Clipping Over the Scope for Recurrent Peptic Ulcer Bleeding is Cost-Effective as Compared to Standard Therapy: An Initial Assessment.

Clipping over the scope (C-OTS) is a novel closure technique used for the treatment of nonvariceal gastrointestinal bleeding, especially for high-risk lesions. C-OTS devices cost more than clipping through the scope and thermal devices. The high upfront cost of C-OTS may pose a barrier to its use and the cost-effectiveness of C-OTS for peptic ulcer disease bleeding is unknown. Cost-effectiveness studies of C-OTS for peptic ulcer bleeding as both first-line and second-line therapy can provide the current estimate of the conditions in which the use of C-OTS is cost-effective and give insights of the determinants to the cost-effectiveness of C-OTS.

Timing or Dosing of Intravenous Proton Pump Inhibitors in Acute Upper Gastrointestinal Bleeding Has Low Impact on Costs.

OBJECTIVES: High-dose intravenous proton pump inhibitors (PPIs) post endoscopy are recommended in non-variceal upper gastrointestinal bleeding (UGIB), as they improve outcomes of patients with high-risk lesions. Determine the budget impact of using different PPI regimens in treating non-variceal UGIB, including pre- and post-endoscopic use, continuous infusion (high dose), and intermittent bolus (twice daily) dosing. METHODS: A budget impact analysis using a decision model informed with data from the literature adopting a US third party payer's perspective with a 30-day time horizon was used to determine the total cost per patient (US$2014) presenting with acute UGIB. The base-case employing high-dose pre- and post-endoscopic IV PPI was compared with using only post-endoscopic PPI. For each, continuous or intermittent dosing regimens were assessed with associated incremental costs. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: The overall cost per patient is $11,399 when high-dose IV PPIs are initiated before endoscopy. The incremental costs are all inferior in alternate-case scenarios: $106 less if only post-endoscopic high-dose IVs are used; with intermittent IV bolus dosing, the savings are $223 if used both pre and post endoscopy and $191 if only administered post endoscopy. Subgroup analysis suggests cost savings in patients with clean-base ulcers who are discharged early after endoscopy. Results are robust to sensitivity analysis. CONCLUSIONS: The incremental costs of using different IV PPI regimens are modest compared with total per patient costs.

Stress ulcer prophylaxis with a proton pump inhibitor versus placebo in critically ill patients (SUP-ICU trial): study protocol for a randomised controlled trial.

BACKGROUND: Critically ill patients in the intensive care unit (ICU) are at risk of clinically important gastrointestinal bleeding, and acid suppressants are frequently used prophylactically. However, stress ulcer prophylaxis may increase the risk of serious adverse events and, additionally, the quantity and quality of evidence supporting the use of stress ulcer prophylaxis is low. The aim of the SUP-ICU trial is to assess the benefits and harms of stress ulcer prophylaxis with a proton pump inhibitor in adult patients in the ICU. We hypothesise that stress ulcer prophylaxis reduces the rate of gastrointestinal bleeding, but increases rates of nosocomial infections and myocardial ischaemia. The overall effect on mortality is unpredictable. METHODS/DESIGN: The SUP-ICU trial is an investigator-initiated, pragmatic, international, multicentre, randomised, blinded, parallel-group trial of stress ulcer prophylaxis with a proton pump inhibitor versus placebo (saline) in 3350 acutely ill ICU patients at risk of gastrointestinal bleeding. The primary outcome measure is 90-day mortality. Secondary outcomes include the proportion of patients with clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection or myocardial ischaemia, days alive without life support in the 90-day period, serious adverse reactions, 1-year mortality, and health economic analyses. The sample size will enable us to detect a 20 % relative risk difference (5 % absolute risk difference) in 90-day mortality assuming a 25 % event rate with a risk of type I error of 5 % and power of 90 %. The trial will be externally monitored according to Good Clinical Practice standards. Interim analyses will be performed after 1650 and 2500 patients. CONCLUSION: The SUP-ICU trial will provide high-quality data on the benefits and harms of stress ulcer prophylaxis with a proton pump inhibitor in critically ill adult patients admitted in the ICU. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02467621 .

Risk Factors Associated with Mortality and Increased Drug Costs in Nonvariceal Upper Gastrointestinal Bleeding.

BACKGROUND/AIMS: To determine risk factors associated with mortality and increased drug costs in patients with nonvariceal upper gastrointestinal bleeding. METHODOLOGY: We retrospectively analyzed data from patients hospitalized with nonvariceal upper gastrointestinal bleeding between January 2001-December 2011. Demographic and clinical characteristics and drug costs were documented. Univariate analysis determined possible risk factors for mortality. Statistically significant variables were analyzed using a logistic regression model. Multiple linear regression analyzed factors influencing drug costs. p < 0.05 was considered statistically significant. RESULTS: The study included data from 627 patients. Risk factors associated with increased mortality were age > 60, systolic blood pressure<100 mmHg, lack of endoscopic examination, comorbidities, blood transfusion, and rebleeding. Drug costs were higher in patients with rebleeding, blood transfusion, and prolonged hospital stay. CONCLUSION: In this patient cohort, re-bleeding rate is 11.20% and mortality is 5.74%. The mortality risk in patients with comorbidities was higher than in patients without comorbidities, and was higher in patients requiring blood transfusion than in patients not requiring transfusion. Rebleeding was associ-ated with mortality. Rebleeding, blood transfusion, and prolonged hospital stay were associated with increased drug costs, whereas bleeding from lesions in the esophagus and duodenum was associated with lower drug costs.

Use of proton pump inhibitors for the provision of stress ulcer prophylaxis: clinical and economic consequences.

The provision of stress ulcer prophylaxis (SUP) for the prevention of clinically significant bleeding is widely recognized as a crucial component of care in critically ill patients. Nevertheless, SUP is often provided to non-critically ill patients despite a risk for clinically significant bleeding of roughly 0.1 %. The overuse of SUP therefore introduces added risks for adverse drug events and cost, with minimal expected benefit in clinical outcome. Historically, histamine-2-receptor antagonists (H2RAs) have been the preferred agent for SUP; however, recent data have revealed proton pump inhibitors (PPIs) as the most common modality (76 %). There are no high quality randomized controlled trials demonstrating superiority with PPIs compared with H2RAs for the prevention of clinically significant bleeding associated with stress ulcers. In contrast, PPIs have recently been linked to several adverse effects including Clostridium difficile diarrhea and pneumonia. These complications have substantial economic consequences and have a marked impact on the overall cost effectiveness of PPI therapy. Nevertheless, PPI use remains widespread in patients who are at both high and low risk for clinically significant bleeding. This article will describe the utilization of PPIs for SUP and present the clinical and economic consequences linked to their use/overuse.

Increased mortality with peptic ulcer bleeding in patients with both compensated and decompensated cirrhosis.

BACKGROUND: Cirrhosis is associated with worse outcomes in peptic ulcer bleeding (PUB). There are no population-based studies from the United States on the impact of cirrhosis on PUB outcomes. OBJECTIVE: To investigate the impact of cirrhosis on outcomes of patients with PUB. DESIGN: Cross-sectional study. SETTING: Nationwide Inpatient Sample 2009. PATIENTS: International Classification of Diseases, the 9th revision, codes were used to identify patients with PUB and cirrhosis. The control group was patients with PUB without cirrhosis. MAIN OUTCOME MEASUREMENTS: In-hospital mortality, length of stay, and hospitalization costs. RESULTS: A total of 96,887 discharges with PUB as a diagnosis were identified-3574 with PUB and cirrhosis and 93,313 with PUB alone without cirrhosis. Mortality of PUB with concomitant cirrhosis was higher than in the control group without cirrhosis (5.5% vs 2%; P = .01); decompensated cirrhosis had higher mortality than did compensated cirrhosis (6.6% vs 3.9%; P = .01). In multivariate analysis, the presence of cirrhosis independently increased mortality (adjusted odds ratio (aOR) 3.3; 95% confidence interval [CI], 2.2-4.9). Stratified analysis showed that decompensated cirrhosis (aOR 4.4; 95% CI, 2.6-7.3) had higher mortality than compensated cirrhosis (aOR 1.9; 95% CI, 1.04-3.6). There was no difference in the proportion of patients who underwent endoscopy within 24 hours (51.9% vs 51.1%; P = .68) between those with cirrhosis and controls. Patients with cirrhosis received less surgical intervention (aOR 0.8; 95% CI, 0.6-0.9) compared with controls. Hospitalization costs also were increased in patients with decompensated cirrhosis. LIMITATIONS: Administrative data set. CONCLUSION: Both decompensated and compensated cirrhosis are associated with increased mortality in patients with PUB.

End-stage renal disease is associated with worse outcomes in hospitalized patients with peptic ulcer bleeding.

BACKGROUND: Patients with end-stage renal disease (ESRD) are at increased risk of peptic ulcer bleeding (PUB). To our knowledge, there are no population-based studies of the impact of ESRD on PUB. OBJECTIVE: To determine nationwide impact of ESRD on outcomes of hospitalized patients with PUB. DESIGN: Cross-sectional study. SETTING: Hospitals from a 2008 Nationwide Inpatient Sample. PATIENTS: We used the International Classification of Diseases, the 9th Revision, Clinical Modification codes to identify patients who had a primary discharge diagnosis of PUB. MAIN OUTCOME MEASUREMENT: In-hospital mortality, length of stay, and hospitalization charges. INTERVENTIONS: Comparison of PUB outcomes in patients with and without ESRD. RESULTS: Of a total of 102,525 discharged patients with PUB, 3272 had a diagnosis of both PUB and ESRD, whereas 99,253 had a diagnosis of PUB alone without ESRD. The mortality of ESRD patients with PUB was significantly higher than that of the control group without ESRD (4.8% vs 1.9%, P < .0001). On multivariate analysis, patients with PUB and ESRD had greater mortality than patients admitted to the hospital with PUB alone (adjusted odds ratio [aOR] 2.1; 95% confidence interval [CI], 1.3-3.4), were more likely to undergo surgery (aOR 1.4; 95% CI, 1.2-1.7), and had a longer hospital stay (aOR 2.1; 95% CI, 1.2-2.9). These patients also incurred higher hospitalization charges ($54,668 vs $32,869, P < .01) compared with patients with PUB alone. LIMITATIONS: Administrative data set. CONCLUSIONS: ESRD is associated with a significant health care burden in hospitalized patients with PUB. The presence of ESRD contributes to a higher mortality rate, longer hospital stay, and increased need for surgery.

Intravenous esomeprazole: a pharmacoeconomic profile of its use in the prevention of recurrent peptic ulcer bleeding.

Intravenous esomeprazole (Nexium®) is approved in Europe for the prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. In a pivotal clinical trial, patients with peptic ulcer bleeding and high-risk stigmata who received intravenous esomeprazole for 72 hours following endoscopic haemostatic therapy were significantly less likely than those receiving intravenous placebo to experience recurrent peptic ulcer bleeding at days 3, 7 and 30. In addition, the need for repeat endoscopic haemostatic therapy, the total amount of blood transfused and the number of additional hospital days required because of rebleeding were significantly lower in intravenous esomeprazole recipients than in intravenous placebo recipients. All patients received oral esomeprazole for 27 days following intravenous study drug administration. Intravenous esomeprazole was generally well tolerated in the pivotal trial, with infusion-site reactions being among the most commonly reported adverse events. Two pharmacoeconomic analyses conducted from a healthcare payer perspective used decision-tree models with 30-day time horizons to examine the cost effectiveness and cost utility of intravenous esomeprazole in patients with bleeding peptic ulcers who had undergone endoscopic haemostatic therapy. With regard to the incremental cost per bleed averted, intravenous esomeprazole was predicted to be dominant in Spain and cost effective in Sweden and the US compared with no intravenous esomeprazole. Efficacy results and resource utilization data from the pivotal clinical trial were inputted into this model, and the results of the analysis were generally robust to plausible variations in key variables. In the cost-utility analysis, which was conducted in the UK and is available as an abstract and poster, esomeprazole was considered to be the most cost-effective treatment alternative, compared with omeprazole or pantoprazole. For this analysis, clinical outcomes data were obtained from a systematic review and mixed treatment comparison (given the absence of head-to-head trial data), and utility values were proxied from the literature. In conclusion, intravenous esomeprazole prevents peptic ulcer rebleeding in patients who have undergone endoscopic haemostatic therapy. Pharmacoeconomic analyses support the use of intravenous esomeprazole following endoscopic haemostatic therapy in patients with peptic ulcer bleeding and high-risk stigmata.

Prevalencia de nueva hemorragia por úlcera péptica en pacientes tratados con inhibidores de la bomba de protones por vía intravenosa / Prevalence of rebleeding from peptic ulcer in patients treated with proton pump inhibitors

Fundamento y objetivo: El objetivo de este estudio es la evaluación de la prevalencia de resangrado por úlcera péptica comparando pacientes que habían recibido omeprazol frente a pantoprazol por vía intravenosa y estudiar los costes derivados de cada tratamiento. Pacientes y métodos: estudio observacional y retrospectivo. Se recogió información sobre el sexo y la edad de los pacientes, el diagnóstico de la hemorragia digestiva alta (HDA) según la clasificación de Forrest, el tipo de inhibidor de la bomba de protones (IBP) utilizado por vía intravenosa y la pauta de tratamiento, presencia o no de resangrado, mortalidad y datos referentes a los costes sanitarios mediante un modelo farmacoeconómico de coste-efectividad. Resultados: Se incluyó a 807 pacientes, 490 de los cuales (60,7%) recibieron pantoprazol y 317 (39,3%) omeprazol. No hubo diferencias entre la edad media de ambos grupos (61,2 frente a 62,3 años, p=0,544), sexo (el 71% de varones frente al 68,6% de mujeres; p=0,78), porcentaje de enfermos dentro del grado I de Forrest (el 35,1 frente al 42%; p=0,05), en el grado II (el 50,2 frente al 40,4%; p=0,006) y en el grado III (el 14,7 frente al 17,7%; p=0,259). El número de viales por día de tratamiento por vía intravenosa fue significativamente inferior en el grupo de pantoprazol desde el tercer al quinto día, sin diferencias en los dos primeros días y a partir del sexto. Hubo resangrado en el 8,2% de los pacientes tratados con pantoprazol y en el 11,7% de los tratados con omeprazol (p=0,098). Falleció el 2,2% de los pacientes tratados con pantoprazol frente al 2,6% de los tratados con omeprazol (p=0,086). El coste esperado de un paciente tratado con pantoprazol es de 2.188,25€ mientras que con omeprazol es de 3.279,02€ (p<0,001). Conclusiones: Si bien los resultados de la administración de omeprazol frente a pantoprazol por vía intravenosa en pacientes con HDA ulcerosa son similares, este último resulta tener mejor perfil de coste-efectividad (AU)

Background and objective: The aim of this study is to assess the prevalence of peptic ulcer rebleeding by comparing patients who received omeprazole versus pantoprazole i.v. as well as to study the costs of each treatment.Patients and methods: Retrospective and observational study. Information was gathered on sex and age of the patients, the diagnosis of upper gastrointestinal bleeding (UGB) according to the classification of Forrest, the type of proton pump inhibitor (PPI) i.v. used and the treatment regimen, presence or absence of rebleeding, mortality and data on health costs through a pharmacoeconomic cost-effectiveness analysis. Results: We included 807 patients, 490 of whom (60.7%) received pantoprazole and 317 (39.3%) omeprazole. There was no difference between the average age of both groups, 61.2 years vs 62.3, p=0.544; sex, 71% men vs 68.6%, P=.78; the percentage of patients within Forrest I was 35.1% vs 42%, P=.05, in grade II was 50.2% vs 40.4%, P=.006 and in grade III was 14.7% vs 17.7%, P=.259. The number of vials per day of treatment was significantly lower in the pantoprazole group from the third to fifth day, with no differences in the first two days and the sixth. There was rebleeding in 8.2% of patients treated with pantoprazole and 11.7% with omeprazole, P=.098. 2.2% of patients treated with pantoprazole died vs 2.6% treated with omeprazole, P=.086. The expected cost of a patient treated with pantoprazole was 2188.25€ vs 3279.02€ with omeprazole, P<.001. Conclusions: While the results of the administration of omeprazole vs pantoprazole i.v. in patients with UGB are similar, the latter turns out to have a better cost-effectiveness profile (AU)

[Prevalence of rebleeding from peptic ulcer in patients treated with proton pump inhibitors]. / Prevalencia de nueva hemorragia por úlcera péptica en pacientes tratados con inhibidores de la bomba de protones por vía intravenosa.

BACKGROUND AND OBJECTIVE: The aim of this study is to assess the prevalence of peptic ulcer rebleeding by comparing patients who received omeprazole versus pantoprazole i.v. as well as to study the costs of each treatment. PATIENTS AND METHODS: Retrospective and observational study. Information was gathered on sex and age of the patients, the diagnosis of upper gastrointestinal bleeding (UGB) according to the classification of Forrest, the type of proton pump inhibitor (PPI) i.v. used and the treatment regimen, presence or absence of rebleeding, mortality and data on health costs through a pharmacoeconomic cost-effectiveness analysis. RESULTS: We included 807 patients, 490 of whom (60.7%) received pantoprazole and 317 (39.3%) omeprazole. There was no difference between the average age of both groups, 61.2 years vs 62.3, p=0.544; sex, 71% men vs 68.6%, P=.78; the percentage of patients within Forrest I was 35.1% vs 42%, P=.05, in grade II was 50.2% vs 40.4%, P=.006 and in grade III was 14.7% vs 17.7%, P=.259. The number of vials per day of treatment was significantly lower in the pantoprazole group from the third to fifth day, with no differences in the first two days and the sixth. There was rebleeding in 8.2% of patients treated with pantoprazole and 11.7% with omeprazole, P=.098. 2.2% of patients treated with pantoprazole died vs 2.6% treated with omeprazole, P=.086. The expected cost of a patient treated with pantoprazole was 2188.25 euro vs 3279.02 euro with omeprazole, P<.001. CONCLUSIONS: While the results of the administration of omeprazole vs pantoprazole i.v. in patients with UGB are similar, the latter turns out to have a better cost-effectiveness profile.

Cost effectiveness of high-dose intravenous esomeprazole for peptic ulcer bleeding.

Peptic ulcer bleeding (PUB) is a serious and sometimes fatal condition. The outcome of PUB strongly depends on the risk of rebleeding. A recent multinational placebo-controlled clinical trial (ClinicalTrials.gov identifier: NCT00251979) showed that high-dose intravenous (IV) esomeprazole, when administered after successful endoscopic haemostasis in patients with PUB, is effective in preventing rebleeding. From a policy perspective it is important to assess the cost efficacy of this benefit so as to enable clinicians and payers to make an informed decision regarding the management of PUB. Using a decision-tree model, we compared the cost efficacy of high-dose IV esomeprazole versus an approach of no-IV proton pump inhibitor for prevention of rebleeding in patients with PUB. The model adopted a 30-day time horizon and the perspective of third-party payers in the USA and Europe. The main efficacy variable was the number of averted rebleedings. Healthcare resource utilization costs (physician fees, hospitalizations, surgeries, pharmacotherapies) relevant for the management of PUB were also determined. Data for unit costs (prices) were primarily taken from official governmental sources, and data for other model assumptions were retrieved from the original clinical trial and the literature. After successful endoscopic haemostasis, patients received either high-dose IV esomeprazole (80 mg infusion over 30 min, then 8 mg/hour for 71.5 hours) or no-IV esomeprazole treatment, with both groups receiving oral esomeprazole 40 mg once daily from days 4 to 30. Rebleed rates at 30 days were 7.7% and 13.6%, respectively, for the high-dose IV esomeprazole and no-IV esomeprazole treatment groups (equating to a number needed to treat of 17 in order to prevent one additional patient from rebleeding). In the US setting, the average cost per patient for the high-dose IV esomeprazole strategy was $US14 290 compared with $US14 239 for the no-IV esomeprazole strategy (year 2007 values). For the European setting, Sweden and Spain were used as examples. In the Swedish setting the corresponding respective figures were Swedish kronor (SEK)67 862 ($US9220 at average 2006 interbank exchange rates) and SEK67 807 ($US9212) [year 2006 values]. Incremental cost-effectiveness ratios were $US866 and SEK938 ($US127), respectively, per averted rebleed when using IV esomeprazole. For the Spanish setting, the high-dose IV esomeprazole strategy was dominant (more effective and less costly than the no-IV esomeprazole strategy) [year 2008 values]. All results appeared robust to univariate/threshold sensitivity analysis, with high-dose IV esomeprazole becoming dominant with small variations in assumptions in the US and Swedish settings, while remaining a dominant approach in the Spanish scenario across a broad range of values. Sensitivity variables with prespecified ranges included lengths of stay and per diem assumptions, rebleeding rates and, in some cases, professional fees. In patients with PUB, high-dose IV esomeprazole after successful endoscopic haemostasis appears to improve outcomes at a modest increase in costs relative to a no-IV esomeprazole strategy from the US and Swedish third-party payer perspective. Whereas, in the Spanish setting, the high-dose IV esomeprazole strategy appeared dominant, being more effective and less costly.

Non-invasive testing for Helicobacter pylori in patients hospitalized with peptic ulcer hemorrhage: a cost-effectiveness analysis.

PURPOSE: Guidelines recommend routine invasive screening for Helicobacter pylori in patients with peptic ulcer hemorrhage (PUH). However, compliance with screening remains suboptimal. The aim of this study was to determine if a simplified approach based on noninvasive screening is cost effective in PUH. RESULTS: In the base case, post-endoscopy urea breath test (UBT) dominated the invasive testing with 34 fewer hemorrhages and cost savings of $406,600 in a cohort of 10,000 patients. When compliance with invasive testing decreases to 60%, post-endoscopy UBT leads to 109 fewer hemorrhages and cost savings of $1,089,600. The invasive strategy becomes the preferred choice if the sensitivity of UBT reduces to <75%, such as in patients taking proton-pump inhibitors (PPI) before hospitalization. CONCLUSIONS: Post-endoscopy UBT is cost effective in PPI-naïve patients presenting with PUH. This strategy, once prospectively validated, can prove to be a preferred approach in institutions where compliance with invasive testing is suboptimal.

What is the best strategy for diagnosis and treatment of Helicobacter pylori in the prevention of recurrent peptic ulcer bleeding? A cost-effectiveness analysis.

BACKGROUND: Clinical trials provide evidence of the high effectiveness of Helicobacter pylori eradication for preventing recurrent ulcer-related gastrointestinal hemorrhage. The best strategy for curing the infection in this setting is, however, still under debate. OBJECTIVE: To evaluate four different strategies for prevention of rebleeding in patients with peptic ulcer hemorrhage: 1) test for H. pylori and treatment, if positive; 2) proton pump inhibitor maintenance; 3) no preventive treatment; 4) empirical H. pylori eradication immediately after bleeding. METHODS: A decision analysis model was used, with a time horizon of 2 years and a third-party payer perspective. Costs were estimated for two different settings: a low-cost-for-care area (Spain) and a high-cost area (USA). Main outcome measure was incremental cost-effectiveness ratio for each upper gastrointestinal hemorrhage avoided. RESULTS: Empirical H. pylori eradication was the dominant strategy: its estimated rate of recurrent bleeding was lower (6.1%) than those of strategies 1 (7.4%), 2 (11.1%), and 3 (18.4%) and it was the least expensive strategy. The results remained stable when variables were changed inside a wide range of plausible values. Sensitivity analysis also showed that the prevalence of H. pylori in bleeding ulcer was the variable that most influenced the results: when it was below 45% in Spain or below 51% in the United States, empirical eradication was not a dominant strategy although it remained cost-effective. CONCLUSION: In patients with bleeding peptic ulcer, empirical treatment of H. pylori infection immediately after feeding is restarted is the most cost-effective strategy for preventing recurrent hemorrhage.

Introducing a clinical pathway for acute peptic ulcer bleeding in general internal medicine wards.

OBJECTIVE: Management of acute peptic ulcer bleeding (PUB) is expensive and there is little evidence to prove the cost-effectiveness of a clinical pathway. The purpose of this study was to introduce a clinical pathway in hospitalized patients with acute PUB to evaluate its impact on costs and other outcomes. MATERIAL AND METHODS: The clinical pathway was designed for and implemented in hospitalized patients, and a physicians reminder system that included chief residents, checklists, and case review meetings was also utilized. Use of medicine for acid suppression, length of hospital stay (LOS), and treatment costs were compared between patients before and after implementation of the clinical pathway. Outcome measures included the rate of recurrent bleeding, rate of repeat upper gastrointestinal (UGI) endoscopy, and rate of readmission within 30 days of discharge. RESULTS: This clinical pathway significantly reduced the use of intravenous medicine for acid suppression from 88% to 34%, with mean LOS down from 6.7 to 3.6 days, mean cost of medications decreased from New Taiwan Dollars (NTD) 8768 to NTD 3940 (cost down 55.1%), mean cost of diagnostic tests lowered from NTD 12,560 to NTD 9493 (cost down 24.4%), and mean total hospital cost down from NTD 33,142 to NTD 19,519 (cost down 41.1%). Outcome measures were not significantly different. CONCLUSIONS: Introduction of a clinical pathway is an effective method for reducing costs while maintaining quality of care in the management of PUB.

Systematic reviews of the clinical effectiveness and cost-effectiveness of proton pump inhibitors in acute upper gastrointestinal bleeding.

OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of proton pump inhibitors (PPIs) in the prevention and treatment of acute upper gastrointestinal (UGI) haemorrhage, as well as to compare this with H2-receptor antagonist (H2RA), Helicobacter pylori eradication (in infected patients) or no therapy, for the prevention of first and/or subsequent bleeds among patients who continue to use non-steroidal anti-inflammatory drugs (NSAIDs). Also to evaluate the clinical effectiveness of PPI therapy, compared with other treatments, for the prevention of subsequent bleeds in patients who had previously experienced peptic ulcer (PU) bleeding. DATA SOURCES: Electronic databases and major conference proceedings were searched up to February 2006. REVIEW METHODS: Data were collected from the systematic reviews addressing each research objective. These were then entered into an economic model to compare the costs and quality-adjusted life-days of alternative management strategies over a 28-day period for patients who have had UGI bleeding. A Markov model with a Monte Carlo simulation used data from the systematic reviews to identify the most cost-effective treatment strategy for the prevention of UGI bleeding (first and subsequent) among NSAID users using an outcome of costs per quality-adjusted life-years (QALYs) over a lifetime from age 50 years. RESULTS: PPI treatment initiated after endoscopic diagnosis of PU bleeding significantly reduced re-bleeding and surgery compared with placebo or H2RA. Although there was no evidence of an overall effect of PPI treatment on all-cause mortality, PPIs significantly reduced mortality in subgroups when studies conducted in Asia were examined in isolation or when the analysis was confined to patients with high-risk endoscopic findings. PPI treatment initiated prior to endoscopy in UGI bleeding significantly reduced the proportion of patients with stigmata of recent haemorrhage (SRH) at index endoscopy compared with placebo or H2RA, but there was no evidence that PPI treatment affected clinically important outcomes. Giving oral PPI both before and after endoscopy, with endoscopic haemostatic therapy (EHT) for those with major SRH, is preferred to all others on cost-effectiveness grounds at any threshold over 25,000 pounds per QALY, even if only short-term effects are taken into account, and at any threshold over 200 pounds per life-year gained if long-term effects are included. The risk of NSAID-induced endoscopic gastric and duodenal ulcers was reduced by standard doses of PPI and misoprostol, and double doses of H2RAs. Standard doses of H2RAs reduced the risk of endoscopic duodenal ulcers. PPIs reduced NSAID-induced dyspepsia. PPIs were superior to misoprostol in preventing recurrence of NSAID-induced endoscopic duodenal ulcers, but PPIs were comparable to misoprostol in preventing the recurrence of NSAID-induced endoscopic gastric ulcers. Full-dose misoprostol reduced bleeding, perforation or gastric outlet obstruction due to NSAID-induced ulcers, but misoprostol was poorly tolerated and associated with frequent adverse effects. H. pylori eradication treatment was equally effective with PPI treatment for the primary or secondary prevention of endoscopic ulcers in NSAID users. H. pylori eradication treatment was more effective than placebo for the primary prevention of endoscopic PU and for the prevention of re-bleeding from PU in NSAID users. With regard to primary and secondary prevention of bleeding PU in NSAID users, the two most cost-effective strategies are H. pylori eradication alone, and H. pylori eradication followed by misoprostol (substituted by a PPI, if misoprostol is not tolerated) at an additional 4810 pounds per QALY. In patients who had previously experienced a bleed from a PU, re-bleeding was less frequent after H. pylori eradication therapy than after non-eradication antisecretory therapy, whether or not the latter was combined with long-term maintenance antisecretory therapy. CONCLUSIONS: PPI treatment compared with placebo or H2RA reduces mortality following PU bleeding among patients with high-risk endoscopic findings, and reduces re-bleeding rates and surgical intervention. PPI treatment initiated prior to endoscopy in UGI bleeding significantly reduces the proportion of patients with SRH at index endoscopy but does not reduce mortality, re-bleeding or the need for surgery. The strategy of giving oral PPI before and after endoscopy, with EHT for those with major SRH, is likely to be the most cost-effective. Treatment of H. pylori infection was found to be more effective than antisecretory therapy in preventing recurrent bleeding from PU. H. pylori eradication alone or eradication followed by misoprostol (with switch to PPI, if misoprostol is not tolerated) are the two most cost-effective strategies for preventing bleeding ulcers among H. pylori-infected NSAID users, although the data cannot exclude PPIs also being cost-effective. Further large randomised controlled trials are needed to address areas such as PPI administration prior to endoscopic diagnosis, different doses and administration of PPIs, as well as the primary and secondary prevention of UGI bleeding.

Endoscopic Doppler ultrasound versus endoscopic stigmata-directed management of acute peptic ulcer hemorrhage: a multimodel cost analysis.

Recurrent bleeding from acute peptic ulcer hemorrhage is problematic. Studies have shown that Doppler ultrasound (DOP-US) is useful in decreasing rebleeding. We analyzed associated costs and outcomes to better define the role of DOP-US versus Conventional (Forrest classification endoscopic stigmata) in the management of acute peptic ulcer bleeding. Two separate decision analyses were constructed. Recurrent bleeding, failed esophagogastroduodenoscopy (EGD) hemostasis, complications, and surgery rates were derived from medical literature. Costs were based on Medicare data. DOP-US is preferred over Conventional in acute peptic ulcer bleeding with average cost savings per patient ranging from 853 dollars (decision-tree modeling) to 1,160 dollars (Monte Carlo simulation). High-dose intravenous proton-pump inhibitors lowered rates of recurrent bleeding for both Conventional and DOP-US, resulting in a lower but still persistent average cost savings per patient for DOP-US (decision-tree modeling = 328 dollars, Monte Carlo simulation = 560 dollars). This decision analyses identified DOP-US as the preferred cost-minimizing strategy in acute peptic ulcer hemorrhage. Results of cost analyses were most dependent on hospitalization costs and recurrent bleeding rates.

The cost-effectiveness and budget impact of intravenous versus oral proton pump inhibitors in peptic ulcer hemorrhage.

BACKGROUND & AIMS: The most cost-effective route of administering proton pump inhibitor (PPI) therapy in peptic ulcer hemorrhage remains uncertain. Oral (PO) PPI therapy may be less effective than intravenous (IV) PPI therapy, but is less expensive and does not mandate a 72-hour posthemostasis hospital stay to complete a full therapeutic course. Because there are currently no published head-to-head clinical trials comparing IV vs PO PPIs, we used decision analysis with budget impact modeling to measure the clinical and economic outcomes of these competing modes of administration. METHODS: We compared 3 postendoscopic strategies for high-risk peptic ulcer hemorrhage: (1) PO PPI therapy, (2) IV PPI therapy, and (3) IV histamine(2) receptor antagonist therapy. The primary outcomes were cost per quality-adjusted life-year gained, and per-member per-month cost in a hypothetical managed care organization with 1,000,000 covered lives. RESULTS: Compared with the PPI strategies, the histamine(2) receptor antagonist strategy was more expensive and less effective. Of the 2 PPI strategies, using IV instead of PO PPI cost an incremental 708,735 US dollars per year to gain 1 additional quality-adjusted life-year. Substituting IV in lieu of PO PPI cost each member 2.86 US dollars per month to subsidize. The IV PPI strategy became dominant when the rebleed rate with PO PPIs exceeded 24% (base case = 13%), and when the hospital stay on IV PPIs decreased to less than 72 hours. CONCLUSIONS: The higher effectiveness of IV PPI therapy may not offset its increased costs vs PO PPI therapy in ulcer hemorrhage. The managed care budget impact of IV PPIs exceeds most benchmarks.

[Clinical pathway for bleeding peptic ulcers].

We devised and evaluated a clinical pathway (CP) protocol for patients with bleeding peptic ulcers (BPU). Patients without severe comorbidities, who had been diagnosed with BPU and who had undergone endoscopic treatment, were enrolled in our study. The CP adaptation rate for BPU patients was 78.8% (89/113). The variance rate was 13.5% (12/89). The median length of admission was 10.0 +/- 4.6 days (n = 78) before and 7.4 +/- 2.9 days (n = 77) after introducing CP. Our CP for BPU was safe and resulted in shorter hospital stays and, therefore, cost reductions. In elder patients, our CP was also successful, but the variance rate was higher than in younger patients.

Inappropriate use of intravenous pantoprazole: extent of the problem and successful solutions.

BACKGROUND & AIMS: Indications for intravenous proton pump inhibitors (IV PPI) include upper gastrointestinal bleeding (UGIB) from peptic ulcer disease with high-risk stigmata and patients receiving nothing by mouth (NPO). The objectives were to assess the extent of errors in indications for IV PPI use and to determine whether multidisciplinary interventions could improve IV PPI use and costs. METHODS: Part 1: Patients prescribed IV PPI during a period of 4 months were divided into 2 settings, UGIB or non-UGIB. The setting-specific appropriateness of the IV PPI indication and dosing regimen was determined. Part 2: Patients prescribed IV PPI before and after multidisciplinary interventions (educating physicians, a computerized dose template, pharmacists altering IV PPI orders in non-UGIB patients who were not NPO, and recommending a GI consult when a continuous infusion was ordered) were studied. Incidence of prescribing errors, IV PPI costs, and potential confounders were compared. RESULTS: Part 1: Only 50% of UGIB (n = 145) patients received IV PPI for an appropriate indication. Both indication and dosing regimen were appropriate in 21%. In the non-UGIB group (n = 95), 33% were truly NPO; 51% had a correct dosing frequency. Part 2: The postintervention (n = 105) group (vs the preintervention group, n = 113) showed a significant absolute reduction in the degree of inappropriate indication in the UGIB (26%; 95% confidence interval [CI], 10%-42%; P < .0001) and in the non-UGIB (41%; 95% CI, 24%-58%; P < .0001) subgroups. However, a greater improvement in underspending than overspending meant that overall costs were unchanged. CONCLUSIONS: IV PPI was frequently prescribed inappropriately and incorrectly; simple maneuvers resulted in reductions in errors.

Pathophysiology and prophylaxis of stress ulcer in intensive care unit patients.

Gastrointestinal complications frequently occur in patients admitted to the intensive care unit. Of these, ulceration and bleeding related to stress-related mucosal disease (SRMD) can lengthen hospitalization and increase mortality. The purpose of this review is to discuss the many risk factors and underlying illnesses that have a role in the pathophysiology of SRMD and evaluate the evidence pertaining to SRMD prophylaxis in the intensive care unit population. Suppressing acid production is fundamental to preventing stress-related mucosal ulceration and clinically important gastrointestinal bleeding. Traditional prophylactic options for SRMD in critically ill patients include antacids, sucralfate, histamine 2 -receptor antagonists (H 2 RAs), and proton pump inhibitors. Many clinicians prescribe intermittent infusions of H 2 RAs for stress ulcer prophylaxis, a practice that has not been approved for this indication and may not provide the necessary degree or duration of acid suppression required to prevent stress ulcer-related bleeding. New data suggest that proton pump inhibitors suppress acid production more completely in critically ill patients, but more studies are required to assess their clinical effectiveness and safety for this indication. The prophylactic regimen chosen to prevent stress ulcer bleeding should take into account the risk factors and underlying disease state of individual patients to provide the best therapy to those most likely to benefit.