Nonsteroidal anti-inflammatory drug exposure and the risk of microscopic colitis.

Background: Medication consumption has been suggested as a risk factor for microscopic colitis (MC), but studies of varying design have yielded inconsistent results. Our aim was to evaluate the association between medications and MC.

Methods: A hybrid cohort of prospectively identified patients undergoing colonoscopy with biopsies for suspicion of MC (N = 144) and patients with MC enrolled within three months of diagnosis into an MC registry (N = 59) were surveyed on medication use.

Polygenic risk score is a predictor of adenomatous polyps at screening colonoscopy.

Background: Single nucleotide polymorphism (SNP)-based polygenic risk scoring is predictive of colorectal cancer (CRC) risk. However, few studies have investigated the association of genetic risk score (GRS) with detection of adenomatous polyps at screening colonoscopy.

Methods: We randomly selected 1769 Caucasian subjects who underwent screening colonoscopy from the Genomic Health Initiative (GHI), a biobank of NorthShore University HealthSystem.

Bile Acid Sequestrant Therapy in Microscopic Colitis.

Goals: There is an unmet need in investigating corticosteroid-sparing treatments for induction and maintenance of remission in microscopic colitis (MC). The authors' aim was to evaluate the outcomes of patients with MC treated with bile acid sequestrants (BAS).

Background: MC is a common chronic diarrheal illness.

Hepatitis C Screening in Commercially Insured U.S. Birth-cohort Patients: Factors Associated with Testing and Effect of an EMR-based Screening Alert.

Background And Objectives: Hepatitis C virus (HCV) testing rates among U.S. birth-cohort patients have been studied extensively, limited data exists to differentiate birth-cohort screening from risk- or liver disease-based testing.

Screening Colonoscopy Withdrawal Time Threshold for Adequate Proximal Serrated Polyp Detection Rate.

Introduction: For adequate adenoma detection rate (ADR), guidelines recommend a mean withdrawal time (MWT) of ≥ 6 min. ADR has been shown to correlate strongly with proximal serrated polyp detection rate (PSP-DR), which is another suggested quality measure for screening colonoscopy. However, the impact of directly measured withdrawal time on PSP-DR has not been rigorously studied.

A randomized trial of the effects of the no-carrageenan diet on ulcerative colitis disease activity.

Carrageenan is a very common food additive in Western diets, but predictably causes inflammation in thousands of cell-based and animal experiments. To assess the impact of carrageenan exposure on the interval to relapse in patients with ulcerative colitis in remission. A randomized, double-blind, placebo-controlled, multicenter, clinical trial was conducted to assess if patients with ulcerative colitis in remission would have a longer interval to relapse if they followed a diet with no carrageenan.

Predicting Progression in Barrett's Esophagus: Development and Validation of the Barrett's Esophagus Assessment of Risk Score (BEAR Score).

Objective: To develop and validate a scoring tool capable of accurately predicting which patients with Barrett's esophagus (BE) will progress to dysplasia and/or esophageal adenocarcinoma.

Background: Endoscopic therapies have emerged capable of eradicating BE with high efficacy and low complication rates, but which patients should receive treatment is still debated. Current knowledge of risk factors is insufficient to allow for the accurate prediction of which patients will progress to dysplasia or adenocarcinoma.

Aspirin Use in Secondary Cardiovascular Protection and the Development of Aspirin-Associated Erosions and Ulcers.

Aspirin for secondary cardiovascular disease prevention is well established, but treatment discontinuation, often because of gastrointestinal mucosal injury or symptoms, can lead to increased risk for cardiovascular events. Proton pump inhibitor therapy is recommended for aspirin-treated patients at gastrointestinal risk. PA32540 [enteric-coated aspirin (EC-ASA) 325 mg + immediate-release omeprazole 40 mg] was compared with EC-ASA 325 mg alone once daily for 6 months in 2 duplicate, randomized double-blind trials in gastrointestinal-risk patients taking aspirin for ≥3 months for secondary prevention.

Long-Term Safety of a Coordinated Delivery Tablet of Enteric-Coated Aspirin 325 mg and Immediate-Release Omeprazole 40 mg for Secondary Cardiovascular Disease Prevention in Patients at GI Risk.

Introduction: In two, 6-month, randomized, double-blind Phase 3 trials, PA32540 (enteric-coated aspirin 325 mg and immediate-release omeprazole 40 mg) compared to aspirin alone was associated with fewer endoscopic gastric and duodenal ulcers in patients requiring aspirin therapy for secondary cardiovascular disease (CVD) prevention who were at risk for upper gastrointestinal (UGI) events.

Aims: In this 12-month, open-label, multicenter Phase 3 study, we evaluated the long-term cardiovascular and gastrointestinal safety of PA32540 in subjects who were taking aspirin 325 mg daily for ≥ 3 months for secondary CVD prevention and were at risk for aspirin-associated UGI events. Enrolled subjects received PA32540 once daily for up to 12 months and were assessed at baseline, month 1, month 6, and month 12.

Reflux control is important in the management of Barrett's Esophagus: results from a retrospective 1,830 patient cohort.

Background: It is unknown whether acid/reflux control prevents progression in Barrett's esophagus. In this study, we investigate whether medical or surgical control of reflux is associated with a decreased risk of progression to dysplasia/esophageal adenocarcinoma.

Methods: We retrospectively collected and analyzed data from a cohort of Barrett's esophagus patients participating in this single-center study comprised of all patients diagnosed with Barrett's esophagus at NorthShore University Health System hospitals and clinics over a 10-year period.

Gastrointestinal injury associated with NSAID use: a case study and review of risk factors and preventative strategies.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective anti-inflammatory and analgesic agents and are among the most commonly used classes of medications worldwide. However, their use has been associated with potentially serious dose-dependent gastrointestinal (GI) complications such as upper GI bleeding. GI complications resulting from NSAID use are among the most common drug side effects in the United States, due to the widespread use of NSAIDs.

PA32540 (a coordinated-delivery tablet of enteric-coated aspirin 325 mg and immediate-release omeprazole 40 mg) versus enteric-coated aspirin 325 mg alone in subjects at risk for aspirin-associated gastric ulcers: results of two 6-month, phase 3 studies.

Background: Discontinuations and/or interruptions in aspirin therapy for secondary cardioprotection due to upper gastrointestinal (UGI) complications or symptoms have been shown to increase the risk for subsequent cardiovascular events. PA32540 is a coordinated-delivery, combination tablet consisting of enteric-coated aspirin (EC-ASA) 325 mg and immediate-release (IR) omeprazole 40 mg.

Methods: Two identically-designed, 6-month, randomized, double-blind trials evaluated PA32540 vs.

Predicting regression of Barrett's esophagus: results from a retrospective cohort of 1342 patients.

Introduction: Barrett's esophagus (BE) is the most predictive risk factor for development of esophageal adenocarcinoma (EAC), a malignancy with the fastest increasing incidence in the US. The aim of this study was to investigate differences in exposures, demographics, and comorbidities between regressing and non-regressing patients.

Methods And Procedures: We retrospectively collected and analyzed data from a cohort of BE patients participating in a single-center study comprised of all patients diagnosed with BE over a 10-year period.

Healthcare resource utilization and economic impact of a ≥2 g/dL decrease in hemoglobin in osteoarthritis patients.

Objective: In non-steroidal anti-inflammatory drug (NSAID) users, chronic occult blood loss may lead to decreases in hemoglobin, which may lead to increased healthcare expenditures. This study, therefore, sought to quantify healthcare resource utilization of ≥2 g/dL hemoglobin decrease in osteoarthritis patients.

Methods: Using a large US managed care database, osteoarthritis patients aged ≥18 years who had exposure to ≥90 days of non-selective or selective COX-2 NSAID use, a hemoglobin value within 6 months before index NSAID, and at least one hemoglobin value 24 months after were evaluated.

Adherence to gastroprotection during cyclooxygenase 2 inhibitor treatment and the risk of upper gastrointestinal tract events: a population-based study.

Objective: Guidelines recommend coprescription of gastroprotective agents (GPAs) in patients receiving cyclooxygenase 2 inhibitors (coxibs) who are at high risk of upper gastrointestinal (UGI) tract complications (i.e., patients with a previous complicated ulcer or with multiple risk factors).

Suboptimal gastroprotective coverage of NSAID use and the risk of upper gastrointestinal bleeding and ulcers: an observational study using three European databases.

Background: Gastro-protective agents (GPA) are co-prescribed with non-steroidal anti-inflammatory drugs (NSAID) to lower the risk of upper gastrointestinal (UGI) events. It is unknown to what extent the protective effect is influenced by therapy adherence.

Aim: To study the association between GPA adherence and UGI events among non-selective (ns) NSAID users.

Cost-effectiveness model of endoscopic biopsy for eosinophilic esophagitis in patients with refractory GERD.

Objectives: The population prevalence of eosinophilic esophagitis (EoE) is ~7% in adults. Current American Gastroenterology Association guidelines recommend endoscopic biopsy (Bx) in patients with symptoms of dysphagia. We conducted a cost-effectiveness model to determine if endoscopic Bx is cost effective in patients with refractory gastroesophageal reflux disease (GERD) without dysphagia.

Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial.

Background: Cyclo-oxygenase (COX)-2-selective non-steroidal anti-inflammatory drugs (NSAIDs) and non-selective NSAIDs plus a proton-pump inhibitor (PPI) have similar upper gastrointestinal outcomes, but risk of clinical outcomes across the entire gastrointestinal tract might be lower with selective drugs than with non-selective drugs. We aimed to compare risk of gastrointestinal events associated with celecoxib versus diclofenac slow release plus omeprazole.

Methods: We undertook a 6-month, double-blind, randomised trial in patients with osteoarthritis or rheumatoid arthritis at increased gastrointestinal risk at 196 centres in 32 countries or territories.

A novel composite endpoint to evaluate the gastrointestinal (GI) effects of nonsteroidal antiinflammatory drugs through the entire GI tract.

Objective: Nonsteroidal antiinflammatory drugs (NSAID) not only cause damage to the upper gastrointestinal (GI) tract but also affect the lower GI tract. To date, there is no endpoint that evaluates serious GI events in the entire GI tract. The objective of this report is to introduce a novel composite endpoint that measures damage to the entire GI tract - clinically significant upper and lower GI events (CSULGIE) - in patients with NSAID-induced GI damage.

GERD-related health care utilization, therapy, and reasons for transfer of GERD patients between primary care providers and gastroenterologists in a US managed care setting.

Purpose: Patient flow between primary care physicians and gastroenterologists in the continuum of gastroesophageal reflux disease (GERD) care is poorly understood. Using administrative claims data from a large US health plan linked with data abstracted from medical records, we examined: health care resource utilization for GERD subjects treated by primary care physicians (PCPs) and gastroenterologists (GEs), determinants of GERD subject transfer between these physician types, and reasons for GERD therapy change.

Results: Within a sample of 169,884 patients, 211,043 PCP-based episodes of care and 40,304 GE-based episodes of care were developed.

Celecoxib plus aspirin versus naproxen and lansoprazole plus aspirin: a randomized, double-blind, endoscopic trial.

Background & Aims: Patients requiring low-dose aspirin along with nonsteroidal anti-inflammatory drugs are at increased risk for gastrointestinal injury. This study compared the incidence of gastroduodenal ulcers in patients treated with low-dose aspirin and a cyclooxygenase-2 selective nonsteroidal anti-inflammatory drug or a nonselective nonsteroidal anti-inflammatory drug plus the proton pump inhibitor lansoprazole.

Methods: Subjects 18 years or older with osteoarthritis, without gastroduodenal ulcer or erosive esophagitis at baseline endoscopy, and a cardiovascular indication for prophylaxis low-dose (81 or 325 mg) aspirin were prescribed open-label aspirin and blindly randomized to celecoxib 200 mg/day or naproxen 500 mg twice daily plus lansoprazole 30 mg once daily.

Endoscopic ulcer rates in healthy subjects associated with use of aspirin (81 mg q.d.) alone or coadministered with celecoxib or naproxen: a randomized, 1-week trial.

Aim: To determine the rate of endoscopic gastric/duodenal ulcers (GDUs) associated with use of aspirin (81 mg q.d.) alone or coadministered with celecoxib or naproxen.

Withdrawal of COX-2 selective inhibitors rofecoxib and valdecoxib: impact on NSAID and gastroprotective drug prescribing and utilization.

Objective: Cyclo-oxygenase-2 (COX-2) inhibitors rofecoxib and valdecoxib were withdrawn from the market because of their association with cardiovascular problems. There is a lack of information on the impact of the COX-2 inhibitors withdrawal on the prescribing and utilization of related drugs. The main objective of this study was to evaluate to what extent prescriptions of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and gastroprotective drugs changed after the removal of the two COX-2 inhibitors.

Impact of adherence to concomitant gastroprotective therapy on nonsteroidal-related gastroduodenal ulcer complications.

Background & Aims: The clinical impact of nonadherence to gastroprotective agents (GPAs) coprescribed with anti-inflammatory therapies has not been evaluated. In a large, commercial, managed-care database, we retrospectively characterized the use of GPAs among patients receiving nonselective nonsteroidal anti-inflammatory drugs (ns-NSAIDs) or cyclooxygenase-2-selective inhibitors (coxibs) and determined the impact of nonadherence on the likelihood of gastroduodenal ulcer complications.

Methods: Analyses identified the populations of patients with concomitant histamine-2 receptor antagonist or proton pump inhibitor (PPI) therapy and determined adherence with the prescribed therapy with respect to the duration of anti-inflammatory treatment.