Lansoprazole Group Research Articles

Bone density in proton pump inhibitors users: a prospective study

Patients with gastroesophageal reflux disease (GERD) receive long-term therapy with proton pump inhibitor (PPI) agents. Several studies have recently been published suggesting that treatment with PPI may cause bone fractures, although the number of prospective studies in this regard is limited. The aim of this study is to prospectively investigate the effect of PPIs on bone density. Between March 2009 and January 2011, 114 GERD patients (18-56 years) and 110 healthy controls were included in the present study. Bone mineral densitometry (BMD) by using dual-energy X-ray absorptiometry was assessed at lumbar spine and femur neck. BMD measurements were performed on all subjects at the beginning of the study. The patients were divided according to three drugs by their treatment with esomeprazole, lansoprazole, or pantoprazole. The study group was followed for at least 6 months on PPI therapy, and then BMD measurements were repeated. The mean duration of treatment with PPIs was 8.5 ± 2.3 months. In patients receiving PPIs, the mean reduction in total vertebra T score following treatment compared to pre-treatment values was 00.23 ± 0.42 units (95 % CI 0.15-0.30) (p < 0.01), while the mean reduction in the femur T score was 0.10 ± 0.40 units (95 % CI 0.03-0.18) (p = 0.03). Reduction following treatment in L4 and total vertebra T scores of lansoprazole group was significantly higher than of pantoprazole group (p = 0.04). Reduction in femur T score of esomeprazole group was higher than of lansoprazole group and pantroprazole group, but it is not statistically significant. Treatment with a PPI results in a significant reduction in bone density. Close monitoring is beneficial for patients who are to receive long-term treatment with PPI.

The effect of itopride combined with lansoprazole in patients with laryngopharyngeal reflux disease

The objective of this study is to determine the efficacy of adding a prokinetic agent to proton pump inhibitors (PPI) for the treatment of laryngopharyngeal reflux (LPR) disease. A prospective, randomized open trial comparing lansoprazole plus itopride to lansoprazole single therapy was performed for 12 weeks. Sixty-four patients with a reflux finding score (RFS) >7 and a reflux symptom index (RSI) >13 were enrolled and received either lansoprazole 30 mg once daily with itopride 50 mg three times daily or lansoprazole 30 mg once daily for 12 weeks. RSI and RFS were completed at baseline, after 6 weeks, and after 12 weeks. During the treatment period, RSI and RFS were significantly improved compared with the pretreatment scores in both study groups. Reductions of total RSI and globus symptom were significantly higher in the lansoprazole plus itopride group compared to the lansoprazole group. In the RFS, however, there were no significant differences between the two groups. In conclusion, itopride in addition to PPI did not show any superior RFS improvement compared to PPI single therapy, but was helpful in speeding up relief of reflux symptoms in LPR patients. Thus, itopride may be considered as the secondary additive agent in the PPI treatment of LPR patients.

Therapeutic effects of mosapride citrate and lansoprazole for prevention of aspiration pneumonia in patients receiving gastrostomy feeding

Aspiration pneumonia is an emerging problem in patients receiving gastrostomy feeding. This study is designed to clarify the therapeutic effects of mosapride citrate and lansoprazole for prevention of aspiration pneumonia in patients receiving gastrostomy feeding. The study subjects were 119 patients with dysphasia who required gastrostomy feeding. They were randomly assigned to the control (without medication), lansoprazole (15mg, 1/day), and mosapride (5mg, 3/day) groups. The number of days with fever (≥37.8°C), vomiting, and antibiotics administration, as well as the occurrence of pneumonia were investigated during the 6-month observation period. The incidence of pneumonia during the observation period was significantly lower in the mosapride group as compared to the control (7/38 vs. 16/40, p=0.038) and lansoprazole (vs. 20/41, p=0.005) groups. The mosapride group also showed a significant decrease in days with fever and antibiotics administration as compared to the other groups. Multivariate analysis revealed that the presence of hiatal hernia was a significant risk factor and administration of mosapride was a significant preventive factor for pneumonia. Mosapride has a preventive effect on occurrence of pneumonia in patients receiving gastrostomy feeding.

Impact of proton pump inhibitors or famotidine on the antiplatelet actions during dual-antiplatelet therapy in Japanese patients

It has been reported that the antiplatelet action becomes attenuated when a proton pump inhibitor is used in combination with clopidogrel. The effect of an antacid causing platelet aggregation during the administration of clopidogrel was investigated. The subjects consisted of 265 patients with coronary artery disease. Platelet aggregation function testing (light transmittance aggregometry) was conducted while aspirin and clopidogrel 75mg were taken orally and the minimum concentration of aggregation induction platelet aggregation threshold index was measured. The ADP-PATI, measured with ADP as the inducing substance, was compared and investigated according to the type of concomitantly used antacid. The results of the ADP-PATI were: control group: 3.47±0.95μM (N=67), famotidine group: 3.80±0.52μM (N=32), rabeprazole group: 3.43±0.93μM (N=87), lansoprazole group: 3.28±1.04μM (N=63) and omeprazole group: 3.33±0.81μM (N=16). No statistically significant difference was observed regarding the ADP-PATI of respective groups compared to the control group. The concomitant use of famotidine, rabeprazole, lansoprazole, and omeprazole did not affect the antiplatelet action of clopidogrel in Japanese patients.

Oral versus intravenous proton pump inhibitors in preventing re-bleeding for patients with peptic ulcer bleeding after successful endoscopic therapy

BackgroundHigh dose intravenous proton pump inhibitor after endoscopic therapy for peptic ulcer bleeding has been recommended as adjuvant therapy. Whether oral proton pump inhibitor can replace intravenous proton pump inhibitor in this setting is unknown. This study aims to compare the clinical efficacy of oral and intravenous proton pump inhibitor after endoscopic therapy.MethodsPatients with high-risk bleeding peptic ulcers after successful endoscopic therapy were randomly assigned as oral lansoprazole or intravenous esomeprazole group. Primary outcome of the study was re-bleeding rate within 14 days. Secondary outcome included hospital stay, volume of blood transfusion, surgical intervention and mortality within 1 month.ResultsFrom April 2010 to Feb 2011, 100 patients were enrolled in this study. The re-bleeding rates were 4% (2/50) in the intravenous group and 4% (2/50) in the oral group. There was no difference between the two groups with regards to the hospital stay, volume of blood transfusion, surgery or mortality rate. The mean duration of hospital stay was 1.8 days in the oral lansoprazole group and 3.9 days in the intravenous esomeprazole group (p > 0.01).ConclusionPatients receiving oral proton pump inhibitor have a shorter hospital stay. There is no evidence of a difference in clinical outcomes between oral and intravenous PPI treatment. However, the study was not powered to prove equivalence or non-inferiority. Future studies are still needed.Trial registrationNCT01123031

Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial

BackgroundLow-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain.MethodsThis multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively.ResultsThe cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan–Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P < 0.0001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400–0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event.ConclusionLansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term NSAID therapy.Electronic supplementary materialThe online version of this article (doi:10.1007/s00535-012-0541-z) contains supplementary material, which is available to authorized users.

Lansoprazole for recurrent abdominal pain in adolescents

Background Recurrent abdominal pain is common among adolescents. School absenteeism and lower quality of life are associated with severity of symptoms. Lansoprazole has been used to treat recurrent abdominal pain.Objective To investigate the effectiveness of lansoprazole as a treatment for recurrent abdominal pain in adolescents.Methods We conducted a randomized, double-blind, controlled trial from August 2009 to October 2009. Adolescents suffering recurrent abdominal pain were eligible for the study. Simple randomization was done to divide subjects into two groups. Groups received 30 mg of lansoprazole or placebo, once a day for 14 days. Before treatment, we performed laboratory and physical examinations. Pain frequency was measured in number of abdominal pain episodes per month. Duration was measured in minutes and pain intensity was measured by a pain rating scale. Drug efficacy was measured before, during and after intervention. Data was analyzed using Mann-Whitney U-test and t-test.Results One hundred sixteen recurrent abdominal pain patients were randomized into two groups of 58 patients. There were no statistically significant differences in pain frequency before and after treatment for either the lansoprazole group or the placebo group (P=0.083, 95%CI, -0.033 to 0.021 and P=0.096, 95%CI -0.376 to 0.031, respectively). In addition, there were no significant differences in frequency, duration, and degree of abdominal pain at baseline and after 1, 2 and 3 months of treatment between the two groups.Conclusion Lansoprazole was not more effective than the placebo for treatment of recurrent abdominal pain among adolescents.

Levofloxacin Based Sequential and Triple Therapy Compared with Standart Plus Probiotic Combination for Helicobacter Pylori Eradication

Development of resistance to standard therapy for Helicobacter pylori (H. pylori) eradication is rapid. The aim of this study is to compare the efficacy of alternative treatment modalities for H. pylori. Compared treatments were standard triple treatment plus probiotic, sequential therapy with levofloxacin, and a 14-day regimen of PPI (proton pump inhibitor) and levofloxacin/amoxicillin combination. Overall 285 patients were enrolled in the study and allocated into three groups. Group I (n=98) received lansoprazole, clarithromycin, amoxicillin and saccharomyces boulardii (probiotic) and group II (n=95) received esomeprazole, levofloxacin and amoxicillin for 14 days. Finally, group III (n=92) received esomeprazole and amoxicillin for five days, followed by esomeprazole, levofloxacin and metronidazole for seven days. Testing for H. pylori infection post-treatment was done using a stool antigen test five weeks after the completion of therapy. Patients in all three groups were treatment-naive. Response to treatment (Per Protocol/ITT analysis) was 77.1/72.4% in Group I, 89.1/86.3% in Group II, and 95.5% in Group III. Response to treatment was significantly higher in Groups II and III compared to Group I (p=0.03 and p<0.001, respectively). There was no difference between Groups II and III in terms of response to treatment (p=0.1). Levofloxacin-based sequential therapy and levofloxacin based triple therapy were significantly superior to standard triple therapy plus probiotic.

Effect of lansoprazole versus roxatidine on prevention of bleeding and promotion of ulcer healing after endoscopic submucosal dissection for superficial gastric neoplasia

Proton pump inhibitors have been reported to be more useful than histamine-2 receptor antagonists for the prevention of bleeding after endoscopic submucosal dissection (ESD) for superficial gastric neoplasia. The aim of this study was to assess the effects of the proton pump inhibitor lansoprazole and the histamine-2 receptor antagonist roxatidine for the prevention of bleeding and the promotion of ulcer healing after ESD and to compare the cost-effectiveness of these two drugs. The study subjects were 129 patients who underwent ESD for superficial gastric neoplasia. The patients were randomly assigned to the lansoprazole group (L group) or the roxatidine group (R group). Either drug was administered intravenously from the morning of the ESD day to the day after the ESD, followed by oral treatment for an additional 8 weeks. A second-look endoscopy was performed on the day after the ESD, and a repeat endoscopy was performed at 8 weeks after the ESD. The incidence of bleeding and the ulcer-healing rate at 8 weeks after the ESD were analyzed, as well as the total cost of treatment with these antisecretory agents. Three patients in each group were excluded from the analysis, leaving 62 patients in L group and 61 in R group. Two of the 62 patients (3.2%) in L group and three of the 61 patients (4.9%) in R group showed bleeding after ESD ; there was no significant difference between the two groups (P = 0.68). The ulcer-healing rate was 93.5% (58/62) in L group and 93.4% (57/61) in R group (P = 1). The total cost of treatment with the antisecretory agent from the day of the ESD to day 56 after the ESD was Yen 13,212 for lansoprazole and Yen 5,841 for roxatidine. Roxatidine appears to have high cost-effectiveness in the prevention of bleeding and in the promotion of ulcer healing after ESD for superficial gastric neoplasia.

Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term low-dose aspirin therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial

BackgroundThe efficacy of low-dose lansoprazole has not been established for the prevention of recurrent gastric or duodenal ulcers in those receiving long-term low-dose aspirin (LDA) for cardiovascular and cerebrovascular protection. This study sought to examine the efficacy of low-dose lansoprazole (15 mg once daily) for the secondary prevention of LDA-associated gastric or duodenal ulcers.MethodsPatients were randomized to receive lansoprazole 15 mg daily (n = 226) or gefarnate 50 mg twice daily (n = 235) for 12 months or longer in a prospective, multicenter, double-blind, randomized active-controlled trial, followed by a 6-month follow-up study with open-label lansoprazole treatment. The study utilized 94 sites in Japan and 461 Japanese patients with a history of gastric or duodenal ulcers who required long-term LDA therapy for cardiovascular and cerebrovascular disease.ResultsThe primary endpoint was the development of gastric or duodenal ulcers. The cumulative incidence of gastric or duodenal ulcers on days 91, 181, and 361 from the start of the study was calculated by the Kaplan–Meier method as 1.5, 2.1, and 3.7%, respectively, in the lansoprazole group versus 15.2, 24.0, and 31.7%, respectively, in the gefarnate group. The risk of ulcer development was significantly (log-rank test, P < 0.001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.099 (95% confidence interval [CI] 0.042–0.230).ConclusionLansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term LDA therapy.Electronic supplementary materialThe online version of this article (doi:10.1007/s00535-011-0397-7) contains supplementary material, which is available to authorized users.

Effect of Jianpi Yiqi Qingyou decoction on lymphocyte subsets and IL-2 mRNA in gastric tissue in rats with chronic superficial gastritis

To investigate the effect of Jianpi Yiqi Qingyou decoction on lymphocyte subsets and IL-2 mRNA in gastric tissue in rats with chronic superficial gastritis. Wistar rats were randomly divided into 6 groups (11 for each): a blank control groups, the model of the control groups, the treatment groups (low-dose groups of traditional Chinese medicine, moderate-dose groups of traditional Chinese medicine, high-dose groups of traditional Chinese medicine) and lansoprazole groups. The models were made with the method in reference except a blank control groups. These rats are drinking freely with 0. 02% ammonia, continuous 90 days, and made preparations for experimental animal model of superficial gastritis. Making the model were detected by HE dying. The count of CD3+, CD4+ and CD8+ T cells were detected by immunohistochemistry. Using reverse transcriptase polymerase chain reaction (RT-PCR), the expression levels of IL-2 mRNA in gastric tissue were quantified. Compared with that in model groups, the content of CD3+ T cells and CD4+ T cells in gastric tissue obviously increased in high dose of traditional Chinese medicine groups , the content of CD8+ T cells in gastric tissue obviously decreased in high dose of traditional Chinese medicine groups and the difference was significant (P < 0.01). The expression levels of IL-2 mRNA in gastric tissue obviously increased in moderate and high doses of traditional Chinese medicine groups, and the difference was significant compared with that in model group (P < 0.01). Jianpi Yiqi Qingyou decoction can obviously improve the content of CD3+ T cells and CD4+ T cells and the expression levels of IL-2 mRNA, decrease the content of CD8+ T cells in gastric tissue, improve immunity of rats. So the research results can provide some evidences for the treatment for chronic superficial gastritis.

Effectiveness of ranitidine bismuth citrate and proton pump inhibitor based triple therapies of Helicobacter pylori in Turkey

Background: Helicobacter pylori infection is the main cause of gastritis, gastroduodenal ulcer disease, MALT lymphoma, and adenocarcinoma of the stomach. The reported prevalence of H. pylori in the adult population in Turkey is 67.6%–81.3%. A national meta-analysis showed that the average H. pylori eradication rate with proton pump inhibitor-based triple regimens in Turkey had decreased from 84% in 1997 to 55.3% in 2004, suggesting a need to evaluate alternative regimens.Materials and methods: The study was a prospective, single-center trial with a parallel group design. After the selection procedure, consecutive out-patients were assigned to one of six study groups using random sampling numbers. All patients received amoxicillin 1,000 mg b.i.d. and clarithromycin 500 mg b.i.d. along with ranitidine bismuth citrate 400 mg b.i.d., or omeprazole 20 mg b.i.d., or lansoprazole 30 mg b.i.d., or rabeprazole 20 mg b.i.d., or pantoprazole 40 mg b.i.d., or esomeprazole 40 mg b.i.d. for 14 days.Results: When we look at the eradication rates of the treatment groups, only two groups (ranitidine bismuth citrate and rabeprazole groups) had eradication rates greater than 80%, both at intention to treat and per protocol analyses. The other four groups (omeprazole, lansoprazole, pantoprazole, and esomeprazole groups) showed statistically significant lower eradication rates both at intention to treat (between 57.6 and 66.7%) and per protocol (between 60.3 and 72.1%) analyses when compared with ranitidine bismuth citrate and rabeprazole groups (p<.05).Conclusion: Ranitidine bismuth citrate and/or rabeprazole based triple therapies must be preferred for the first-line treatment of H. pylori infection.

Prospective, Randomized Comparison of Lansoprazole Suspension, and Intermittent Intravenous Famotidine on Gastric pH and Acid Production in Critically ill Neurosurgical Patients

There is a paucity of studies comparing stress ulcer prophylaxis (SUP) agents in high-risk neurosurgical patients. In this prospective, randomized study, critically ill neurosurgical patients received lansoprazole 30 mg suspension via NG/NJ tube daily or famotidine 20 mg IV q12 h for SUP. Gastric pH and residual volumes were recorded for 3 days and adverse events for 7 days after admission. There were 51 patients randomized to lansoprazole (n = 28) or famotidine (n = 23) who received SUP for ≥ 3 days. All patients had at least two risk factors for SRMD, and 75% had a baseline GCS < 9. On day 1 of therapy, more famotidine patients had a gastric pH ≥ 4 at least 80% of the time as compared to lansoprazole patients (74 vs. 36%, P = 0.01, respectively); however, there was no difference on days 2 and 3. Enteral feedings on day 1 predicted a pH ≥ 4 (P = 0.01). There were no significant differences in the percentages of time gastric residual volumes < 28 ml (P = NS). Heme-positive aspirates were present in 18-39% of patients (P = NS); one patient receiving famotidine met the criteria for overt bleeding. Thrombocytopenia occurred in 17% in the famotidine group and 4% in the lansoprazole group (P = NS). Neurosurgery ICU patients receiving famotidine for SUP achieved a gastric pH ≥ 4 more often than lansoprazole-treated patients, but only on day 1 of the 3-day study period. Both agents were equally effective in reducing gastric acid production. There was no difference in the incidence of mucosal damage and thrombocytopenia.

Treatment with a proton pump inhibitor improves glycaemic control in Psammomys obesus, a model of type 2 diabetes

Aims/hypothesisGastrin has been implicated in islet growth/neogenesis, and proton pump inhibitors (PPIs) have been shown to increase endogenous gastrin levels in animals and humans. Therefore, we investigated the effect of PPIs in a model of type 2 diabetes, Psammomys obesus.Methods P. obesus (morning blood glucose [mBG] 16.9 ± 0.6 mmol/l) were treated with vehicle or different doses (1–15 mg/kg) of lansoprazole for 17 days.ResultsTreatment with lansoprazole resulted in up to ninefold dose-dependent increases in endogenous gastrin levels (p < 0.05 for 10 mg/kg lansoprazole vs vehicle). There was a significant reduction in mBG levels in all animals in the high-dose lansoprazole groups during the 17 day treatment period, whereas there was no significant improvement in mBG in animals in the vehicle groups. The mBG at end of study was 18.2 ± 2.1, 8.7 ± 2.2 (p < 0.01), and 6.1 ± 2.3 (p < 0.001) mmol/l for vehicle and lansoprazole 10 and 15 mg/kg, respectively. The animals treated with 15 mg/kg lansoprazole, compared with vehicle, had a 2.3-fold increase in the intensity of insulin staining in beta cells (p=0.0002) and 50% higher beta cell mass (p=0.04).Conclusions/interpretationsThe PPI lansoprazole had significant glucose-lowering effects in an animal model of type 2 diabetes, an effect that is most likely mediated through an increase in endogenous gastrin levels.

Levofloxacin-based triple therapy for first-line Helicobacter pylori eradication treatment: a multi-central, randomized, controlled clinical study

To compare efficacy and tolerability of 7-day standard triple therapy versus 7-day levofloxacin-based triple therapy in first-line treatment for Helicobacter pylori (H. pylori) infection. Three hundred consecutive H.pylori positive patients were randomized to receive: clarithromycin, amoxicillin, lansoprazole (Group A: n = 150); or amoxicillin, levofloxacin, lansoprazole (Group B: n = 150). H. pylori status was rechecked by (13)C-urea breath test 4 weeks after the end of therapy. The eradication rates in intention to treat (ITT) and per protocol (PP) analyses were: Group A, 74.5% (111/149) and 78.2% (111/142); and Group B, 82.4% (122/148) and 83.0%(122/147). Although the eradication rate achieved with levofloxacin-based triple therapy was higher than that with standard therapies in either ITT or PP analysis, but no significantly difference was found between the two triple therapies. The incidence of side effects was similar among groups. A 7-day levofloxacin-based triple therapy can achieve higher H.pylori eradication rate than standard regimen. The levofloxacin-based regimen can be one effective therapy for the first-line anti-H.pylori treatment.

Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience

Dexlansoprazole MR is a dual delayed release formulation of dexlansoprazole, an enantiomer of lansoprazole. To assess safety of dexlansoprazole MR in phase 3 clinical trials. Data from 4270 patients receiving dexlansoprazole MR 30 mg (n = 455), 60 mg (n = 2311) or 90 mg (n = 1864); lansoprazole 30 mg (n = 1363); or placebo (n = 896) in six randomized controlled trials and a 12-month safety study were pooled. Safety was assessed via adverse events, vital signs, electrocardiograms, clinical laboratory results and gastric biopsies. Adverse events were summarized per 100 patient-months of exposure to account for imbalances in study drug exposure. The number of patients with > or =1 treatment-emergent adverse event per 100 patient-months was higher in placebo (24.49) and lansoprazole (21.06) groups than in any dexlansoprazole MR (15.64-18.75) group. Fewer patients receiving dexlansoprazole MR discontinued therapy because of an adverse event (P < or = 0.05 vs. placebo). Seven patients died of events considered unrelated to study drug. Mean serum gastrin rose in all groups except placebo; increases were not dose-related. No clinically concerning trends were seen in gastric biopsy results. Endocrine cell hyperplasia, dysplasia and neoplasia were not observed. Dexlansoprazole MR 30-90 mg has a safety profile comparable to that of lansoprazole.

Efficacy of a single 24‐hour pre‐anesthetic dose of proton pump inhibitors

The H(2) receptor antagonist roxatidine is routinely used as an oral pre-anesthetic medication in surgical patients at night and 2 h before surgery. In the present study, we have compared the effects of roxatidine, rabeprazole and lansoprazole given singly at night as an alternative to the standard double roxatidine medication. 120 adult patients undergoing urological surgery were randomly assigned to three groups: roxatidine, rabeprazole and lansoprazole (n = 40 each). Following induction of anesthesia, gastric fluid was obtained by aspiration using a syringe to measure pH and volume of gastric contents. Gastric volume (14.1 +/- 1.9 mL) in the lansoprazole group was significantly larger than that in roxatidine (8.6 +/- 1.7 mL) and rabeprazole (7.5 +/- 1.1 mL) groups (P < 0.05). Gastric pH in lansoprazole group (4.10 +/- 0.38) was also significantly lower than that in the roxatidine group (5.41 +/- 0.31, P < 0.05). The numbers of patients with critical factors for acid aspiration pneumonia (gastric pH < 2.5 or volume > 25 mL) in the lansoprazole group was significantly higher than in the roxatidine group (P < 0.05). Gastric pH and volume in all groups were constant even in the afternoon. Single rabeprazole (but not lansoperazole) medication may be a suitable alternative to standard roxatidine for prophylaxis of acid aspiration pneumonia.

Lansoprazole 15 mg Once Daily for 14 Days Is Effective for Treatment of Frequent Heartburn: Results of 2 Randomized, Placebo-Controlled, Double-Blind Studies

Objective: To investigate the efficacy and safety of a 14-day treatment period with lansoprazole 15 mg for frequent heartburn in patients who are likely to select a nonprescription medication before consulting a prescriber. Methods: Adults with untreated frequent heartburn ≥ 2 days a week over the past month were recruited for 2 identical multicenter, double-blind studies conducted with a 1-week screening and heartburn medication washout, a 1-week placebo run-in, a 2-week placebo-controlled treatment, and a 1-week placebo follow-up. After the washout and placebo run-in, subjects were randomly assigned to receive lansoprazole 15 mg or placebo once daily for 14 days in a double-blind fashion. Antacid tablets were permitted as rescue medication. Endpoints included percentage of 24-hour days without heartburn (primary), percentage of night-times without heartburn, and percentage of subjects without heartburn during day 1 of treatment (secondary endpoints). Data were collected daily via an interactive voice response system. Results: In studies 1 and 2, 282 and 288 subjects, respectively, were randomly assigned to lansoprazole, and 282 in each study received placebo. The mean percentage of days without heartburn was greater among lansoprazole recipients compared with placebo recipients (P < 0.0001). Significantly more subjects treated with lansoprazole also reported no night-time heartburn and no heartburn during day 1 of the 14-day treatment. Adverse events were infrequent and were similar for lansoprazole and placebo groups. Conclusion: During the 14-day treatment period in a population with frequent heartburn who were likely to select a medication without consulting a prescriber, lansoprazole 15 mg once daily showed rapid and sustained effectiveness throughout a 24-hour period and was well tolerated.

Intravenous lansoprazole in treating duodenal ulcer bleeding:a multi-center clinical trial

Objective To assess the efficacy and safety of intravenous infusion of lansoprazole in treating duodenal ulcer bleeding.Methods A multi-center,randomized,parallel-controlled,and positive-drug contrast clinical trial was conducted in 216 patients with endoscopic proved duodenal ulcer bleeding.The patients were randomly divided into lansoprazole group(n=110)and control group (n=106).Patients in lansoprazole group were intravenously received lansoprazole(Allwell)of 30 mg twice daily for 5 days,while those in control group were intravenously received omeprazole sodium (Losee)of 40 mg twice daily for 5 days.Results There were 212 cases qualified for analysis of efficacy and safety.The effective rate and response rate were 73.39 0A and 95.41%in lansoprazole group respectively,while they were 81.55%and 95.15%in control group,respectively(P＞0.05).Haemostatic time and haemostatic rate were(31.90±18.58)h and 98.17%in lansoprazole group respectively,while they were(28.00±18.31)h and 99.03%in control group,respectively(P＞0.05).The major adverse events were leucopenia,slight elevated transaminase and rach(P＞0.05).Conclusion Intravenous lansoprazole is a safe and effective drug for treatment of duodenal ulcer bleeding. Key words: Duodenal ulcer; Bleeding; Lansoprazole

On‐demand requirements of patients with endoscopy‐negative gastro‐oesophageal reflux disease: H2‐blocker vs. proton pump inhibitor

It is questionable whether a symptomatic condition with few serious medical consequences requires proton pump inhibitor (PPI) treatment. If effective, a less-potent treatment may be preferable. To compare an H2-blocker in an effervescent formulation with a PPI in on-demand treatment of endoscopy-negative gastro-oesophageal reflux disease (GERD). Included were patients with heartburn and/or acid regurgitation for at least 3 months duration, a negative endoscopy and a positive response to 7 days of lansoprazole 60 mg daily. Following pH-metry, the patients were randomized to receive either ranitidine effervescent tablets 75 mg or lansoprazole capsules 15 mg to a maximum of four per day on-demand. The numbers taken were registered monthly for 6 months. If treatment was unsuccessful (lack of efficacy or side effects), patients were registered as failures. One hundred and three patients were included and 63 were considered for statistical analysis; 32 on lansoprazole and 31 on ranitidine. Seventeen (55%) on ranitidine and four (13%) on lansoprazole failed. The average number of tablets per day was 1.2 in the lansoprazole group and 3.1 in the ranitidine group. On-demand treatment in patients with endoscopy-negative GERD gives a high success rate with a fairly low dose of PPI. The H2-blocker had significantly less success; nevertheless, almost half were satisfied with the treatment.