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

ABSTRACT: 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.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.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).Following endoscopic haemostasis, infusional pantoprazole at either 192 mg day(-1) or 40 mg every 6 h appear similar.

SUBMITTER: Hsu YC

PROVIDER: S-EPMC2829694 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature

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

Hsu Yao-Chun YC Perng Chin-Lin CL Yang Tzeng-Huey TH Wang Chaur-Shine CS Hsu Wei-Lun WL Wu Huei-Tang HT Cheng Yang-Chih YC Chiang Ming-Feng MF Lin Hwai-Jeng HJ

British journal of clinical pharmacology 20100301 3

<h4>Aim</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 20233195

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Project description:Background:Peptic ulcer disease is common with a lifetime prevalence in the general population of 5-10% and an incidence of 0.1-0.3% per year. Despite a sharp reduction in incidence and rates of hospital admission and mortality over the past 30?years, complications are still encountered in 10-20% of these patients. Peptic ulcer disease remains a significant healthcare problem, which can consume considerable financial resources. Management may involve various subspecialties including surgeons, gastroenterologists, and radiologists. Successful management of patients with complicated peptic ulcer (CPU) involves prompt recognition, resuscitation when required, appropriate antibiotic therapy, and timely surgical/radiological treatment. Methods:The present guidelines have been developed according to the GRADE methodology. To create these guidelines, a panel of experts was designed and charged by the board of the WSES to perform a systematic review of the available literature and to provide evidence-based statements with immediate practical application. All the statements were presented and discussed during the 5th WSES Congress, and for each statement, a consensus among the WSES panel of experts was reached. Conclusions:The population considered in these guidelines is adult patients with suspected complicated peptic ulcer disease. These guidelines present evidence-based international consensus statements on the management of complicated peptic ulcer from a collaboration of a panel of experts and are intended to improve the knowledge and the awareness of physicians around the world on this specific topic. We divided our work into the two main topics, bleeding and perforated peptic ulcer, and structured it into six main topics that cover the entire management process of patients with complicated peptic ulcer, from diagnosis at ED arrival to post-discharge antimicrobial therapy, to provide an up-to-date, easy-to-use tool that can help physicians and surgeons during the decision-making process.

Project description:Background:A recent prospective randomised controlled trial ('STING') showed superiority of over-the-scope clips compared to standard treatment in recurrent peptic ulcer bleeding. Cost-effectiveness studies on haemostasis with over-the-scope clips have not been reported so far. Objective:The aim of this study was to investigate whether the higher efficacy of the over-the-scope clips treatment outweighs the higher costs of the device compared to standard clips. Methods:For the analysis, the study population of the STING trial was used. Costs for the hospital stay in total as well as treatment-related costs were obtained. The average cost-effectiveness ratio, representing the mean costs per designated outcome, and the incremental cost-effectiveness ratio, expressing the additional costs of a new treatment strategy per difference in outcome were calculated. The designated outcome was defined as successful haemostasis without rebleeding within seven days, which was the primary endpoint of the STING trial. Average cost-effectiveness ratio and incremental cost-effectiveness ratio were calculated for total costs of the hospital stay as well as the haemostasis treatment alone. The cost-effectiveness analysis is taken from the perspective of the care provider.Results: Total costs and treatment-related costs per patient were 13,007.07?€ in the standard group vs 12,808.56?€ in the over-the-scope clip group (p?=?0.812) and 2084.98?€ vs 1984.71?€ respectively (p?=?0.663). The difference was not statistically significant. Total costs per successful haemostasis (average cost-effectiveness ratio) were 30,677.05?€ vs 15,104.43?€ and 4917.41?€ vs 2340.46?€ for the haemostasis treatment. The additional costs per successful haemostasis with over-the-scope clip treatment (incremental cost-effectiveness ratio) is -468.18?€ for the whole treatment and -236.49€ for the haemostasis treatment. Conclusions:Over-the-scope clip treatment is cost-effective in recurrent peptic ulcer bleeding.

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

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

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