Cost-effectiveness of golimumab for the treatment of patients with moderate-to-severe ulcerative colitis in Quebec using a patient level state transition microsimulation.

Objective: To conduct cost-effectiveness analyses comparing the addition of golimumab to the standard of care (SoC) for treatment of patients with moderate-to-severe ulcerative colitis (UC) who are refractory to conventional therapies in Quebec (Canada).

Methods: An individual patient state transition microsimulation model was developed to project health outcomes and costs over 10 years, using a payer perspective. The incremental benefit estimates for golimumab were driven by induction response and risk of a flare.

Early combined immunosuppression for the management of Crohn's disease (REACT): a cluster randomised controlled trial.

Background: Conventional management of Crohn's disease features incremental use of therapies. However, early combined immunosuppression (ECI), with a TNF antagonist and antimetabolite might be a more effective strategy. We compared the efficacy of ECI with that of conventional management for treatment of Crohn's disease.

The probiotic VSL#3 has anti-inflammatory effects and could reduce endoscopic recurrence after surgery for Crohn's disease.

Background & Aims: Probiotic formulations of single species of bacteria have not been effective in preventing the recurrence of Crohn's disease after surgery. We investigated the ability of VSL#3, a mixture of 8 different bacterial probiotic species, to prevent Crohn's disease recurrence after surgery in a multicenter, randomized, double-blind, placebo-controlled trial.

Methods: Within 30 days of ileocolonic resection and re-anastomosis, patients with Crohn's disease were randomly assigned to groups given 1 sachet of VSL#3 (900 billion viable bacteria, comprising 4 strains of Lactobacillus, 3 strains of Bifidobacterium, and 1 strain of Streptococcus salivarius subspecies thermophilus) (n = 59) or matching placebo (n = 60).

Systematic review of stimulant and nonstimulant laxatives for the treatment of functional constipation.

Background: Constipation is an uncomfortable and common condition that affects many, irrespective of age. Since 1500 BC and before, health care practitioners have provided treatments and prevention strategies to patients for chronic constipation despite the significant variation in both medical and personal perceptions of the condition.

Objective: To review relevant research evidence from clinical studies investigating the efficacy and safety of commercially available pharmacological laxatives in Canada, with emphasis on studies adopting the Rome criteria for defining functional constipation.

Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease.

Background & Aims: Methotrexate and infliximab are effective therapies for Crohn's disease (CD). In the combination of maintenance methotrexate-infliximab trial, we evaluated the potential superiority of combination therapy over infliximab alone.

Methods: In a 50-week, double-blind, placebo-controlled trial, we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy (15-40 mg/day) within the preceding 6 weeks.

The approach to diagnosis and treatment of chronic constipation: suggestions for a general practitioner.

Chronic constipation is a frequent complaint. Symptoms of obstructive defecation (straining, hard and lumpy stools, or incomplete evacuation) are more frequent and bothersome than the frequency of bowel movements. Patient assessment is clinically based on the presence or absence of red flags.

Counselling by primary care physicians may help patients with heartburn-predominant uninvestigated dyspepsia.

Objective: To determine whether strategies to counsel and empower patients with heartburn-predominant dyspepsia could improve health-related quality of life.

Methods: Using a cluster randomized, parallel group, multicentre design, nine centres were assigned to provide either basic or comprehensive counselling to patients (age range 18 to 50 years) presenting with heartburn-predominant upper gastrointestinal symptoms, who would be considered for drug therapy without further investigation. Patients were treated for four weeks with esomeprazole 40 mg once daily, followed by six months of treatment that was at the physician's discretion.

Phenotypic and genotypic characteristics of inflammatory bowel disease in French Canadians: comparison with a large North American repository.

Objectives: Phenotype characteristics of inflammatory bowel disease (IBD) may differ significantly among ethnic subpopulations. The aim of this study was to characterize the IBD phenotype in French Canadians, the most prominent founder population in North America.

Methods: Using well-characterized phenotype data in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-IBD Genetics Consortium repository on patients with IBD, we compared phenotypic characteristics of 202 French Canadians with those of 1,287 other Caucasian patients.

Ulcerative colitis-risk loci on chromosomes 1p36 and 12q15 found by genome-wide association study.

Ulcerative colitis is a chronic inflammatory disease of the colon that presents as diarrhea and gastrointestinal bleeding. We performed a genome-wide association study using DNA samples from 1,052 individuals with ulcerative colitis and preexisting data from 2,571 controls, all of European ancestry. In an analysis that controlled for gender and population structure, ulcerative colitis loci attaining genome-wide significance and subsequent replication in two independent populations were identified on chromosomes 1p36 (rs6426833, combined P = 5.

Treatment of active Crohn's disease with MLN0002, a humanized antibody to the alpha4beta7 integrin.

Background & Aims: Selective blockade of lymphocyte-vascular endothelium interactions in the gastrointestinal tract is a promising therapeutic strategy for inflammatory bowel disease. This randomized, double-blind, controlled trial assessed the efficacy and safety of MLN0002, a monoclonal antibody targeting the alpha4beta7 integrin, in patients with active Crohn's disease.

Methods: Patients were randomized to receive MLN0002 2.

Tegaserod for female patients suffering from IBS with mixed bowel habits or constipation: a randomized controlled trial.

Objectives: Though the greatest proportion of irritable bowel syndrome (IBS) patients report a mixed bowel pattern (IBS-Mixed), no available therapies have been rigorously evaluated in this subgroup. This study aimed to evaluate the efficacy and safety of the 5-HT(4) agonist tegaserod in women with IBS-Mixed and IBS with constipation (IBS-C).

Methods: This prospective, double-blind, randomized, placebo-controlled, multicenter study was conducted in 100 centers in North America, South America, and Europe.

Omega-3 free fatty acids for the maintenance of remission in Crohn disease: the EPIC Randomized Controlled Trials.

Context: Maintenance therapy for Crohn disease features the use of immunosuppressive drugs, which are associated with an increased risk of infection. Identification of safe and effective maintenance strategies is a priority.

Objective: To determine whether the oral administration of omega-3 free fatty acids is more effective than placebo for prevention of relapse of Crohn disease.

Health-related quality of life, work productivity, and health care resource utilization of subjects with irritable bowel syndrome: baseline results from LOGIC (Longitudinal Outcomes Study of Gastrointestinal Symptoms in Canada), a naturalistic study.

Background: Abdominal pain/discomfort, bloating, and constipation are gastrointestinal dysmotility and sensory symptoms associated with irritable bowel syndrome (IBS). No studies have followed patients with IBS symptoms for 1 year under conditions of routine clinical practice to assess prospectively the impact of treatments on health outcomes.

Objective: The objective of this ongoing, naturalistic study is to assess the long-term impact of IBS treatments on quality of life (QOL), work productivity, and resource utilization.

Canadian consensus on medically acceptable wait times for digestive health care.

Background: Delays in access to health care in Canada have been reported, but standardized systems to manage and monitor wait lists and wait times, and benchmarks for appropriate wait times, are lacking. The objective of the present consensus was to develop evidence- and expertise-based recommendations for medically appropriate maximal wait times for consultation and procedures by a digestive disease specialist.

Methods: A steering committee drafted statements defining maximal wait times for specialist consultation and procedures based on the most common reasons for referral of adult patients to a digestive disease specialist.

Inflammatory bowel disease characteristics among African Americans, Hispanics, and non-Hispanic Whites: characterization of a large North American cohort.

Objectives: Inflammatory bowel disease (IBD), comprising primarily of Crohn's disease (CD) and ulcerative colitis (UC), is increasingly prevalent in racial and ethnic minorities. This study was undertaken to characterize racial differences in disease phenotype in a predominantly adult population.

Methods: Phenotype data on 830 non-Hispanic white, 127 non-Hispanic African American, and 169 Hispanic IBD patients, recruited from six academic centers, were abstracted from medical records and compiled in the NIDDK-IBD Genetics Consortium repository.

Treatment of ulcerative colitis with a humanized antibody to the alpha4beta7 integrin.

Background: Selective blockade of interactions between leukocytes and vascular endothelium in the gut is a promising strategy for the treatment of inflammatory bowel diseases.

Methods: We conducted a multicenter, double-blind, placebo-controlled trial of MLN02, a humanized antibody to the alpha4beta7 integrin, in patients with active ulcerative colitis. We randomly assigned 181 patients to receive 0.

Pantoprazole rapidly improves health-related quality of life in patients with heartburn: a prospective, randomized, double blind comparative study with nizatidine.

Background: Health-related quality of life (HRQoL) is impaired in untreated patients with gastroesophageal reflux disease (GERD). In the absence of an objective marker such as erosions, assessment of treatment efficacy can be based on symptoms and HRQoL.

Objective: To evaluate changes in HRQoL during treatment with pantoprazole or nizatidine in patients with GERD.

Validation of the GSFQ, a self-administered symptom frequency questionnaire for patients with gastroesophageal reflux disease.

Background: Although the diagnosis of gastroesophageal reflux disease (GERD) is based primarily on symptoms experienced by a patient, relatively little attention has been paid to the development and validation of self-administered questionnaires specific to GERD symptoms. The present article presents the validation of the short, self-administered GERD Symptom Frequency Questionnaire (GSFQ).

Methods: Patients with GERD participating in a randomized clinical trial comparing pantoprazole and nizatidine were asked to complete the GSFQ together with validated instruments for measurement of health-related quality of life (Medical Outcome Study Short Form 12) and gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale).

Cure of gastric antral vascular ectasia by liver transplantation despite persistent portal hypertension: a clue for pathogenesis.

Gastric antral vascular ectasia (GAVE) is a rare cause of chronic bleeding in cirrhotic patients. It has been suggested that these gastric lesions might be related to portal hypertension, hepatic insufficiency, or both parameters. We report two cases of cirrhotic patients in whom GAVE was the source of recurrent bleeding.

CARD15 genetic variation in a Quebec population: prevalence, genotype-phenotype relationship, and haplotype structure.

The caspase recruitment domain gene (CARD15) was recently identified as the underlying gene associated with the IBD1 locus that confers susceptibility to Crohn disease (CD). CARD15 is related to the NOD1/Apaf-1 family of apoptosis regulators, and three sequence variants (Arg702Trp, Gly908Arg, and Leu1007fsinsC) in the gene were demonstrated to be associated with CD. We collected a cohort of 231 patients with CD and 71 healthy control individuals from the Canadian province of Quebec, to determine the prevalence of these sequence variants in an independent population.

Recommendations for the appropriate use of anti-inflammatory drugs in the era of the coxibs: defining the role of gastroprotective agents.

Treatment with anti-inflammatory drugs and the analgesic efficacy of conventional nonsteroidal anti-inflammatory drugs (NSAIDs) are compromised by a two- to fourfold increased risk of gastrointestinal complications. This increased risk has resulted in an increasing use of the new selective cyclooxygenase-2 inhibitors or coxibs, which, in clinical trials and outcomes studies, reduced gastrointestinal adverse events by 50% to 65% compared with conventional NSAIDs. However, the coxibs are not available to all patients who need them, and NSAIDs are still widely used.

Coeliac disease.

Increased awareness of non-classical presentations and more reliable screening tests have led to higher detection rates for coeliac disease in elderly adults. Clinical presentations are influenced largely by the long-standing course of the subclinical disease before diagnosis. In the majority of elderly patients, weight loss, diarrhoea and iron deficiency anaemia are present.

Diagnosis of constipation in family practice.

Background: Patients who complain of constipation to their family doctor may not be truly constipated. Variability in stool frequency and consistency, and perception of symptoms may lead to inaccurate patient reporting or diagnosis of constipation.

Objectives: To determine whether patients visiting their family doctor with a complaint of, or diagnosed with, constipation fulfilled the Rome II criteria for functional constipation and had stool characteristics of constipation.