Low-dose Aspirin Users Research Articles

Validation of low-dose aspirin prescription data in The Health Improvement Network: how much misclassification due to over-the-counter use?

PurposeWe aimed to quantify the extent of over‐the‐counter (OTC) low‐dose aspirin use among patients in The Health Improvement Network (THIN) in the UK.MethodsIn September 2013, a random sample of low‐dose aspirin users (75 past users and 75 never users) was identified based on prescriptions recorded in THIN. Primary care practitioners (PCPs) were sent questionnaires to provide information on patients' use of OTC low‐dose aspirin.ResultsOne hundred and forty valid questionnaires were received (93.30% [95%CI: 88.16–96.34] response rate). Current use of low‐dose aspirin was reported by PCPs in 4.23% (95%CI: 1.45–11.70) (n = 3) of past users (OTC use in one patient) and in 2.9% (95%CI: 0.78–9.70) (n = 2) of never users (OTC use in one patient). In addition, PCPs reported past use of low‐dose aspirin in 88.70% (95%CI: 79.31–94.18) (n = 63) of past users (all prescribed; none as OTC) and in 2.82% (95%CI: 0.78–9.70) (n = 2) of never users (as OTC). Among past users, PCPs reported the indication for low‐dose aspirin as primary cardiovascular disease (CVD) prevention in 63.16% (95%CI: 50.18–74.48) of patients and secondary CVD prevention in 31.58% (95%CI: 21.00–44.48) of patients. Corresponding percentages based on THIN were 78.95% (95%CI: 66.71–87.53) and 21.1% (95%CI: 12.47–33.29), respectively.ConclusionOur findings show the small impact of potential misclassification of low‐dose aspirin use in THIN due to unrecorded OTC use. The small proportion of false negatives confirms the utility of THIN for utilization and outcome studies of low‐dose aspirin. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

Risk Factors for Upper GI Damage in Low-Dose Aspirin Users and the Interaction Between H. pylori Infection and Low-Dose Aspirin Use.

Nowadays, low-dose aspirin is widely administered at low dose as an antithrombotic drug for the prevention of cerebrovascular and cardiovascular diseases. However, aspirin, even at a low dose, can induce varying degrees of gastroduodenal mucosal injury (erosion, ulcer, ulcer bleeding). Hence, co-prescription of proton pump inhibitors with low-dose aspirin is recommended for those at high risk for adverse gastroduodenal events. At present, a history of peptic ulcer, especially that of complicated ulcer, is the most important risk factor for low-dose aspirin-associated gastroduodenal adverse events. Additionally, concomitant use of non-steroidal anti-inflammatory drugs including COX-2 selective inhibitors, anti-platelet agents, anti-coagulants, and oral corticosteroid is recognized to increase the risk for adverse gastroduodenal events in low-dose aspirin users. H. pylori infection could also be associated with the increased risk for adverse gastroduodenal events in low-dose aspirin users, especially in patients with histories of peptic ulcers. Therefore, eradication therapy for such patients can prevent ulcer recurrence. However, the efficacy of eradication therapy on low-dose aspirin-related gastroduodenal lesions in unselected H. pylori-positive lowdose aspirin users without histories of peptic ulcers remains to be clarified.

Prevention of Upper Gastrointestinal Ulcer and Complications in Low-Dose Aspirin Users.

Low-dose aspirin (LDA) has been increasingly used worldwide to prevent atherothrombotic events. At the same time, the adverse events, most frequent of which are gastrointestinal (GI) ulcers and complications have been raising a big concern with its wider use. These adverse events including reflux and dyspeptic symptoms not only jeopardize adherence of LDA, but my cause more serious outcomes. To reduce GI events by informing best evidence for physicians prescribing LDA, guidelines were published some years ago. Since then, more clinical evidence concerning preventive strategies for upper GI events has been accumulated. Notable differences between East and West are also recognized in terms of primary prevention strategy. Among several options to provide cardiovascular protection with LDA while reducing GI risk, PPI co-therapy is considered to be preferred approach for wider populations according to recent cost-effectiveness analyses based on increasing awareness of importance on adherence of LDA together with declining cost of PPI. This review will focus on these new developments on the prevention of upper gastrointestinal ulcer and complications in LDA users.

Low-dose aspirin use does not diminish the immune response to monovalent H1N1 influenza vaccine in older adults.

Non-steroidal anti-inflammatory drugs (NSAIDs) may inhibit antibody production by peripheral blood mononuclear cells; one consequence of this could be decreased effectiveness of vaccines in NSAID users. Because many older adults use low-dose aspirin for primary or secondary prevention of coronary events, any inhibitory effect of aspirin on vaccine immune response could reduce the benefits of vaccination programmes in older adults. We tested whether immune response to vaccination differed between users vs. non-users of low-dose aspirin, using data from four randomized trials of monovalent 2009 pandemic influenza A(H1N1) vaccine. Geometric mean haemagglutination inhibition antibody titres were not significantly lower in low-dose aspirin users compared to non-users. Our results provide reassurance that influenza vaccination effectiveness is probably not reduced in older adults taking chronic low-dose aspirin.

Proton pump inhibitors are associated with lower gastrointestinal tract bleeding in low-dose aspirin users with ischaemic heart disease

BackgroundImpact of acid suppressants on lower gastrointestinal bleeding remains unclear in low-dose aspirin users; we aimed to investigate this relationship. MethodsRetrospective cohort study of low-dose aspirin users who underwent coronary angiography for ischaemic heart disease in our institution between October 2005 and December 2006; patients were evaluated for upper or lower gastrointestinal bleedings within 3 years post-angiography. Results538 patients were enrolled (males, 74.4%; mean age 67.4±10.6 years). Risk for upper gastrointestinal bleeding decreased with concomitant use of statins (HR, 0.37; 95% CI, 0.15–0.89), calcium channel blockers (HR, 0.29; 95% CI, 0.10–0.85), and histamine-2 receptor antagonists (HR, 0.26; 95% CI, 0.08–0.89). Concomitant use of proton pump inhibitors tended to decrease risk of upper gastrointestinal bleeding (HR, 0.27; 95% CI, 0.06–1.18). Risk for lower gastrointestinal bleeding increased with both concomitant use of warfarin (HR, 15.68; 95% CI, 4.43–55.53) and proton pump inhibitors (HR, 6.55; 95% CI, 2.01–21.32), but not with histamine-2 receptor antagonists. Hyperuricemia lowered risk for lower gastrointestinal bleeding (HR, 0.12; 95% CI, 0.02–0.88). ConclusionsIn low-dose aspirin users, concomitant use of proton pump inhibitors increased lower gastrointestinal bleeding risk, independent from effects on upper gastrointestinal bleeding.

Time-trends in the prescribing of gastroprotective agents to primary care patients initiating low-dose aspirin or non-steroidal anti-inflammatory drugs: a population-based cohort study.

Low-dose aspirin (LDA) and non-steroidal-anti-inflammatory drugs (NSAIDs) both increase the risk of upper gastrointestinal events (UGIEs). In the Netherlands, recommendations regarding the prescription of gastroprotective agents (GPAs) in LDA users were first issued in 2009 in the HARM-Wrestling consensus. National guidelines on gastroprotective strategies (GPSs) in NSAID users were issued in the first part of the preceding. The aim of the present study was to examine time-trends in GPSs in patients initiating LDA and those initiating NSAIDs between 2000 and 2012. Within a large electronic primary healthcare database, two cohorts were selected: (i) patients newly prescribed LDA and (ii) patients newly prescribed NSAIDs between 2000 and 2012. Patients who had been prescribed a GPA in the previous six months were excluded. For both cohorts, patients' risk of a UGIE was classified as low, moderate or high, based on the HARM-Wrestling consensus, and the presence of an adequate GPSwas determined. A total of 37 578 patients were included in the LDA cohort and 352 025 patients in the NSAID cohort. In both cohorts, an increase in GPSs was observed over time, but prescription of GPAs was lower in the LDA cohort. By 2012, an adequate GPS was present in 31.8% of high-risk LDA initiators, vs. 48.0% of high-risk NSAID initiators. Despite a comparable risk of UGIEs, GPSs are prescribed less in high-risk LDA initiators than in high-risk NSAID initiators. For both groups of patients, there is still room for improvement in guideline adherence.

Should patients prescribed long-term low-dose aspirin receive proton pump inhibitors? A systematic review and meta-analysis.

Several clinical guidelines recommend the use of proton pump inhibitors (PPIs) in patients taking low-dose aspirin but report no or limited supporting data. We conducted a systematic review and meta-analysis to examine the effects of co-administration of PPIs in patients taking low-dose aspirin on the risks of adverse gastrointestinal (GI) and cardiovascular (CV) events, and on patient adherence to aspirin. We searched PUBMED, EMBASE and Cochrane Central Register of Controlled Trials databases for relevant articles published through November 2013. We included randomised controlled trials (RCTs) and observational studies in patients taking low-dose aspirin with and without PPIs. Risk of bias was assessed using the Cochrane Collaboration's tool (for RCTs) and the Newcastle-Ottawa Scale (for observational studies). Pooled risk ratios (RRs) were computed using a random-effects model. We included 13 studies, of which 12 (2 RCTs and 10 observational studies) reported on GI events, and one (cohort study) on both GI bleeding and CV events. No study reported on adherence to aspirin. Co-administration of PPIs in patients receiving low-dose aspirin was associated with risk reductions of 73% (RR 0.27, 95% CI 0.17-0.42) and 50% (RR 0.50, 95% CI 0.32-0.80) in the occurrence of peptic ulcer and GI bleeding respectively. There was evidence of bias in publications reporting on the GI events. The practice of co-prescribing PPIs in patients taking low-dose aspirin is supported by some data, but the evidence is rather weak. It currently remains unclear whether the benefits of co-administration of PPIs in users of low-dose aspirin outweigh their potential harms.

Association between low-dose aspirin and periodontal disease: results from the continuous national health and nutrition examination survey (NHANES) 2011-2012.

Low-dose aspirin has been hypothesized as being a potential host modulatory agent for periodontitis treatment. We investigated the relationship between low-dose aspirin use and periodontitis prevalence in the continuous National Health and Nutrition Examination Survey, 2011-2012. We analysed n=2335 adult men and women who received a full-mouth periodontal examination and responded to an aspirin use questionnaire. Periodontal disease was defined as severe, moderate or mild according to established case definitions. Mean full-mouth probing depth, attachment loss and tooth loss were also considered. Low-dose aspirin was defined by any self-reported, physician prescribed aspirin use of ≤162mg/day. Participants had mean age (SE) 55.8years (0.42). The prevalences of periodontitis and low-dose aspirin use were 49.5% and 25% respectively. In multivariable logistic regression models controlling for age, sex, race, socioeconomic variables and comorbidities, the odds ratios [95%CI] for moderate or severe periodontitis among low-dose aspirin users (versus non-users) were: 0.91 [0.56-1.50] and 1.06 [0.74-1.50] respectively. Results were unchanged among participants without diabetes or coronary heart disease. Within the limitations of this cross-sectional study we conclude that low-dose aspirin is not associated with prevalent periodontal status in a nationally representative sample of US adults.

410 Upper Gastrointestinal Mucosal Injury and Symptoms in Elderly Low-Dose Aspirin Users

410 Upper Gastrointestinal Mucosal Injury and Symptoms in Elderly Low-Dose Aspirin Users

Distinct effects of anti-inflammatory and anti-thrombotic drugs on cancer characteristics at diagnosis

BackgroundA previous study showed that regular use of low-dose aspirin was associated with smaller tumour size and fewer metastases for colorectal and lung cancer. We aim to explain these distinct effects in terms of the anti-inflammatory and anti-thrombotic properties of aspirin. MethodsFrom the Swedish Cancer Register, we identified patients diagnosed with colorectal and lung cancers between 1st October 2006 and 31st December 2009; each cancer was assessed in terms of tumour size/extent (T), lymph-node (N) and metastatic (M) status. Linkage with the Swedish Prescribed Drug Register was performed to obtain information on the use of low-dose aspirin, anti-inflammatory and anti-thrombotic drugs prior to cancer diagnosis. ResultsWe identified 14,743 individuals with colorectal cancer and 5888 with lung cancer. For low-dose aspirin users we observed a statistically significant association with smaller tumour size and fewer metastases. For both cancers, the use of non-aspirin anti-inflammatory drugs was associated with smaller tumour size in all categories T2–T4 odds ratio (OR=0.76, 95% confidence interval (CI) 0.63–0.92 for T2 versus T1 in colorectal cancer), but not with metastatic status (OR=0.94, 95% CI 0.84–1.06 in colorectal cancer). In contrast, anti-thrombotic drug use was associated with fewer metastases, but not with tumour categories T2 and T3. ConclusionsThe results suggest that the use of anti-inflammatories is associated with tumour-growth inhibition at the primary site, while the use of anti-thrombotics is associated with restriction of cancer-cell metastasising capability. These have clinical implications on the potential use of these drugs for chemoprevention or chemotherapy.

Evaluation of low-dose aspirin for primary prevention of ischemic stroke among patients with diabetes: a retrospective cohort study.

BackgroundLow-dose aspirin is recommended to reduce the risk of cardiovascular disease. However, the questions with regard to primary prevention have been raised among patients with diabetes. We evaluated low-dose aspirin use for preventing ischemic stroke in patients with diabetes using a national health insurance database.MethodsUsing data from the Korean Health Insurance Review and Assessment Service database from January 1, 2005, through December 31, 2009, a population-based retrospective cohort study was conducted with incident patients with diabetes aged 40 to 99 years old with the initial use of low-dose aspirin during the index period from January 1, 2006 to December 31, 2007. We matched each low-dose aspirin user to one non-user using a propensity score. The Cox proportional hazards model was used to compare the risk of hospitalization for ischemic stroke in users and nonusers of low-dose aspirin until December 31, 2009.ResultsOut of 261,065 incident patients with diabetes, 15,849 (6.2%) were low-dose aspirin users. Compared to non-users, the adjusted hazard ratio (95% confidence interval) of low-dose aspirin users for hospitalization due to ischemic stroke was 1.73 (95% CI; 1.41-2.12). In a sensitivity analysis of study subjects with more than 1 year follow-up periods, slightly higher adjusted hazard ratio (1.97, 95% CI; 1.51-2.62) was observed. In the subgroup analyses, there were no significant changes in the risk of hospitalization for ischemic stroke irrespective of gender, age, or comorbidity.ConclusionsIn this study of patients with diabetes, the use of low-dose aspirin showed an increased risk of hospitalization for ischemic stroke. These results suggest that low-dose aspirin use for the primary prevention of ischemic stroke should be reconsidered in patients with diabetes.

Upper gastrointestinal mucosal injury and symptoms in elderly low-dose aspirin users.

Background. We investigated the prevalence, symptoms, and QOL impact of esophageal (EI), gastric (GI), and duodenal mucosal injury (DI) individually between low-dose aspirin (LDA) users and nonusers to reveal the clinical features of LDA-related mucosal injury. Methods. Data were extracted from the records of subjects who underwent upper gastrointestinal endoscopy at our department between April 2008 and December 2013. Responses from 3162 elderly patients on Frequency Scale for Symptoms of GERD (FSSG) and SF-8 QOL questionnaires (SF-8) were analyzed. FSSG items were classified into total score (TS), reflux score (RS), and dyspepsia score (DS). The SF-8 questionnaire consisted of the physical component summary (PCS) and mental component summary (MCS). Results. Prevalence among LDA users and nonusers, respectively, was 9.6% and 10.0% (P = 0.83) for EI, 35.9% and 27.5% (P = 0.0027) for GI, 3.3% and 3.4% (P = 0.84) for DI, and 8.2% and 5.2% (P = 0.036) for mucosal injury in 2 or more organs. LDA users diagnosed with EI had significantly lower PCS, LDA users diagnosed with GI had significantly lower DS, and LDA users diagnosed with DI had significantly lower RS and significantly lower MCS. Conclusion. These results provide important clinical information indicating that symptom-based management is not appropriate in LDA users regarding upper gastrointestinal mucosal injury.

Geographic differences in low-dose aspirin-associated gastroduodenal mucosal injury.

Aspirin, even at low doses, has been known to cause upper gastro-intestinal complications, such as gastroduodenal ulcers, despite the definite benefits from its antithrombotic effects. Helicobacter pylori (H. pylori) is major pathogen responsible for gastroduodenal ulcer formation. There have been conflicting results about the potential interaction between these two ulcerogenic factors and the geographic areas involved. In Western countries, the prevalence of gastroduodenal ulcers is consistently higher in H. pylori-positive low-dose aspirin (LDA) users than in H. pylori-negative ones, suggesting that H. pylori infection exacerbates LDA-induced gastroduodenal mucosal injury in these geographic areas. Meanwhile, previous studies from Japan have generally reported a similar prevalence of LDA-induced gastroduodenal mucosal injury regardless of the presence of H. pylori infection, indicating that the infection is not an overall exacerbating factor for drug-induced injury. H. pylori infection could have a synergistic or antagonistic interaction with LDA use in adverse gastroduodenal events depending on gastric acid secretion. It is well-recognized that the net effect of H. pylori infection on gastric acid secretion shows considerable geographic variation at the population level. While gastric acid secretion levels were not decreased and were well-preserved in most patients with H. pylori infection from Western countries, the majority of Japanese patients with H. pylori infection exhibited decreased gastric acid secretion. Such large geographic differences in the net effect of H. pylori infection on gastric acid secretion could be at least partly responsible for the geographically distinct interaction between LDA use and H. pylori infection on adverse gastroduodenal lesions.

Risk factors for small-bowel mucosal breaks in chronic low-dose aspirin users : data from a prospective multicenter capsule endoscopy registry.

Risk factors for small-bowel mucosal breaks in chronic low-dose aspirin users : data from a prospective multicenter capsule endoscopy registry.

Small bowel injury in low-dose aspirin users.

The use of low-dose aspirin (LDA) is well known to be associated with an increased risk of serious upper gastrointestinal complications, such as peptic ulceration and bleeding. Until recently, attention was mainly focused on aspirin-induced damage of the stomach and duodenum. However, recently, there has been growing interest among gastroenterologists on the adverse effects of aspirin on the small bowel, especially as new endoscopic techniques, such as capsule endoscopy (CE) and balloon-assisted endoscopy, have become available for the evaluation of small bowel lesions. Preliminary CE studies conducted in healthy subjects have shown that short-term administration of LDA can induce mild mucosal inflammation of the small bowel. Furthermore, chronic use of LDA results in a variety of lesions in the small bowel, including multiple petechiae, loss of villi, erosions, and round, irregular, or punched-out ulcers. Some patients develop circumferential ulcers with stricture. In addition, to reduce the incidence of gastrointestinal lesions in LDA users, it is important for clinicians to confirm the differences in the gastrointestinal toxicity between different types of aspirin formulations in clinical use. Some studies suggest that enteric-coated aspirin may be more injurious to the small bowel mucosa than buffered aspirin. The ideal treatment for small bowel injury in patients taking LDA would be withdrawal of aspirin, however, LDA is used as an antiplatelet agent in the majority of patients, and its withdrawal could increase the risk of cardiovascular/cerebrovascular morbidity and mortality. Thus, novel means for the treatment of aspirin-induced enteropathy are urgently needed.

Proton pump inhibitors: Are we still prescribing them without valid indications?

Evidence from several Western studies has shown an alarmingly high and inappropriate rate of prescription of proton pump inhibitors (PPIs), which may be associated with increased healthcare costs and adverse outcomes. PPI prescribing patterns remain largely unknown in well-developed healthcare systems in Southeast Asia. We aimed to determine the prevalence of inappropriate prescription of PPI among elderly patients without documentation of valid indications, in a tertiary teaching hospital in Singapore. We carried out a retrospective clinical records review of 150 elderly patients aged ≥65 years that had been admitted to two internal medicine wards between 25 May 2011 and 28 June 2011 to determine the appropriateness of indications for PPIs prescribed at hospital discharge. PPI indications were categorised as "valid", "likely invalid", and "probable" based on current clinical literature. Pre-admission and discharge prescriptions were reviewed to determine continuation of pre-admission and new PPI prescriptions at discharge. Data on clinical characteristics and concurrent use of ulcerogenic medications were collected. From a total of 150 patients, 80 (53 per cent) received prescriptions for PPIs. Of these, 65 (81.2 per cent) had no valid documented indications (i.e., the indication was classed as "likely invalid"); 10 (12.5 per cent) had valid indications; and in five cases (6.2 per cent) the indication was "probable". The most common "likely invalid" indication was primary gastrointestinal bleeding prophylaxis (GIP) among low-dose aspirin users in 28 patients (43 per cent) of invalid PPI prescriptions. Inappropriate prescribing of PPIs without documented valid indications was prevalent among elderly patients at our tertiary teaching hospital in Singapore, providing evidence that shows a similar trend to PPI prescribing to data from Western countries.

Identification of a high-risk group for low-dose aspirin-induced gastropathy by measuring serum pepsinogen in H. pylori-infected subjects.

We recently demonstrated in humans that the extent of low-dose aspirin (LDA)-induced gastropathy was directly related to the individual gastric acid secretion level. We also established reliable cutoff serum pepsinogen (PG) values to predict gastric acid secretion status. In this study, we investigated the clinical usefulness of measuring the serum pepsinogen values for identifying a high-risk group for gastric mucosal injury among chronic LDA users. One hundred long-term LDA users were enrolled in this analysis. Serum from each subject was subjected to determination of H. pylori status and measurement of pepsinogen values. According to our recent report, a PG I value ≥ 50 ng/mL was defined as estimated hyperchlorhydria in H. pylori-negative subjects, while a PG I/II ≥ 3.3 was defined as estimated hyperchlorhydria in H. pylori-positive subjects. The grade of gastric mucosal injury was assessed endoscopically, and multiple logistic regression analyses were used to estimate the risk. Estimated hyperchlorhydria was a strong independent risk for intensive gastric mucosal injury with an OR (95% CI): 34.0 (4.5-259) and for gastric ulcer with an OR (95% CI): 10.2 (1.8-58.3) in H. pylori-positive subjects, while it was not a significant risk in H. pylori-negative subjects. The association persisted even after excluding those with conventional risks for LDA-gastropathy such as ulcer histories. Using simple serum measurement of H. pylori antibody and pepsinogen concentrations, an extremely high-risk group for LDA-induced gastropathy could be extracted, and these patients should become a therapeutic target for prevention of LDA-induced gastropathy.

Risk factors for small-bowel mucosal breaks in chronic low-dose aspirin users: data from a prospective multicenter capsule endoscopy registry

To develop appropriate management strategies for patients who take low-dose aspirin, it is important to identify the risk factors for GI injury. However, few studies have described the risk factors for small-bowel injury in these patients. To investigate factors influencing the risk of small-bowel mucosal breaks in individuals taking continuous low-dose aspirin. Capsule endoscopy data were collected prospectively from 5 institutions. Yokohama City University Hospital and 4 other hospitals. A total of 205 patients receiving treatment with low-dose aspirin for over 3 months. Colonoscopic and upper GI endoscopy had been performed in all of the patients before the capsule endoscope evaluation. Risk factors for small-bowel mucosal breaks. Of the 198 patients (141 male; mean age 71.9 years) included in the final analysis, 114 (57.6%) had at least 1 mucosal break. Multivariate analysis identified protein pump inhibitor (PPI) use (OR 2.04; 95% confidence interval [CI], 1.05-3.97) and use of enteric-coated aspirin (OR 4.05; 95% CI, 1.49-11.0) as independent risk factors for the presence of mucosal breaks. Cross-sectional study. PPI use appears to increase the risk of small-bowel injury in patients who take continuous low-dose aspirin. Clinicians should be aware of this effect of PPIs; new strategies are needed to treat aspirin-induced gastroenteropathy.

1033 Underestimation of Small Bowel Bleeding in Users of Nonselective Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Low-Dose Aspirin (ASA): A Prospective Study

G A A b st ra ct s the recurrence of LDA-related peptic ulcers has not been reported. We conducted a randomized, double-blind, double-dummy, active-controlled trial to assess the efficacy, doseresponse relationship and safety of rabeprazole for peptic ulcer recurrence in Japanese patients in long-term LDA therapy. Methods: Patients were eligible for the trial if they had an endoscopically confirmed gastric or duodenal ulcer scars and were receiving long-term LDA (81 mg/day or 100 mg/day) therapy for cardiovascular and cerebrovascular protection. Patients on long-term LDA therapy were also eligible if they had a previous history of endoscopically confirmed active peptic ulcers, but did not present them at baseline endoscopy. Patients were randomly segregated into three groups receiving rabeprazole 10 mg once daily (standard dose in Japan), rabeprazole 5 mg once daily or teprenone (mucosal protective agent commercially available in Japan) 50 mg three times per day as an active control. The primary endpoint was recurrence of gastric and duodenal ulcers over 24 weeks. Secondary endpoints included an occurrence of bleeding ulcers with stigmata of recent hemorrhage or drop in hemoglobin level of more than 2 g/dl, changes from baseline in the modified Lanza score (endoscopic scoring system for gastroduodenal damage) or upper gastrointestinal symptom score, and newly-developed erosive esophagitis. Results: Among 472 randomized patients, 452 patients (rabeprazole 10 mg, n=151; rabeprazole 5 mg, n= 150; teprenone 150 mg, n=151) constituted the full analysis set. The cumulative recurrence rates of gastric and duodenal ulcers over 24 weeks in the 5and 10-mg rabeprazole groups were 2.8% and 1.4%, respectively, and both were significantly lower than that in the teprenone group (21.7%). The cumulative occurrence rate of bleeding ulcers over 24 weeks in the teprenone group was 6.1%, while bleeding ulcers were not observed in the 5or 10-mg rabeprazole groups. The rates of worsening in the modified Lanza and upper gastrointestinal symptom scores in the 5and 10-mg rabeprazole groups were significantly lower than those in the teprenone group. Significantly fewer patients developed erosive esophagitis in the 5 mg rabeprazole group (2%) and 10 mg rabeprazole group (0%), compared with the teprenone group (8.6%). Rabeprazole was well-tolerated at both doses. Conclusions: Rabeprazole prevents the recurrence of gastroduodenal ulcers with no evidence of a major dose response effect in patients taking LDA, and is well-tolerated.

Tu1243 Risk Factors for Small Bowel Mucosal Breaks in Chronic Low-Dose Aspirin Users: Data From a Prospective Multicenter Capsule Endoscopy Registry

Tu1243 Risk Factors for Small Bowel Mucosal Breaks in Chronic Low-Dose Aspirin Users: Data From a Prospective Multicenter Capsule Endoscopy Registry