Discontinuation of Infliximab Therapy in Patients with Crohn's Disease.

BACKGROUND: Whether infliximab therapy can be successfully discontinued after patients with Crohn's disease have attained sustained, clinical, biochemical, and endoscopic remission is unknown. METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled withdrawal study of infliximab in patients with Crohn's disease who were in clinical, biochemical, and endoscopic remission after standard infliximab maintenance therapy for at least 1 year. Patients were randomly assigned 1:1 to continue infliximab therapy or to receive matching placebo for 48 weeks. The primary end point was time to relapse. RESULTS: This study randomly assigned 115 patients to either the infliximab-continuation group or to the infliximab-discontinuation group. No relapses were observed among the 59 patients continuing infliximab, whereas 23 of 56 patients discontinuing infliximab experienced relapse. Time to relapse was significantly shorter among patients who discontinued infliximab than among those who continued infliximab (hazard ratio, 0.080; 95% confidence interval [CI], 0.035 to 0.186; P<0.001). At the end of the trial at week 48, relapse-free survival was 100% in the infliximab-continuation group and 51% in the infliximab-discontinuation group. The key secondary end point, time to loss of remission, was significantly shorter among patients discontinuing infliximab therapy than those continuing infliximab (hazard ratio, 0.025; 95% CI, 0.003 to 0.187; P<0.001). No unexpected adverse events were reported. CONCLUSIONS: Discontinuation of infliximab for patients with Crohn's disease receiving long-term infliximab therapy and in clinical, biochemical, and endoscopic remission leads to a considerable risk of relapse. (Funded by the Nordic Trial Alliance [NordForsk], the Medical Fund of the Danish Regions [Regionernes Medicin og Behandlingspulje], the Danish Colitis-Crohn Association, and the A.P. Moller Foundation; ClinicalTrials.gov number, NCT01817426; EudraCT number, 2012-002702-51.)

How dyspepsia, gastroesophageal reflux symptoms, and overlapping symptoms affect quality of life, use of health care, and medication - a long-term population based cohort study.

BACKGROUND AND AIM: The prevalence of gastroesophageal reflux symptoms (GERS) and dyspepsia is high. Overlapping of GERS and dyspepsia has been described to affect quality of life. However, studies are few. This long-term population-based study evaluates how GERS, dyspepsia, and overlapping symptoms, affect quality of life, and the use of health care and medication. METHODS: This study presents data for the control group of the randomised population study, HEP-FYN. At baseline 10,000 individuals, aged 40-65 years, received questionnaires at baseline and after 1, 5 and 13 years. The questionnaire included questions regarding demographics, use of health care resources, gastrointestinal symptoms (the Gastrointestinal Symptom Rating Scale (GSRS)), and the Short-Form 36-Item Health Survey (SF-36) to assess quality of life. RESULTS: Complete data was available for 4.403 individuals at 13-year follow-up. Of these 13.6% reported GERS only, 11.6% dyspepsia only, and 27.1% overlapping symptoms during follow-up. Individuals reporting overlapping symptoms had compared to individuals reporting GERS only or dyspepsia only more visits at general practitioner (last year:16.7% vs. 8.5% vs. 12.3%), more sick leave days (last month: 4.3% vs. 2.9% vs 0.7%), used more ulcer drugs (last month: 30.5% vs 16.4% vs 9.4%). In addition, individuals with overlapping symptoms reported a lower quality of life in all eight dimensions of SF-36 compared to individuals with GERS alone or dyspepsia alone. CONCLUSIONS: Overlapping symptoms was associated with lower quality of life scores and substantial use of health-care resources. Having solely GERS affected quality of life and health care use least.

When does proton pump inhibitor treatment become long term? A scoping review.

OBJECTIVE: Proton pump inhibitor (PPI) use has risen substantially, primarily driven by ongoing use over months to years. However, there is no consensus on how to define long-term PPI use. Our objectives were to review and compare definitions of long-term PPI use in existing literature and describe the rationale for each definition. Moreover, we aimed to suggest generally applicable definitions for research and clinical use. DESIGN: The databases PubMed and Cochrane Library were searched for publications concerning long-term use of PPIs and ClinicalTrials.gov was searched for registered studies. Two reviewers independently screened the titles, abstracts, and full texts in two series and subsequently extracted data. RESULTS: A total of 742 studies were identified, and 59 met the eligibility criteria. In addition, two ongoing studies were identified. The definition of long-term PPI use varied from >2 weeks to >7 years. The most common definition was ≥1 year or ≥6 months. A total of 12/61 (20%) of the studies rationalised their definition. CONCLUSION: The definitions of long-term PPI treatment varied substantially between studies and were seldom rationalised.In a clinical context, use of PPI for more than 8 weeks could be a reasonable definition of long-term use in patients with reflux symptoms and more than 4 weeks in patients with dyspepsia or peptic ulcer. For research purposes, 6 months could be a possible definition in pharmacoepidemiological studies, whereas studies of adverse effects may require a tailored definition depending on the necessary exposure time. We recommend to always rationalise the choice of definition.

Proton pump inhibitor use among patients at risk of peptic ulcer bleeding: a nationwide register-based study.

BACKGROUND: Proton pump inhibitors reduce the risk of peptic ulcer bleeding in patients at risk. The knowledge about the extent of gastroprotection in patients at increased risk and factors associated with prophylactic treatment is limited. AIMS: (1) to analyze the extent of gastroprotective undertreatment in patients using aspirin/non-steroidal anti-inflammatory drugs and (2) to analyze which patient characteristics are associated with proton pump inhibitor prophylaxis among those at increased ulcer bleeding risk. METHODS: A Danish nationwide register-based study. Based on a risk stratification model we identified citizens at increased ulcer bleeding risk and analyzed the proportion concomitantly treated with proton pump inhibitors. Further, we analyzed associations between use of ulcer prophylaxis and comorbidity and socioeconomic characteristics. RESULTS: Some 44.4% of the high-risk patients were concomitantly treated with proton pump inhibitors. In the crude analyses cohabiting, having a high educational level and a high income were significantly associated with lower odds of being treated with proton pump inhibitors. When adjusting for medication use, age, sex and comorbidity the associations were insignificant. CONCLUSIONS: There is room for improvement in the extent of ulcer prophylaxis but no clear social gradient in under prescribing of gastroprotection. With the substantial risk-reducing possibility concomitant proton pump inhibitor use could save numerous patients from ulcer bleeding each year. Our study calls for increased awareness of peptic ulcer bleeding risk and dissemination of knowledge to clinicians about risk factors for gastrointestinal hemorrhage and the risk reducing potential of co-prescribing proton pump inhibitors to patients at risk.

The cost effectiveness of Helicobacter pylori population screening-economic evaluation alongside a randomised controlled trial with 13-year follow-up.

BACKGROUND: Helicobacter pylori eradication improves dyspeptic symptoms in 8%-10%, prevents peptic ulcer and may reduce the risk of gastric cancer. Availability of a high quality diagnostic test and an effective treatment makes population screening and eradication of Helicobacter pylori an attractive option. AIM: To evaluate the cost effectiveness of Helicobacter pylori population screening and eradication. METHODS: Cost effectiveness analysis and cost utility analysis alongside randomised controlled trial with 13 years follow-up. The evaluation has a societal perspective. A random general population sample of 20 011 individuals aged 40-65 were randomised and invited in 1998-1999; 12 530 were enrolled and, of these, 8658 have been successfully followed up at 1, 5, and 13 years after intervention. Questionnaires included the quality of life instrument SF-36. From SF-36 responses an SF-6D score was derived and used for calculation of quality-adjusted life years. Register data on costs, use of health care resources and medication were obtained for all randomised individuals. The intervention was an invitation to Helicobacter pylori screening by in-office blood test; positive tests were validated by 13 C-urea breath test. Those who tested positive were offered eradication therapy. Main outcome measures were Incremental cost per quality-adjusted life year and life-years gained. RESULTS: Helicobacter pylori population screening and eradication with 13 years follow-up was not effective in regards to quality of life and the cost per screened person was higher than not screening (mean difference 11 269 DKK [95% CI: 3175-19 362]). The probability of being cost-effective was 80% at a threshold of 400 000 DKK (approximately 53,800 Euros) of willingness-to-pay per life-year gained. CONCLUSIONS: Helicobacter pylori population screening and eradication with 13 years follow-up was not effective in regards to quality of life and the cost of screening was higher than not screening.

Effects of Community Screening for Helicobacter pylori: 13-Year Follow-Up Evaluation of a Randomized Controlled Trial.

BACKGROUND & AIMS: Helicobacter pylori eradication improves the prognosis of peptic ulcer disease (PUD), dyspepsia, and possibly gastric cancer. H pylori screening tests are accurate and eradication therapy is effective. H pylori population screening seems attractive. The aim of this study was to evaluate the long-term effect of H pylori population screening and eradication on dyspepsia prevalence and the incidence of PUD, and as secondary outcomes to assess the effect on health care consumption and quality of life. METHODS: At baseline in 1998 to 1999, 20,011 individuals aged 40 to 65 years were randomized to H pylori screening and eradication or a control group with no screening. Both groups received a questionnaire on dyspepsia and quality of life. Register data were obtained for all randomized individuals. RESULTS: The baseline questionnaire response rate was 63%. Of the 5749 individuals screened, 1007 (17.5%) were H pylori positive. Complete symptom data were obtained for 8658 (69%) individuals after 13 years. Dyspepsia prevalence decreased in both groups during the follow-up period, but multivariate analysis showed no effect of H pylori screening and eradication (adjusted odds ratio, 0.93; 95% confidence interval, 0.82-1.04); compared with usual care. Intention-to-treat and per-protocol analyses of register data provided similar results. H pylori screening neither reduced PUD incidence significantly (adjusted odds ratio, 0.88; 95% confidence interval, 0.70-1.11) nor did it have a beneficial effect on health care consumption. H pylori screening had no long-term effect on quality of life. CONCLUSIONS: This randomized clinical trial with 13 years of follow-up evaluation, designed to provide evidence on the effect of H pylori population screening, showed no significant long-term effect when compared with usual care in this low-prevalence area. ClinicalTrials.gov identifier: NCT02001727.

Snus and risk of gastroesophageal reflux. A population-based case-control study: the HUNT study.

OBJECTIVE: Tobacco smoking is a risk factor for gastroesophageal reflux, but whether other tobacco products increase the risk is unclear. The aim of this study was to investigate if snus increases the risk of gastroesophageal reflux symptoms (GERS). MATERIAL AND METHODS: The study was based on the third Nord-Trøndelag health study (HUNT3), a population-based study of all adult residents in Nord-Trøndelag County, Norway, performed in 2006-2009. The association between self-reported severe heartburn/regurgitation and snus use was assessed by logistic regression. RESULTS: Compared to never snus users, daily snus users had a reduced risk of GERS (OR 0.77, 95% confidence interval [CI] 0.64-0.93), while previous snus users and those using <2 boxes of snus/month had an increased risk (OR 1.20, 95% CI 1.00-1.46 and OR 1.41, 95% CI 1.02-1.96, respectively). There was no association between age when starting using snus and GERS. Snus users who started using snus to quit or cut down on cigarette smoking, who started using both snus and cigarettes or cigarettes alone had an increased risk of GERS. Snus users <30 years of age had an increased risk of GERS (OR 1.49, 95% CI 1.02-2.16), while those aged between 50-60 and 60-70 years had a reduced risk (OR 0.67, 95% CI 0.49-0.93 and OR 0.51, 95% CI 0.28-0.94, respectively). CONCLUSIONS: Daily snus users had a reduced risk of GERS. However, previous snus users and subgroups of snus users had an increased risk of GERS indicating reverse causality, such that snus use could increase the risk of GERS.

The excess long-term mortality in peptic ulcer bleeding is explained by nonspecific comorbidity.

OBJECTIVE: Previous studies have concluded that peptic ulcer bleeding (PUB) is associated with increased long-term mortality. The underlying mechanism of this excess mortality is poorly understood. The aim of the present study was to examine if PUB patients have an increased long-term mortality compared to a matched control group when adjusting for comorbidity and socioeconomic status. Additionally, we identified predictive factors for mortality and examined causes of death. MATERIAL AND METHODS: We performed an observational study, comparing consecutive patients admitted with PUB with a matched control cohort from the source population. Predictors of mortality were identified using proportional hazards models. Causes of death were retrieved from death certificates. Long-term mortality was analyzed with adjustment for Charlson comorbidity index (CCI) and average income in residence municipality using proportional hazards models. RESULTS: We included 455 PUB cases and 2224 control subjects. Median follow up was 9.7 years, and median survival for the PUB and control cohorts was 7 and 12 years, respectively (p < 0.001). PUB patients had a higher level of comorbidity (mean CCI: 0.92 vs. 0.49; p < 0.0001). After adjustments, PUB patients had an excess mortality lasting at least 10 years after presentation. Age, comorbidity, male sex, anemia, and smoking were predictors for long-term mortality. The distribution of causes of death was similar in the two cohorts. CONCLUSION: PUB patients have an increased long-term mortality that is explained by nonspecific comorbidity.

Patient characteristics among users of analgesic over-the-counter aspirin in a Danish pharmacy setting.

BACKGROUND: Use of over-the-counter (OTC) high-dose acetylsalicylic acid (ASA) is a risk factor for experiencing gastric bleeding. However, more detailed knowledge on the characteristics of users of OTC ASA is needed. OBJECTIVE: To characterise users of OTC high-dose ASA in a Danish pharmacy setting. METHOD: We conducted an interview based survey among users of OTC high-dose ASA. Questions were asked regarding: (1) demographic characteristics; (2) use patterns; (3) knowledge about adverse events; (4) risk factors for experiencing gastric bleeding; (5) reasons for choosing an ASA-containing medicine; and (6) whether their GP was informed on their use of high-dose ASA. RESULTS: One-hundred-seventeen interviews were completed. Nineteen percent and 37 % used high-dose ASA on a daily or weekly basis respectively. Sixty-eighth percent found high-dose ASA to be more effective than other analgesics. Fourty-seven percent had one or more risk factors for experiencing ulcer bleeding, most commonly age >60 years (32 %) and previous peptic ulcer (9 %). The most well-known adverse events were abdominal pain (32 %) and peptic ulcer (26 %). The most common source of information was friends and family (32 %). CONCLUSION: A large proportion of users of high-dose ASA have risk factors for experiencing gastric bleeding. Health-care professionals needs to provide more information on potential adverse events.

Rapidly increasing prescribing of proton pump inhibitors in primary care despite interventions: a nationwide observational study.

BACKGROUND: Guideline and reimbursement modifications have been introduced to optimize prescribing of antisecretory medication in Danish general practice. Impacts of the interventions have not been evaluated. OBJECTIVES: To analyse developments in prescribing of antisecretory medication in Denmark 2001-2011 and to assess the impacts of interventions on prescribing of antisecretory medication. METHODS: Register-based cohort study covering the entire Danish population of currently 5.5 million inhabitants. Developments in the prescribing of antisecretory medication over time in Denmark between 2001 and 2011 and association with age and gender of users along with the impact of interventions on the prescribing of drug subgroups are analysed. RESULTS: 96.8% of all antisecretory drugs sold are proton pump inhibitors (PPIs) and 94.4% of the PPIs are prescribed in primary care. Prescribing of PPIs has increased substantially during the past decade. Both number of users and the average individual use have increased. The prescribing of ulcerogenic drugs to the elderly has stagnated in the same time range. Reimbursement modifications and scientific guidelines do not seem to have had a substantial influence on the steadily increasing prescribing of PPIs. CONCLUSION: Use of PPIs has increased substantially during the past decade, without a change in indications for use of PPIs in the same time range. Interventions to enhance adherence to guidelines and promote rational use of PPIs do not seem to have had a substantial influence on the overall prescribing rate.

Supplementary arteriel embolization an option in high-risk ulcer bleeding--a randomized study.

OBJECTIVE: One of the major challenges in peptic ulcer bleeding (PUB) is rebleeding which is associated with up to a fivefold increase in mortality. We examined if supplementary transcatheter arterial embolization (STAE) performed after achieved endoscopic hemostasis improves outcome in patients with high-risk ulcers. MATERIAL AND METHODS: The study was designed as a non-blinded, parallel group, randomized-controlled trial and performed in a university hospital setting. Patients admitted with PUB from Forrest Ia - IIb ulcers controlled by endoscopic therapy were randomized (1:1 ratio) to STAE of the bleeding artery within 24 h or continued standard treatment. Randomization was stratified according to stigmata of hemorrhage. Patients were followed for 30 days. Primary outcome was a composite endpoint where patients were classified into five groups based on transfusion requirement, development of rebleeding, need of hemostatic intervention and mortality. Secondary outcomes were rebleeding, number of blood transfusions received, duration of admission and mortality. RESULTS: Totally 105 patients were included. Of the 49 patients allocated to STAE 31 underwent successful STAE. There was no difference in composite endpoint. Two versus eight patients re-bled in the STAE and control group, respectively (Intention-to-treat analysis; p = .10). After adjustment for possible imbalances a strong trend was noted between STAE and rate of rebleeding (p = .079). CONCLUSIONS: STAE is potentially useful for preventing rebleeding in high-risk PUB. STAE can safely be performed in selected cases with high risk of rebleeding. Further studies are needed in order to confirm these findings; ClincialTrials.gov number, NCT01125852.

The Glasgow Blatchford score is the most accurate assessment of patients with upper gastrointestinal hemorrhage.

BACKGROUND & AIMS: Risk scoring systems are used increasingly to assess patients with upper gastrointestinal hemorrhage (UGIH). There have been comparative studies to identify the best system, but most have been retrospective and included small sample sizes, few patients with severe bleeding and with low mortality. We aimed to identify the optimal scoring system. METHODS: We performed a prospective study to compare the accuracy of the Glasgow Blatchford score (GBS), an age-extended GBS (EGBS), the Rockall score, the Baylor bleeding score, and the Cedars-Sinai Medical Center predictive index in predicting patients' (1) need for hospital-based intervention or 30-day mortality, (2) suitability for early discharge, (3) likelihood of rebleeding, and (4) mortality. We analyzed the area under receiver operating characteristic (AUROC) curve, sensitivity, specificity, and positive and negative predictive values for each system. The study included 831 consecutive patients admitted with UGIH during a 2-year period. RESULTS: The GBS and EGBS better predicted patients' need for hospital-based intervention or 30-day mortality than the other systems (AUROC, 0.93; P < .001) and were also better in identifying low-risk patients (sensitivity values, 0.27-0.38; specificity values, 0.099-1). The EGBS identified a significantly higher proportion of low-risk patients than the GBS (P = .006). None of the systems accurately predicted which patients would have rebleeding or patients' 30-day mortality, on the basis of low AUROC and specificity values. CONCLUSIONS: The GBS accurately identifies patients with UGIH most likely to need hospital-based intervention and also those best suited for outpatient care. The EGBS seems promising but must be validated externally. No scoring system seems to accurately predict patients' 30-day mortality or rebleeding. ClinicalTrials.gov number, NCT01589250.

An association between selective serotonin reuptake inhibitor use and serious upper gastrointestinal bleeding.

BACKGROUND & AIMS: In vitro studies have shown that selective serotonin reuptake inhibitors (SSRIs) inhibit platelet aggregation. It is controversial whether use of SSRIs is a cause of clinically important bleeding; results from observational studies have been equivocal. METHODS: A population-based case-control study was conducted in Denmark. The 3652 cases all had a first discharge diagnosis of serious upper gastrointestinal bleeding (UGB) from 1995 to 2006. Controls (n = 36,502), matched for age and sex, were selected by risk-set sampling. Data on drug exposure and medical history were retrieved from a prescription database and the county's patient register. Confounders were controlled for by conditional logistic regression and the case-crossover design. RESULTS: The adjusted odds ratio (OR) of UGB among current, recent, and past users of SSRIs was 1.67 (95% confidence interval [CI], 1.46-1.92), 1.88 (95% CI, 1.42-2.5), and 1.22 (95% CI, 1.07-1.39). The adjusted OR for concurrent use of SSRI and nonsteroidal anti-inflammatory drugs (NSAIDs) was 8.0 (95% CI, 4.8-13). The adjusted OR for the concurrent use of NSAID, aspirin, and SSRI was 28 (95% CI, 7.6-103). Of the UGB cases, 377 were current users of SSRI; the adjusted OR for UGB in the case crossover analysis was 2.8 (95% CI, 2.2-3.6). The adjusted OR among users of proton pump inhibitors was 0.96 (95% CI, 0.50-1.82). CONCLUSIONS: Use of SSRI was associated with UGB, consistent with its antiplatelet effects. SSRIs should be prescribed with caution for patients at high risk for UGB.

Gastroesophageal reflux symptoms in a Danish population: a prospective follow-up analysis of symptoms, quality of life, and health-care use.

OBJECTIVES: The prevalence of gastroesophageal reflux symptoms (GERS) in the population is high; however, data on long-term follow-up and incidence of GERS in the population are sparse. This study describes the long-term natural history of GERS, the related health-care use, and quality of life in a population followed up for 5 years. METHODS: A total of 10,000 randomly selected inhabitants, 40-65 years old, received, as a part of a controlled trial of Helicobacter pylori screening and treatment (control group), a mailed questionnaire regarding demographic data, gastrointestinal symptoms (the Gastrointestinal Symptom Rating Scale (GSRS)), and quality of life (the Short-Form 36-Item Health Survey (SF-36)) at inclusion and after 5 years. GERS was defined as a mean score > or =2 in the reflux dimension in the GSRS. Information on use of health-care resources was drawn from the questionnaires and registers. RESULTS: In all, 6,781 individuals answered the first questionnaire and 5-year symptom data were complete for 5,578 (82.3%) of them. The mean age at inclusion was 52.4 years, 48% were men. At inclusion, 22% reported GERS. During follow-up, symptoms resolved in 43%, of whom 10% received acid inhibitory treatment at 5-year follow-up. The incidence of GERS was 2.2% per year. Health-care use during follow-up was significantly higher in individuals with GERS at baseline than in individuals without GERS. Quality of life at 5-year follow-up was lower in individuals with GERS at inclusion than in individuals without GERS at inclusion. CONCLUSIONS: GERS are prevalent, long lasting, and associated with an impaired quality of life and substantial health-care use.

Do statins protect against upper gastrointestinal bleeding?

AIMS: Recently, an apparent protective effect of statins against upper gastrointestinal bleeding (UGB) was postulated in a post hoc analysis of a randomized trial. We aimed to evaluate the effect of statin use on acute nonvariceal UGB alone or in combinations with low-dose aspirin and other antithrombotic drugs. METHODS: A population-based case-control study was conducted in the County of Funen, Denmark. Cases (n = 3652) were all subjects with a first discharge diagnosis of serious UGB from a hospital during the period 1995 to 2006. Age- and gender-matched controls (10 for each case) (n = 36 502) were selected by a risk set sampling. Data on all subjects' drug exposure and past medical history were retrieved from a prescription database and from the County's patient register. Confounders were controlled by conditional logistic regression. RESULTS: The adjusted odds ratios (ORs) associating use of statins with UGB were 0.94 (0.78-1.12) for current use, 1.40 (0.89-2.20) for recent use and 1.42 (0.96-2.10) for past use. The lack of effect was consistent across most patient subgroups, different cumulative or current statin doses and different statin substances. In explorative analyses, a borderline significant protective effect was observed for concurrent users of low-dose aspirin [OR 0.43 (0.18-1.05)]. CONCLUSION: Statins do not prevent UGB, except possibly in users of low-dose aspirin.

[Bleeding peptic ulcer. Prevalence of Helicobacter pylori and use of nonsteroidal anti-inflammatory drugs/acetylsalicylic acid]. / Blødende peptisk ulcus. Helicobacter pylori -praevalens og forbrug af non-steroide antiinflammatoriske stoffer/acetylsalicylsyre.

INTRODUCTION: Helicobacter pylori (HP) infection and use of nonsteroidal anti-inflammatory drugs (NSAIDs)/acetyl salicylic acid (ASA) are risk factors for bleeding peptic ulcer. HP eradication reduces the risk of rebleeding. Antibiotics, proton pump inhibitors (PPI) and presence of blood in the stomach can affect the HP test. The objectives of this study were to determine the HP prevalence and NSAID/ASA use in patients with bleeding ulcer in a low-prevalence HP area, to determine the proportion of idiopathic ulcers and to estimate the proportion of initially false negative HP tests. In addition, the objective was to describe changes in the characteristics of the patients who were admitted with ulcer bleeding during the last two decades. MATERIAL AND METHODS: Retrospective review of the records of patients who were admitted with a bleeding ulcer in 2003 to 2006 at The Department of Medical Gastroenterology S, Odense University Hospital. Patients with initially negative or missing HP tests were offered a urea breath test. This population was compared with prospective registrations for the periods 1990-1992 and 2000. RESULTS: A total of 264 patients were admitted in 2003-2006. The mean age was 72 years. The HP-prevalence was 34%, and 81% had used NSAID/ASA, as compared with 55% in 1990-1992. The proportion of idiopathic peptic ulcer disease was 6.6%. At admission, 19% and 17% of the patients were in treatment with PPI and antibiotics, respectively. Thirteen percent of the initially HP-negative patients were later found to be HP-positive. CONCLUSION: Compared to previous studies, we found a lower HP prevalence (34%) and a higher proportion of NSAID/ASA usage (81%) in 2003-2006. As we found 13% false negative HP-tests when factors that may affect the HP test were present, we advise that a retest be made where these factors are present and the initial HP test is negative.

[Use of anti-thrombotic agents--monotherapy or combination and risk of upper gastrointestinal bleedings: a population-based case-control study. Secondary publication]. / Brug af antitrombotisk behandling i monoterapi eller kombination og risikoen for øvre gastrointestinal blødning. Et populationsbaseret case-kontrol-studie. Sekundaerpublikation.

The clinical use of anti-thrombotic agents has shifted towards more aggressive therapy and towards regimes with more than one drug. Data on the risk of upper gastrointestinal bleedings (UGB) with combined anti-thrombotic therapy are scarce. In the period 2000 through 2004, 1,443 cases of serious UGB and 57,720 control subjects were identified in Funen County. Anti-thrombotic therapy is becoming increasingly aggressive. Combined anti-thrombotic therapy confers particular risk and is associated with high incidence rates of GI bleeding.

Use of single and combined antithrombotic therapy and risk of serious upper gastrointestinal bleeding: population based case-control study.

OBJECTIVES: To assess the risk of serious upper gastrointestinal bleeding associated with the newer antithrombotic agents used alone or in combination with other antithrombotic drugs; to describe the trends in use of antithrombotic drugs in the background population. DESIGN: Population based case-control study. SETTING: Funen County, Denmark (population 470,000). SUBJECTS: 1443 cases of serious upper gastrointestinal bleeding identified during 2000-4; 57,720 age and sex matched controls. MAIN OUTCOME MEASURE: Exposure to low dose aspirin, clopidogrel, dipyridamole, vitamin K antagonists, and combined antithrombotic treatment. RESULTS: Adjusted odds ratios associating drug use with upper gastrointestinal bleeding were 1.8 (95% confidence interval 1.5 to 2.1) for low dose aspirin, 1.1 (0.6 to 2.1) for clopidogrel, 1.9 (1.3 to 2.8) for dipyridamole, and 1.8 (1.3 to 2.4) for vitamin K antagonists. Corresponding figures for combined use were 7.4 (3.5 to 15) for clopidogrel and aspirin, 5.3 (2.9 to 9.5) for vitamin K antagonists and aspirin, and 2.3 (1.7 to 3.3) for dipyridamole and aspirin. Other combinations were used too infrequently to allow estimation. The number of treatment years needed to produce one excess case varied from 124 for the clopidogrel-aspirin combination to 8800 for clopidogrel alone. During the study period, exposure to combined antithrombotic regimens increased by 425% in the background population. CONCLUSION: Antithrombotic treatment is becoming increasingly aggressive. Combined antithrombotic treatment confers particular risk and is associated with high incidence of gastrointestinal bleeding.

Risk factors for dyspepsia in a general population: non-steroidal anti-inflammatory drugs, cigarette smoking and unemployment are more important than Helicobacter pylori infection.

OBJECTIVE: Dyspepsia, a common condition in the community, affects quality of life and imposes costs on both the individual and the community. Several factors including Helicobacter pylori, acetylic salicylic acid (ASA)/non-steroidal anti-inflammatory drugs (NSAIDs) use, low-dose ASA use, alcohol consumption, cigarette smoking and social status might be responsible. MATERIAL AND METHODS: A cross-sectional study from the inclusion (intervention group) of a general population study evaluating rates of dyspepsia after H. pylori screening and eradication was carried out. A total of 10,007 individuals aged 40-64 years received questionnaires and an invitation to take part in H. pylori screening. Information on dyspepsia (the gastrointestinal symptom rating scale (GSRS) and "most bothersome symptom"), use of ASA/NSAIDs, use of low-dose ASA, lifestyle factors and level of education and employment status was obtained from the questionnaire. Dyspepsia was defined as a score of =2 in the GSRS dimension abdominal pain syndrome (aps), allowing for a maximum of one light problem score in any of the 3 items in the dimension to be overlooked. RESULTS: In all, 5749/10,007 individuals participated in the study; 24.9% reported dyspepsia. In a multiple logistic regression analysis H. pylori infection was found to be a risk factor for dyspepsia, odds ratio (OR) 1.21 (CI; 1.03-1.42). However, the highest ORs for dyspepsia were: for daily use of ASA/NSAIDs 2.33 (CI; 1.72-3.15), unemployment 2.18 (CI; 2.86-2.56) and cigarette smoking =20 g/day 1.55 (CI; 1.29-1.86). CONCLUSIONS: H. pylori infection is a significant risk factor for dyspepsia although of less importance than ASA/NSAIDs use, unemployment and heavy smoking.