Consumption of medicines used for gastric acid-related disorders in Australia and South Korea: a cross-country comparison.

PURPOSE: The study's aim was to compare the use of proton pump inhibitors (PPIs), histamine 2-receptor antagonists (H2RAs) and mucoprotective medicines (MPs) used for gastric acid-related disorders (GARD) in Australia and South Korea (Korea) from 2004 to 2017. METHODS: Prescription data for PPIs, H2RAs and MPs for Australian outpatients were extracted from the Australian Statistics on Medicines annual reports, with dose-specific and expenditure data obtained from Medicare. Similar data were obtained from Korean National Health Insurance Service claims data. We analysed the volume and expenditure of medicines use annually using the defined daily dose per 1,000 population per day. We calculated which medicines accounted for 90% of use and estimated the proportions of use for low- and high-dose PPIs. RESULTS: While total utilisation for GARD medicines increased over time in both countries, patterns of use differed. Overall, use was somewhat higher in Australia but increased more rapidly in Korea. PPIs were used more extensively in Australia, while more MPs and H2RAs were used in Korea. Expenditure and use of low-dose PPIs is escalating in Korea. CONCLUSION: There were substantial differences in the use of GARD medicines in Australia and Korea over 14 years. Both countries face similar challenges to promote rational medicines use and contain medical care costs. The discrepant prescribing patterns can be attributed to differences in healthcare systems, pharmaceutical policies and demographics. This study provides a baseline to influence more rational use of these medicines. It provides insight into medicines policies for other countries that face similar challenges.

The appropriate use of proton-pump inhibitors.

The introduction of proton-pump inhibitors (PPIs) into clinical practice since about thirty years has greatly improved our therapeutic approach to acid-related diseases for their well recognized efficacy and safety. Accordingly, the role of surgery has been enormously reduced in this field. The main indications for PPI use are universally acknowledged by many scientific societies and are the following: treatment of gastroesophageal reflux disease in its various forms and complications, eradication of H. pylori infection in combination with two or more antibiotics, therapy of H. pylori-negative peptic ulcers, healing and prevention of NSAID-associated gastric ulcers, co-therapy with endoscopic procedures to control upper digestive bleeding and medical treatment of Zollinger-Ellison Syndrome. Despite the above well-defined indications, however, the use of PPIs continues to grow every year in both Western and Eastern countries and this phenomenon poses serious queries about the appropriate prescription of these drugs worldwide. In fact, the endless expansion of PPI market has created important problems for many regulatory authorities for two relevant features: the progressive and irreversible increase of the costs of therapy with this class of drugs and the greater potential harms for the patients. So, there is the need for a reappraisal of PPI correct indications for both general practitioners and various specialists in order to re-establish a correct use of these effective drugs in daily clinical practice, according to the best evidence-based guidelines.

A Successful Pharmacist-Based Quality Initiative to Reduce Inappropriate Stress Ulcer Prophylaxis Use in an Academic Medical Intensive Care Unit.

Stress ulcer prophylaxis (SUP) is often inappropriately utilized, particularly in critically ill patients. The objective of this study is to find an effective way of reducing inappropriate SUP use in an academic medical intensive care unit (ICU). Medical ICU patients receiving SUP were identified over a 1-month period, and their charts were reviewed to determine whether American Society of Health-System Pharmacists guidelines were followed. Inappropriate usage was calculated as inappropriate patient-days and converted to incidence per 100 patient-days. Two interventions were implemented: (1) Pharmacists reviewed indications for SUP on each patient during daily team rounds and daily medication reconciliation and (2) residents rotating on ICU services were educated on a bimonthly basis. Postintervention data were obtained in a similar fashion. Prior to intervention, the incidence of inappropriate SUP usage was calculated to be 26.75 per 100 patient-days (n = 1099 total patient-days). Total cost attributable to the inappropriate use was $2433. Post intervention, we were able to decrease the inappropriate incidence of SUP usage to 7.14 per 100 patient-days (n = 1149 total patient-days). In addition, total cost of inappropriate use was reduced to $239.80. Our study highlights an effective multidisciplinary approach to reduce the inappropriate use of SUP in an academic medical ICU. We were able to reduce the incidence of inappropriate use of SUP by 73.31% ( P < .001). Furthermore, we were able to decrease the costs by approximately $2200/month.

Proton pump inhibitor prescribing and costs in a large outpatient clinic.

UNLABELLED: Concerns have been raised regarding potential adverse effects and high costs of proton pump inhibitors (PPIs). Our objective was to assess issues of PPI utilization and expense in a large outpatient clinic population. METHODS: Two hundred-fifty-nine outpatient records were reviewed regarding PPI prescribing and indications during 2009. A cost analysis was performed to project cost differences if histamine-2 receptor antagonists (H2RAs) were used as an alternative to PPIs in appropriate clinical situations. RESULTS: Eighty-three (32.0%) were taking PPIs. Problem-listed gastroesophageal reflux disease (GERD) was the primary diagnosis in 69 (83.1%) of patients on PPIs. GERD was not apparent by documented history and/or endoscopy in 46.3% of problem-listed GERD patients. Symptom severity had been documented in only 36.2%. Cost analysis projected substantial savings if H2RAs had been used initially for mild to moderate symptoms. CONCLUSIONS: Outpatient PPI prescribing indications are not well documented and PPI use is probably excessive. H2RA therapy is likely underutilized.

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

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

Cost-effectiveness of histamine receptor-2 antagonist versus proton pump inhibitor for stress ulcer prophylaxis in critically ill patients*.

OBJECTIVE: To examine the cost-effectiveness of using histamine receptor-2 antagonist or proton pump inhibitor for stress ulcer prophylaxis. DESIGN: Decision analysis model examining costs and effectiveness of using histamine receptor-2 antagonist or proton pump inhibitor for stress ulcer prophylaxis. Costs were expressed in 2012 U.S. dollars from the perspective of the institution and included drug regimens and the following outcomes: clinically significant stress-related mucosal bleed, ventilator-associated pneumonia, and Clostridium difficile infection. Effectiveness was the mortality risk associated with these outcomes and represented by survival. Costs, occurrence rates, and mortality probabilities were extracted from published data. SETTING: A simulation model. PATIENTS: A mixed adult ICU population. INTERVENTIONS: Histamine receptor-2 antagonist or proton pump inhibitor for 9 days of stress ulcer prophylaxis therapy. MAIN MEASUREMENTS AND RESULTS: Output variables were expected costs, expected survival rates, incremental cost, and incremental survival rate. Univariate sensitivity analyses were conducted to determine the drivers of incremental cost and incremental survival. Probabilistic sensitivity analysis was conducted using second-order Monte Carlo simulation. For the base case analysis, the expected cost of providing stress ulcer prophylaxis was $6,707 with histamine receptor-2 antagonist and $7,802 with proton pump inhibitor, resulting in a cost saving of $1,095 with histamine receptor-2 antagonist. The associated mortality probabilities were 3.819% and 3.825%, respectively, resulting in an absolute survival benefit of 0.006% with histamine receptor-2 antagonist. The primary drivers of incremental cost and survival were the assumptions surrounding ventilator-associated pneumonia and bleed. The probabilities that histamine receptor-2 antagonist was less costly and provided favorable survival were 89.4% and 55.7%, respectively. A secondary analysis assuming equal rates of C. difficile infection showed a cost saving of $908 with histamine receptor-2 antagonists, but the survival benefit of 0.0167% favored proton pump inhibitors. CONCLUSIONS: Histamine receptor-2 antagonist therapy appears to reduce costs with survival benefit comparable to proton pump inhibitor therapy for stress ulcer prophylaxis. Ventilator-associated pneumonia and bleed are the variables most affecting these outcomes. The uncertainty in the findings justifies a prospective trial.

Gastroprotective strategies in chronic NSAID users: a cost-effectiveness analysis comparing single-tablet formulations with individual components.

OBJECTIVES: To evaluate the cost-effectiveness of competing gastroprotective strategies, including single-tablet formulations, in the prevention of gastrointestinal (GI) complications in patients with chronic arthritis taking nonsteroidal anti-inflammatory drugs (NSAIDs). METHODS: We performed a cost-utility analysis to compare eight gastroprotective strategies including NSAIDs, cyclooxygenase-2 inhibitors, proton pump inhibitors (PPIs), histamine-2 receptor antagonists, misoprostol, and single-tablet formulations. We derived estimates for outcomes and costs from medical literature. The primary outcome was incremental cost per quality-adjusted life-year gained. We performed sensitivity analyses to assess the effect of GI complications, compliance rates, and drug costs. RESULTS: For average-risk patients, NSAID + PPI cotherapy was most cost-effective. The NSAID/PPI single-tablet formulation became cost-effective only when its price decreased from €0.78 to €0.56 per tablet, or when PPI compliance fell below 51% in the NSAID + PPI strategy. All other strategies were more costly and less effective. The model was highly sensitive to the GI complication risk, costs of PPI and NSAID/PPI single-tablet formulation, and compliance to PPI. In patients with a threefold higher risk of GI complications, both NSAID + PPI cotherapy and single-tablet formulation were cost-effective. CONCLUSIONS: NSAID + PPI cotherapy is the most cost-effective strategy in all patients with chronic arthritis irrespective of their risk for GI complications. For patients with increased GI risk, the NSAID/PPI single-tablet formulation is also cost-effective.

Histamine-2 receptor antagonists and risk of lung cancer in diabetic patients ­ an exploratory analysis.

PURPOSE: Histamine-2 receptor blockers (H2RBs) might have anti-tumorogenic effect, but the clinical effect on lung cancer occurrence was unclear. METHODS: A total of 640,173 type 2 diabetic patients were identified from the Taiwan National Health Insurance claims database in 2000. Patients were followed from cohort entry to the earliest of cancer diagnosis, death, disenrollment from the national health insurance, or 31 December 2007. For each participant, H2RB use during the follow-up period was ascertained from the outpatient pharmacy prescription database. Patients with incident squamous cell carcinoma (SCC) and adenocarcinoma were included as cases and up to four age- and sex-matched controls were selected by risk-set sampling. Conditional logistic regression models were applied to estimate the association between H2RBs and lung cancer incidence. RESULTS: A total of 1182 incident SCC and 2345 adenocarcinoma cases were identified, and 13,108 matched controls were selected. An increased risk was observed for H2RBs use <1 year with adjusted OR of 1.33 (95% confidence interval (CI): 1.22­1.44). After excluding all exposures occurring in the year before lung cancer diagnosis, H2RBs use with cumulative dosage ≥ 360 "defined daily doses" was associated with a significantly decreased risk of lung cancer (OR: 0.60; 95% CI: 0.38­0.96). When we stratified on types of lung cancer, the protective association of higher cumulative use of H2RBs seemed more evident for lung adenocarcinoma, with an adjusted OR of 0.49 (95% CI: 0.26­0.90). CONCLUSIONS: Higher cumulative use of H2RBs might be associated with a reduced risk for non-small cell lung cancer in diabetic patients.

Selection of generic preparations of famotidine orally disintegrating tablets for use in unit-dose packages.

Changes in the hardness, dissolution, and the disintegration time of brand name and generic preparations (6 preparations) of famotidine orally disintegrating tablets were investigated. Tablets had been stored in a thermo-hygrostat-controlled environment set to simulate the home conditions of patients up to 8 weeks after unit-dose packaging. Among the tablets in unit-dose packaging prepared immediately after blister packs (BP) were opened, one generic had decreased hardness to less than 2.0 kg after 1 week, 55.1% of its initial hardness value, and a shorter disintegration time of about 1/5 of its initial disintegration time. Generics met the standard for dissolution 8 weeks after unit-dose packaging. The decrease in hardness after unit-dose packaging is presumed to be associated with additives, and particularly the types and amounts of binding agents, but evidence of this association was lacking. The hardness noted in drug interview forms (IFs) and the state of sales of bulk tablet packages must be determined to facilitate the selection of generics that remain hard even after unit-dose packaging.

Chronic urticaria--assessment and treatment.

BACKGROUND: Chronic urticaria is a common condition encountered in general practice and a frequent source of referral to the clinical immunologist, allergist and dermatologist. OBJECTIVE: This article discusses the assessment and management of chronic urticaria in the general practice setting. DISCUSSION: Chronic urticaria is defined as the occurrence of transient wheals lasting more than 6 weeks in duration. In 80% of cases, a cause is not identified and this is classified as chronic idiopathic urticaria. A physical trigger, vasculitis or systemic disease account for a smaller proportion of cases. Allergic causes are rarely responsible. A detailed history provides the most useful information in determining the presence of chronic urticaria and a possible aetiology. Apart from thyroid function tests and thyroid autoantibodies, other investigations should only be performed if clinically indicated. Second generation antihistamines are the mainstay of treatment and usually twice daily regimens are required for adequate control. H2 antagonists, doxepin and immunomodulation may be necessary in some patients.

Ventilator-associated pneumonia in neonatal and pediatric intensive care unit patients.

Ventilator-associated pneumonia (VAP) is the second most common hospital-acquired infection among pediatric intensive care unit (ICU) patients. Empiric therapy for VAP accounts for approximately 50% of antibiotic use in pediatric ICUs. VAP is associated with an excess of 3 days of mechanical ventilation among pediatric cardiothoracic surgery patients. The attributable mortality and excess length of ICU stay for patients with VAP have not been defined in matched case control studies. VAP is associated with an estimated $30,000 in attributable cost. Surveillance for VAP is complex and usually performed using clinical definitions established by the CDC. Invasive testing via bronchoalveolar lavage increases the sensitivity and specificity of the diagnosis. The pathogenesis in children is poorly understood, but several prospective cohort studies suggest that aspiration and immunodeficiency are risk factors. Educational interventions and efforts to improve adherence to hand hygiene for children have been associated with decreased VAP rates. Studies of antibiotic cycling in pediatric patients have not consistently shown this measure to prevent colonization with multidrug-resistant gram-negative rods. More consistent and precise approaches to the diagnosis of pediatric VAP are needed to better define the attributable morbidity and mortality, pathophysiology, and appropriate interventions to prevent this disease.

Efficiency of potent gastric acid inhibition.

The evidence regarding the efficiency of potent gastric acid inhibition is exposed after a systematic search and a critical evaluation of its quality, using a specific score. The aim was to review alternative options, in economic terms, especially related with gastro-oesophageal reflux disease. The results show that the superiority of the proton pump inhibitors over the histamine H2 receptor antagonist is clear in moderate and severe oesophagitis and in patients with persistent or severe symptoms. This evidence is clearly related with the intensity of the gastric inhibition. An associated benefit is the improvement of the quality of life obtained with this potent gastric acid inhibition profile.

Diagnosis and treatment of gastroesophageal reflux disease in Ohio Medicaid patients: practice patterns and temporal trends.

PURPOSE: There is a paucity of data about the use of procedures and prescription medications in the treatment of gastroesophageal reflux disease (GERD) in actual clinical practice. METHODS: Outpatient Ohio Medicaid claims from 1994 to 1998 were searched to identify patients with an initial diagnosis of GERD along with associated prescriptions and gastrointestinal procedures. Complications of GERD and comorbid illnesses were also determined. RESULTS: A total of 5579 patients were identified. Histamine-2 receptor antagonists (H2RA's) were prescribed in 59%, followed by proton pump inhibitors (PPI's) (30%) and prokinetic drugs (17%). PPI's were more frequently prescribed to patients with GERD-related complications, peptic ulcer disease and major comorbidities, and patients who received PPI's were also more likely to undergo upper gastrointestinal endoscopy. The frequencies of upper endoscopy and barium studies were 20% and 11% respectively, with no change over the study period. There was an increased frequency of PPI therapy (17-43%) and decreased frequency of H2RA therapy (72-47%) from 1994 to 1998 which persisted after adjusting for potential differences in case mix. CONCLUSIONS: In this population-based study, prescription of PPI's increased over time which likely reflected changes in clinician practice rather than patient mix. Despite a greater awareness of GERD complications, use of upper endoscopy did not increase. Although the cohort consists of predominantly low socioeconomic status, female patients, further studies should be conducted in other populations to confirm these findings.

[On-demand treatment with gastric acid inhibitors for gastroesophageal reflux disease]. / Zuurremming op maat voor patiënten met gastro-oesofageale reflux.

Gastric acid inhibitors are effective and safe drugs for the treatment of gastro-oesophageal reflux disease. Since reflux disease is frequent in Western populations, the use of gastric acid inhibitors leads to a considerable financial burden to the community. However, a large proportion of the patients with reflux symptoms do not take their medication continuously but use the drugs as required by their symptoms. This opens the possibility of a more cost-effective approach in which optimal symptom relief is achieved in combination with cost reduction. The type of on-demand therapy must be based on the individual pattern of reflux symptoms. In this approach, the patient determines the actual therapy whereas the physician functions as advisor. It is presently unknown whether any adverse effects result from the long-term on-demand therapy of reflux disease.

[As-needed treatment with gastric acid inhibitors in gastroesophageal reflux disease]. / 'Zo nodig'-gebruik van zuurremmende middelen bij refluxziekte.

Although proton pump inhibitors and H2-receptor antagonists are usually prescribed for continuous use by patients with gastro-oesophageal reflux disease, at least 50% of such patients do not take their medication daily and some take it only sporadically. On-demand treatment with proton pump inhibitors or H2-receptor antagonists is safe and cost-effective. Indications are: (a) incidental reflux episodes of short duration, (b) periodic reflux lasting several weeks or months, (c) chronic reflux not requiring continuous treatment. On-demand treatment is unsuitable for patients with reflux disease who either require daily medication or in whom the maximal dosage is insufficient. There are three types of on-demand treatment. Type 1: use of medication only in case of incidental symptoms. Type 2: continuous medication for 2-4 weeks when symptoms appear. Type 3: continuous use because of chronic symptoms, but the interval between doses is determined by the patient on the basis of his symptoms. All antacids can in principle be used for on-demand treatment; for type 3 treatment, antacids with a rapid onset of action are preferred. A favourable response to the two weeks of initial therapy is a good predictor for successful on-demand treatment.

On-demand and intermittent therapy for gastro-oesophageal reflux disease: economic considerations.

Since gastro-oesophageal reflux disease (GORD) is a prevalent condition characterised by frequent relapses, long-term costs of management for this disease are high. Thus, strategies to decrease resource expenditures without impairing patient quality of life are desirable. On-demand therapy (one-dose when symptoms occur) and intermittent therapy (short course of medication when symptoms occur) are attractive since pharmaceutical expenditures may be decreased, and many patients self-employ this strategy. The purpose of this paper was to examine the economic implications of on-demand or intermittent therapy for GORD. A review of selected studies evaluating medication suitable for on-demand or intermittent administration was performed. A complete search for published studies on the cost effectiveness of on-demand or intermittent therapy for GORD was conducted, and the results discussed in detail. Antacids, alginates, topically active agents, histamine(2)-receptor antagonists, and proton pump inhibitors have all demonstrable efficacy compared with placebo when administered on-demand. Proton pump inhibitors constitute the most effective pharmacological means to treat GORD. Although step-up strategies initially using less potent medication may decrease resource use, cost-effectiveness analysis illustrates that on-demand or intermittent therapy with proton pump inhibitors may be reasonable options. Further work that defines quality of life and patient preferences associated with GORD may allow for proper allocation of resources for the management of this condition.

Cost impact of switching histamine(2)-receptor antagonists to nonprescription status.

BACKGROUND: There is a recent trend to switching medications from prescription to nonprescription status. Often, such switches are accompanied by dramatic changes in utilization due to increased availability or decreased insurance coverage. The histamine(2)-receptor antagonists (H(2)RAs) underwent such status change in the UK in 1994, the US in 1995, and Canada in 1996. OBJECTIVE: To examine the impact of the status change for H(2)RAs on the market for gastrointestinal (GI) agents in the US, UK, and Canada. METHODS: IMS market sales data from 1992 to 1997 were procured. All costs were converted to 1997 US dollars using the consumer price index. Per capita sales figures were determined using population data from the US Census Bureau's International Database. RESULTS: Overall spending on GI remedies increased in all 3 markets between 1992 and 1997; however, the contribution of prescription sales and number of prescriptions varied across the 3 countries. An increased market share for nonprescription H(2)RAs occurred in the US, correlating with a decline in prescription numbers for GI remedies. The opposing trend occurred in the UK, where market share of nonprescription H(2)RAs was minimal and use of prescription H(2)RAs increased. Prescription and nonprescription H(2)RA sales could not be differentiated for Canada. CONCLUSIONS: The impact of the H(2)RA status change varied across countries. Differences in utilization may be attributed to many factors such as differing healthcare systems, patient convenience, and physician prescribing practices. Further research is required to identify the reasons for differences in utilization and to quantify the potential clinical impact.

Helicobacter pylori eradication in patients on long-term H2 receptor antagonists. Economic and symptomatic benefits. A large prospective study in primary care.

BACKGROUND: A large proportion of patients in primary care are still being maintained on long-term acid suppression, without any attempts to identify Helicobacter pylori status and to treat those that test positive. OBJECTIVES: To assess the prevalence and economic and symptomatic benefits of H. pylori eradication in patients maintained on long-term H2 receptor antagonists (H2RA) in primary care. PATIENTS AND METHODS: Patients on long-term (i.e. 6 months or longer) H2RA were identified from the computerised records of six practices in north England. Helicobacter pylori status was identified using serology and H. pylori positive patients were then offered standard 7-day proton pump based triple therapy, followed by a urea breath test (UBT) to confirm H. pylori eradication. Those who had a positive UBT were offered a second line course of H. pylori eradication therapy. Follow up period was 1 year. The main outcome measures were improvement in dyspepsia symptom scores, amount of H2RA being consumed, and economic benefits after H. pylori eradication. RESULTS: One thousand and seven patients (1.5%) were identified on long-term H2RA, of whom 471 (46%) ultimately had their H. pylori serology assessed. Sixty-three (297) percent of the patients tested had a positive serology for H. pylori, the majority of whom (58%, 172) had prior evidence of peptic ulcer disease. The mean duration of therapy and mean time since endoscopy/barium studies was significantly longer in patients with peptic ulcer disease compared to their counterparts with nonulcer dyspepsia and gastro-oesophageal reflux disease, p =.0002 and.0001, respectively. After successful H. pylori eradication (which was possible in 84% of the patients), at the end of the 1-year study period, on an intention to treat basis 62% of the patients could either stop or significantly reduce dosage of their H2RA. There was also significant reduction in the mean dose of H2RA being consumed and severity of symptoms at the end of the study period (p <.00001). CONCLUSION: Almost two-thirds of patients on long-term H2RA in primary care will have a positive serology for H. pylori; the majority of these will have peptic ulcer disease. In over 60% of cases H. pylori eradication led to significant improvement in symptom scores and reduction in dosage of H2RA being consumed. Cessation or reduction in long-term H2RA prescribing is cost effective.

Acid-suppressive therapy use associated with antihypertensive agents.

Nitrates and calcium channel blockers (CCBs) have been shown to decrease lower esophageal sphincter pressure and theoretically may precipitate or aggravate gastroesophageal reflux. Thus, the authors hypothesized that patients who receive these agents would have greater use of acid-suppressive drug use, defined as histamine2 antagonists or proton pump inhibitors. A retrospective cohort design was used to assess the use of acid-suppressive drug use in hypertensive patients with respect to both nitrates and antihypertensive therapy. Of 15,662 treated hypertensive patients, 20% received acid-suppressive therapy. An increased use of acid-suppressive therapy was associated with nitrate (odds ratio [OR] = 1.71), CCB (OR = 1.46), and alpha 1 antagonist (OR = 1.32) treatment, which appeared to be additive when patients received two or more of the agents. Within the class of CCBs, there was no significant difference among the individual agents. As the clinical and economic burden may be substantial, further study is warranted.

Cost effectiveness of rabeprazole versus generic ranitidine for symptom resolution in patients with erosive esophagitis.

OBJECTIVE: To compare the cost effectiveness of rabeprazole (RAB) and ranitidine (RAN) in acute and maintenance therapy for erosive esophagitis using symptom response, rather than endoscopic healing, as the clinical outcome. STUDY DESIGN: Decision analysis was used to model the cost effectiveness of competing therapies based on the results of clinical trials of RAB versus RAN and estimates from the medical literature. METHODS: The model's base case scenario compared brand-name RAB (estimated average wholesale price) with generic RAN (25% of the average wholesale price of brand-name RAN). Medical costs for hospitalizations, procedures, and office visits reflected 1998 Medicare payments. The 1-year maintenance model accounted for drug-class switching and symptomatic, rather than endoscopic, recurrences. Effectiveness was reported as the percentage of patients in whom a symptomatic recurrence was prevented. The cost per symptomatic recurrence prevented was reported as an average and an incremental cost-effectiveness ratio. RESULTS: The per-patient cost of RAB therapy was higher than that of RAN therapy ($2020 vs $1917); RAB therapy, however, was more effective than RAN therapy in preventing symptomatic recurrences (74% vs 41%). The average cost-effectiveness ratio was lower for RAB therapy than for RAN therapy ($2748 per symptomatic recurrence prevented vs $4719 per symptomatic recurrence prevented). The cost of preventing one additional symptomatic recurrence with RAB rather than RAN was $313 (incremental cost-effectiveness ratio). Sensitivity analysis conducted on key clinical and cost variables supported the robustness of the decision model. CONCLUSION: This analysis demonstrates that management of esophagitis with RAB is more effective, and may be more cost effective, than management with generic RAN, despite RAB's higher per-unit cost.