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Low Dose Bolus Pantoprazole Following Succesful Endoscopic Treatment for Acute Peptic Ulcer Bleeding Is Effective: A Randomised, Prospective, Double-Blind, Double Dummy Pilot Study

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Journal Gastroenterology
Year 2013
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This article is included in 1 Systematic review Systematic reviews (1 reference) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND/AIMS: Proton pump inhibitors has high efficacy in alone or with endoscopic intervention for peptic ulcer bleeding (PUB). However, the dose and treatment duration of PPIs needed to prevent re-bleeding are not well established. Our aim is to compare highdose infusion of pantoprazole (standard treatment) and low-dose bolus pantoprazole in patients given endoscopic treatment for control of PUB. METHODS: This study was a singlecenter, prospective, randomized, double-blind, double-dummy, comparative pilot study. The Ethics Committee of Mersin University approved this study and all patients provided written informed consent. Patients admitted with PUB in which the bleeding was controlled by endoscopic intervention (sclerotherapy with epinephrine) were randomized to a highdose group (Pantoprazole 80 mg IV bolus followed by 8 mg/h IV infusion for 72 h) or a low dose group (Pantoprazole 80 mg IV bolus followed by 40 mg IV bolus every 12 h for 72 h). A double-dummy technique was used to keep the patients blinded, so all patients in the low-dose group received isotonic saline infusion for 3 days as placebo. After 3 days of treatment, all patients were given oral Pantoprazole (40 mg bid) until day-30. The primary endpoints were early re-bleeding (within 72 h), need for blood transfusion, surgery due to bleeding, mortality, and duration of hospitalization. Cost of treatment was also determined. RESULTS: Total 73 patients enrolled the study. There were 36 patients in the high-dose group and were 37 patients in the low-dose group. There were no significant differences between the two treatment groups in age, gender, reason for admission, presence of comorbid diseases, Hb level at admission, drug use, smoking, alcohol use, and Rockall score. Re-bleeding occurred in 10 patients (27.8%) in the high-dose group and in 3 patients (8.1%) in the low-dose group (p = 0.028). The mean blood transfusion dose was 4.5±4.2 units in the high dose group and 2.5±2.2 units in the low dose group (p = 0.040). Rate of surgery (2/ 1), and mortality (3/2), and duration of hospitalization (5.6±3.4 days/5.0±5.2 days) were similar in the two groups (p-values of 0.536, 0.710, and 0.575, respectively). The cost of pantoprazole per patient was 252.62 Turkish Liras (168.41 USD) in the high-dose group and 104.02 Turkish Liras (69.30 USD) in the low-dose group. There was no side effect related to any pantoprazol medications. CONCLUSIONS: Low-dose pantoprazole treatment after successful endoscopic therapy in PUB was as effective as high-dose. Also there was less rebleeding, and need for transfusion in low-dose group. The low-dose treatment had lower costs and was easier to administer. Thus, low-dose bolus pantoprazole administration following successful endoscopic therapy should be considered for treatment of PUB

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Randomized controlled trial of high dose bolus versus continuous intravenous infusion pantoprazole as an adjunct therapy to therapeutic endoscopy in massive bleeding peptic ulcer.

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Authors Yamada S , Wongwanakul P
Journal Journal of the Medical Association of Thailand = Chotmaihet thangphaet
Year 2012
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This article is included in 1 Systematic review Systematic reviews (1 reference) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND: After therapeutic endoscopy is performed in high-risk patients with peptic ulcer bleeding, rebleeding occurs in about 25 to 30%. High dose intravenous proton pump inhibitors (PPI) have been recommended for the use in high-risk patients to prevent rebleeding following successful therapeutic endoscopy. OBJECTIVE: Compare the efficacy between pantoprazole high dose bolus injections and continuous intravenous infusion to prevent rebleeding in peptic ulcer patients after initial hemostasis is achieved by the therapeutic endoscopy. MATERIAL AND METHOD: A clinical block randomized control trial was conducted at Maharaj Nakorn Chiang Mai Hospital in massive peptic ulcer bleeding patients. All patients underwent endoscopic diagnosis and treatment within six hours of admission. Hemostasis was achieved by therapeutic endoscopy in 28 patients who received 80 mg pantoprazole as a loading dose before intervention. They were randomized into two groups. The first group was given a high dose of pantoprazole, 40 mg bolus injections twice daily for seven days (n = 13). The second group was given continuous intravenous infusion of pantoprazole, 8 mg per hour for the first three days, followed with a 40 mg bolus injection twice daily similar to the first group from day 4 until day 7 (n = 15). After the seventh day, both groups were given 20 mg of oral pantoprazole once daily for two months. The data was analyzed by Fisher's exact test to compare the frequency of rebleeding within seven days after therapeutic endoscopy. RESULTS: The frequency of recurrent bleeding between the high dose pantoprazole bolus injection group and the continuous intravenous infusion group was not significantly different, 30.8% and 33.3% respectively (p = 1.0). Three patients in the high dose bolus group and five in the continuous infusion group underwent surgery (p = 0.68). There was no statistically significant difference between the two groups by volume of blood transfusion, length of hospital stay, or mortality. CONCLUSION: In the present study, both PPI drug administration methods showed an equally effective for massive peptic ulcer bleeding. Further studies with a larger sample size are recommended.

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

Authors Yen HH , Yang CW , Su WW , Soon MS , Wu SS , Lin HJ
Journal BMC gastroenterology
Year 2012
Links Pubmed DOI PubMed Central

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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BACKGROUND: High 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. METHODS: Patients 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. RESULTS: From 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). CONCLUSION: Patients 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 REGISTRATION: NCT01123031.

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Randomised clinical trial: high-dose vs. standard-dose proton pump inhibitors for the prevention of recurrent haemorrhage after combined endoscopic haemostasis of bleeding peptic ulcers.

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Journal Alimentary pharmacology & therapeutics
Year 2012
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This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND: The optimal dosage of intravenous proton pump inhibitors (PPIs) for the prevention of peptic ulcer rebleeding remains unclear. AIM: To compare the rebleeding rate of high-dose and standard-dose PPI use after endoscopic haemostasis. METHODS: A total of 201 patients with bleeding ulcers undergoing endoscopic treatment with epinephrine injection and heater probe thermocoagulation were randomised to receive a high-dose regimen (80 mg bolus, followed by pantoprazole 8 mg/h infusion, n = 100) or a standard-dose regimen (pantoprazole 40 mg bolus daily, n = 101). After 72 h, all patients were given 40 mg pantoprazole daily orally for 27 days. RESULTS: There were no statistical differences in mean units of blood transfused, length of hospitalisation ≦5 days, surgical or radiological interventions and mortality within 30 days between two groups. Bleeding recurred within 30 days in six patients [6.2%, 95% confidence interval (CI) 1.3-11.1%] in the high-dose group, as compared to five patients (5.2%, 95% CI 0.6-9.7%) in the standard-dose group (P = 0.77). The stepwise Cox regression analysis showed end-stage renal disease, haematemesis, chronic obstructive pulmonary disease (hazard ratio: 37.15, 10.07, 9.12, 95% CI: 6.76-204.14, 2.07-49.01, 1.66-50.00 respectively) were independent risk factors for rebleeding and Helicobacter pylori infection was associated with lower risk of rebleeding (hazard ratio: 0.20, 95% CI: 0.04-0.94). CONCLUSIONS: Following combined endoscopic haemostasis of bleeding ulcers, co-morbidities, haematemesis and H. pylori Status, but not PPI dosage, are associated with rebleeding (http://www.Clinical Trials.gov.ID: NCT00709046).

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1079 Effects of Intravenous and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy

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Journal Gastroenterology
Year 2012
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This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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OBJECTIVES: The use of intravenous proton-pump inhibitors (PPIs) has shown to reduce recurrent bleeding and improve patient outcome after endoscopic hemostasis on patients with peptic ulcer. However, the efficacy of oral PPI is uncertain. Studies from Asia indicated that even oral PPI can achieve the same therapeutic effect. This study is designed to compare the efficacy of high-dose intravenous PPI to oral PPI in preventing recurrent bleeding after endoscopic hemostasis. METHODS: This is a single-center, randomized-controlled, double-blind, and double-dummy study. Patients had Forrest IA/IB or IIA/IIB peptic ulcer bleeding and received endoscopic hemostasis before recruitment into the study. They were randomized to receive either (i) esomeprazole IV bolus at a dose of 80 mg plus infusion at 8 mg/h for 72 h and oral placebo every 12 h (IVP group), or (ii) IV placebo bolus plus infusion for 72 h and high-dose oral esomeprazole at a dose of 40 mg every 12 h (ORP group). Patients were followed up for 30 days after index bleeding. The primary end point was defined as the 30-day recurrent bleeding after successful endoscopic hemostasis. RESULTS: A total of 118 patients were randomized to the IVP group and 126 to the ORP group in this study. In all, 39.8% in the IVP and 42.9% in the ORP group used non-steroidal anti-inflammatory drug and/or aspirin before bleeding. In the IVP group (vs. ORP), Forrest IA represented 1.7% (5.6%), IB 41.5% (38.1%), IIA 52.5% (50.8%), and IIB 4.2% (5.6%). Recurrent bleeding in 30 days was reported in 7.7% of patients in the IVP group and 6.4% of patients in the ORP group, and the difference of recurrent bleeding was −1.3% (95% CI: −7.7%, 5.1%). There was no difference in blood transfusion, repeated endoscopic therapy, and hospital stay between the two groups. CONCLUSIONS: High-dose oral esomeprazole at 40 mg BID may be considered as a useful alternative to IV bolus plus infusion of esomeprazole in the management of ulcer bleeding in patients who are not candidates for high-dose IV infusion. However, as this study was stopped prematurely and was not designed as an equivalency trial, a much larger study would be necessary to document whether there is equivalency or non-inferiority of the two treatments in a heterogeneous patient population.

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Effect of high-dose oral rabeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers

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Journal Gastroenterology research and practice
Year 2012
Links Pubmed DOI PubMed Central

This article is included in 1 Systematic review Systematic reviews (1 reference) 1 Broad synthesis Broad syntheses (1 reference)

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Background. The aim of this study was to compare the effect of high-dose oral rabeprazole versus high-dose IV PPI on rebleeding after endoscopic treatment of bleeding peptic ulcers. Methods. This was a two-center, prospective, randomized, controlled trial. Patients with a high-risk bleeding peptic ulcer had endoscopic hemostasis and were randomly assigned to the high-dose oral rabeprazole group (20 mg twice daily for 72 hours) or the high-dose IV omeprazole group (80 mg as a bolus injection followed by continuous infusion at 8 mg/h for 72 hours). Results. The study was stopped because of slow enrollment (total n = 106). The rebleeding rates within 3 days were 3.7% (2 of 54 patients) given oral rabeprazole and 1.9% (1 of 52 patients) given IV omeprazole (P = 1.000). The rebleeding rates after 3 days were 1.9% and 0% (P = 1.000), respectively. The surgical intervention rates were 3.7% and 0% (P = 0.495), and the mortality rates were 1.9% and 0% (P = 1.000), respectively. Conclusions. The effect of high-dose oral rabeprazole did not differ significantly from that of high-dose IV omeprazole on rebleeding, surgical intervention, or mortality after endoscopic treatment of bleeding peptic ulcers, but this requires further evaluation. Copyright © 2012 Hyung-Keun Kim et al.

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Comparison of oral and intravenous proton pump inhibitor on patients with high risk bleeding peptic ulcers: a prospective, randomized, controlled clinical trial.

Journal Iranian Red Crescent medical journal
Year 2011
Links Pubmed DOI PubMed Central

This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND: Proton pump inhibitors (PPIs) decrease the rate of rebleeding following endoscopic hemostatic therapy in patients with bleeding peptic ulcers. This study compares the efficacy of oral omeprazole vs intravenous pantoprazole in decrease of rebleeding of peptic ulcer patients. METHODS: One hundred and six patients with high risk peptic ulcer were randomized to receive either oral omeprazole (80 mg BID for 3 days) or IV pantoprazole (80 mg bolus and 8 mg/hour infusion for 3 days) followed by omeprazole (20 mg each day for 30 days). All patients underwent upper endoscopy and endoscopic therapy within 24 hours. RESULTS: Seventeen patients were excluded from the study. Forty four patients were randomly allocated into omeprazole group and 41 patients to IV pantoprazole group. Both groups were similar for factors affecting the outcome. Bleeding reoccurred in five patients of omeprazole group and four patients in pantoprazole group (11.4% vs 9.8 %). The mean hospital stay and blood transfusion were not different in both groups. CONCLUSION: Oral omeprazole and IV pantoprazole had equal effects on prevention of rebleeding after endoscopic therapy in patients with high risk bleeding peptic ulcers.

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Randomized controlled trial of standard versus high-dose intravenous omeprazole after endoscopic therapy in high-risk patients with acute peptic ulcer bleeding.

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Authors Chan WH , Khin LW , Chung YF , Goh YC , Ong HS , Wong WK
Journal The British journal of surgery
Year 2011
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This article is included in 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Rebleeding from peptic ulcers is a major contributor to death. This study compared standard (40-mg intravenous infusion of omeprazole once daily for 3 days) and high-dose (80-mg bolus of omeprazole followed by 8-mg/h infusion for 72 h) in reducing the rebleeding rate (primary endpoint), need for surgery, duration of hospital stay and mortality in patients with peptic ulcer bleeding after successful endoscopic therapy. METHODS: This was a single-institution prospective randomized controlled study based on a postulated therapeutic equivalence of the two treatments. All patients who had successful endoscopic haemostasis of a bleeding peptic ulcer (Forrest classification Ia, Ib, IIa or IIb) were recruited. Informed consent was obtained and patients were randomized to receive standard- or high-dose infusions of intravenous omeprazole. RESULTS: Two (3 per cent) of 61 patients in the high-dose group and ten (16 per cent) of 61 in the standard-dose group exhibited rebleeding, a difference of - 13 (95 per cent confidence interval - 25 to - 2) per cent. The upper limit of the one-sided confidence interval exceeded a predefined equivalence absolute difference of 16 per cent. Equivalence of standard- and high-dose omeprazole in preventing rebleeding was not demonstrated. CONCLUSION: Intravenous standard-dose omeprazole was inferior to high-dose omeprazole in preventing rebleeding after endoscopic haemostasis for peptic ulcer bleeding. REGISTRATION NUMBER: NCT00519519 (http://www.clinicaltrials.gov).

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A randomized controlled trial comparing two different dosages of infusional pantoprazole in peptic ulcer bleeding

Journal British journal of clinical pharmacology
Year 2010
Links Pubmed DOI PubMed Central

This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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Aim: The optimal dosage of proton pump inhibitor in bleeding peptic ulcers remains controversial. The aim was to compare the clinical effectiveness of two doses of infusional pantoprazole in peptic ulcer bleeding. Methods: Peptic ulcer patients (n = 120) with bleeding stigmata were enrolled after successful endoscopic therapy. After an initial bolus injection of 80 mg pantoprazole, patients were randomized to receive continuously infused pantoprazole at either 192 mg day-1 or 40 mg every 6 h (i.e. 160 mg day-1) for 3 days. Clinical outcomes between the two groups within 14 days were compared, with 14-day recurrent bleeding regarded as the primary end-point. Results: Both groups (n = 60 each) were well matched in demographic and clinical factors upon entry. Bleeding totally recurred in 11 (9.2%) patients, with six (10%) in the 192 mg day-1 group and five (8.3%) in the 160 mg day-1 group (relative risk of bleeding recurrence between two treatments 1.2; 95% CI 0.39, 3.72). All secondary outcomes between the two groups were similar, including the amount of blood transfusion (mean 1179 ml vs. 1203 ml, P > 0.1), hospital stay (mean 9.5 days vs. 9.9 days, P > 0.1), need for surgery (n = 1 vs. n = 0, P > 0.1), and mortality (n = 1 vs. n = 0, P > 0.1). Conclusions: Following endoscopic haemostasis, infusional pantoprazole at either 192 mg day-1 or 40 mg every 6 h appear similar. © 2010 The British Pharmacological Society.

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Optimal dose of intravenous pantoprazole in patients with peptic ulcer bleeding requiring endoscopic hemostasis in Korea

Journal Journal of gastroenterology and hepatology
Year 2009
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This article is included in 3 Systematic reviews Systematic reviews (3 references) 2 Broad syntheses Broad syntheses (2 references)

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Background and Aim: The lowest effective dose of proton pump inhibitors (PPI) for prevention of peptic ulcer rebleeding remains unclear. The objective of the present study was to evaluate whether low-dose PPI has a similar efficacy to high-dose i.v. administration for maintaining intragastric pH above 6. Methods: Sixty-one patients with bleeding ulcers were randomized into one of three groups after endoscopic hemostasis: pantoprazole 80 mg bolus followed by 8 mg/h; 40 mg, 4 mg/h infusion; and bolus injection of 40 mg every 24 h. Intragastric pH values and rebleeding rates were measured. In addition, pharmacokinetic parameters and association with CYP2C19 polymorphisms and H. pylori infection were assessed. Results: Mean percentage of time with intragastric pH > 6, and the proportion of patients with pH > 6 for more than 60% of the time were significantly higher in the 40 mg, 4 mg/h infusion group compared to the 40 mg bolus injection. There was no significant difference between the 80 mg, 8 mg/h and the 40 mg, 4 mg/h groups. In the H. pylori (-) group, only 40% of patients that received continuous infusion reached the target pH > 6 for more than 60% of the time; this was significantly lower than the H. pylori (+) group, 87.5% (P = 0.026). Conclusions: A continuous infusion, regardless of high or low dose, was more effective for acid suppression than a 40 mg bolus PPI injection in Korea. H. pylori infection was an important factor for the maintenance of an intragastric pH > 6. © 2009 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd.