Non-alcoholic Steatohepatitis: From Pathophysiology to Clinical Practice.

Non-alcoholic steatohepatitis (NASH) is becoming a global disease with significant associated comorbidities. To date, there are no commercialized drugs to treat NASH, outside of India; however, there is an abundance of new molecular entities which are in clinical development, some in phase III trials. Many of these trials have created an especially heavy demand for USA-based subjects. Hepatologists currently play a major role in the diagnosis, treatment and clinical-trial enrolment of patients with NASH. However, NASH has a strong metabolic component, with patients often carrying comorbid diseases, such as type 2 diabetes mellitus, obesity, hyperlipidaemia, hypothyroidism and sex steroid disorders. The primary care physician, internist and endocrinologist stand at a pivotal position in the NASH healthcare delivery system, as many of the diseases they commonly encounter are associated with a higher risk of developing NASH. Specialty society practice guidelines are evolving regarding the identification and care of patients with NASH. This review of the literature, and assessment of IQVIA's proprietary patient claims database of diagnosis codes, patient encounters and treatments, substantiates the importance of the primary care provider and endocrinologist in the clinical care and clinical research of patients with NASH.

Recruitment and Retention of Patients for Nonalcoholic Steatohepatitis Clinical Trials.

The volume of clinical studies globally in nonalcoholic fatty liver disease has created tremendous competition among sponsors and investigators to identify patients. Patients with nonalcoholic steatohepatitis are often asymptomatic and personally unaware and uneducated about the disease. In addition, many physicians caring for undiagnosed patients are also poorly informed of the disease. This has created a perfect storm of high demand for clinical research participants among a pool of difficult to identify patients with nonalcoholic steatohepatitis. Based on the current data, the current volume of nonalcoholic fatty liver disease studies requires 13,049 patients to fulfill their patient enrollment requirements.

Enteral Access and Associated Complications.

Enteral access is the foundation for feeding in patients unable to meet their nutrition needs orally and have a functional gastrointestinal tract. Enteral feeding requires placement of a feeding tube. Tubes can be placed through an orifice or percutaneously into the stomach or proximal small intestine at the bedside or in specialized areas of the hospital. Bedside tubes can be placed by the nurse or the physician, such as in the intensive care unit. Percutaneous feeding tubes are placed by the gastroenterologist, surgeon, or radiologist. This article reviews the types of enteral access and the associated complications.

A nutrition strategy for obese ICU patients with special consideration for the reference of protein.

Hypocaloric, high protein feeding regimens have been proposed for feeding obese critically ill patients. However, the exact amount of energy and protein that should be provided to the obese patients with these regimens is still under discussion. Furthermore, the body compartment to be used as a reference for appropriate protein dosing has not yet been determined. While both actual and ideal body weight have been proposed, neither is an accurate reflection of total body protein content in obese individuals. Alternatively, dosing protein based on lean body mass (LBM), which is highly correlated with total body protein, might be the most appropriate method of calculating protein requirements as defined by actual body composition. LBM can be measured or estimated by various methods. We herein discuss a rationale to determine both the energy and protein needs to use in hypocaloric feeding regimens for obese patients based on the use of Standard Body Weight (SBW) and LBM, using previously published body composition data from 1420 healthy volunteers. When applied to the obese population, and compared to current practices, this method results in highly significant differences for both total and gender-specific protein dosing.

Nutrition support in the intensive care patient.

Nutrition intervention plays a significant role in changing patient clinical outcomes in the intensive care unit. Identifying patients at nutrition risk with a validated tool is essential. The decision to use enteral or parenteral nutrition is patient dependent and should include an assessment of the patient's gastrointestinal function. Protein is a critical component of the nutrition prescription, and prescribed levels may need to be higher than current guidelines recommend. Alternative lipids, such as olive oil and fish oil, are still being evaluated for their potential clinical impact. Avoiding nutrition therapy-associated complications, such as catheter infection and hyperglycemia, are important factors in being able to maximize the effectiveness of a nutritional intervention.

Mortality among patients who receive or defer gastrostomies.

BACKGROUND & AIMS: There are few data on outcomes and mortality of patients who have received gastrostomies. We assessed 30-day and 1-year mortalities of patients in the United Kingdom who were referred to hospitals for gastrostomies and of patients who deferred this intervention. METHODS: We collected data from 1327 patients referred to 2 hospitals in Sheffield, United Kingdom, for gastrostomies from February 2004 through May 2010. Data were analyzed to determine 30-day and 1-year mortalities. Predicted mortality by using the validated Sheffield Gastrostomy Scoring System (SGSS) was then compared with actual mortality by using area under the receiver operator curves to determine levels of agreement in patients referred for gastrostomy. RESULTS: Three hundred four patients (23%) did not undergo gastrostomy after multidisciplinary team discussion, which was based on physicians' recommendations. This group had 35.5% mortality at 30 days and 74.3% at 1 year, whereas mortality among patients who underwent gastrostomy (n = 1027) was 11.2% at 30 days and 41.1% at 1 year (P < .0001, compared with patients who deferred the procedure). The area under the receiver operator curves for the SGSS demonstrated acceptable agreement between predicted and actual mortality in patients who underwent or were deferred gastrostomy. CONCLUSIONS: On the basis of data from 1327 patients, those who undergo gastrostomy have significantly lower mortality than those who defer the procedure. Without applying the SGSS, clinicians are able to select patients most likely to benefit from gastrostomy. The SGSS could provide objective support to clinicians involved in making ethically contentious or potentially litigious decisions.

The ratio of energy expenditure to nitrogen loss in diverse patient groups--a systematic review.

BACKGROUND & AIMS: The ratio of energy expenditure to nitrogen loss respectively of energy to nitrogen provision (E/N) is considered a valuable tool in the creation of an enteral or parenteral formulation. Specific E/N ratios for parenteral nutrition (PN) have not yet been clearly defined. To determine the range of energy expenditure, nitrogen (protein) losses, and E/N ratios for various patient groups, we performed a systematic review of the literature. METHODS: Medline 1950-2011 was searched for all studies on patients or healthy controls reporting energy expenditure and nitrogen loss at the same time. RESULTS: We identified 53 studies with 91 cohorts which comprised 1107 subjects. Mean TEE ± standard deviation (SD) was 31.2 ± 7.2 kcal/kg BW/day in patients (n = 881) and 35.6 ± 4.3 kcal/kg BW/day in healthy controls (n = 266). Mean total protein loss (TPL) was 1.50 ± 0.57 g/kg BW/day in patients and 0.94 ± 0.24 g/kg BW/day in healthy controls. A non-linear significant correlation was found between TPL and the E/N ratio. CONCLUSION: The E/N ratio is not a constant value but decreases continuously with increasing protein loss. These variations should be considered in the nutritional support of patients.

Parenteral nutrition therapy over the next 5-10 years: where are we heading?

Parenteral nutrition (PN) is one of the most complex medical therapies prescribed by healthcare professionals because it is dependent on the compounding of multiple base solutions to arrive at the final formulation. The delivery of PN is associated with errors in ordering, transcribing, compounding, and delivery of the PN formulations. New compounding technologies will attempt to minimize the potential for these errors. In addition, the associated infectious complications associated with PN therapy need to be minimized. Commercially prepared, premixed, terminally sterilized PN solutions may have an impact. Broader decontamination technologies will be implemented to reduce the incidence of overall nosocomial infections. Modification of PN nutrients, particularly intravenous fat emulsions, will be provided by alternative biological sources, creating fats that may have an improved impact on the patient's immune system and ultimately affecting clinical outcomes.

The gastroenterologist and industry: changing winds.

The medical device and pharmaceutical industry is facing mounting pressure to produce cost-effectiveness and clinical-effectiveness data in order for their products to be acceptable for approval by the Federal Drug Administration and then for payer reimbursement. The implications of these increasing burdens on our field will become apparent in everyday practice. This article outlines these challenges and discusses possible ways to improve the situation.

Endoscopic approaches for the treatment of obesity: fact or fiction?

Obesity is a common medical problem that is growing in both numbers of patients and cost to the healthcare system. In addition, the disabilities associated with obesity can have significant impact on a patient's quality of life. The interventions to date for treating obesity are generally divided into 2 categories: conservative (diet, exercise, behavioral management, and pharmacology) and surgical. The success rate of conservative management has been modest, at best. Surgical therapy, which can create enduring and significant weight loss in some situations, has its associated morbidity, mortality, and cost. Surgical therapy is not appropriate for someone seeking to lose a modest amount of weight. Internationally, endoscopic devices for obesity are available. Published reports have demonstrated some success in obtaining weight loss with these endoscopic devices. The most common is the intragastric balloon. Other endoscopic obesity devices are in development. These devices may play a role in weight loss therapy and serve as part of the therapeutic continuum between conservative management and surgery that clinicians and patients can choose from for the treatment of obesity.

Enteral feeding in the critically ill: the role of the gastroenterologist.

Expertise in enteral nutrition (EN) is an important aspect of the skill set of the clinical gastroenterologist. Delivery of adequate EN in critically ill patients is an active therapy that attenuates the metabolic response to stress and favorably modulates the immune system. EN is less expensive than parenteral nutrition and is favored in most cases because of improvement in patient outcomes, including infections and length of stay. Newer endoscopic techniques for placing nasoenteric feeding tubes have been developed, which improve placement success and efficiency. It appears that there is an ideal window period of 24-48 h when enteral feeding should be started in critically ill patients. Most patients can be fed into the stomach, but certain groups may benefit from small bowel feeding. Protocols on how to start and monitor enteral feeding have been developed. Immune-modulating feeding formulations also appear to be beneficial in specific patient populations. The gastroenterologist is a crucial member of the multidisciplinary team for nutritional support in the intensive care unit patient, with his knowledge of gastrointestinal pathophysiology, nutrition, and endoscopic feeding-tube placement.

Intragastric balloon therapy in the management of obesity: why the bad wrap?

For the first time in the history of the United States, in the 21st century, there may be a decline in life expectancy, as a result of the increasing rate of obesity. It is known that even the modest reduction of 10% of excess body weight significantly reduces obesity-associated comorbidities. Conservative measures such as diet and exercise seldom give durable results in the long term. Bariatric surgery has been shown to achieve durable weight loss but is not without significant risks and complications. As a result, greater focus has turned toward minimally invasive endoscopic therapies for the management of obesity. There have been multiple reports of creative endoscopic devices and techniques in the literature, but most have only demonstrated early pilot data. By far, the most widely studied of the minimally invasive endoscopic therapies for obesity is the gastric balloon. Now obsolete, the Garren-Edwards gastric bubble was removed from the market in the United States after several sham-controlled studies showed that diet and behavior modification were equally efficacious and that the device was associated with a prohibitive number of complications. However, the concept and technique of intragastric balloon placement has evolved considerably since that time, and we now have data on nearly 3,000 patients who have undergone placement of the BioEnterics Intragastric Balloon (Carpenteria, CA) worldwide. The balloon is approved as part of a multifaceted approach to obesity in many countries and has been shown to result in at least a 10% excess weight loss durable over 1 year. However, the device is not yet approved for use in the United States. In this article, the authors review the efficacy, indications, complications, and potential uses for the intragastric balloon. The intragastric balloon might be the best start as gastroenterologists in the United States begin to play an increasing role in the treatment of the obesity pandemic.