Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole--results from the STARS II study.

BACKGROUND: Patients with dyspepsia often experience troublesome symptoms. AIM: To assess the burden of uninvestigated dyspepsia (symptoms, health-related quality of life [HRQL] and work productivity) before and after 8 weeks' esomeprazole treatment. METHODS: Patients (n=1250) with uninvestigated dyspepsia (no endoscopy within 6 months and ≤ 2 endoscopies within 10 years) underwent a 1-week esomeprazole acid-suppression test before randomisation to 7 weeks' esomeprazole or placebo. The Reflux Disease Questionnaire (RDQ), Quality of Life in Reflux and Dyspepsia (QOLRAD) and Work Productivity and Activity Impairment (WPAI) questionnaires were completed at baseline (1-week off-treatment) and 8 weeks. WPAI results were further analysed among patients who responded to the acid-suppression test. RESULTS: The highest baseline symptom score was for the RDQ dyspepsia domain, and the highest disease burden was for QOLRAD vitality and food/drink problems. After 8 weeks, significant improvements vs. placebo were observed for all RDQ and QOLRAD domains. The sub-population of acid-suppression test responders, but not the total WPAI population, had a significant work productivity improvement vs. placebo. CONCLUSIONS: Uninvestigated dyspepsia is associated with high symptom load and impacts on HRQL and work productivity. Esomeprazole improves HRQL among such patients, and improves work productivity among 1-week acid-suppression trial responders. ClinicalTrials.gov identifier: NCT00251992.

Relationship between symptom load of gastro-oesophageal reflux disease and health-related quality of life, work productivity, resource utilization and concomitant diseases: survey of a US cohort.

BACKGROUND: Analysis of the burden of gastro-oesophageal reflux disease (GERD) in relation to the severity and frequency of symptoms is essential to identify individuals and groups in whom targeted management is justified. AIM: To describe the relationship between symptoms of GERD and self-reported health-related quality of life (HRQL), work productivity, healthcare utilization and concomitant diseases. METHODS: US respondents to the Internet-based 2004 National Health and Wellness Survey who had self-reported GERD (n = 10,028, mean age: 52 years, 58% female) were age- and gender-matched to a control group without GERD (n = 10,028). Respondents with GERD were classified according to symptom severity and frequency. HRQL and productivity were assessed using the Short-Form 8 survey (SF-8) and Work Productivity and Activity Impairment questionnaire, respectively. RESULTS: Symptom frequency increased with increasing symptom severity. Compared with controls, respondents with GERD had more concomitant diseases [mean difference (MD): 1.6], lower SF-8 physical and mental health scores (MD: 4.1 units and 3.1 units, respectively), increased absenteeism (MD: 0.9 h/week), reduced percent productivity at work (MD: 7.5%) and increased healthcare utilization. All tested variables deteriorated with increasing symptom severity and/or frequency. CONCLUSIONS: Increasing severity and frequency of GERD symptoms is associated with more concomitant diseases, lower HRQL, lower work productivity and increased healthcare utilization, suggesting that patients with moderate or severe GERD should receive targeted management with the most effective treatment strategies.

Cost of gastro-oesophageal reflux disease to the employer: a perspective from the United States.

BACKGROUND: Employers pay more than just salary for their employees. Previous studies have largely focused on direct medical and prescription drug costs of gastro-oesophageal reflux disease (GERD), and few have reported on total absenteeism costs. AIMS: To examine the annual cost of illness of GERD in an employed US population by benefit category and by place of service for direct medical costs. METHODS: Retrospective data analysis from 2001 to 2004. International Classification of Diseases (ICD)-9 codes (530.1, 530.10, 530.11, 530.12, 530.19, 530.81, 787.1x, 787.2x or 251.5x) were used to identify employees with and without GERD (the control group). Measures included medical and prescription drug claims, plus indirect costs for sick leave, short- and long-term disability, and workers' compensation. For a subset of the population, the direct medical claims were analysed by place of service. RESULTS: Data were available for 267,269 eligible employees of which 11,653 had gastro-oesophageal reflux disease. GERD was associated with a mean incremental cost of US $3,355 per employee of which direct medical costs accounted for 65%, prescription drug costs 17%, and indirect costs 19%. The place of service 'out-patient hospital or clinic' accounted for the largest part (47%) of the difference in medical costs. CONCLUSIONS: GERD is associated with substantial direct and indirect costs, which highlight the importance of managing the disease effectively.

Six-month management of patients following treatment for gastroesophageal reflux disease symptoms -- a Norwegian randomized, prospective study comparing the costs and effectiveness of esomeprazole and ranitidine treatment strategies in a general medical practitioners setting.

This study assesses the difference in direct medical costs between on-demand treatment with esomeprazole 20 mg, continuous treatment with esomeprazole 20 mg once-daily and continuous treatment with ranitidine 150 mg twice-daily to prevent symptomatic relapse in patients with gastroesophageal reflux disease over 26 weeks. Two hundred eighty-one GP clinics in Norway enrolled 2156 patients to an open, randomized, parallel group, Norwegian society perspective study during 2000-2001. The total direct medical costs of each strategy were 171.9 Euros for on-demand esomeprazole (n = 634), 221.6 Euros for ranitidine (n = 610) and 248.8 Euros for continuous esomeprazole (n = 658). The total costs for on-demand and continuous esomeprazole treatment and ranitidine treatment were 221.5, 286.5 and 295.8 Euros, respectively. The highest proportion of costs was because of the study medication cost in each strategy. The on-demand and continuous treatment strategies with esomeprazole were found to be cost-effective, compared with ranitidine.

Impact of functional dyspepsia on quality of life and health care consumption after cessation of antisecretory treatment. A multicentre 3-month follow-up study.

BACKGROUND: The impact of response to treatment on subsequent symptoms, quality of life, health care consumption, and absence from work in functional dyspepsia is unknown. METHODS: Patients with functional dyspepsia from Denmark, France, Germany, The Netherlands, Hungary, and Poland (n = 567 (215 men), 18-80 years old) were followed up for 3 months after a 4-week treatment trial with omeprazole (20 mg or 10 mg) or placebo. The patients were blinded to the initial treatment. Dyspeptic symptoms and quality of life were assessed, and dyspepsia-related costs were calculated in terms of number of clinic visits, days on medication, and absence from work. RESULTS: Responders had fewer clinic visits than non-responders (1.5 versus 2.0 mean visits) and fewer days on medication (mean, 9 days versus 23 days) over the 3-month period (both, P < 0.001). The quality of life in responders was better at study entry and persisted over 3 months (all, P < 0.001). When analysed country by country, health care costs due to clinic visits and medications were significantly lower in responders in all countries (P < 0.05), except Denmark and The Netherlands. CONCLUSION: Symptom resolution in patients with functional dyspepsia has a positive impact on quality of life and reduces the subsequent costs over a 3-month period after cessation of initial treatment.

Pharmacoeconomic aspects of non-steroidal anti-inflammatory drug gastropathy.

Non-steroidal anti-inflammatory drugs are commonly used to reduce inflammation and pain associated with arthritis. However, non-steroidal anti-inflammatory drugs induce gastrointestinal side-effects such as dyspeptic symptoms, duodenal or gastric ulcers and, in some cases, serious complications. The aim has been to compare the benefits with the drawbacks of non-steroidal anti-inflammatory drug treatment using a hypothetical population representing patients with arthritis. A problem description was made on the basis of a literature review, and a simple and hypothetical health economic model was constructed. Including direct and indirect costs, the annual total costs in Sweden for gastrointestinal side-effects per non-steroidal anti-inflammatory drug user were estimated to be 3,420 SEK (438 US$), and the approximated costs of arthritis were 60,000 SEK (7,692 US$). The benefits of non-steroidal anti-inflammatory drug treatment were found to outweigh the drawbacks if the patient's arthritis symptoms, expressed as a difference in utility value between having and not having symptoms of arthritis, are improved by 6% or more. Costs for non-steroidal anti-inflammatory drug-induced gastrointestinal side-effects should be evaluated in relation to the benefits of non-steroidal anti-inflammatory drugs in the treatment of inflammation and pain. A simple modelling approach indicated that treatment with non-steroidal anti-inflammatory drugs may be highly cost-effective as both the clinical and economic benefits for patients responding to such treatment out-weighed possible drawbacks.

Management of nonsteroidal anti-inflammatory drug-associated lesions: a cost-effectiveness perspective.

Results are presented from a cost-effectiveness analysis of the acute healing phases of two new clinical studies. Acute treatment with omeprazole, 20 mg once daily, is compared with misoprostol, 200 microg four times daily, or ranitidine, 150 mg twice daily, in patients with nonsteroidal anti-inflammatory drug (NSAID)-associated gastroduodenal lesions (gastric ulcer, duodenal ulcer, and/or >10 erosions in either the stomach or duodenum). The cost-effectiveness comparisons indicate that omeprazole is cost-effective when compared with ranitidine in the treatment of gastric ulcers, duodenal ulcers, and erosions only, and that omeprazole is cost-effective when compared with misoprostol in the treatment of gastric ulcers and duodenal ulcers. In patients with erosions only, misoprostol is cost-effective when compared with omeprazole. When assessing the uncertainty of these estimates, a definite conclusion can be made in only two comparisons: omeprazole is cost-effective when compared with ranitidine in the treatment of gastric ulcers, and misoprostol is cost-effective when compared with omeprazole in the treatment of erosions only. However, the clinical studies were not powered for assessing the cost-effectiveness of the treatment alternatives, which impedes the uncertainty assessment. The determinants of the cost-effectiveness of prophylactic strategies are also discussed, as well as the need for further studies that include relevant outcome measures and a design that reflects actual clinical practice.