Health Care Cost Analysis of PPI or P-CAB-First Treatment in Patients With Gastroesophageal Reflux Disease.

GOALS: The aim was to examine actual health care cost in patients with gastroesophageal reflux disease (GERD) who were initiated on proton pump inhibitor (PPI) or potassium-competitive acid blocker (P-CAB) as first-line therapy in Japanese real-world clinical settings. BACKGROUND: To date, cost-utility evaluation of acid-suppressants treatment in Japan has only been conducted by model analysis. STUDY: A cost utilization analysis was performed using a Japanese nationwide hospital-based claim database by extracting patients with GERD initiated on either PPI or P-CAB (242,102 pairs) and esomeprazole (EPZ) or P-CAB (241,825 pairs). Health care costs were compared in each comparison cohort with propensity-score matched pairs. The switching rates of initial acid-suppressants were also examined. RESULTS: Baseline characteristics were well-balanced after matching. The 3-year mean cumulative GERD-related and hospitalization costs per patient were ¥142,620 and ¥122,444 in PPI-first and P-CAB-first treatment groups, and ¥105,263 and ¥121,958 in EPZ-first and P-CAB-first treatment groups, respectively. Most hospitalization costs were non-GERD related in all the groups. The switching rates of PPI to P-CAB and P-CAB to PPI in 12 months were 7.5% and 20.2%, respectively. CONCLUSIONS: In this propensity-score matched analysis, health care cost was higher in patients with GERD initiated on PPI than in those initiated on P-CAB mainly owing to non-GERD-related hospitalization cost, whereas it was lower in those initiated on EPZ than in those initiated on P-CAB. When considering health care costs except hospitalization costs, PPI-first treatment was less expensive than P-CAB-first treatment. Low switching rate from PPI to P-CAB in the real-world practice may partially explain the discrepancy.

Impact of chronic constipation on health-related quality of life and work productivity in Japan.

BACKGROUND AND AIM: The impact of chronic constipation on health-related quality of life (HRQoL), work productivity, and healthcare resource use in Japan is not well understood. This study aimed to evaluate and compare the humanistic burden of respondents with chronic constipation to respondents without chronic constipation and to respondents with type 2 diabetes mellitus (T2DM), irritable bowel syndrome (IBS), and gastroesophageal reflux disease (GERD), respectively. METHODS: This cross-sectional study collected demographic and general health data and HRQoL data as measured by the Short Form 12-Item (Version 2) Health Survey and EuroQol 5-dimension health surveys. Health impacts on employment-related activities and indirect costs were measured using the Work Productivity and Activity Impairment questionnaire. Propensity score matching was used to identify a control group without chronic constipation. Multivariate generalized linear models were used to identify potential factors that may impact the outcomes of respondents. RESULTS: A total of 30 001 individuals responded to the Japan National Health and Wellness Survey 2017, whereof 3373 (11.2%) reported having chronic constipation; 963 were physician diagnosed. Compared with matched controls, patients with physician-diagnosed chronic constipation had lower mean HRQoL scores and higher mean absenteeism, presenteeism, total Work Productivity and Activity Impairment, and indirect costs. Physician-diagnosed chronic constipation was associated with a higher health burden than T2DM, IBS, and GERD. CONCLUSIONS: Chronic constipation is associated with a considerable health burden, which is higher compared with T2DM, IBS, and GERD. These results suggest an urgent need for effective treatment of Japanese patients with chronic constipation to improve their quality of life.

How to select patients for antireflux surgery? The ICARUS guidelines (international consensus regarding preoperative examinations and clinical characteristics assessment to select adult patients for antireflux surgery).

OBJECTIVE: Antireflux surgery can be proposed in patients with GORD, especially when proton pump inhibitor (PPI) use leads to incomplete symptom improvement. However, to date, international consensus guidelines on the clinical criteria and additional technical examinations used in patient selection for antireflux surgery are lacking. We aimed at generating key recommendations in the selection of patients for antireflux surgery. DESIGN: We included 35 international experts (gastroenterologists, surgeons and physiologists) in a Delphi process and developed 37 statements that were revised by the Consensus Group, to start the Delphi process. Three voting rounds followed where each statement was presented with the evidence summary. The panel indicated the degree of agreement for the statement. When 80% of the Consensus Group agreed (A+/A) with a statement, this was defined as consensus. All votes were mutually anonymous. RESULTS: Patients with heartburn with a satisfactory response to PPIs, patients with a hiatal hernia (HH), patients with oesophagitis Los Angeles (LA) grade B or higher and patients with Barrett's oesophagus are good candidates for antireflux surgery. An endoscopy prior to antireflux surgery is mandatory and a barium swallow should be performed in patients with suspicion of a HH or short oesophagus. Oesophageal manometry is mandatory to rule out major motility disorders. Finally, oesophageal pH (±impedance) monitoring of PPI is mandatory to select patients for antireflux surgery, if endoscopy is negative for unequivocal reflux oesophagitis. CONCLUSION: With the ICARUS guidelines, we generated key recommendations for selection of patients for antireflux surgery.

Comparison of the detection of Helicobacter pylori infection by commercially available serological testing kits and the 13C-urea breath test.

BACKGROUND: Serum Helicobacter pylori (H. pylori) antibody kits (LZ and LIA) using the latex agglutination immunoassay method are commercially available, but few studies have been performed to determine their diagnostic accuracy or to compare their results with those of enzyme-linked immunosorbent assay (ELISA) kits (EP and EIA). METHODS: Sera were obtained from 213 hospital outpatients with dyspeptic symptoms. The serological results were compared with the result of the 13C-urea breath test (UBT) which seems to be reliable. RESULTS: Of the 213 subjects, 154 were diagnosed as positive for H. pylori infection according to the UBT. The sensitivities and specificities of these tests were 97.4% and 76.3%, 98.1% and 78.0%, 99.4% and 74.6%, and 98.1% and 71.2% for the EP, LZ, EIA and LIA tests, respectively. When the 13 subjects whose seropositive results of the four kits were completely opposite to the negative results of the UBT were excluded, the specificities of evaluated kits were all higher than 90%. The concordance rate between the EP and EIA tests was 98.1% (Spearman's rank correlation coefficient = 0.83) and that between the LZ and LIA tests was 97.1% (correlation coefficient = 0.91). The LZ gave higher antibody titer value than EP (p < 0.0001, Z = 9.82; Wilcoxon signed-rank test), and EIA gave higher value than LIA (p < 0.0001, Z = 6.43; Wilcoxon signed-rank test). CONCLUSIONS: The latex immunoassay method provided the same reliability to ELISA in terms of the diagnostic accuracy for current H. pylori infection, although we should take into account the titer value differences by each test method in practical use.

Medical cost, incidence rate, and treatment status of gastroesophageal reflux disease in Japan: analysis of claims data.

OBJECTIVES: Published reports have shown the prevalence and incidence of gastroesophageal reflux disease (GERD) is increasing in Japan. The objective of this study is to examine change in GERD incidence, and to understand current patient demographics, medical costs, treatment status, and the suitability of current treatment based on analysis of an insurance claims database. METHODS: An insurance claims database with data on ∼1.9 million company employees from January 2005 to May 2015 was used. Prevalence, demographics, and medical costs were analyzed by cross-sectional analysis, and incidence and treatment status were analyzed by longitudinal analysis among newly-diagnosed GERD patients. RESULTS: GERD prevalence in 2014 was 3.3% among 20-59 year-olds, accounting for 40,134 people in the database, and GERD incidence increased from 0.63% in 2009 to 0.98% in 2014. In 2014, mean medical cost per patient per month for GERD patients aged 20-59 was JPY 31,900 (USD 266 as of January 2016), which was ∼2.4-times the mean national healthcare cost. The most frequently prescribed drugs for newly-diagnosed GERD patients were proton pump inhibitors (PPIs). Although PPIs were prescribed more often in patients with more doctor visit months, over 20% of patients that made frequent doctor visits (19 or more visits during a 24 calendar months period) were prescribed PPIs during only 1 calendar month or not at all. LIMITATIONS: The database included only reimbursable claims data and, therefore, did not cover over-the-counter drugs. The database also consisted of employee-based claims data, so included little data on people aged 60 years and older. CONCLUSIONS: Given the increasing incidence of GERD in Japan there is a need for up-to-date information on GERD incidence. This study suggests that some GERD patients may not be receiving appropriate treatment according to Japanese guidelines, which is needed to improve symptom control.

Questionnaire based assessment of patients' acceptability of leukocytapheresis for the treatment of inflammatory bowel disease.

The aim of the present study was to assess patients' acceptance of therapeutic leukocytapheresis known as cytapheresis (CAP) for the treatment of an active flare of inflammatory bowel disease (IBD). A questionnaire was sent to 155 IBD patients who had been treated with CAP for an active flare of IBD at the IBD center of Hyogo College of Medicine between January 2009 and July 2012. In the questionnaire, patients were asked to evaluate CAP including efficacy, safety, unfavorable features and their willingness to be retreated with CAP for a subsequent IBD flare-up. Seventy-eight percent (112 of 155 patients) including 86 with ulcerative colitis and 26 with Crohn's disease completed the questionnaire. The need for coming to hospital for CAP, needle pain during blood access, sparing time for CAP process were scored by 57%, 58%, and 58.9% of the patients, respectively as unfavorable. Patients highly favored the safety of CAP, the sum of very and relatively favorable was 89%, higher than for efficacy (68%). Seventy-two percent of patients favored retreatment with CAP. In binary logistic regression analysis, the levels of satisfaction for efficacy (P < 0.001), and inconvenience for CAP treatment time (P < 0.001) were highly significant factors for patients' willingness to be retreated. Bearing in mind that CAP is a non-pharmacologic treatment intervention, our analyses indicated that IBD patients favored high efficacy, as well as comfort of CAP or maintaining their normal social activity even during an active phase of the disease. Patient's acceptability for CAP appeared to be determined by the balance of these factors.

Response to gastroesophageal reflux disease therapy: assessment at 4 weeks predicts response/non-response at 8 weeks.

BACKGROUND: Many questionnaires that assess subjective symptoms or health-related quality of life (HRQOL) have been developed to confirm the efficacy of treatment in patients with gastroesophageal reflux disease (GERD). However, few reports have correlated early improvements in scale scores with predictions of subsequent therapeutic responses. Our aim was to investigate the appropriate timing for evaluating therapeutic response and subsequent changes in symptoms and HRQOL. METHODS: This was a post hoc analysis of a multicenter prospective cohort study. A total of 5,279 GERD patients with Frequency Scale for the Symptoms of GERD (FSSG) scores ≥ 8 points at baseline were analyzed. Correlations between HRQOL and FSSG were investigated and logistic regression analysis was performed. RESULTS: The FSSG scores and HRQOL improvements in responders were significantly greater than in non-responders. Positive correlation between FSSG and HRQOL was observed. Based on the analysis, severity of esophagitis at baseline, complications of hypertension, higher HRQOL mental score at baseline, and higher FSSG score at baseline were predictors of responders. Gastrectomy, complication of insomnia, and prior medication with proton pump inhibitors were predictors of non-responders. CONCLUSION: Evaluating patients' symptoms during the fourth week of rabeprazole therapy allows predictions of subsequent changes in subjective symptoms and HRQOL.

Comparison of endoscopic findings with symptom assessment systems (FSSG and QUEST) for gastroesophageal reflux disease in Japanese centres.

BACKGROUND AND AIM: We compared endoscopic findings of the frequency scale for the symptoms of gastroesophageal reflux disease (FSSG), a written questionnaire developed in Japan, to that for the questionnaire for the diagnosis of reflux esophagitis (QUEST) for the diagnosis of reflux esophagitis. METHODS: We registered 475 patients with untreated symptoms of upper abdominal pain (male/female: 252/223, average age 52.4 +/- 17.8 years). Subjects were assessed first with the FSSG and QUEST questionnaires, then by endoscopy, before allocation to a gastric ulcer (GU), duodenal ulcer (DU), gastroesophageal reflux disease (GERD) or functional dyspepsia (FD) group. RESULTS: On the basis of the endoscopic findings the diagnoses for the 475 subjects were as follows: FD 52.2%, DU 7.6%, GU 7.8%, and GERD 32.4% (Grade M 10.1%, Grade A + B 20.2%, Grade C + D 2.3%). There was no difference between the FSSG and QUEST in sensitivity, specificity or accuracy for any condition. The FSSG score rose with increasing endoscopic severity of GERD, but there was no correlation between the QUEST score and endoscopic severity. The FSSG total score was inferior to QUEST in terms of distinguishing GERD from other conditions, but when only the questions relating to reflux symptoms were used, the FSSG was able to distinguish GERD from other conditions as well as QUEST. CONCLUSIONS: The FSSG score reflects the severity of the endoscopic findings of GERD.

[Indication of H. pylori eradication therapy].

In the guideline, for H. pylori the Japanese Society of Helicobacter published diagnosis and treatment in July 2000. Only peptic ulcers and low grade MALT lymphomas are recommended as an indication of H. pylori eradication and other diseases such as atrophic gastritis, post EMR state for early gastric cancer and post-operated stomach due to gastric cancer, hyperplastic polyps and non-ulcer dyspepsia, were not included. In addition, Japanese social security foundation approves only peptic ulcers for indication of H. pylori eradication treatment. However, eradication therapy for atrophic gastritis should be considered in aspect of decreasing gastric cancer risk. Since accumulated epidemiological, experimental and clinical data strongly support its positive correlation with cancer risk, patients in high risk group for gastric cancer should be included for a target eradication therapy. Indication of the treatment should be expanded to histological gastritis caused by H. pylori in our country, where prevalence of gastric cancer is very high.