus placebo. Twice-daily administration of nizatidine 150 mg or 300 mg provides prompt relief from the major symptom of GERD, heartburn, and complete healing of esophagitis is seen in many patients.     

Comparison of efficacy of pantoprazole alone versus pantoprazole plus mosapride in therapy of gastroesophageal reflux disease: a randomized trial

The present study aimed to compare the efficacy for the therapy of GERD of pantoprazole alone with a combination of pantoprazole and mosapride. The study was a prospective, randomized trial involving 68 patients suffering heartburn and/or regurgitation at least twice a week for 6 weeks. Sixty-one patients consented to be randomized to receive either pantoprazole 40 mg b.i.d. (n = 33, group A) or pantoprazole 40 mg b.i.d. plus mosapride 5 mg t.d.s. (n = 28, group B) for 8 weeks. Twenty-four-hour esophageal pH-metry and endoscopy were conducted at recruitment and endoscopy was repeated at 8 weeks in all the patients studied. There were no differences in symptomatic responses to therapy between the groups (69.7% vs 89.2%; P = 0.11). The mean symptom score after 8 weeks was significantly lower in group B (3.78 +/- 3.62 vs 1.67 +/- 2.09; P = 0.009). Nonerosive esophagitis was present in 29 patients. In patients with nonerosive GERD there was no significant difference in symptomatic response to either regimen (17/20 in group A and 7/9 in group B responded; P = 0.63). In erosive esophagitis, symptomatic responses occurred more frequently in group B, 18/19 (94.7%), than in group A, 6/13 (46.2%; P = 0.003). However endoscopic healing of esophagitis occurred equally with either regimen (6/11, 54.5% in group A; 12/17, 70.5% in group B; P = 0.44). In nonerosive GERD, the addition of mosapride offers no benefit over pantoprazole alone. A combination of pantoprazole and mosapride is more effective than pantoprazole alone in providing symptomatic relief to patients with erosive GERD.     

Short-term treatment of gastroesophageal reflux disease

OBJECTIVE: To investigate the efficacy of acid suppressant drugs in the empirical treatment of gastroesophageal reflux disease (GERD) and in the treatment of endoscopy-negative reflux disease (ENRD). DESIGN: medline, embase, and the Cochrane Controlled Trials Register were searched. Bibliographies were reviewed. SETTING: Studies were eligible that compared the short-term use of proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) with each other or with placebo in adults with GERD who were enrolled irrespective of endoscopic findings (empirical cases) or in whom endoscopy showed no signs of esophagitis (endoscopy-negative cases). MEASUREMENTS: Of 1,408 studies, only 13 could be included for meta-analysis. Data on 3,433 patients empirically treated for GERD and 2,520 patients treated for ENRD were extracted. The primary endpoint was relief of heartburn. MAIN RESULTS: In the empirical treatment of GERD, the summary relative risk (sRR) for symptom relief from H2RAs versus placebo was 0.77 (95% confidence interval [95% CI], 0.60 to 0.99). RR in the only placebo-controlled PPI trial was 0.35 (95% CI, 0.26 to 0.46). The sRR for standard dose PPIs versus H2RAs was 0.55 (95% CI, 0.44 to 0.68). In treatment of ENRD, both PPIs (sRR, 0.64; 95% CI, 0.52 to 0.79) and H2RAs (sRR, 0.78; 95% CI, 0.62 to 0.97) were superior to placebo, and PPIs were superior to H2RAs (sRR, 0.81; 95% CI, 0.70 to 0.95). CONCLUSIONS: Acid suppressant therapy (with a PPI or an H2RA) is more effective than placebo for short-term relief of heartburn in patients with persistent symptoms who are treated empirically for GERD and in those in whom esophagitis was excluded after endoscopy. The benefit of PPIs compared with H2RAs is more pronounced in patients treated empirically.     

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.     

Effect of pantoprazole in older patients with erosive esophagitis

Several studies suggest that older adults with gastroesophageal reflux disease (GERD) are more likely to develop complications, including erosive esophagitis, but it is unclear whether erosive esophagitis is more difficult to treat in older patients. The purpose of this study was to determine if adults > or = 65 years with erosive esophagitis are more difficult to treat than younger adults. The study was a post hoc analysis of two double-blind, randomized, multicenter trials of patients with erosive esophagitis. Patients received pantoprazole 40 mg once daily, nizatidine 150 mg twice daily or placebo. Patients were evaluated for endoscopic healing at 4 and 8 weeks. Patients recorded typical reflux symptoms using a daily diary to note presence or absence of symptoms. Results showed that 44, 13 and 11 patients > or = 65 years and 210, 69, and 71 patients < 65 received pantoprazole 40 mg daily, nizatidine 150 mg twice daily, or placebo, respectively. Eighty-six percent (86%[76%, 97% CI]) of older and 83% (78%, 88% CI) of younger pantoprazole-treated patients were healed at 8 weeks; 46% (19%, 73% CI) and 35% (24%, 46% CI) of nizatidine-treated and 27% (1%, 54% CI) and 34% (23%, 45% CI) of placebo-treated were healed at 8 weeks. Median time to persistent absence of GERD-related symptoms was similar for older and younger patients treated with pantoprazole. We conclude that older patients with erosive esophagitis do not appear to have more difficult-to-treat disease. Erosive esophagitis is effectively healed and GERD symptoms are controlled in older patients using pantoprazole 40 mg daily.     

Pantoprazole rapidly improves health-related quality of life in patients with heartburn: a prospective,randomized, double blind comparative study with nizatidine

BACKGROUND: Health-related quality of life (HRQoL) is impaired in untreated patients with gastroesophageal reflux disease (GERD). In the absence of an objective marker such as erosions, assessment of treatment efficacy can be based on symptoms and HRQoL. OBJECTIVE: To evaluate changes in HRQoL during treatment with pantoprazole or nizatidine in patients with GERD. METHODS: This was a prospective, randomized, double blind Canadian multicenter study. Patients with GERD, characterized by heartburn that had occurred 4 or more times per week for at least 6 months, were treated for 28 days with either pantoprazole 40 mg once daily or nizatidine 150 mg twice daily. HRQoL assessment was performed before endoscopy (baseline) and on days 7 and 28 after treatment. HRQoL was assessed using 4 domains of the SF-36, the SF-12 summary scales and the gastrointestinal system rating scale (GSRS). RESULTS: A total of 208 patients (n = 106 pantoprazole treatment group, n = 102 nizatidine treatment group) was available for intention-to-treat analysis. Baseline HRQoL scores were comparable between the 2 treatment groups. After 7 days, treatment with pantoprazole led to a statistically significant greater improvement in HRQoL in 2 SF-36 domains: bodily pain (pantoprazole versus nizatidine, P = 0.0088) and vitality (pantoprazole versus nizatidine, P = 0.0137), and in the GSRS reflux score (pantoprazole versus nizatidine, P = 0.0078). After 28 days of treatment, the changes in scores relative to baseline were still greater with pantoprazole than with nizatidine. The improvement in the 4 SF-36 domains and the GSRS reflux score achieved by pantoprazole after 7 days were also significantly greater than those achieved by nizatidine after 28 days. CONCLUSIONS: HRQoL improves more rapidly and to a greater degree following treatment with pantoprazole than nizatidine. Control of heartburn strongly predicts HRQoL improvement during the acute treatment of GERD. Our data support the approach to use pantoprazole instead of nizatidine as the initial therapy for patients with heartburn in a primary care practice setting.     

Lanzoptol efficacy at gastroesophageal reflux disease: results of multicenter study leader

Results of multicenter study "Efficacy of Lansoptol (lansoprazole, KRKA) and its influence on the Dynamics of GERD symptoms" (LIEDER) are presented. The impact of 56-days treatment with lansoprazole 30 mg once daily on symptoms relief, a quality of life of 121 patients with gastroesophageal reflux disease (GERD) and healing of esophageal lesions of 30 patients with reflux esophagitis were investigated. Rapid acid inhibition effect of first dose of lansoptol was shown by 48-hr pH-monitoring. At the first day of the treatment 43.1% of patients reported decreasing of intensity of heartburn and 36.5%--of regurgitation. It were shown that the treatment with lansoptol provided symptoms relief in 25% patients at day 3, in 50% of patients at day 5 and in 75% at day 8 for heartburn, and at days 2, 6 and 9--for regurgitation. It was conducted improvement of quality of life. Healing rate of esophagitis at 28 day was 83.3%.     

Comparative study of omeprazole, lansoprazole, pantoprazole and esomeprazole for symptom relief in patients with reflux esophagitis

AIM： To clarify whether there is any difference in the symptom relief in patients with reflux esophagitis following the administration of four Proton pump inhibitors （PPIs）. METHODS： Two hundred and seventy-four patients with erosive reflux esophagitis were randomized to receive 8 wk of 20 mg omeprazole （n = 68）, 30 mg of lansoprazole （n = 69）, 40 mg of pantoprazole （n = 69）, 40 mg of esomeprazole （n = 68） once a day in the morning. Daily changes in heartburn and acid reflux symptoms in the first 7 d of administration were assessed using a six-point scale （0： none; 1： mild; 2： mild-moderate; 3： moderate; 4： moderate-severe; 5： severe）. RESULTS： The mean heartburn score in patients treated with esomeprazole more rapidly decreased than those receiving other PPI. Complete resolution of heartburn was also more rapid in patients treated with esomeprazole for 5 d compared with omeprazole （P = 0.0018, P = 0.0098, P = 0.0027, P = 0.0137, P = 0.0069, respectively）, lansoprazole （P = 0.0020, P = 0.0046, P = 0.0037, P = 0.0016, P = 0.0076, respectively）, and pantoprazole （P = 0.0006, P = 0.0005, P = 0.0009, P = 0.0031, P = 0.0119, respectively）. There were no significant differences between the four groups in the rate of endoscopic healing of reflux esophagitis at week 8. CONCLUSION： Esomeprazole may be more effective than omeprazole, lansoprazole, and pantoprazole for the rapid relief of heartburn symptoms and acid reflux symptoms in patients with reflux esophagitis.     

Efficacy of omeprazole for the treatment of symptomatic acid reflux disease without esophagitis

BACKGROUND: Up to three quarters of patients with gastroesophageal reflux disease (GERD) have symptoms, such as heartburn, but no macroscopic evidence of erosive esophagitis, making symptomatic GERD a common clinical problem in the primary care setting. OBJECTIVE: To compare the efficacy and safety of omeprazole, 20 mg once daily; omeprazole, 10 mg once daily; and placebo in the treatment of symptomatic GERD without erosive esophagitis. METHODS: Patients with a history of heartburn (> or =12 months) and episodes of moderate to severe heartburn on 4 or more of the 7 days before endoscopy were eligible to participate in this 4-week, randomized, double-blind, placebo-controlled trial. The absence of erosive esophagitis was established through endoscopy. Eligible patients were randomized to 1 of 3 treatment groups: omeprazole, 20 mg once daily; omeprazole, 10 mg once daily; or placebo. Patients were assessed at weeks 2 and 4. The efficacy of omeprazole for the treatment of heartburn was determined mainly through the following diary card data: daily resolution of heartburn and complete resolution of heartburn every day during 1 week of treatment. The efficacy of omeprazole for the treatment of acid regurgitation, dysphagia, epigastric pain, and nausea was also assessed. RESULTS: Of 359 randomized patients, 355 were included in the statistical analysis (intention-to-treat population). Daily proportions of patients with no heartburn were consistently greater in the 20-mg omeprazole group (62%, day 7; 74%, day 27) than in the 10-mg omeprazole group (41%, day 7; 49%, day 27) or the placebo group (14%, day 7; 23%; day 27). Complete resolution of heartburn every day during the last treatment week was significantly (P< or =.002) higher in the 20-mg omeprazole group (48%) than in the 10-mg omeprazole (27%) or placebo (5%) group. Omeprazole was significantly (P< or =.003) more effective than placebo for the treatment of acid regurgitation, dysphagia, epigastric pain, and nausea. CONCLUSIONS: Patients with symptomatic GERD require profound acid suppression to achieve symptomatic relief. Omeprazole, 20 mg once daily, was superior to omeprazole, 10 mg once daily, and to placebo in providing early and sustained resolution of heartburn, as well as treatment of other troublesome GERD symptoms.     

Comparative clinical trial of S-pantoprazole versus racemic pantoprazole in the treatment of gastro-esophageal reflux disease

INTRODUCTION The primary treatment goals in patients with gastroesophageal reflux disease (GERD) are relief of symptoms, prevention of symptom relapse, healing of erosive esophagitis, and prevention of complications of esophagitis[1]. Proton pump inhibito…     

On-demand therapy with pantoprazole 20 mg as effective long-term management of reflux disease in patients with mild GERD: the ORION trial

AIMS: To compare safety and efficacy of on-demand pantoprazole 20 mg/40 mg versus placebo in the long-term management of patients with mild gastroesophageal reflux disease (GERD) after heartburn relief. METHODS: A total of 634 patients with endoscopically confirmed GERD grade 0/I and heartburn were included. During the acute phase, patients were treated with pantoprazole 20 mg once daily for 4 weeks. Those patients relieved from heartburn entered the long-term phase, and were randomly assigned to either treatment group pantoprazole 20 mg, 40 mg or placebo. Over 6 months, patients took study medication on demand (antacids as rescue medication) and discontinued the drug once symptoms abated. RESULTS: After 4 weeks a total of 87.1%/90.0% of patients were free of heartburn (ITT/PP), and entered the subsequent long-term phase. The perceived average daily symptom load (placebo: 3.93, pantoprazole 20 mg: 2.91, pantoprazole 40 mg: 2.71, ITT) and the number of antacid tablets taken (average number, placebo: 0.68, pantoprazole 20 mg: 0.45, pantoprazole 40 mg: 0.33, ITT) were significantly higher in the placebo than in both pantoprazole groups (p<0.0001), with no statistically significant difference between the two pantoprazole groups. The discontinuation rate due to insufficient control of heartburn was significantly lower in both pantoprazole groups compared to placebo (placebo: 10.9, pantoprazole 20 mg: 2.8, pantoprazole 40 mg: 0.9, ITT). CONCLUSIONS: Our findings favor on-demand treatment with pantoprazole 20 mg for the long-term management of heartburn in patients with uncomplicated GERD (grade 0/I) with superiority to placebo.     

Nizatidine versus Placebo in Gastroesophageal Reflux Disease: A 12-Week, Multicenter, Randomized, Double-Blind Study

Two doses of nizatidine (150 mg bid and 300 mg hs), an H2-receptor antagonist, were compared with placebo in a 12-wk, multicenter, randomized, double-blind, parallel study in 466 patients with endoscopically documented gastroesophageal reflux disease. Antacid tablets were given concomitantly as needed for pain. Compared with placebo, nizatidine 150 mg twice daily was highly effective in rapidly reducing the severity of heartburn, regardless of esophagitis severity at entry. Significantly greater complete mucosal healing of esophagitis occurred after 6 wk of therapy with nizatidine 150 mg bid (vs. nizatidine 300 mg hs or placebo) only in patients with erosive esophagitis [16/68 (24%) vs. 8/65 (12%)] and erosive and ulcerative esophagitis combined [21/99 (21%) vs. 10/94 (11%)]. At wk 12, healing with nizatidine 150 mg bid was also significantly greater than placebo in erosive [19/68 (28%) vs. 9/65 (14%)], ulcerative [10/31 (32%) vs. 3/29 (10%)], and erosive and ulcerative esophagitis combined [29/99 (29%) vs. 12/94 (13%)]. These results show that twice-daily therapy with nizatidine 150 mg is very effective at relieving heartburn, and can also heal erosive and ulcerative esophagitis. Nizatidine 300 mg hs was not effective in healing esophagitis, compared with placebo.     

Pharmacologic management of gastroesophageal reflux disease

The burden of gastroesophageal reflux disease (GERD) results from its widespread prevalence and the unfavorable impact of its symptoms on well-being and quality of life. Whereas abnormalities of the antireflux barrier (lower esophageal sphincter) are important in the pathophysiology of GERD, pharmacologic therapy for GERD is based on suppression of acid, which is responsible for the majority of the symptoms and for epithelial damage. Proton pump inhibitors (PPIs) are the agents of choice for achieving the goals of medical therapy in GERD, which include symptom relief, improvement in quality of life, and healing and prevention of mucosal injury. As a class, these drugs are extremely safe. The newest PPI, esomeprazole, brings a statistically significant increase in healing of mucosal injury and symptom relief in patients with erosive esophagitis, compared with omeprazole and lansoprazole. This article reviews the role of medical therapy in the short-and long-term management of symptomatic patients with or without erosive esophagitis, including extraesophageal presentations, GERD during pregnancy, and Barrett’s esophagus. Management of refractory patients is addressed.     

奥美拉唑、泮托拉唑、兰索拉唑和埃索美拉唑对反流性食管炎患者症状缓解的比较研究

目的比较奥美拉唑、泮托拉唑、兰索拉唑和埃索美拉唑对反流性食管炎患者症状缓解之间的差异。方法320例内镜诊断为反流性食管炎患者被随机分为4组,并分别服用奥美拉唑20mg,1次／d,8周;兰索拉唑30mg,1次／d,8周;泮托拉唑40mg,1次／d,8周;埃索美拉唑40mg,1次／d,8周。用six—point scale（0：无,1：轻度,2：轻度-中度,3：中度,4：中度-重度,5：重度）评价服用4种质子泵抑制剂后7天内的烧心和反流症状。结果埃索美拉唑组的平均烧心积分比其他质子泵抑制剂下降更迅速。埃索美拉唑组第1～5天的烧心症状完全消失率明显高于奥美拉唑组（P值分别为0．0054、0．0072、0．0089、0．0107、0．0134）、兰索拉唑组（P值分别为0．0043、0．0034、0．0044、0．0011、0．0052）、泮托拉唑组（P值分别为0．0156、0．0003、0．0005、0,0024、0．0172）。内镜下反流性食管炎愈合率4组之间无明显差异。结论埃索美拉唑比奥美拉唑、兰索拉唑、泮托拉唑更迅速地减轻反流性食管炎患者的烧心和反流症状。     

Esophageal cell proliferation in gastroesophageal reflux disease： Clinical-morphological data before and after pantoprazole

AIM： To evaluate esophageal mucosal defense mechanisms at an epithelial level to establish if pantoprazole treatment can induce ultrastructural healing and improvement in the proliferation activity of the esophageal epithelium in gastroesophageal reflux disease （GERD）. METHODS： This was a single-blinded study for pH- monitoring, and histological, ultrastructural and MIB1 immunostaining evaluation. Fifty eight patients with GERD were enrolled and underwent 24 h pH-monitoring and endoscopy. Patients were treated for 12 and 24 mo with pantoprazole. Esophageal specimens were taken for histological and ultrastructural evaluation, before and after the treatment. RESULTS： With transmission electron microscopy, all patients with GERD showed ultrastructural signs of damage with dilation of intercellular spaces （DIS）. After 3 mo of therapy the mean DIS values showed a significant reduction and the mean MIB1-LI values of GERD showed an increase in cell proliferation. A further 3 mo of therapy significantly increased cell proliferation only in the erosive esophagitis （ERD） group. CONCLUSION： Three months of pantoprazole therapy induced ultrastructural healing of mucosal damage in 89% and 93% of ERD and non-erosion patients, respectively. Moreover, long-term pantoprazole treatment may be helpful in increasing the capability for esophageal cell proliferation in GERD, particularly in ERD patients.     

Proton pump inhibitor resistance,the real challenge in gastro-esophageal reflux disease

Gastro-esophageal reflux disease(GERD)is one of the most prevalent chronic diseases.Although proton pump inhibitors(PPIs)represent the mainstay of treatment both for healing erosive esophagitis and for symptom relief,several studies have shown that up to 40%of GERD patients reported either partial or complete lack of response of their symptoms to a standard PPI dose once daily.Several mechanisms have been proposed as involved in PPIs resistance,including ineffective control of gastric acid secretion,esophageal hypersensitivity,ultrastructural and functional changes in the esophageal epithelium.The diagnostic evaluation of a refractory GERD patients should include an accurate clinical evaluation,upper endoscopy,esophageal manometry and ambulatory pH-impedance monitoring,which allows to discriminate non-erosive reflux disease patients from those presenting esophageal hypersensitivity or functional heartburn.Treatment has been primarily based on doubling the PPI dose or switching to another PPI.Patients with proven disease,not responding to PPI twice daily,are eligible for anti-reflux surgery.     

Efficacy and safety of pantoprazole versus ranitidine in the treatment of patients with symptomatic gastroesophageal reflux disease

BACKGROUND/AIM: Gastroesophageal reflux disease (GERD) is a prevalent disease associated with a high symptom burden and a reduced quality of life. This multicenter, randomized, double-blind study compared relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) and from other gastrointestinal symptoms (epigastric pain, vomiting, nausea, flatulence, retching, and retrosternal feeling of tightness) and safety profiles of the proton pump inhibitor pantoprazole and the H2 antagonist ranitidine in patients suffering from symptomatic GERD. METHODS: The patients [338 intention-to-treat (ITT) population; 284 per-protocol (PP) population] received 20 mg pantoprazole (once daily in the morning) plus ranitidine placebo (once daily in the evening; ITT n = 167, PP n = 136) or pantoprazole placebo (once daily in the morning) plus 300 mg ranitidine (once daily in the evening; ITT n = 171, PP n = 148) for 28 days. The primary efficacy criterion (ITT and PP populations) was relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) after 28 days of treatment. Secondary criteria (PP) included relief from key GERD symptoms on day 14, relief from all gastrointestinal symptoms on days 14 and 28, and relief from key GERD symptoms on days 14 and 28. Safety evaluations included adverse events and laboratory assessments. RESULTS: Significantly more pantoprazole-treated patients were free from key GERD symptoms at day 28 (68.3%, n = 114) as compared with ranitidine-treated patients (43.3%, n = 74; 95% confidence interval for odds ratio 1.84-4.51). Pantoprazole was also significantly more efficacious in controlling all gastrointestinal symptoms of GERD. By day 28, 51.5% (n = 70) of the pantoprazole-treated patients were completely symptom free versus 31.1% (n = 46) of the ranitidine-treated patients (95% confidence interval for odds ratio 1.45-3.83). Both treatments were well tolerated. CONCLUSION: Pantoprazole is significantly superior to ranitidine in the treatment of key and associated gastrointestinal symptoms of GERD and is well tolerated.     

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.     

Pharmacologic management of gastroesophageal reflux disease

Opinion statement The burden of gastroesophageal reflux disease (GERD) results from its widespread prevalence and the unfavorable impact of its symptoms on well-being and quality of life. Whereas abnormalities of the antireflux barrier (lower esophageal sphincter) are important in the pathophysiology of GERD, pharmacologic therapy for GERD is based on suppression of acid, which is responsible for the majority of the symptoms and for epithelial damage. Proton pump inhibitors (PPIs) are the agents of choice for achieving the goals of medical therapy in GERD, which include symptom relief, improvement in quality of life, and healing and prevention of mucosal injury. As a class, these drugs are extremely safe. The newest PPI, esomeprazole, brings a statistically significant increase in healing of mucosal injury and symptom relief in patients with erosive esophagitis, compared with omeprazole and lansoprazole. This article reviews the role of medical therapy in the short- and long-term management of symptomatic patients with or without erosive esophagitis, including extraesophageal presentations, GERD during pregnancy, and Barrett’s esophagus. Management of refractory patients is addressed.     

Association between dinner-to-bed time and gastro-esophageal reflux disease

OBJECTIVE: It is generally recommended that patients with gastro-esophageal reflux disease (GERD) refrain from eating within 3 h of going to sleep. In addition to a remarkable lack of supporting clinical evidence, whether GERD patients have shorter dinner-to-bed time is unknown. This study was designed to determine a possible association between dinner-to-bed time and GERD, compared with healthy adults. METHODS: In a matched case-control study, we enrolled 147 GERD patients, and age- and sex-matched 294 controls without GERD symptoms such as heartburn and acid regurgitation during the previous year. Dinner-to-bed time, defined as the time intervals until going to bed after finishing eating dinner, was examined by a self-report questionnaire. Logistic regression was used to calculate odds ratio (OR) and 95% confidence intervals (CI) for GERD. RESULTS: After adjustment for smoking habits, drinking habits, and body mass index, shorter dinner-to-bed time was significantly associated with an increased OR of GERD (p < 0.0001) and the OR for patients whose dinner-to-bed time was less than 3 h was 7.45 (95% CI 3.38-16.4) compared with patients whose dinner-to-bed time was 4 h or more. These observations were consistent in both patients with non-erosive GERD and erosive esophagitis, and there was no significant difference in dinner-to-bed time intervals between non-erosive GERD and erosive esophagitis. CONCLUSION: In this matched case-control study, shorter dinner-to-bed time was significantly associated with an increased OR for GERD.