Transient alterations in plasma sodium concentrations with NER1006 bowel preparation: an analysis of three phase III, randomized clinical trials.

BACKGROUND: This analysis characterized changes in sodium levels in patients receiving the 1 L polyethylene glycol-based preparation NER1006. METHODS: Data were pooled from three phase III, randomized clinical trials. A post hoc subanalysis included adults who received a 2-day split-dose (evening/morning) NER1006 regimen, a 1-day split-dose (morning only) regimen, or evening-before regimen and had an increase in sodium concentrations from normal to above the upper limit of normal (143-148 mmol/L) at ≥ 1 of three post-treatment visits. Blood samples were collected at baseline, day of colonoscopy (visit 2), 2 ± 1 days post-colonoscopy (visit 3), and 7 ± 1 days post-colonoscopy (visit 4). RESULTS: A total of 214 of 1028 patients were included. Of the 214 patients, sodium concentration increased from a mean baseline value of 141.8 mmol/L to a mean of 147.1 mmol/L (median increase from baseline of approximately 5 mmol/L). The mean sodium concentration was within normal range at visit 3 (142.3 mmol/L) and visit 4 (142.4 mmol/L), as was the median sodium concentration. Overall, ~ 90% of patients had a normal serum concentration at visits 3 and 4. Based on day of colonoscopy test results, there were four adverse events involving hypernatremia (0.4% of 1028), which were mild and did not require medical intervention; sodium levels returned to normal range by visit 3. CONCLUSION: NER1006 was associated with small, transient increases in sodium levels that were not considered clinically significant. Trial registration NOCT (ClinicalTrials.gov: NCT02254486 [registered October 2, 2014]), MORA (ClinTrials.gov: NCT02273167 [registered October 23, 2014]; EudraCT number: 2014-002185-78 [registered August 13, 2014]), DAYB (ClinicalTrials.gov: NCT02273141 [registered October 23, 2014]; EudraCT Number: 2014-002186-30 [registered August 12, 2014]).

Effective Communication Strategies and Tools for Improving Treatment Outcomes in Patients With Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation.

Patients with chronic idiopathic constipation and irritable bowel syndrome with constipation experience an array of gastrointestinal symptoms. Given the subjective nature of these disorders, patient self-reporting is critical to diagnosis and monitoring response to therapy. Unfortunately, many patients are reluctant to discuss bowel symptoms with their healthcare providers. Differences in sex, health literacy, and age can influence symptom reporting. Negative patient-physician relationships and dissatisfaction with care lead patients to seek alternative treatments, switch healthcare providers, or discontinue care. Thus, adopting a patient-centered communication style can help create a shared understanding of patients' symptoms, achieve accurate symptom reporting, expedite diagnosis, and facilitate appropriate treatment plans. Currently, there are multiple symptom and quality-of-life scales available to assist healthcare providers in this endeavor. These scales also allow for the monitoring of constipation-related symptoms and symptom severity. When using patient self-assessments to measure treatment responses, scale selection may depend on the number of symptoms being assessed, the duration and frequency of assessments, and patients' comprehension and language skills.

Real-World Treatment Strategies to Improve Outcomes in Patients With Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation.

Chronic idiopathic constipation and irritable bowel syndrome with constipation are complex, overlapping conditions. Although multiple guidelines have informed healthcare providers on appropriate treatment options for patients with chronic idiopathic constipation and irritable bowel syndrome with constipation, little direction is offered on treatment selection. First-line treatment options usually include fiber and over-the-counter osmotic laxatives; however, these are insufficient for many individuals. When these options fail, prescription secretagogues (plecanatide, linaclotide, lubiprostone, and tenapanor [pending commercial availability]), or serotonergic agents (prucalopride and tegaserod) are generally preferred. Individuals experiencing concurrent abdominal pain and/or bloating may experience greater overall improvements from prescription therapies because these agents have been proven to reduce concurrent abdominal and bowel symptoms. Should initial prescription treatments fail, retrying past treatment options (if not adequately trialed initially), combining agents from alternative classes, or use of adjunctive therapies may be considered. Given the broad spectrum of available agents, therapy should be tailored by mutual decision-making between the patient and practitioner. Overall, patients need to be actively monitored and managed to maximize clinical outcomes.

Colorectal Cancer and Polyp Detection Using a New Preparation-Free, Colon-Scan Capsule: A Pilot Study of Safety and Patient Satisfaction.

BACKGROUND: Current strategies to prevent colorectal cancer (CRC) vary considerably regarding safety, invasiveness, and patient satisfaction. A known deterrent for patients is the required bowel cleansing for colonoscopy. A new colon-scan capsule system is a unique preparation-free approach that provides structural information on colonic mucosa intended for detection of colorectal polyps and masses. AIMS: The aim of this study was to determine safety and patient satisfaction with the colon-scan capsule. METHODS: Prospective single-arm pilot study conducted at two tertiary care centers. Patients with a pre-scheduled colonoscopy for CRC screening or surveillance were included. Patients participating in this study underwent the colon-scan capsule and colonoscopy. Safety was defined by the occurrence of procedure or device-related adverse events. Satisfaction was based on survey questionnaires using a scoring system 1 (strongly disagree) to 5 (strongly agree). Patient satisfaction with the colon-scan capsule was compared to colonoscopy. RESULTS: Forty patients were included (52.9 [5.7] years; 64.1% females). There were no serious adverse events and no occurrences of capsule retention. The most common (12.5%) complaint was self-limiting abdominal cramping. Satisfaction questionnaires were completed by more than 87% of patients, with patients likely to recommend the capsule (score 4.1 [1.03]) compared to colonoscopy (score 2.8 [1.2]), p = 0.001. CONCLUSIONS: The new prepless colon-scan capsule system is an innovative, minimally invasive technology with demonstrated safety and high patient satisfaction. A multicenter pivotal study is planned to validate the performance, safety, and accuracy of polyp detection using the capsule system in comparison with colonoscopy.

Diagnosing Constipation Spectrum Disorders in a Primary Care Setting.

Understanding pathophysiological causes of constipation is worthwhile in directing therapy and improving symptoms. This review aims to identify and fill gaps in the understanding of the pathophysiology of constipation, understand its prevalence, review diagnostic tools available to primary care physicians (PCPs), and highlight patients' expectations for the management of this common spectrum of disorders. Literature searches conducted via PubMed included terms related to constipation, diagnosis, and patient perceptions. Case studies were developed to highlight the differences between patients who may be appropriately managed in the primary care setting and those requiring specialty consultation. Myriad pathophysiological factors may contribute to constipation, including stool consistency, altered intestinal motility, gut microbiome, anorectal abnormalities, as well as behavioral and psychological factors. Common diagnoses of "primary constipation" include slow-transit constipation, defecation disorders, irritable bowel syndrome with constipation, and chronic idiopathic constipation. A detailed medical history should be conducted to exclude alarm features and PCPs should be familiar with pathophysiological factors that cause constipation, available diagnostic tools, alarm signs, and the various classification criteria for constipation subtypes in order to diagnose and treat patients accordingly. PCPs should understand when a referral to a gastroenterologist, anorectal specialist, pelvic floor physical therapist, and/or mental health specialist is appropriate.

Patient experience with NER1006 as a bowel preparation for colonoscopy: a prospective, multicenter US survey.

BACKGROUND: NER1006 (Plenvu®, Salix Pharmaceuticals, Bridgewater, NJ) is a 1 L polyethylene glycol bowel preparation indicated for colonoscopy in adults. A US online survey assessed real-world ease of use and treatment satisfaction in individuals who received NER1006. METHODS: Adults were recruited from 444 US community gastrointestinal practices and provided a kit number for enrollment into an online survey to be completed within 2 weeks. Survey questions evaluated colonoscopy history and prior bowel preparation(s) prescribed, patient experience during NER1006 administration, and patient satisfaction with the bowel preparation process. A 9-point predefined grading scale was used to evaluate ease of NER1006 preparation and consumption (range, 1 "very difficult" to 9 "very easy"); the perceived importance of volume requirement and clear liquid options (range, 1 "not important at all" to 9 "very important"); and patient satisfaction (range, 1 "not satisfied at all" to 9 "very satisfied"). RESULTS: 1630 patients were enrolled, 1606 underwent colonoscopy, and 1598 completed the survey between September 15, 2018 and February 28, 2019. Among 1606 patients who had a colonoscopy, 62.5% were female, and the mean patient age was 54.4 years (range 18-89 years). Most patients (74.7%) did not report a family history of colon cancer, 62.6% had undergone prior colonoscopy, and 64.8% were undergoing colonoscopy for routine colorectal cancer screening. A majority (76.1%) of patients who completed the survey reported that NER1006 was very easy to prepare and take, and 89.9% were very or moderately satisfied with NER1006 overall. Most (97.6%) patients reported consuming all or most of the bowel preparation. Among 1005 patients with previous bowel preparation use, 84.7% indicated that their experience with NER1006 was much better or better (65.3%) or about the same (19.4%) compared with previously used bowel preparations, while only 15.3% rated NER1006 as worse or much worse. CONCLUSIONS: In this first real-world, US multicenter survey, patient-reported experience with NER1006 as a bowel preparation for colonoscopy was favorable and adherence was high. The majority of patients were very or moderately satisfied with the overall experience and found it much better/better than previously used bowel preparations. TRIAL REGISTRATION: Not applicable.

Clinical factors associated with hepatitis B screening and vaccination in high-risk adults.

BACKGROUND: Hepatitis B virus is a viral infection that can lead to acute and/or chronic liver disease, and hepatocellular carcinoma (HCC). Hepatitis B vaccination is 95% effective in preventing infection and the development of chronic liver disease and HCC due to hepatitis B. In 2011, the Centers for Disease Control updated their guidelines recommending that adults at high-risk for hepatitis B infection be vaccinated against hepatitis B including those with diabetes mellitus (DM). We hypothesize that adults at high-risk for hepatitis B infection are not being adequately screened and/or vaccinated for hepatitis B in a large urban healthcare system. AIM: To investigate clinical factors associated with Hepatitis B screening and vaccination in patients at high-risk for Hepatitis B infection. METHODS: We conducted a retrospective review of 999 patients presenting at a large urban healthcare system from 2012-2017 at high-risk for hepatitis B infection. Patients were considered high-risk for hepatitis B infection based on hepatitis B practice recommendations from the Center for Disease Control. Medical history including hepatitis B serology, concomitant medical diagnoses, demographics, insurance status and social history were extracted from electronic health records. Multivariate logistic regression was used to identify clinical risk factors independently associated with hepatitis B screening and vaccination. RESULTS: Among the 999 patients, 556 (55.7%) patients were screened for hepatitis B. Of those who were screened, only 242 (43.5%) patients were vaccinated against hepatitis B. Multivariate regression analysis revealed end-stage renal disease [odds ratio (OR): 5.122; 2.766-9.483], alcoholic hepatitis (OR: 3.064; 1.020-9.206), and cirrhosis or end-stage liver disease (OR: 1.909; 1.095-3.329); all P < 0.05 were associated with hepatitis B screening, while age (OR: 0.785; 0.680-0.906), insurance status (0.690; 0.558-0.854), history of DM (OR: 0.518; 0.364-0.737), and human immunodeficiency virus (OR: 0.443; 0.273-0.718); all P < 0.05 were instead not associated with hepatitis B screening. Of the adults vaccinated for hepatitis B, multivariate regression analysis revealed age (OR: 0.755; 0.650-0.878) and DM were not associated with hepatitis B vaccination (OR: 0.620; 0.409-0.941) both P < 0.05. CONCLUSION: Patients at high-risk for hepatitis B are not being adequately screened and/or vaccinated. Improvements in hepatitis B vaccination should be strongly encouraged by all healthcare systems.

Acetazolamide promotes decreased consumption of carbonated drinks and weight loss.

Excessive consumption of carbonated drinks contributes to the dietary surplus of carbohydrates, and is a main driver of the obesity epidemic in the USA. From a public health standpoint, it is therefore crucial to develop strategies that enable individuals to regulate this calorie-rich, but nutrient-poor food intake. However, conservative medical approaches to this end have met with limited success. Using a pharmacological strategy to eliminate the effervescent aspect of carbonated drinks, we report significant weight loss in a patient with long-standing obesity. Administration of low-dose acetazolamide, a carbonic anhydrase inhibitor, resulted in altered taste of carbonation, and in turn a marked reduction in the patient's carbonated drink intake and the loss of almost 1 kg of body weight per week. The pharmacological intervention also resulted in appetite suppression, which might synergistically contribute to weight loss. These findings point to the use of low-dose acetazolamide as a novel weight reduction strategy.

Endoscopic mucosal resection of colonic lesions: current applications and future prospects.

The introduction of submucosal fluid injection has remarkably extended the range of endoscopically resectable polyps. The limiting factor for endoscopic resection is not polyp size, but polyp depth. Endoscopic ultrasound is a useful adjunctive diagnostic tool to assess the depth of invasion. The success of are section ultimately depends on pathologic confirmation of a benign nature of this lesion or of a cancer limited to the mucosa. Selected well-differentiated cancers without lymphovascular invasion of the superficial submucosa can be successfully resected endoscopically.

Seizures in an Alzheimer's disease patient as a complication of colonoscopy premedication with meperidine.

We describe the first reported case of generalized tonic-clonic seizures induced by meperidine premedication for a colonoscopy procedure in a 63-year-old woman with Alzheimer's disease. The active metabolite of meperidine, normeperidine, is postulated to be the precipitating cause of the seizures, although a cholinesterase inhibitor and an N-methyl-D: -aspartate receptor antagonist, both routinely used for treatment of Alzheimer's disease, may have contributed by reducing the seizure threshold. The neuronal changes which occur in Alzheimer's disease can themselves also predispose to seizures. We recommend avoidance of meperidine for all flexible endoscopic procedures on patients with Alzheimer's disease and in any patient with a condition that predisposes to seizures, and suggest the use of alternative opioids.

Prophylaxis against Pneumocystis pneumonia in patients with inflammatory bowel disease: toward a standard of care.

Patients with Crohn's Disease and ulcerative colitis are increasingly treated with a host of immunomodulatory and immunosuppressive medications, including thiopurines and antibody-based biologic agents. Despite the known infectious complications associated with these therapies from the HIV and solid organ transplant literature, there are currently no well-defined concise guidelines to assist gastroenterologists and other physicians in the utility and indication for prophylaxis against Pneumocystis pneumonia and other infections in inflammatory bowel disease (IBD) patients. In this article, we discuss the evidence of various infections associated with immunocompromise in HIV/AIDS, organ transplantation, and in other immunocompromised states, and discuss the evidence for the efficacy and safety of various infectious prophylaxis protocols. In addition, we discuss the evidence for Pneumocystis and other infections in IBD patients treated with corticosteroids, azathioprine/6-MP, biologic agents and other therapies, and we present the case for various antibiotic (and antiviral) regimens to prevent such infections. Based on the review of the literature, this discussion represents a true call for guidelines for infection prophylaxis, to help guide gastroenterologists and all practitioners who care for the challenging population of IBD patients.