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 the immunopotentiator N-acetyl-glucosamine-N-acetylmuramyl dipeptide during triple anti-Helicobacter pylori therapy].

AIM: To evaluate the efficiency of first-line Helicobacter pylori eradication therapy with glucosaminylmuramyldipeptide (Licopid JSC "Peptek", Russia). SUBJECTS AND METHODS: Eradication therapy was performed in 128 patients (84 men and 34 women; mean age 44.1 +/- 13.5 years) with duodenal bulb ulcer associated with H. pylori. The latter was detected in the gastroduodenal mucosa by a morphological study and rapid urease test before and 6-8 weeks after treatment and discontinuation of all drugs. Gastric metaplasia areas in the duodenum were revealed by periodic acid-Schiff and Alcian blue staining. The patients were divided into 4 groups according to the treatment protocol: 1) omeprazole (O) 0.04 g/day, clarithromycin (C) 1 g/day, amoxicillin (A) 2 g/day for 7 days (OCA7; n = 33); 2) the above drugs for 14 days (OCA14; n = 34); 3) O 0.04 g/day, C 1 g/day, A 2.0 g/day for 7 days, and glucosaminylmuramyldipeptide (Licopid) (L) 0.001 g/day for a day (OCA7L1; n = 34) and 4) the above drugs and L 0.01 g/day for 10 (OCA7L10; n = 27). RESULTS: According to the data of intention-to-treat analysis and per protocol, the H. pylori eradication rate was 81.8 and 87.1% for OCA7; 82.4 and 93.3% for OCA14; 88.2 and 93.8% for OCA7L1; 88.9 and 96% for OCA7L10 after PT and RRT, respectively. The rate of side effects was as follows: 6.1% for OCA7; 17.6% for OCA14 (5.9% stopped treatment); 5.9% for OCA7L1; 7.4% for OCA7L10. The cost of the treatment protocols was $ 32 for OCA7; $ 64 for OCA14; $ 40 for OCA7L1; $ 67 for OCA7L10. The intake of glucosaminylmuramyldipeptide (licopid) 0.001 g/day during 7-day triple anti-Helicobacter pylori therapy increased eradication by 6.4% (ITT) and 6.7% (PP), without raising the rate of side effects. CONCLUSION: H. pylori-positive patients with duodenal bulb ulcer should be given glucosaminylmuramyldipeptide (Licopid) 0.001 g/day during 7-day first-line eradication therapy as alternative to the 14-day treatment regimen.

Clinical and cost impact of intravenous proton pump inhibitor use in non-ICU patients.

AIM: To assess the appropriateness of the indication and route of administration of proton-pump-inhibitors (PPIs) and their associated cost impact. METHODS: Data collection was performed prospectively during a 6-mo period on 340 patients who received omeprazole intravenously during their hospital stay in non-intensive care floors. Updated guidelines were used to assess the appropriateness of the indication and route of administration. RESULTS: Complete data collection was available for 286 patients which were used to assess intravenous (IV) PPIs utilization. Around 88% of patients were receiving PPIs for claimed stress ulcer prophylaxis (SUP) indication; of which, only 17% met the guideline criteria for SUP indication, 14% met the criteria for non-steroidal-anti-inflammatory drugs-induced ulcer prophylaxis, while the remaining 69% were identified as having an unjustified indication for PPI use. The initiation of IV PPIs was appropriate in 55% of patients. Half of these patients were candidates for switching to the oral dosage form during their hospitalization, while only 36.7% of these patients were actually switched. The inappropriate initiation of PPIs via the IV route was more likely to take place on the medical floor than the surgical floor (53% vs 36%, P = 0.003). The cost analysis associated with the appropriateness of the indication for PPI use as well as the route of administration of PPI revealed a possible saving of up to $17,732.5 and $14,571, respectively. CONCLUSION: This study highlights the over-utilization of IV PPIs in non-intensive care unit patients. Restriction of IV PPI use for justified indications and route of administration is recommended.

[Long- and short-term results of staged treatment of ulcer patients working in oil production industry].

AIM: To determine clinical and cost-effect efficacy of staged (hospital-day hospital-outpatient clinic) treatment and rehabilitation of patients with ulcer disease (UD). MATERIAL AND METHODS: Of 160 patients with duodenal ulcer 80 patients (controls) received treatment in hospital and 80 patients (the study group) were treated in hospital and day hospital. Efficacy of the treatment was assessed by clinical data, results of device and cost-effect investigations. RESULTS: Clinical and endoscopic remission of duodenal ulcer was achieved for the same time in both the groups. The cost of the treatment of 1 patient was 23,393 and 21,163 rub in the controls and in the study group, respectively. Therefore, treatment in a day hospital reduced cost of the treatment. Later, the remission was consolidated by active follow-up in an outpatient clinic. CONCLUSION: Staged treatment of UD provides good therapeutic and economic effects compared to hospital treatment.

Cost of detecting malignant lesions by endoscopy in 2741 primary care dyspeptic patients without alarm symptoms.

BACKGROUND & AIMS: Current guidelines recommend empirical, noninvasive approaches to manage dyspeptic patients without alarm symptoms, but concerns about missed lesions persist; the cost savings afforded by noninvasive approaches must be weighed against treatment delays. We investigated the prevalence of malignancies and other serious abnormalities in patients with dyspepsia and the cost of detecting these by endoscopy. METHODS: We studied 2741 primary-care outpatients, 18-70 years in age, who met Rome II criteria for dyspepsia. Patients with alarm features (dysphagia, bleeding, weight loss, etc) were excluded. All patients underwent endoscopy. The cost and diagnostic yield of an early endoscopy strategy in all patients were compared with those of endoscopy limited to age-defined cohorts. Costs were calculated for a low, intermediate, and high cost environment. RESULTS: Endoscopies detected abnormalities in 635 patients (23%). The most common findings were reflux esophagitis with erosions (15%), gastric ulcers (2.7%), and duodenal ulcers (2.3%). The prevalence of upper gastrointestinal malignancy was 0.22%. If all dyspeptic patients 50 years or older underwent endoscopy, 1 esophageal cancer and no gastric cancers would have been missed. If the age threshold for endoscopy were set at 50 years, at a cost of $500/endoscopy, it would cost $82,900 (95% CI, $35,714-$250,000) to detect each case of cancer. CONCLUSIONS: Primary care dyspeptic patients without alarm symptoms rarely have serious underlying conditions at endoscopy. The costs associated with diagnosing an occult malignancy are large, but an age cut-off of 50 years for early endoscopy provides the best assurance that an occult malignancy will not be missed.

[Clinical and economical efficacy of the different variants of inpatient treatment of ulcerative diseases].

We spent the comparative studying of treatment effectiveness of patients with duodenal ulcer disease at the all-day hospital, all-day hospital with following treatment at the day-staying hospital and at the day-staying hospital. It was received equal clinical effectiveness at the different stages of treatment, but at the day-staying hospital economical effect was achieved, besides medical one.

[Clinical and economic assessment of treatment efficacy of uncomplicated duodenal ulcer with different antisecretory agents in hospital].

A study of 197 patients with uncomplicated duodenal ulcer revealed clinical and pH-metric particular features of the action of pariet (rabeprazole) and six secretolytics: cimetidine, ranitidine, ranisan, quamatel, omez. It was established that the main clinical criteria of treatment efficacy is duration of ulcer cicatrisation and percentage of cicatrized ulcers during 21 days, and additional criteria are duration of disappearance of clinical signs and stage of acid production suppression. Possibilities of applying methods of pharmacoeconomic study were examined: analysis of the treatment cost, cost minimization, and cost-efficacy with the definition of the increase of expense efficacy for drug selection. It was shown that the cost of the antisecretory therapy makes up from 0.45 to 9.14% of inpatient treatment. A cost-efficacy analysis showed that it is most expedient to use pariet.

[Pharmacoeconomic evaluation of the efficacy of treating patients with duodenal ulcers].

High cost of medical care provided to the patients with duodenal ulcers requires improvement of treatment organization. This study is aimed at pharmacoeconomic evaluation of the efficacy of treating patients with duodenal ulcers. Two groups of patients were made up for the investigation. The first group was made up of patients who had undergone an individual antisecretory therapy based on intragastric pH-monitoring. The other group was made up of patients undergoing standard treatment without using intragastric pH-monitoring. Upon the comparison of the results in both groups, it was revealed that the "cost of illness" and "cost-efficacy" turned out to be lower in the group of patients where intragastric pH-monitoring for selecting individual antisecretory therapy was used.

Does seropositivity for Helicobacter pylori antibodies increase outpatient costs for gastric and duodenal ulcer or inflammation?

BACKGROUND: Helicobacter pylori is regarded as an important cause of both peptic ulcer and chronic gastritis. In particular, seropositivity is highest in patients with duodenal ulcer. No studies have determined whether there are differences in the direct medical costs associated with gastric/duodenal ulcer or inflammation, between seropositive and seronegative patients. OBJECTIVE: To examine the relationship between seropositivity for H. pylori and outpatient visits and direct medical costs for gastric/duodenal ulcer or inflammation in Japan from the perspective of the payor and patients. METHODS: Participants were males (n = 653) who worked for an agricultural co-operative in Fukuoka Prefecture, attended an annual health examination (including a written lifestyle and medical survey), belonged to the same health insurance society consistently for 4 years from April 1996 to March 2000, and provided a blood sample. The survey asked about lifestyle, including smoking and drinking, and past medical history. We retrospectively analysed the annual number of outpatient visits per person and outpatient medical cost (Yen, 2000 values) per person for visits relating to gastric or duodenal ulcer or inflammation using International Classification of Diseases (9th edition) -- Clinical Modification codes. We assessed for potential confounding factors using analysis of covariance and the chi-square test. RESULTS: The annual outpatient incidence of disease, the number of visits to physicians, and the medical costs for gastric or duodenal ulcer or inflammation were about 2-fold greater in individuals with antibodies to H. pylori compared with those without antibodies. CONCLUSION: Population-based studies and/or randomised controlled clinical trials that target high-risk groups and account for the unique way in which data are collected in Japan are needed to determine whether medical costs for gastric and duodenal ulcer might be reduced by treating asymptomatic patients who have antibodies to H. pylori.

Polymorphisms and the pocketbook: the cost-effectiveness of cytochrome P450 2C19 genotyping in the eradication of Helicobacter pylori infection associated with duodenal ulcer.

The clinical outcome of duodenal ulcer treated with proton pump inhibitor (PPI)-based, anti-Helicobacter pylori (H.p.) regimens varies according to cytochrome P450 2C19 (CYP2C19) genotype. CYP2C19 genotypes differ markedly in peoples of Pacific Rim descent compared with another ethnicity. The authors sought to determine the specific impact that these factors have on the cost-effectiveness of duodenal ulcer management. Their model consisted of two patient cohorts with Helicobacter pylori and duodenal ulcer, trichotomized into CYP2C19 homozygous extensive metabolizers (EMs), heterozygous EMs, and poor metabolizers (PMs), altering the anti-H.p. regimen in the genotyped cohort only. The authors took the perspective of a third-party payer, and the denominator was ulcer episode prevented. In the reference case, the use of CYP2C19 genotyping prior to initiating anti-H.p. therapy was dominant (costs were saved with each ulcer episode prevented) in all geographic regions of the United States. The subsequent break-even analysis showed a range of 89.20 dollars to 118.96 dollars--from Hawaii to the Midwest, respectively--required to eliminate the cost-savings from each genotype test performed. Using probabilities most unfavorable to genotyping, the variation of peoples with Pacific Rim origins from 0% to 100% altered the cost-effectiveness from 495 dollars to 2125 dollars per ulcer event prevented, respectively. The results suggest that treatment decisions for H.p. infection that are based on a patient's CYP2C19 genotype decreases expenses for health plans implementing testing. This analysis provides an economic basis to support recent calls to expand this technology into routine clinical care to prevent toxicity of narrow therapeutic index drugs.

Sequential treatment for Helicobacter pylori eradication in duodenal ulcer patients: improving the cost of pharmacotherapy.

BACKGROUND: Several studies have shown that Helicobacter pylori eradication rates with standard 7-day triple therapy are unsatisfactory. A novel 10-day sequential treatment regimen recently achieved a significantly higher eradication rate. To improve the pharmacotherapeutic cost, we evaluated whether an acceptable eradication rate could be achieved in peptic ulcer patients by halving the dose of clarithromycin. METHODS: In a prospective, open-label study, 152 duodenal ulcer patients with H. pylori infection, assessed by rapid urease test and histology, were enrolled. Patients were randomized to receive either a 10-day sequential treatment comprising rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days (high-dose therapy), or a similar schedule with the clarithromycin doses halved to 250 mg b.d. (low-dose therapy). No further antisecretory drugs were offered. Four to six weeks after therapy, H. pylori eradication and ulcer healing rates were assessed by endoscopy. RESULTS: Similar H. pylori eradication rates were observed following high- and low-dose regimens for both per protocol (97.3% vs. 95.9%; P = N.S.) and intention-to-treat (94.7% vs. 92.2%; P = N.S.) analyses. No major side-effects were reported. At repeat endoscopy, peptic ulcer healing was observed in 93% and 93% of patients following high- and low-dose therapy, respectively. CONCLUSION: The cheaper low-dose sequential regimen may be suggested for H. pylori eradication in duodenal ulcer patients, even without continued proton pump inhibitor therapy after eradication treatment.

Recurrent duodenal ulcer haemorrhage: a pharmacoeconomic comparison of various management strategies.

BACKGROUND: Duodenal ulcer (DU) bleeding has a 7 - 13% mortality rate and bleeding often recurs. Prevention of recurrence is, therefore, an important goal. Eradication of Helicobacter pylori or maintenance treatment with a proton pump inhibitor (PPI) may reduce recurrent DU bleeding. Economic comparison of these options is sparse. METHODS: After the control of index bleeding with endotherapy and drugs, three strategies were evaluated: empirical treatment for possible H. pylori infection followed by a PPI for 2 months; test for H. pylori, eradication if positive, maintenance PPI if negative; maintenance PPI alone. Probability and direct cost data were obtained from a Medline search and Indian hospitals, respectively. Cost-minimisation, cost-utility, one- and two-way sensitivity analyses and threshold values were evaluated. RESULTS: Treatment of H. pylori, particularly empirical, was the preferred strategy and dominated maintenance treatment with PPI. The test-and-treat strategy was better than the empirical treatment strategy only when the probabilities of H. pylori eradication, ulcer healing following eradication and of frequency of H. pylori infection in bleeding DU were less than 58, 73 and 58%, respectively. CONCLUSIONS: Eradication of H. pylori is preferred in preventing recurrent bleeding from DU.

[Medico-economic efficacy of eradication schemes in helicobacter infections in patients with duodenal ulcers]. / Mediko-ékonimicheskaia éffektivnos' éradikatsionnykh skhem pri khelikobakternoi infektsii u bol'nykh s iazvennoi bolezn'iu dvenadtsatiperstnoi kishki.

The purpose of the study was to make a comparative medical and economic analysis of the application of Rabeprazole (Pariet) and Omeprazole generic in a seven-day eradication therapy.

[Pharmacoeconomic aspects of the 1-week eradication treatment of duodenal ulcer associated with Helicobacter pylori]. / Farmakoékonomicheskie aspekty 1-nedel'noi éradikatsionnoi terapii iazvennoi bolezni dvenadsatiperstnoi kishki, assotsiirovannoi s Helicobacter pylori.

There is a disclosure of the results of one-week eradication therapy (esomeprazole, 20 mg + Flemoxin Solutab, 1,000 mg + Clarithromycin, 500 mg, twice a day) without any subsequent antisecretory therapy. In order to control the healing of non-complicated ulcers of the duodenal bulb, the first control endoscopy (esophagogastroduodenoscopy) was conducted after 7 days, and the second one was conducted 4 weeks after the termination of patients' treatment. The healing of ulcers of the duodenal bulb was recorded in 89.5% and 89.5% of cases, respectively. A control determination of the H. pylori semination of the mucous coating of stomach was accomplished 4 weeks after the termination of patients' treatment. According to the data of the fast urease test and 13C-urease respiratory test, the HP eradication was recorded in all of the patients (100%), and according to the data of the histologic method of target biopsy materials studies, it was recorded in 94.7% of cases. A pharmacoeconomic analysis of the acquired data showed that the seven-day eradication therapy of non-complicated duodenal ulcer, where esomeprazole was used as the basic preparation, is most efficient and most economically expedient.