Search

Aim: To evaluate the costs and effectiveness of on-demand maintenance therapy with oral esomeprazole, lansoprazole, omeprazole, pantoprazole or rabeprazole in patients with endoscopy-confirmed non-erosive reflux disease (NERD) in the UK., Methods: A probabilistic model was developed to compare the costs and effectiveness of five proton pump inhibitors (PPIs) in endoscopy-negative, symptomatic NERD patients who had complete resolution of heartburn symptoms following 4 weeks of open-label acute PPI treatment. The total annual expected costs (euro, 2003 values) and utilities gained per patient were measured over a 1-year horizon from the perspective of the UK NHS. Model uncertainty was addressed by sensitivity analyses., Results: The base-case annual median costs and utilities gained with on-demand PPI therapy were: 123 euro and 0.89 for rabeprazole 10mg; 176 euro and 0.90 for pantoprazole 20mg; 190 euro and 0.89 for esomeprazole 20mg; 195 euro and 0.91 for lansoprazole 15mg; 201 euro and 0.90 for omeprazole 20mg; and 210 euro and 0.91 for omeprazole 10mg. Differences in costs, but not in outcomes, were statistically significant. The results were robust to sensitivity analyses., Conclusions: In this analysis, on-demand use of rabeprazole for the management of NERD incurred the least cost in comparison with the other PPIs evaluated. Utility gains were comparable for all on-demand PPIs. The place of on-demand PPIs in therapy, however, requires further evaluation.

Objective: Summarize the Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QOL) development and provide results on its reliability and validity from the international psychometric validation in dyspepsia, GastroEsophageal Reflux Disease (GERD), and gastroparesis., Methods: Subjects completed the pilot PAGI-QOL at baseline and 8 weeks; and a subsample also at 2 weeks. Other assessments were: Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index, SF-36, number of disability days., Results: 1736 patients completed the PAGI-QOL at baseline. The questionnaire was reduced, producing a 30-item final version covering five domains: Daily Activities, Clothing, Diet and Food Habits, Relationship (REL), and Psychological Well-Being and Distress. Internal consistency was excellent (Cronbach's alpha range: 0.83-0.96). Test-retest reproducibility was good: intraclass correlations coefficients were over 0.70 except for the REL scale (0.61). Concurrent validity between the PAGI-QOL total score and all SF-36 subscale scores was good with moderate (0.52) to strong (0.72) correlations. PAGI-QOL scores showed excellent discriminant properties: patients who had spent some days in bed, had missed some days at work, and were kept from usual activities had much lower PAGI-QOL scores than those who did not (p < 0.0001)., Conclusion: The PAGI-QOL is a valid and reliable instrument assessing quality of life in patients with dyspepsia, GERD, or gastroparesis.

Objective: Describe the development and evaluation of a new self-report instrument, the patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) in subjects with gastroesophageal reflux disease (GERD), dyspepsia, or gastroparesis., Methods: Recruited subjects with GERD (n=810), dyspepsia (n = 767), or gastroparesis (n = 169) from the US, France, Germany, Italy, the Netherlands, and Poland. Subjects completed the PAGI-SYM, SF-36, a disease-specific HRQL measure (PAGI-QOL), and disability day questions. Two-week reproducibility was evaluated in 277 stable subjects. We evaluated construct validity by correlating subscale scores with SF-36, PAGI-QOL, disability days, and global symptom severity scores., Results: The final 20-item PAGI-SYM has six subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Internal consistency reliability was good (alpha = 0.79-0.91); test-retest reliability was acceptable (Intraclass correlation coefficients alpha=0.60-0.82). PAGI-SYM subscale scores correlated significantly with SF-36 scores (all p < 0.0001), PAGI-QOL scores (all p < 0.0001), disability days (p < 0.0001), and global symptom severity (p < 0.0001). Mean PAGI-SYM scores varied significantly in groups defined by disability days (all p < 0.0001), where greater symptom severity was associated with more disability days., Conclusions: Results suggest the PAGI-SYM, a brief symptom severity instrument, has good reliability and evidence supporting construct validity in subjects with GERD, dyspepsia, or gastroparesis.

Background and Aims: The Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) has been developed and validated to assess quality of life in gastroesophageal reflux disease, dyspepsia, and gastroparesis. The aim of this work was to assess responsiveness of the PAGI-QOL to clinical changes and provide guidance for the interpretation of score changes., Methods: The analysis was based on 2 observational multicenter, longitudinal, 8-week observation studies, one in the United States and one in 5 European countries. The Overall Treatment Effect scale completed by patients and clinicians at 8 weeks was used to define groups of improved, worsened, and stable patients. Responsiveness was assessed by describing the change in PAGI-QOL scores for each of these groups, comparing these changes over time, and calculating effect sizes and standardized response means. These data were used to define the minimal clinically important difference., Results: A total of 1736 patients with upper gastrointestinal disorders were analyzed. High sensitivity to change over time was demonstrated, with effect sizes and standardized response means in improved patients for the PAGI-QOL total score ranging from 0.79-1.41. A change of 0.4 for the PAGI-QOL total score might be considered as the minimal clinically important difference when comparing pretreatment and post-treatment PAGI-QOL total scores., Conclusions: The PAGI-QOL questionnaire is a responsive and clinically relevant instrument for assessing quality of life in patients with upper gastrointestinal disorders.

Background and Aims: Determining clinically meaningful change of patient-reported outcome measures is important for evaluating effectiveness of treatments for gastrointestinal (GI) diseases. This study evaluates responsiveness of the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) in gastroesophageal reflux disease (GERD) and dyspepsia., Methods: The PAGI-SYM was based on a review of the published literature and interviews with patients and clinicians. Items were developed to be linguistically and culturally appropriate for multicountry studies. The PAGI-SYM includes 6 subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Subjects with GERD (n = 810) or dyspepsia (n = 767) participated in this multicountry, observational study. All subjects completed the PAGI-SYM, a global symptom relief questionnaire, and a measure of patient-rated change in GI-related symptoms, the Overall Treatment Effect (OTE) scale. Responsiveness was evaluated at 8 weeks by comparing groups by disease, symptom relief, and OTE (improved, stable, and worsened)., Results: Subjects reporting symptom relief reported significantly lower (better) PAGI-SYM scores than those reporting no symptom relief ( P < 0.0001 to P < 0.0005). Subjects with improvements in overall GI symptoms exhibited significant decreases in PAGI-SYM subscale scores compared with those who remained the same or worsened (all P values < 0.0001). Effect sizes ranged from 0.21-1.28, and standard errors of measurement ranged from 0.29-0.63, depending on subscale and disease sample., Conclusions: The PAGI-SYM is a brief symptom severity instrument that measures common GI symptoms. Results suggest that the PAGI-SYM is responsive and sensitive to change in clinical status in subjects with GERD or dyspepsia.

Background: Compliance studies have shown that patients with reflux symptoms generally take their medication only when experiencing these symptoms., Aim: To evaluate the efficacy of on-demand rabeprazole maintenance therapy in patients with non-erosive reflux disease., Methods: This multicentre, randomized, double-blind, placebo-controlled, withdrawal study compared 6 months of on-demand treatment with rabeprazole 10 mg vs. placebo. Adults with a history of reflux symptoms, a negative endoscopy, and > or = 3 days of moderate to very severe heartburn in the 7 days before enrollment (N = 535) entered 4 weeks of open-label, acute treatment with rabeprazole 10 mg once daily. Patients with complete symptom relief then entered the on-demand phase. The primary end-point was discontinuation due to lack of heartburn control during the on-demand phase., Results: Eighty-three percent (432 of 523) of patients reported complete symptom relief at the end of the acute phase. During on-demand treatment, rates of discontinuation because of inadequate heartburn control were 20% (28 of 139) for placebo vs. 6% (16 of 279) for rabeprazole (P < 0.00001). Antacid use was twofold higher in the placebo group vs. the rabeprazole group (P = 0.0009)., Conclusions: Rabeprazole 10 mg once daily is highly effective in acute symptom relief and as on-demand long-term maintenance therapy in non-erosive reflux disease patients.

Background: Previous evaluation of the cost effectiveness of antireflux medication used in gastro-oesophageal reflux disease (GORD) have been based on results obtained in controlled clinical trials. Unfortunately such an approach does not necessarily identify the therapeutic option which provides the greatest benefit from available resources in real life situations. To make an informed choice requires a recognition that the costs and benefits of therapy in practice may differ from those identified in trials., Aims: To evaluate, based on a retrospective prescription database analysis, the cost effectiveness of alternative treatment options for patients with uncomplicated GORD. The analysis assesses health service resource use during the first six months of treatment in three groups of patients initially prescribed cisapride (CIS), ranitidine (RAN), or omeprazole (OME)., Methods: The MediPlus UK database was used to identify all health care resources consumed by patients in the three treatment groups during their first six months of treatment. Patients with more complicated GORD, as indicated by initial referral to a specialist or outpatient hospital visit (< 13%), were excluded from the analysis., Results: The average cost per patient for the initial six months of treatment for CIS, RAN, and OME based therapies was 136 Pounds, 177 Pounds, 189 Pounds per patient, respectively. A major element underlying this cost variation was the acquisition cost and quantity of antireflux medication required by patients. The average number of one month equivalent prescriptions consumed during this six month period was 1.85 (CIS), 2.57 (RAN), and 2.96 (OME) with associated costs of 49 Pounds (CIS), 67 Pounds (RAN), and 105 Pounds (OME). Antacid and alginate/antacid use was higher in the CIS and RAN groups (about 1.0 antacid prescription per patient versus 0.4 for OME), but their contribution to the total cost per patient was less than 2%. The number of general practitioner consultations over the six month period for each treatment group was 2.4 (CIS), 2.9 (RAN), and 2.6 (OME) with associated costs of 60.31 Pounds (CIS), 73.06 Pounds (RAN), and 65.52 Pounds (OME). The average number of non-drug interventions (referrals, outpatient visits, endoscopies, barium meals, or x rays) was 0.34 in the RAN group compared with less than 0.2 in the CIS and OME groups. The costs associated with such interventions were 23.80 Pounds (RAN), 9.60 Pounds (CIS), and 11.10 Pounds (OME) per patient., Conclusion: The data indicate that the "step up" approach, starting with a prokinetic or H2 receptor antagonist, represents the most cost effective initial therapeutic strategy for a primary care physician to adopt when faced with a patient with first diagnosis of uncomplicated GORD.