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.

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.

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.

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.

[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.

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.

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.

[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.

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 .

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.

Prevention of complicated ulcer disease among chronic users of nonsteroidal anti-inflammatory drugs: the use of a nomogram in cost-effectiveness analysis.

BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with an increased risk of clinical upper gastrointestinal tract (UGI) events, namely, symptomatic ulcer, perforation, bleeding, and obstruction. Our objective in this study was to compare the cost-effectiveness of several strategies aimed at reducing the risk of clinical UGI events in NSAID users. METHODS: A decision tree model was used for patients requiring long-term treatment with NSAIDs to compare conventional NSAID therapy alone with 7 other treatment strategies to reduce the risk of NSAID-related clinical UGI events (cotherapy with proton-pump inhibitor, cotherapy with misoprostol, cyclooxygenase [COX]-2-selective NSAID therapy, or Helicobacter pylori treatment followed by each of the previous strategies, including conventional NSAID treatment, respectively). The outcome measure is the incremental cost per clinical UGI event prevented compared with conventional NSAID treatment over 1 year. RESULTS: The use of a COX-2-selective NSAID and cotherapy with proton-pump inhibitors were the 2 most cost-effective strategies. However, the incremental cost associated with these strategies was high (>$35 000) in persons with a low risk of clinical UGI event with conventional NSAIDs (eg, 2.5% per year). If the baseline risk of clinical UGI events is moderately high (eg, 6.5%), using a COX-2-selective NSAID becomes the most effective and least costly (dominant) treatment strategy, followed closely by cotherapy with a daily proton-pump inhibitor. Because small changes in costs or assumed efficacy of these drugs could change the conclusions, the incremental cost-effectiveness ratios between any 2 strategies were presented in a nomogram that allows the flexible use of a wide range of values for costs and rates of clinical UGI events. CONCLUSIONS: The risk of clinical UGI events in NSAID users depends on their baseline risk, the added risk associated with the individual NSAID, and the protection conferred by cotherapy. A nomogram can be used to incorporate these factors and derive estimates regarding cost-effectiveness of competing strategies aimed at reducing the risk of clinical UGI events.

Final report on the cost of treating arthritic disease: comparison between salicylates and nonsalicylate nonsteroidal anti-inflammatory drugs.

The cost of antacids or other drugs and hospital admission for the treatment of gastrointestinal side effects must be factored into any comparison between costs of nonsteroidal anti-inflammatory drugs and salicylate drugs in the treatment of arthritis. Records and interviews of 534 patients treated for arthritis, 310 treated with nonsalicylate nonsteroidal anti-inflammatory drugs and 224 treated with salicylates, were evaluated for this comparison. Costs of the basic drug, medical treatment for gastrointestinal side effects, and hospitalization for such treatment were added, averaged for 30-day per patient treatment periods, and compared. When hospital costs were excluded, costs per patient per month of nonsteroidal anti-inflammatory drug therapy were comparable to costs of nonacetylated salicylate therapy, and both sums were more than twice the cost of therapy with an aspirin compound. When hospital costs were included, average non-acetylated salicylate costs per patient per month were far higher than those for treatment with either aspirin or nonsteroidal anti-inflammatory drugs. These findings suggest the value of randomized multicenter studies to establish the cost-effectiveness nonsteroidal anti-inflammatory drug therapy v salicylate therapy in the treatment of arthritis.

The cost-effectiveness of high-dose oral proton pump inhibition after endoscopy in the acute treatment of peptic ulcer bleeding.

BACKGROUND: Recent data suggest a role for high-dose oral proton pump inhibition in ulcer bleeding. AIM: To compare the cost-effectiveness of oral high-dose proton pump inhibition to both high-dose intravenous proton pump inhibition and placebo administration. METHODS: The model adopted a 30-day time horizon, and focused on patients with ulcer haemorrhage initially treated endoscopically for high-risk stigmata. Re-bleeding rates were set a priori based on non-head-to-head data from the literature, and charges and lengths of stay from a national American database. Sensitivity analyses were carried across a broad range of clinically relevant assumptions. RESULTS: Re-bleeding rates for patients receiving intravenous, oral, or placebo therapies were 5.9%, 11.8%, and 27%, respectively. The mean lengths of stay and costs for admitted patients with and without re-bleeding were 4.7 and 3 days; $11,802, and $7993, respectively. High-dose intravenous proton pump inhibition was more effective and less costly (dominant) than high-dose oral proton pump inhibition with incremental savings of $136.40 per patient treated. The oral high-dose strategy in turn dominated placebo administration. Results remained robust according to one- and two-way sensitivity analyses. CONCLUSION: In patients undergoing endoscopic haemostasis, subsequent high-dose intravenous proton pump inhibition is more cost-effective than high-dose oral proton pump inhibition, which in turn dominates placebo. The results from this exploratory-type cost analysis require confirmation by head-to-head prospective trials performed in Western populations.

High-dose intravenous proton pump inhibition following endoscopic therapy in the acute management of patients with bleeding peptic ulcers in the USA and Canada: a cost-effectiveness analysis.

BACKGROUND: The efficacy of high-dose intravenous proton pump inhibition has recently been shown, yet its cost-effectiveness remains poorly studied. AIM: To assess the cost-effectiveness of this approach separately for American and Canadian health care settings. METHODS: A validated decision model included patients with bleeding ulcers after successful endoscopic haemostasis. Probabilities were determined from the literature, and charges and lengths of stay from national databases. A third-party payer perspective was adopted over a 30-day time horizon. RESULTS: Re-bleeding rates were 5.9% for patients who received high-dose intravenous proton pump inhibition and 22.9% for those who did not. Hospitalization costs for patients with and without re-bleeding were 11,802 US dollars and 7993 US dollars, and 5220 Canadian dollars and 2696 Canadian dollars, respectively. High-dose intravenous proton pump inhibition was more effective and less costly than the alternative of not administering it. The cost-effectiveness ratios for high-dose and no high-dose intravenous proton pump inhibition were 9112 US dollars and 11,819 US dollars (3293 dollars and 4284 dollars for the Canadian case), respectively. Sensitivity and threshold analyses showed that the results were robust across a wide range of clinically relevant assumptions. CONCLUSION: In the USA and Canada, administering high-dose intravenous proton pump inhibition for 3 days is both more effective and less costly than not doing so for patients with bleeding ulcers after successful endoscopic haemostasis.

Economic analysis of strategies in the prevention of non-steroidal anti-inflammatory drug-induced complications in the gastrointestinal tract.

BACKGROUND: It is unclear what the best therapeutic approach is in patients who require non-steroidal anti-inflammatory drugs. In clinical practice, choice of prescriptions are often based on drug costs. AIM: To evaluate costs per upper gastrointestinal bleeding avoided with different prevention strategies. METHODS: Two major strategies have been considered (coxibs vs. non-steroidal anti-inflammatory drugs plus generic/brand gastroprotective agent). The number of patients needed to treat to prevent a bleeding event, the cost of the drug and duration of treatment were used to estimate costs. RESULTS: Based on hospitalization costs of a bleeding event, no therapeutic strategy is cost-effective in patients without risk factors. All strategies (including omeprazole + coxib) are cost-effective in patients with bleeding ulcer history. With other risk factors, all strategies are cost-effective but prevention of events is twice as expensive in patients <75 years of age. No strategy shows superiority unless the cheapest generics are prescribed or a 50% reduction in the incidence of lower gastrointestinal complications with coxibs is confirmed. CONCLUSIONS: Current prevention strategies to reduce serious non-steroidal anti-inflammatory drug-associated gastrointestinal events are only cost-effective in patients with risk factors. No strategy shows superiority, but coxib strategy would be more cost-effective if it were associated with a reduction of events of the lower gastrointestinal tract.

Economic analysis of celecoxib versus diclofenac plus omeprazole for the treatment of arthritis in patients at risk of ulcer disease.

AIM: To evaluate the economic impact of celecoxib therapy vs. diclofenac plus omeprazole therapy for the treatment of arthritis in Chinese patients with a high risk of bleeding, from the perspective of a public health organization in Hong Kong. METHODS: The medical records of 287 Chinese arthritic patients with a history of bleeding ulcers who had previously participated in a randomised study of celecoxib 200 mg twice daily and extended-release diclofenac 75 mg twice daily plus 20 mg of omeprazole daily for 6 months were reviewed. RESULTS: Compared to the diclofenac plus omeprazole group, the average total direct cost per patient in the celecoxib group showed a significant reduction of 11%, from HK 10,915 (range HK dollars 10,915-57,899) to HK dollars 9714 (range HK dollars 9714-89,770) (P<0.0001) (1 US dollars=7.8 HK dollars). The median direct medical cost for routine management in the celecoxib group was significantly lower (11%) than that for the diclofenac plus omeprazole group [HK dollars 10,915 (range 10,915-28,048) vs. HK dollars 9714 (range HK dollars 6946-26,179) (P<0.0001)]. In patients who experienced recurrent bleeding, the celecoxib group showed a significantly higher median cost of management of recurrent bleeding than the diclofenac plus omeprazole group [HK dollars 8466 (range 572-29,851) vs. HK dollars 23,210 (range HK dollars 12,318-65,823)] (P=0.036). CONCLUSIONS: Celecoxib therapy appears to cost less compared with diclofenac plus omeprazole for treatment of arthritis in Chinese patients with a high risk of bleeding.

Helicobacter pylori eradication is superior to ulcer healing with or without maintenance therapy to prevent further ulcer haemorrhage.

BACKGROUND: Helicobacter pylori eradication decreases ulcer recurrence and should prevent recurrent ulcer haemorrhage. AIM: By meta-analysis, to compare treatment of H. pylori infection with other approaches to prevent recurrent ulcer haemorrhage and, by cost minimization analysis, to determine the least costly strategy. METHODS: We searched for randomized, controlled trials comparing treatment of H. pylori infection with ulcer healing alone or with maintenance therapy in preventing recurrent ulcer haemorrhage. We calculated the relative and absolute risk reductions and numbers needed to treat. RESULTS: Treatment of H. pylori infection decreased recurrent bleeding by 17% (numbers needed to treat=6) compared with ulcer healing treatment alone. Compared with ulcer healing treatment followed by maintenance therapy, recurrent bleeding was decreased by 4% (numbers needed to treat=25). Decision model-based cost minimization analysis demonstrated that treatment of H. pylori infection was the least costly strategy unless the incidence of complicated recurrences after treatment was over 6%, or the cost of confirming eradication was over $741. CONCLUSIONS: Treatment of H. pylori infection is superior to ulcer healing treatment with or without maintenance therapy in preventing recurrent ulcer haemorrhage. All patients with ulcer bleeding should be tested for H. pylori infection and appropriately treated if positive.