Mesalazine induced myocarditis: a case report

Background: Myocarditis is a rare complication of therapy with mesalazine, a drug widely prescribed in the treatment of inflammatory bowel disease. Case presentation: We report a case of myocarditis occurring in a 49-year-old British man 10 days following initiation of mesalazine therapy for treatment of ulcerative colitis. He presented with troponin-positive chest pain, and the diagnosis of myocarditis was confirmed on the basis of cardiac magnetic resonance imaging, which showed subepicardial delayed gadolinium enhancement in the basal to middle inferior and inferolateral segments of the heart. The patient’s symptoms and condition improved upon stopping mesalazine, and he made a full recovery. Conclusions: Mesalazine-induced myocarditis may be more common than first appreciated and is potentially fatal. Therefore, it is imperative that clinicians be aware of this potentially life-threatening adverse effect of mesalazine therapy and warn patients to seek urgent medical attention if cardiac symptoms arise

EndoBarrier®: a safe and effective novel treatment for obesity and type 2 diabetes?

BACKGROUND AND AIMS: Obesity associated with diabetes mellitus is a significant worldwide problem associated with considerable health care costs. Whilst surgical intervention is effective, it is invasive, costly and associated with complications. This study aims to evaluate the safety and efficacy of the EndoBarrier®, a duodenal-jejunal sleeve bypass as an alternative treatment of diabetes mellitus in obese patients. MATERIALS AND METHODS: This was a multi-centre, non-randomised trial recruiting obese patients with type 2 diabetes from three sites in the UK. Eligible participants had a BMI of 30-50 kg/m2and HbA1c levels of 7.5-10%. The study comprised a 12-month period with the EndoBarrier® inserted and a 6-month follow-up period after it had been explanted. The primary study outcomes were weight, BMI, HbA1c levels and fasting insulin and glucose levels. RESULTS: Forty-five patients were recruited and 31 patients (69%) completed the 12-month study period. Significant reductions in weight (95%CI 0.62-29.38; p < 0.05) and BMI (95%CI 1.1-8.7; p < 0.005) were documented 12 months after device insertion. The mean HbA1c was significantly reduced (95%CI 0.1-1.6; p < 0.05) after the device insertion period and reductions in metabolic parameters (fasting insulin and glucose levels) were also documented during the study. Adverse events were also assessed in all patients, the vast majority of which were reported as mild. CONCLUSIONS: The EndoBarrier® appears to be a safe and effective treatment strategy in overweight patients with poor glycaemic control despite medical therapy, or in those who are eligible but decline bariatric surgery

Case-based discussion: perceptions of feedback

BACKGROUND: Over recent years there has been a trend towards developing high-quality assessments to assess a doctor's performance in the workplace. Case-based discussion (CbD) is a form of workplace-based assessment that has the potential to provide feedback to trainees on their performance or management of a specific case. The aim of this study was to explore how CbDs are perceived and implemented in practice amongst a UK cohort of medical trainees. METHODS: This study involved 78 medical trainees at a UK hospital completing a questionnaire rating their last CbD experience, including the duration spent receiving feedback, whether it was pre-planned or ad hoc and how they responded to the feedback received. Focus groups were conducted involving 12 trainees to discuss common themes on feedback arising from the questionnaire, and thematic analysis was carried out following these discussions. RESULTS: Only 19 per cent of assessments were pre-planned and the average duration of assessments was 6-10 minutes, with feedback lasting less than 5 minutes. A total of 76 per cent of trainees responded to the feedback they received by completing self-directed learning or by addressing the specific action points arising from the feedback. The focus groups highlighted the barriers to incorporating these assessments into everyday practice, including appreciating the time constraints and the importance of trainer engagement in the assessment process. The aim of this study was to explore how CbDs are perceived and implemented in practice CONCLUSION: This study demonstrates that most trainees appreciate the educational value of CbDs, but more emphasis and training is required in planning these assessments and in providing feedback that is both specific and actionable

ENDOBARRIER (R) : A SAFE AND EFFECTIVE NOVEL TREATMENT FOR OBESITY AND TYPE 2 DIABETES?

Introduction Obesity is a modern pandemic. One of the major complications of obesity is the development of diabetes which leads to considerable mortality, morbidity and enormous health care costs.1 The EndoBarrier is an endoscopically implantable duodenal-jejunal sleeve bypass (DJSB); anchored in the duodenum, preventing ingested food from coming into contact with the proximal intestine and induces weight loss and improvement in glycaemic control. The aim of this prospective study was to assess the safety and efficacy of the EndoBarrier in obese patients with type 2 diabetes. Method This was a non-randomised study conducted at three investigational sites (Southampton, London, and Manchester) over an 18 month period with clinical and biochemical assessments carried out at 3 monthly intervals. The device was implanted for 12 months with 6 months follow up. All patients were obese with poorly controlled diabetes. Adverse events were recorded and statistical analysis was performed. Results A total of 45 subjects were enrolled into the study At 12 months following implant: 1) HbA1c significantly reduced from baseline at 0.8% below the mean at baseline (95% CI 0.1–1.6; p<0.05). 2) Mean weight loss was 15 kg (95% CI 0.62–29.38; p<0.05) 3) BMI was reduced by 4.9kg/m2 (95% CI 1.1–8.7; p<0.005). 14 patients withdrew from the study, 6 required premature EndoBarrier removal. Of these, only 2 patients presented with device related complications (device migration and gastrointestinal bleeding), the others withdrew due to unrelated medical adverse events. Conclusion The EndoBarrier appears to be a safe and effective treatment strategy in those who are overweight and have poor glycaemic control despite medical therapy, or in those who are eligible but decline bariatric surgery. Larger randomised controlled trials with longer follow-up periods post-explant of the device need to be performed to investigate the device’s effects on long term glycaemic control and weight

A randomised controlled trial of a duodenal-jejunal bypass sleeve device (EndoBarrier) compared with standard medical therapy for the management of obese subjects with type 2 diabetes mellitus

Introduction The prevalence of obesity and obesity-related diseases, including type 2 diabetes mellitus (T2DM), is increasing. Exclusion of the foregut, as occurs in Roux-en-Y gastric bypass, has a key role in the metabolic improvements that occur following bariatric surgery, which are independent of weight loss. Endoscopically placed duodenal-jejunal bypass sleeve devices, such as the EndoBarrier (GI Dynamics, Lexington, Massachusetts, USA), have been designed to create an impermeable barrier between chyme exiting the stomach and the mucosa of the duodenum and proximal jejunum. The non-surgical and reversible nature of these devices represents an attractive therapeutic option for patients with obesity and T2DM by potentially improving glycaemic control and reducing their weight. Methods and analysis In this multicentre, randomised, controlled, non-blinded trial, male and female patients aged 18–65 years with a body mass index 30–50 kg/m2 and inadequately controlled T2DM on oral antihyperglycaemic medications (glycosylated haemoglobin (HbA1c) 58–97 mmol/mol) will be randomised in a 1:1 ratio to receive either the EndoBarrier device (n=80) for 12 months or conventional medical therapy, diet and exercise (n=80). The primary outcome measure will be a reduction in HbA1c by 20% at 12 months. Secondary outcome measures will include percentage weight loss, change in cardiovascular risk factors and medications, quality of life, cost, quality-adjusted life years accrued and adverse events. Three additional subgroups will investigate the mechanisms behind the effect of the EndoBarrier device, looking at changes in gut hormones, metabolites, bile acids, microbiome, food hedonics and preferences, taste, brain reward system responses to food, eating and addictive behaviours, body fat content, insulin sensitivity, and intestinal tissue gene expression

Can old people on oral anticoagulants be safely managed as out-patients?

Of 62 patients (mean age 75, range 65-92 years) referred to an out-patient anticoagulant clinic specifically for those aged 65 years or more, treatment was considered unsafe in only one patient and was discontinued. Minor bleeding which did not require a significant change in management was recorded on 25 (7%) of 381 clinic visits and one major haemorrhage occurred requiring emergency hospital admission. Anticoagulation was maintained within the therapeutic range on 284 (75%) visits. The results confirm that with appropriate out-patient care and supervision, the risks of oral anticoagulant therapy in the elderly need be no greater than in younger patients