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A new tablet-based bowel prep for colonoscopy has been developed containing poorly absorbed sulfate salts which act to retain water within the intestinal lumen resulting in a copious diarrhea, thereby cleansing the bowel. This study evaluated the safety and efficacy of these oral sulfate tablets (OST) compared with a US FDA-approved bowel prep solution containing PEG3350, electrolytes, and ascorbate (polyethylene glycol and ascorbate [PEG-EA]). Five hundred fifteen adult patients (mean 57y) were enrolled in this single-blind, multicenter, noninferiority study. Subjects were assigned either PEG-EA or OST to be administered in a split-dose regimen starting the evening before colonoscopy. PEG-EA was taken according to its approved labeling (1 L of prep solution with 16 oz. of additional water) in the evening and again in the morning. OST patients took a total of 24 tablets. OST patients were administered 12 tablets in the evening, and the following morning. Patients consumed 16 ounces of water with each dose of 12 tablets and drank an additional 32 oz. of water with each dose. Colonoscopies were performed by blinded investigators. Cleansing efficacy was evaluated globally and segmentally using a 4-point scale (Excellent-no more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa. Good-feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa. Fair-enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa. Poor-large amounts of fecal residue and additional bowel preparation required). Scores of Good or Excellent were considered to be a success. Safety was assessed by spontaneously reported adverse events, solicited ratings of expected prep symptoms, and laboratory testing. A high rate of cleansing success was seen with OST (92%), which was noninferior to PEG-EA (89%). Only a small proportion of subjects rated their expected gastrointestinal symptoms as severe (<5% for both preps). No clinically significant differences were seen between preps for chemistry and hematology parameters. No serious adverse experiences were reported with OST. Sulfate tablets achieved a high level of cleansing in the study, comparable with US FDA-approved preps. OST was noninferior to PEG-EA in this study and achieved significantly more Excellent preps overall and in the proximal colon. The OST prep was well-tolerated, with a similar rate of spontaneously reported adverse experiences to PEG-EA and a low rate of severe expected gastrointestinal symptoms.

PurposeThis paper studies the sociocultural drivers of materialism cross-culturally. Research in this area is scarce, even though rapid social transformations worldwide, fueled by globalization, make it imperative to identify the conditions under which commonalities and differences in materialistic tendencies are most likely to evidence among consumers as they seek to assert, restore, or enhance their self-concept and status in the context of global consumption trends.Design/methodology/approachThe psychographic determinants of materialism were rigorously validated across a diverse set of eight countries, by investigating which facets of acculturation to global consumer culture and national ethnic identity, along with consumer ethnocentrism, encourage or repel materialism. Using multigroup SEM and other analyses, the authors confirmed construct dimensionality and ascertained the stability of the relationships.FindingsThe most consistent positive drivers of materialism were self-identification with global consumer culture and exposure to American-based global mass media. The results demonstrated the compatibility of national identity and traditions with materialistic tendencies. Materialism was positively related to or independent of consumer ethnocentrism.Research limitations/implicationsThe findings offer consequential insights for both research and practice, although the cross-sectional character of survey research and certain sampling characteristics limit their generalizability.Practical implicationsThe results pinpoint segments that spill over national boundaries, and those that remain geographically constrained, thus providing guidance for marketing and communication strategies to practitioners.Social implicationsThe authors shed light on two widely held yet insufficiently researched assumptions: that the homogenizing effect of global consumer culture may be fomenting materialism worldwide, and that nationalistic, parochially oriented consumers may be more capable of resisting materialistic values.Originality/valueThe study design addresses several shortcomings of prior research, and its findings advance the understanding of materialism and its antecedents by identifying the conditions driving materialistic tendencies.

Although there is a consensus that industries are globalizing, the notion that consumer attitudes and behaviors worldwide are likewise homogenizing remains disputed. Despite widespread discourse on this topic, there is a dearth of empirical investigations. This international research examines similarities and differences with respect to the nature of three consumer attitudinal dispositions: cosmopolitanism, consumer ethnocentrism, and materialism. The authors cross-culturally compare demographic antecedents with these dispositions, as well as behavioral outcomes. They test the validation of the construct measures and associated hypotheses using survey data drawn from consumers in eight countries and structural equation modeling techniques, including multigroup analysis. Empirical findings broadly support the cross-cultural applicability of the constructs, though the links to the various demographic antecedents vary considerably from sample to sample. The role of each construct on behavior also varies substantially across the range of product categories considered and across and between national groups.

Polyethylene glycol (PEG) 3350 (MiraLAX) is currently approved for the short-term treatment of occasional constipation. This study was designed to compare the safety and efficacy of PEG laxative versus placebo over a 6-month treatment period in patients with chronic constipation. Study subjects who met defined criteria for chronic constipation were randomized in this double-blind, placebo-controlled, parallel, multicenter study to receive PEG laxative as a single daily dose of 17 g or placebo for 6 months. Baseline constipation status was confirmed during a 14-day observation period. As a primary efficacy variable, treatment success was defined as relief of modified ROME criteria for constipation for 50% or more of their treatment weeks. Various secondary measures were assessed. An Interactive Voice Response System (IVRS) recorded daily bowel movement experience and study efficacy and safety information. Laboratory testing at baseline and monthly for the study duration was analyzed for hematology, blood chemistry including amylase, GGT, uric acid, lipids, and urinalysis. A total of 304 patients were enrolled and received treatment at one of 50 centers. Successful treatment according to the primary efficacy variable was seen in 52.0% of PEG and 11% of placebo subjects (P < 0.001). Similar efficacy was seen in a subgroup of 75 elderly subjects. According to the primary efficacy definition (based on individual treatment weeks), 61% of PEG treatment weeks versus 22% of the placebo weeks were successful (P < 0.001). There were no significant differences in laboratory findings or adverse events except for the gastrointestinal category where diarrhea, flatulence, and nausea were the most frequent with PEG although they were not individually statistically significant compared with placebo. Similar results were observed when analyzed for differences due to gender, race, or age. PEG laxative is safe and effective for use in patients with chronic constipation for 6 months.

We sought to evaluate a new, low-volume, oral sulfate solution as a bowel preparation for colonoscopy in adult patients. The investigations were designed as two multicenter, single-blind, randomized, non-inferiority studies to show that the sulfate regimen would effect cleansing that is acceptable and equivalent to polyethylene glycol electrolyte solution with ascorbic acid (PEG-EA), and would be suitable for colonoscopy. One study evaluated same-day administration; the other compared the two study preparations given by split-dose administration in which the first portion was taken the evening before colonoscopy and the second portion on the morning of the procedure. The primary efficacy variable was based on bowel cleansing graded by an investigator who was unaware of the preparation method received. Study 1 randomized 408 outpatients scheduled for colonoscopy for routine indications, with 387 subjects taking the preparation. In all, 364 subjects were randomized and took the preparation in study 2. The demographics of the enrolled subjects were similar across both treatment groups in the two studies, including gender, race, and ethnic characteristics. The primary efficacy analysis supports the conclusion that the oral sulfate solution produces the same degree of cleansing as PEG-EA. Successful preparations were seen in 82.4% and 80.3% in study 1 and 97.2% and 95.6% in study 2 for the oral sulfate solution and the PEG-EA regimen, respectively. Although no difference in excellent preparations was seen in the 1-day preparation, split-dose administration resulted in more excellent preparations in the sulfate group than in the PEG-EA group (63.3 vs. 52.5%, P=0.043). Preparation-related symptoms of cramping, bloating, nausea, and vomiting were generally mild and infrequent. Sulfate subjects reported slightly increased gastrointestinal events and higher vomiting scores (P=0.009) in the 1-day preparation but not in the split-dose regimen. There were no other differences for adverse events or clinically significant laboratory findings, including no increased creatinine. The new 960 -ml oral sulfate solution is effective for colonoscopy cleansing and has an acceptable safety profile.

Background Acceptability and tolerance of bowel preparation is critical to overcome patient hesitancy in undergoing colon cancer screening and surveillance colonoscopy. To improve patient experience, a new sports drink-flavored bowel preparation containing polyethylene glycol (PEG) and sulfate salts (FPSS) was developed to provide a similar experience to a commonly used but not United States Food and Drug Administration (FDA) approved PEG and sports drink bowel preparation (PEG-SD), while also achieving improved cleansing efficacy. Methods This FPSS preparation, approved by the FDA in June 2023, was evaluated in a non-randomized Phase 2 study in which 40 patients requiring colonoscopy were prepared with FPSS and 20 with PEG-SD. Results Overall cleansing success was high with FPSS based on unblinded local endoscopist assessment (93%) and blinded central reading (97%), exceeding PEG-SD which achieved success rates of 84% (local read), 74% and 68% (blinded central reads). Similar differences favoring FPSS were seen for excellent preparations and cleansing success by colon segment as rated by local endoscopists. Both preparations were well-tolerated, with 93% of FPSS patients rating their preparation as Tolerable to Very Easy to consume, compared to 100% of PEG-SD. Patients who had previously taken a preparation for colonoscopy found FPSS and PEG-SD better than their prior preparation (73% and 70%, respectively) and nearly all would request their assigned study preparation again in the future. About two thirds of FPSS patients agreed that the preparation tasted similar to a sports drink. Conclusion The new sports drink-like flavored preparation compares favorably to PEG-SD for bowel cleansing efficacy while achieving similar patient satisfaction. The study was registered at www.clinicaltrials.gov (NCT03328507) on 01/11/2017.

Purpose Cosmopolitanism and xenocentrism denote distinct individual orientations toward cultural outgroups. The former considers an individual’s openness to cultural diversity and ability to navigate through intercultural environments, whereas the latter describes an individual’s feelings of admiration or preference for specific cultural outgroup(s), over his/her ingroup. Few studies have simultaneously examined these constructs and fewer still have considered these within a nomological framework of key predictors (i.e. basic psychological needs) and practical outcomes (e.g. influentialness and friendships across different groups). The paper aims to discuss these issues. Design/methodology/approach The authors hypothesized a series of relationships of various antecedents and outcomes of cosmopolitanism and xenocentrism, and tested these conjectures using survey data from Canadians (n=238) and Americans (n=239). Findings The findings support the psychometric robustness of our tripartite operationalization of xenocentrism, and clearly distinguish this construct from cosmopolitanism. Beyond confirming earlier findings, the authors illuminate several novel relationships (e.g. between basic psychological needs, cosmopolitanism and xenocentrism), and elucidate the role played by a key personality dimension, neuroticism, in mediating the relationships between basic psychological needs and the two outgroup orientations. Research limitations/implications Samples of this study are drawn from North America and a cross-sectional research design is used. Originality/value Whereas for xenocentric consumers admiration of one or more foreign culture(s) displaces customary preferences for one’s own cultural group, cosmopolitan consumers are able to embrace outside cultures without disaffection from their sociocultural ingroup. Given the obvious repercussions of these differences for targeting international consumer segments and for positioning brands across borders, our research has numerous practical applications as well as theoretical implications.

Introduction: Colonic cleansing lavages are osmotically active solutions, usually containing salts and/or PEG. To optimize efficacy and safety, the cleansing solution composition should be balanced to promote both adequate fluid volume (to induce a cleansing diarrhea) while also minimizing electrolyte losses or gains from the body. Poorly formulated preparations may provide sufficient cleansing volume but can alter electrolyte concentrations due to diarrheal losses increasing the likelihood of hyponatremia and other hematological abnormalities. A balanced formulation provides sufficient electrolyte supplementation to minimize blood electrolyte excursions. Methods: Healthy men (< 50 yoa) were restricted to a clinic on ad-libitum liquid diet. Cohorts of 5 subjects were given FDA approved bowel preparations: an Oral Sulfate Solution (OSS-SUPREP® Bowel Prep Kit, Braintree Laboratories, Inc.), PEG-ELS (NuLYTELY®, Braintree Laboratories, Inc.) or PEG-EA (MoviPrep® Salix Pharmaceuticals, Inc.), administered according to the manufacturer's instructions in a split dose regimen. Blood samples were collected for analysis before each dose (pre-dose), and at 1 and 2 hour intervals post dosing. Results: Analysis of blood electrolytes from subjects revealed small fluctuations from baseline in Na, Cl and K post-dosing for all preparations. Small decreases in Na (OSS/PEG-ELS) and Cl (OSS) and increases in Na (PEG-EA), Cl (PEG-EA) and K (OSS/PEG-EA), were determined to be statistically significant (P<0.05) however, in all cases, the mean electrolyte concentration did not deviate outside of the normal ranges for this population. Conclusion: The consumption of osmotically active lavage solutions promotes cleansing by maximizing the fluid volume traversing the colon. However, this process has the potential to alter electrolyte concentrations thereby increasing the possibility of hyponatremia and other hematological imbalances. An investigation of the FDA approved bowel preparations OSS, PEG-ELS and PEG-EA, which were specifically formulated to minimize electrolyte shifts, demonstrates minimal impact on overall blood electrolyte concentration over the duration of the experimental period.