Prospective observational study of the use of omeprazole and maropitant citrate in veterinary specialist care.

The proton pump inhibitor omeprazole is administered to dogs with gastroduodenal ulceration or oesophagitis, whereas the neurokinin-1 receptor antagonist maropitant citrate is licensed as an antiemetic drug. In people, omeprazole is overprescribed in hospitals, increasing the risk of adverse effects and imposing unnecessary costs in healthcare. To investigate the use of omeprazole and maropitant in our veterinary specialist hospital, we conducted a prospective observational study in its Medicine and Surgery wards, recording patient data and obtaining contemporaneous information from clinicians about their reasons for administering either drug. In doing so, we find omeprazole and maropitant are administered to a large proportion of dogs, including to many of those with no presenting signs suggestive of gastrointestinal disease. We find prescribing clinicians consider both drugs safe but often underestimate their financial cost. We find the stated reasons and objective predictors of administration of both drugs vary according to clinical setting but that these modalities yield concordant results. Reviewing the manner of administration and stated indications for use of both drugs, we find omeprazole is often administered outside dosing recommendations, and both drugs are frequently administered for aims that are unlikely to be achieved when considering their known biological effects in dogs. In conclusion, our work reveals probable overprescribing of omeprazole and maropitant citrate in hospitalised dogs, highlighting a need for initiatives to decrease inappropriate prescribing.

Using Drug Prescribing Patterns to Identify Stewards of Cost-Conscious Care.

PURPOSE: To characterize family physicians (FPs) who are stewards of care by consistently prescribing omeprazole over esomeprazole. METHODS: Cross-sectional analysis of physicians prescribing omeprazole or esomeprazole under Medicare Part D in 2014. RESULTS: There was a regional trend with 49% of Western FPs but only 6% of Southern FPs rarely prescribing esomeprazole. Physicians had increased odds of being a steward if they worked with a care coordinator (P < .001), at a patient-centered medical home (P < .001), or in a large practice (P < .001). CONCLUSIONS: If these findings are replicated across multiple drugs, future outreach could be conducted based on provider prescribing patterns.

Rethinking the laryngopharyngeal reflux treatment algorithm: Evaluating an alternate empiric dosing regimen and considering up-front, pH-impedance, and manometry testing to minimize cost in treating suspect laryngopharyngeal reflux disease.

OBJECTIVES/HYPOTHESIS: Empiric proton pump inhibitor (PPI) trials for laryngopharyngeal reflux (LPR) are common. A majority of the patients respond to acid suppression. This work intends to evaluate once-daily, 40 mg omeprazole and once-nightly, 300 mg ranitidine (QD/QHS) dosing as an alternative regimen, and use this study's cohort to evaluate empiric regimens prescribed for LPR as compared to up-front testing with pH impedance multichannel intraluminal impedance (MII) with dual pH probes and high-resolution manometry (HRM) for potential cost minimization. STUDY DESIGN: Retrospective cohort review and cost minimization study. METHODS: A chart review identified patients diagnosed with LPR. All subjects were treated sequentially and outcomes recorded. Initial QD/QHS dosing increased after 3 months to BID if no improvement and ultimately prescribed MII and HRM if they failed BID dosing. Decision tree diagrams were constructed to determine costs of two empiric regimens and up-front MII and HRM. RESULTS: Ninety-seven subjects met the criteria. Responders and nonresponders to empiric therapy were identified. Seventy-two subjects (74%) responded. Forty-eight (67% of responders and 49% of all) improved with QD/QHS dosing. Forty-nine (51%) subjects escalated to BID dosing. Twenty-four subjects (33% of responders and 25% of all) improved on BID therapy. Twenty-five subjects (26%) did not respond to acid suppression. Average weighted cost was $1,897.00 per patient for up-front testing, $3,033.00 for initial BID, and $3,366.00 for initial QD/QHS. CONCLUSIONS: An alternate QD/QHS regimen improved the majority who presented with presumed LPR. Cost estimates demonstrate that the QD/QHS regimen was more expensive than the initial BID high-dose PPI for 6 months. Overall per-patient cost appears less with up-front MII and HRM. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:S1-S13, 2017.

The budget impact of using enteric-coated aspirin 325 mg + immediate-release omeprazole 40 mg to prevent recurrent cardiovascular events.

OBJECTIVE: Aspirin (acetylsalicylic acid; ASA) is commonly used for secondary prevention of cardiovascular (CV) events, but may be associated with gastrointestinal (GI) adverse events, which can reduce adherence. Use of ASA co-therapy with proton pump inhibitors in patients at risk may be suboptimal. PA32540 (Yosprala™) is a coordinated-delivery tablet combining EC-ASA 325 mg and immediate-release omeprazole 40 mg. The objective of this flexible budget impact model was to project the financial consequences of introducing PA32540 325 mg/40 mg to prevent recurrent CV events, while reducing ASA-associated GI events in US adults. METHODS: A Markov Model was employed to estimate health state transitions associated with ASA 75-325 mg, ASA 75-325 mg + generic delayed-release omeprazole 40 mg, PA32540, or clopidogrel 75 mg to prevent recurrent CV events. Health states included ulcers, GI bleeding, CV events, and death. Model inputs included demographics, treatment dosages, treatment costs, adverse GI and CV events, and premature death. Data from peer-reviewed literature and censuses enabled appropriate allocation of CV and GI disease prevalence and mortality. The PA32540 non-adherence rate was conservatively set at 20%. PA32540 market share was set to 50%. RESULTS: The model projected annual savings of $81.0 million to $190.9 million within 1-5 years after PA32540 introduction to the plan, which included 134,558 members at risk for recurrent CV events. These values translate into savings of $602 (year 5) to $1,419 (year 1) per patient per year, and $81 (year 5) to $191 (year 1) per member per year. These values were robust to variations in parameters under a deterministic sensitivity analysis. CONCLUSION: PA32540 use to prevent recurrent CV events was associated with cost reductions in each year examined with the model. From a health plan perspective, PA32540 is likely to have a net overall effect, resulting in significant cost savings.

Modeling the cost-effectiveness of ilaprazole versus omeprazole for the treatment of newly diagnosed duodenal ulcer patients in China.

OBJECTIVES: To evaluate the cost-effectiveness of 10 mg ilaprazole once-daily vs 20 mg omeprazole once-daily to treat newly-diagnosed duodenal ulcer patients in China. METHODS: A decision tree model was constructed and the treatment impact was projected up to 1 year. The CYP2C19 polymorphism distribution in the Chinese population, the respective cure rates in the CYP2C19 genotype sub-groups, the impact of Duodenal Ulcer (DU) on utility value and drug-related side-effect data were obtained from the literature. The total costs of medications were calculated to estimate the treatment costs based on current drug retail prices in China. Expert surveys were conducted when published data were not available. Probabilistic sensitivity analysis was performed to gauge the robustness of the results. RESULTS: Ilaprazole, when compared with omeprazole, achieved a better overall clinical efficacy. For the overall population, ilaprazole achieved an incremental cost effectiveness ratio (ICER) of ¥132 056 per QALY gained. This is less than the WHO recommended threshold of 3-times the average GDP per capita in China (2014). Furthermore, sub-group analysis showed that ilaprazole is cost-effective in every province in CYP2C19 hetEM patients and in the most developed provinces in CYP2C19 homEM patients. Probabilistic sensitivity analysis suggests that the results are robust with 97% probability that ilaprozole is considered cost-effective when a threshold of 3-times China's average GDP per capita is considered. LIMITATION: This study didn't have the data of ilaprazole combined with Hp eradication therapy. Caution should be taken when extrapolating these findings to DU patients with an Hp eradication therapy. CONCLUSIONS: The cost-effectiveness analysis results demonstrated that ilaprazole would be considered a cost-effective therapy, compared with omeprazole, in Chinese DU patients based on the efficacy projections in various CYP2C19 polymorphism types.

Initiatives in South Africa to enhance the prescribing of generic proton pump inhibitors: findings and implications.

BACKGROUND: There have been multiple reforms in South Africa to conserve resources including policies to enhance generic use, such as compulsory generic substitution and copayments. However, there are concerns with the limited knowledge of their impact. OBJECTIVE: The objective was to determine utilization and expenditure of different proton pump inhibitors (PPIs). METHODOLOGY: A retrospective drug utilization study was conducted on a prescription database of a medical aid administrator in 2010. RESULTS: The limited prescribing of single-sourced PPIs accounted for 21.5% of total prescriptions. The limited use of originators omeprazole and lansoprazole accounted for 1.8 and 1.4% of total prescriptions for the molecule, respectively. Generic prices accounted for 36-68% of the originator in 2010. Patients received on average 2.91 PPI prescriptions during the year. CONCLUSION: Policies to enhance prescribing of generics appear working. Opportunities exist to further lower generic prices given low prices in some European countries.

BUDGET IMPACT ANALYSIS OF USING OMEPRAZOLE IMMEDIATE-RELEASE ORAL SUSPENSION IN REPLACE OF INTRAVENOUS PANTOPRAZOLE IN CRITICALLY ILL PATIENTS.

OBJECTIVES: The aim of the present study was to estimate the financial consequence of using omeprazole immediate-release (IR) oral suspension versus pantoprazole intravenous infusion for preventing stress-related upper gastrointestinal bleeding in critically ill patients from the perspective of the health care system. METHODS: An Excel-based model was developed to compare the cost of prevention of upper gastrointestinal bleeding early after intensive care admission using the current intravenous (IV) pantoprazole formulation versus omeprazole IR oral suspension. Total costs included the cost of acid suppressive drugs and related clinical outcomes. Inputs were obtained from a local clinical trial, the Ministry of Health database, insurance organizations, hospital and pharmacy registries, the relevant literature, and expert opinion. The robustness of the input data was investigated by one-way sensitivity analysis. The model was developed based on the results of a randomized control trial (RCT), in which experimental and control groups received omeprazole and pantoprazole, respectively. RESULTS: According to the proposed model, the cost of gastrointestinal (GI) bleeding prevention using pantoprazole IV was US$ 950,000 while US$ 750,000 was spent on receiving omeprazole oral suspension. These costs led to the annual cost-saving of almost US$ 200,000 (US$4 per member, per month) for the health care system. CONCLUSIONS: In the present study, a budget impact analysis was performed to assess the financial consequences of using omeprazole IR oral suspension in place of pantoprazole IV for prevention of upper gastrointestinal bleeding. The better preventive effect of omeprazole IR oral suspension when compared with conventional therapy using pantoprazole IV was the major reason for the final comparative budgetary savings.

Evolutions in both co-payment and generic market share for common medication in the Belgian reference pricing system.

BACKGROUND: In Belgium, a co-insurance system is applied in which patients pay a portion of the cost for medicines, called co-payment. Co-payment is intended to make pharmaceutical consumers more responsible, increase solidarity, and avoid or reduce moral hazards. OBJECTIVE: Our objective was to study the possible influence of co-payment on sales volume and generic market share in two commonly used medicine groups: cholesterol-lowering medication [statins (HMG-CoA reductase inhibitors) and fibrates] and acid-blocking agents (proton pump inhibitors and histamine H2 receptor antagonists). METHODS AND DATA: The data were extracted from the Pharmanet database, which covers pharmaceutical consumption in all Belgian ambulatory pharmacies. First, the proportion of sales volume and costs of generic products were modelled over time for the two medicine groups. Second, we investigated the relation between co-payment and contribution by the national insurance agency using change-point linear mixed models. RESULTS: The change-point analysis suggested several influential events. First, the generic market share in total sales volume was negatively influenced by the abolishment of the distinction in the maximum co-payment level for name brands and generics in 2001. Second, relaxation of the reimbursement conditions for generic omeprazole stimulated generic sales volume in 2004. Finally, an increase in co-payment for generic omeprazole was associated with a significant decrease in omeprazole sales volume in 2005. The observational analysis demonstrated several changes over time. First, the co-payment amounts for name-brand and generic drugs converged in the observed time period for both medicine groups under study. Second, the proportion of co-payment for the total cost of simvastatin and omeprazole increased over time for small packages, and more so for generic than for name-brand products. For omeprazole, both the proportion and the amount of co-payment increased over time. Third, over time the prescription of small packages shifted to an emphasis on larger packages. CONCLUSIONS: As maximum co-payment levels decreased over time, they overruled the reference pricing system in Belgium. The changes in co-payment share over time also significantly affected sales volume, but whether physicians or patients are the decisive actors on the demand side of pharmaceutical consumption remains unclear.

Generic substitution, financial interests, and imperfect agency.

Policy makers around the world seek to encourage generic substitution. In this paper, the importance of prescribing physicians' imperfect agency is tested using the fact that some Swiss jurisdictions allow physicians to dispense drugs on their own account (physician dispensing, PD) while others disallow it. We estimate a model of physician drug choice with the help of drug claim data, finding a significant positive association between PD and the use of generics. While this points to imperfect agency, generics are prescribed more often to patients with high copayments or low incomes.

Imperative to consider multiple initiatives to maximize prescribing efficiency from generic availability: case history from Abu Dhabi.

INTRODUCTION: Pharmaceutical expenditure has risen rapidly in Abu Dhabi, resulting in policies surrounding generics. However, various circumstances will reduce potential savings, including pharmacists still being free to dispense either originator or branded generics and be fully reimbursed. OBJECTIVES: To research the changes in utilization patterns of proton pump inhibitors (PPIs) and lipid-lowering drugs before and after combined reforms on generics; and subsequently, calculate potential savings based on 'best practices' among Western European countries. METHODS: An uncontrolled before-and-after observational study of utilization and expenditure of PPIs, statins and ezetimibe between 2004 and 2010, as well as up to 12 months before the first generic policy, to 1 year after the second generic policy, was carried out. Utilization was converted to defined daily doses (DDDs; 2011 DDDs) and DDDs/1000 inhabitants per day. Expenditure/DDD was calculated for omeprazole and simvastatin. RESULTS: PPI utilization rose by 6.5-fold from 2004 to 2010, principally driven by increased utilization of patent-protected PPIs, although more recently stabilization in esomperazole utilization has occurred. Similar changes were seen for statins. Introduction of best practices would reduce PPI expenditure in 2010 by 32.8 million United Arab Emirates dirham (AED; €6.26 million) and statins by over 27 million AED (€5.15 million). CONCLUSION: Limited demand-side measures led to increased utilization of patent-protected products in Abu Dhabi following the generic reforms. Successful measures will release considerable resources.

Multiple initiatives continue to enhance the prescribing efficiency for the proton pump inhibitors and statins in Scotland.

INTRODUCTION: Multiple and intensive demand measures in Scotland have appreciably enhanced prescribing efficiency for proton pump inhibitors (PPIs) and statins in 2007 versus 2001. Statin utilization enhanced by measures to increase doses prescribed, including the Quality and Outcome Framework (QoF). AIMS: Ascertain whether the plethora of measures continue to enhance prescribing efficiency for PPIs and statins. Second, assess whether the combined impact of the QoF targets and guidance enhances the prescribing of higher strength statins, mirroring the situation in England. METHOD: PPI and statin utilization measured in terms of defined daily doses (DDDs) and DDDs per 1000 inhabitants per day (2010 DDDs) between 2001 and 2010, number and strength of simvastatin and atorvastatin tablets dispensed, and reimbursed expenditure per DDD and 1000 inhabitants per year. RESULTS: Expenditure per DDD for generic omeprazole in 2010 was 91% below the 2001 originator price, leading to expenditure per 1000 inhabitants for PPIs in 2010 to be 56% below 2001 despite a threefold increase in utilization. Expenditure per DDD for generic simvastatin in 2010 was 97% below the 2002 originator price. Expenditure per 1000 inhabitants for statins in 2010 only increased by 7% compared with 2001 despite a 6.2-fold increase in utilization. Utilization of higher strength statins has increased in recent years, with higher strength simvastatin (40 and 80 mg) accounting for 85% of total statins (DDD basis) in 2010. CONCLUSION: Reforms appear to be working to further enhance prescribing efficiency. Utilization of higher strength statins in recent years should further improve outcomes.

Sequential therapy versus standard triple drug therapy for eradication of Helicobacter pylori in patients with perforated duodenal ulcer following simple closure.

BACKGROUND: Resistance to clarithromycin, a component of standard triple therapy, leads to inconsistent eradication rates of Helicobacter pylori infection. Some studies have shown higher eradication rates for H. pylori using sequential regimen. This study was done to compare the eradication rates for H. pylori infection between the standard triple drug therapy and the sequential therapy. METHODS: Seventy-three patients with perforated duodenal ulcer following simple closure with H. pylori infection were randomized to receive either standard triple drug therapy or the sequential therapy. Standard triple drug therapy comprised of omeprazole, clarithromycin, and amoxicillin for 10 days. Sequential therapy comprised of omeprazole and amoxicillin or the first 5 days followed by omeprazole, clarithromycin, and amoxicillin for the next 5 days. Follow-up endoscopy was done at 2 months to assess the eradication rates, compliance, and side effects with each regimen. RESULTS: Eradication rates for standard triple therapy and sequential regimen were 81.25% and 87.09%, respectively (p = 0.732). The cost of sequential therapy was cheaper and incidence of side effects and compliance were similar in each group. CONCLUSION: Standard triple therapy and sequential therapy have similar efficacy for eradication of H. pylori and sequential therapy is an economical alternative to standard triple therapy.

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.

Five-year examination of utilization and drug cost outcomes associated with benefit design changes including reference pricing for proton pump inhibitors in a state employee health plan.

BACKGROUND: The Arkansas State Employee Benefits Division (EBD) is a self-insured program comprising public school and other state employees, their spouses, and dependents. Previous research published in JMCP (2006) showed drug cost savings of $2.20 per member per month (PMPM; 37.6%) or annualized savings of $3.4 million associated with a benefit design change and coverage of the proton pump inhibitor (PPI) omeprazole over-the-counter (OTC) beginning in March 2004. On May 1, 2005, brand esomeprazole was excluded from coverage, with current users grandfathered for 4 months until September 2005. Reference pricing for PPIs, including esomeprazole but excluding generic omeprazole, was implemented on September 1, 2005, and the beneficiary cost share for all PPIs except generic omeprazole was determined from comparison of the PPI actual price to the $0.90 omeprazole OTC reference price per unit. OBJECTIVE: To examine PPI utilization and drug costs before and after (a) excluding esomeprazole from coverage (with grandfathering current users) and (b) implementing a therapeutic maximum allowable cost (TMAC), or reference-pricing benefit design, for the PPI class in a large state employee health plan with fairly stable enrollment of approximately 127,500 members in 2005 through 2008 and approximately 128,000 members in 2009 Q1. METHODS: The pharmacy claims database for the EBD was used to examine utilization and cost data for PPIs in a longitudinal analysis for the 61-month period from March 1, 2004, through March 31, 2009. Pharmacy claims data were compared for the period 14 months prior to esomeprazole exclusion (preperiod), 4 months during the esomeprazole exclusion (postperiod 1), and the ensuing 43 months of PPI reference pricing (postperiod 2). PPI cost and utilization data for the intervention group of approximately 127,500 beneficiaries were compared with a group of 122 self-insured employers with a total of nearly 1 million beneficiaries whose pharmacy benefits did not include reference pricing for PPIs. RESULTS: Despite 79% of existing esomeprazole users being grandfathered during the 4-month esomeprazole-exclusion period (postperiod 1), the share of omeprazole OTC claims increased from 35.2% to 42.5% (+ 7.3 percentage points) of all PPI claims, and esomeprazole claims decreased from 16.7% to 12.0% (-4.7 percentage points), with little change in the use of other PPIs. The average allowed charge (price) per day of PPI drug therapy decreased in postperiod 1 by 8.9% from $2.81 to $2.56, while utilization increased by 2.2% from 1.83 days PMPM to 1.87 days PMPM; the net plan cost PMPM decreased by $0.40 PMPM from $3.78 to $3.38 (-10.6%), representing a reduction in spending of $35,664 per month while the average member copayment per claim was essentially unchanged. In the 43 months of reference pricing in postperiod 2, PPI utilization was essentially unchanged at 1.82 days PMPM compared with the preperiod (1.83 days PMPM) and 2.7% lower than the esomeprazole-exclusion period (1.87 days PMPM); however, price (charge per day) decreased by 38.4% during refer- RESEARCH ence pricing to $1.73 from $2.81 in the preperiod and by 32.4% compared with $2.56 in the esomeprazole-exclusion period, despite an increase in the average pharmacy dispensing fee to $5.21 per PPI claim. Net plan cost decreased by $1.87 PMPM (49.5%) to $1.91 PMPM during reference pricing compared with the preperiod ($3.78 PMPM) and by $1.47 PMPM (43.5%) compared with the esomeprazole-exclusion period 1 ($3.38 PMPM). Beneficiary costs (copayment per claim) for PPIs decreased to $1.24 PMPM ($23.27 per claim) compared with the preperiod ($1.37 PMPM, $24.95 per claim) and compared with the esomeprazole-exclusion period ($1.40 PMPM, $25.06 per claim). The reductions in net plan costs represented lower plan spending for the 43 months of reference pricing (postperiod 2) of approximately $9.4 million or an average of approximately $219,500 per month compared with the preperiod or $7.9 million (approximately $183,900 per month) compared with the esomeprazole-exclusion period. Compared with a group of self-insured health plans without pharmacy benefit reference pricing of PPIs, the cost savings over the 43-month period from September 1, 2005, through March 31, 2009, were approximately $7.2 million or $1.31 PMPM. CONCLUSIONS: For this state employee health plan, the policy change that excluded esomeprazole from coverage but grandfathered current users was associated with a relatively small reduction in PMPM spending on PPIs compared with the subsequent policy change that applied reference pricing to the PPI class based on the price (drug cost plus dispensing fee) for omeprazole OTC. Over 43 months of reference pricing, net plan costs fell dramatically by 49.5% PMPM compared with the preperiod or decreased by 43.5% compared with the esomeprazole-exclusion period. While utilization was essentially unchanged compared with the 18 months before reference pricing, the average pharmacy dispensing fee per PPI claim increased, and beneficiary costs PMPM decreased.

Prophylactic use of omeprazole associated with a reduced risk of peptic ulcer disease among maintenance hemodialysis patients.

BACKGROUND: Patients undergoing maintenance hemodialysis (MHD) have a high prevalence of peptic ulcer disease (PUD). Omeprazole is a proton pump inhibitor with proven efficacy in the prevention and treatment of PUD. However, there is little data on the prophylactic use of omeprazole in reducing the risk of PUD among MHD patients. METHODS: This prospective study included 93 patients undergoing MHD at Zen-Ho Dialysis Center between July 2008 and December 2009. Fifty-three patients were assigned to receive 20 mg of omeprazole daily for 18 months and 40 patients served as control. The Kaplan-Meier method was applied to calculate the cumulative incidence of PUD. RESULTS: The per-protocol population comprised 85 patients (omeprazole group, 49; control group, 36). Both groups had similar baseline characteristics. The need for endoscopy was found to be significantly less (10.2 vs. 44.4%, p = 0.001) in the omeprazole group than in the control group. Dialysis patients in the omeprazole group required fewer blood transfusions and erythropoietin doses than did the control group patients. Kaplan-Meier analysis revealed a higher cumulative ulcer rate in the control group (log-rank test, p = 0.04). However, omeprazole did not reduce the risk of PUD in MHD patients on regular aspirin or warfarin. CONCLUSIONS: We conclude that prophylactic use of omeprazole might be effective to lower the incidence of PUD among MHD patients without regular aspirin or warfarin use. Further large-scale controlled trials should be carried out to confirm our findings.

Treatment strategies for acid reflux: EncomPASSing practical solutions for primary care.

Despite a steady diet of randomized controlled trials (RCTs) for over three decades, nearly all of our routine clinical decisions remain incompletely supported, or even totally unaddressed, by the burgeoning pile of RCT data. The biomedical literature tends to focus on explanatory RCTs that compare new agents with placebo; it is less common to find pragmatic clinical trials (PCTs) that test the risks, benefits, and costs of competing active therapies within the context of usual practice settings. In this issue of the American Journal of Gastroenterology, Moayeddi and colleagues report the results of the EncomPASS study-a novel PCT for the primary care management of reflux disease. In this editorial, the results of EncomPASS are discussed, and the study is highlighted as a model for investigators to follow as we continue to emphasize pragmatic trials that address everyday challenges in clinical care.

A one-year economic evaluation of six alternative strategies in the management of uninvestigated upper gastrointestinal symptoms in Canadian primary care.

BACKGROUND: The cost-effectiveness of initial strategies in managing Canadian patients with uninvestigated upper gastrointestinalsymptoms remains controversial. OBJECTIVE: To assess the cost-effectiveness of six management approaches to uninvestigated upper gastrointestinal symptoms in the Canadian setting. METHODS: The present study analyzed data from four randomized trials assessing homogeneous and complementary populations of Canadian patients with uninvestigated upper gastrointestinal symptoms with comparable outcomes. Symptom-free months, qualityadjusted life-years (QALYs) and direct costs in Canadian dollars of two management approaches based on the Canadian Dyspepsia Working Group (CanDys) Clinical Management Tool, and four additional strategies (two empirical antisecretory agents, and two prompt endoscopy) were examined and compared. Prevalence data, probabilities, utilities and costs were included in a Markov model, while sensitivity analysis used Monte Carlo simulations. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were determined. RESULTS: Empirical omeprazole cost $226 per QALY ($49 per symptom-free month) per patient. CanDys omeprazole and endoscopy approaches were more effective than empirical omeprazole, but more costly. Alternatives using H2-receptor antagonists were less effective than those using a proton pump inhibitor. No significant differences were found for most incremental cost-effectiveness ratios. As willingness to pay (WTP) thresholds rose from $226 to $24,000 per QALY, empirical antisecretory approaches were less likely to be the most costeffective choice, with CanDys omeprazole progressively becoming a more likely option. For WTP values ranging from $24,000 to $70,000 per QALY, the most clinically relevant range, CanDys omeprazole was the most cost-effective strategy (32% to 46% of the time), with prompt endoscopy-proton pump inhibitor favoured at higher WTP values. CONCLUSIONS: Although no strategy was the indisputable cost effective option, CanDys omeprazole may be the strategy of choiceover a clinically relevant range of WTP assumptions in the initial management of Canadian patients with uninvestigated dyspepsia.

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)