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Role of icodextrin in the prevention of small bowel obstruction. Safety randomized patients control of the first 300 in the ADEPT trial.
Sakari, T, Sjödahl, R, Påhlman, L, Karlbom, U
Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland. 2016;(3):295-300
Abstract
AIM: Adhesions are the most common cause of small bowel obstruction (SBO). The costs of hospitalization and surgery for SBO are substantial for the health-care system. The adhesion-limiting potential of icodextrin has been shown in patients undergoing surgery for gynaecological diseases. A randomized, multicentre trial in colorectal cancer surgery started in 2009 with the aim of evaluating whether icodextrin could reduce the long-term risk of surgery for SBO. Because of some concerns about complications (especially anastomotic leakage) after icodextrin use, a preplanned interim analysis of morbidity and mortality was conducted. METHOD Patients with colorectal cancer without metastasis were randomized 1:1 to receive standard surgery, with or without instillation of icodextrin in the abdominal cavity. For the first 300 patients, the 30-day follow-up data were collected from the Swedish ColoRectal Cancer Registry (SCRCR). Pre-, per- and postoperative data, morbidity and mortality were analysed. RESULTS Of the 300 randomized patients, 288 had a data file in the SCRCR. Twelve patients did not have cancer and another five did not have a resection, leaving 283 for analysis. The authors were blinded to the randomization groups. Demographic data were similar in both groups. The overall complication rate was 24% in Group 1 and 23% in Group 2 (P = 0.89). Four cases of anastomotic leakage were reported in Group 1 and five were reported in Group 2 (P = 1.0). Mortality, intensive care unit (ICU) stay and re-operations did not differ between the groups. CONCLUSION The pre-planned safety analysis of the first 300 patients enrolled in this randomized trial did not show any differences in adverse effects related to the use of icodextrin. All data were gathered from the SCRCR, giving us a strong message that we can continue to include patients in the trial.
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Icodextrin reduces insulin resistance in non-diabetic patients undergoing automated peritoneal dialysis: results of a randomized controlled trial (STARCH).
de Moraes, TP, Andreoli, MC, Canziani, ME, da Silva, DR, Caramori, JC, Ponce, D, Cassi, HV, de Andrade Bastos, K, Rio, DR, Pinto, SW, et al
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2015;(11):1905-11
Abstract
BACKGROUND Insulin resistance is a common risk factor in chronic kidney disease patients contributing to the high cardiovascular burden, even in the absence of diabetes. Glucose-based peritoneal dialysis (PD) solutions are thought to intensify insulin resistance due to the continuous glucose absorption from the peritoneal cavity. The aim of our study was to analyse the effect of the substitution of glucose for icodextrin on insulin resistance in non-diabetic PD patients in a multicentric randomized clinical trial. METHODS This was a multicenter, open-label study with balanced randomization (1:1) and two parallel-groups. Inclusion criteria were non-diabetic adult patients on automated peritoneal dialysis (APD) for at least 3 months on therapy prior to randomization. Patients assigned to the intervention group were treated with 2L of icodextrin 7.5%, and the control group with glucose 2.5% during the long dwell and, at night in the cycler, with a prescription of standard glucose-based PD solution only in both groups. The primary end-point was the change in insulin resistance measured by homeostatic model assessment (HOMA) index at 90 days. RESULTS Sixty patients were included in the intervention (n = 33) or the control (n = 27) groups. There was no difference between groups at baseline. After adjustment for pre-intervention HOMA index levels, the group treated with icodextrin had the lower post-intervention levels at 90 days in both intention to treat [1.49 (95% CI: 1.23-1.74) versus 1.89 (95% CI: 1.62-2.17)], (F = 4.643, P = 0.03, partial η(2) = 0.078); and the treated analysis [1.47 (95% CI: 1.01-1.84) versus 2.18 (95% CI: 1.81-2.55)], (F = 7.488, P = 0.01, partial η(2) = 0.195). CONCLUSIONS The substitution of glucose for icodextrin for the long dwell improved insulin resistance measured by HOMA index in non-diabetic APD patients.
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Postprandial effects of polydextrose on satiety hormone responses and subjective feelings of appetite in obese participants.
Olli, K, Salli, K, Alhoniemi, E, Saarinen, M, Ibarra, A, Vasankari, T, Rautonen, N, Tiihonen, K
Nutrition journal. 2015;:2
Abstract
BACKGROUND Dietary fibers are associated with enhanced satiety. However, the mechanism of different dietary fibers contributing to satiety-related gastrointestinal (GI) peptide release, especially in an obese population, is still poorly understood. Polydextrose (PDX), a water-soluble glucose polymer, has demonstrated its ability to reduce energy intake at a subsequent meal, but its mechanism of action requires further research. Also, there is limited evidence on its capacity to regulate subjective feelings of appetite. This study examines the effects of PDX on postprandial secretion of satiety-related GI peptides, short chain fatty acids (SCFAs), lactic acid, and subjective appetite ratings in obese participants. METHODS 18 non-diabetic, obese participants (42.0 y, 33.6 kg/m2) consumed a high-fat meal (4293 kJ, 36% from fat) with or without PDX (15 g) in an acute, multicenter, randomized, double-blind, placebo-controlled and crossover trial. Postprandial plasma concentrations of satiety-related peptides, namely ghrelin, cholecystokinin (CCK), glucagon-like peptide 1 (GLP-1), and peptide YY (PYY), as well as SCFAs and lactic acid were assessed. GI peptide, SCFA and lactate concentrations were then modeled using a linear mixed-effects model.The subjective feelings of hunger, satisfaction, and desire to eat were evaluated using visual analogue scales (VAS), which were analyzed as incremental areas under the curve (iAUC) during the satiation and satiety periods. RESULTS We found that PDX supplementation increased plasma GLP-1 levels more than the placebo treatment (P = 0.02). In the whole group, GLP-1 concentrations found in participants older than 40 years old were significantly lower (P = 0.01) as compared to those aged 40 years or less. There were no statistically significant differences in postprandial ghrelin, CCK, or PYY responses. The lactic acid concentrations were significantly (P = 0.01) decreased in the PDX group, while no significant changes in SCFAs were found. PDX reduced iAUC for hunger by 40% (P = 0.03) and marginally increased satisfaction by 22.5% (P = 0.08) during the post-meal satiety period. CONCLUSION Polydextrose increased the postprandial secretion of the satiety hormone GLP-1 and reduced hunger after a high-fat meal. PDX also reduced the elevated postprandial lactic acid levels in plasma. Therefore, PDX may offer an additional means to regulate inter-meal satiety and improve postprandial metabolism in obese participants.
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Chitin-glucan fiber effects on oxidized low-density lipoprotein: a randomized controlled trial.
Bays, HE, Evans, JL, Maki, KC, Evans, M, Maquet, V, Cooper, R, Anderson, JW
European journal of clinical nutrition. 2013;(1):2-7
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Abstract
BACKGROUND/OBJECTIVES Elevated oxidized low-density lipoprotein (OxLDL) may promote inflammation, and is associated with increased risk of atherosclerotic coronary heart disease and worsening complications of diabetes mellitus. The primary objective of this study was to evaluate the efficacy of chitin-glucan (CG), alone and in combination with a potentially anti-inflammatory olive oil (OO) extract, for reducing OxLDL in subjects with borderline to high LDL cholesterol (LDL-C) levels. SUBJECTS/METHODS This 6-week, randomized, double-blind, placebo-controlled study of a novel, insoluble fiber derived from the Aspergillus niger mycelium, CG, evaluated 130 subjects free of diabetes mellitus with fasting LDL-C 3.37-4.92 mmol/l and glucose ≤ 6.94 mmol/l. Participants were randomly assigned to receive CG (4.5 g/day; n=33), CG (1.5 g/day; n=32), CG (1.5 g/day) plus OO extract (135 mg/day; n=30), or matching placebo (n=35). RESULTS Administration of 4.5 g/day CG for 6 weeks significantly reduced OxLDL compared with placebo (P=0.035). At the end of study, CG was associated with lower LDL-C levels relative to placebo, although this difference was statistically significant only for the CG 1.5 g/day group (P=0.019). CG did not significantly affect high-density lipoprotein cholesterol, triglycerides, glucose, insulin or F2-isoprostane levels. Adverse events did not substantively differ between treatments and placebo. CONCLUSIONS In this 6-week study, CG (4.5 g/day) reduced OxLDL, an effect that might affect the risk for atherosclerosis.
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Dose-dependent effects of NY-ESO-1 protein vaccine complexed with cholesteryl pullulan (CHP-NY-ESO-1) on immune responses and survival benefits of esophageal cancer patients.
Kageyama, S, Wada, H, Muro, K, Niwa, Y, Ueda, S, Miyata, H, Takiguchi, S, Sugino, SH, Miyahara, Y, Ikeda, H, et al
Journal of translational medicine. 2013;:246
Abstract
BACKGROUND Cholesteryl pullulan (CHP) is a novel antigen delivery system for cancer vaccines. This study evaluated the safety, immune responses and clinical outcomes of patients who received the CHP-NY-ESO-1 complex vaccine, Drug code: IMF-001. METHODS Patients with advanced/metastatic esophageal cancer were enrolled and subcutaneously vaccinated with either 100 μg or 200 μg of NY-ESO-1 protein complexed with CHP. The primary endpoints were safety and humoral immune responses, and the secondary endpoint was clinical efficacy. RESULTS A total of 25 patients were enrolled. Thirteen and twelve patients were repeatedly vaccinated with 100 μg or 200 μg of CHP-NY-ESO-1 with a median of 8 or 9.5 doses, respectively. No serious adverse events related to the vaccine were observed. Three out of 13 patients in the 100-μg cohort and 7 out of 12 patients in the 200-μg cohort were positive for anti-NY-ESO-1 antibodies at baseline. In the 100-μg cohort, an antibody response was observed in 5 out of 10 pre-antibody-negatives patients, and the antibody levels were augmented in 2 pre-antibody-positive patients after vaccination. In the 200-μg cohort, all 5 pre-antibody-negative patients became seropositive, and the antibody level was amplified in all 7 pre-antibody-positive patients. No tumor shrinkage was observed. The patients who received 200 μg of CHP-NY-ESO-1 survived longer than patients receiving 100 μg of CHP-NY-ESO-1, even those who exhibited unresponsiveness to previous therapies or had higher tumor burdens. CONCLUSIONS The safety and immunogenicity of CHP-NY-ESO-1 vaccine were confirmed. The 200 μg dose more efficiently induced immune responses and suggested better survival benefits. (Clinical trial registration number NCT01003808).
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Gynaecological endoscopic evaluation of 4% icodextrin solution: a European, multicentre, double-blind, randomized study of the efficacy and safety in the reduction of de novo adhesions after laparoscopic gynaecological surgery.
Trew, G, Pistofidis, G, Pados, G, Lower, A, Mettler, L, Wallwiener, D, Korell, M, Pouly, JL, Coccia, ME, Audebert, A, et al
Human reproduction (Oxford, England). 2011;(8):2015-27
Abstract
BACKGROUND Gynaecological laparoscopic surgery outcomes can be compromised by the formation of de novo adhesions. This randomized, double-blind study was designed to assess the efficacy and safety of 4% icodextrin solution (Adept(®)) in the reduction of de novo adhesion incidence compared to lactated Ringer's solution (LRS). METHODS Patients undergoing laparoscopic surgery for removal of myomas or endometriotic cysts were treated with randomized solution as an intra-operative irrigant and 1l post-operative instillate. De novo adhesion incidence (number of sites with adhesions), severity and extent were independently scored at a second-look procedure and the efficacy of the two solutions compared. The effect of surgical covariates on adhesion formation was also investigated. Initial exploratory analysis of individual anatomical sites of clinical importance was progressed. RESULTS Of 498 patients randomized, 330 were evaluable (160 LRS--75% myomectomy/25% endometriotic cysts; 170 Adept--79% myomectomy/21% endometriotic cysts). At study completion, 76.2% LRS and 77.6% Adept had ≥ 1 de novo adhesion. The mean (SD) number of de novo adhesions was 2.58 (2.11) for Adept and 2.58 (2.38) for LRS. The treatment effect difference was not significant (P = 0.909). Assessment of surgical covariates identified significant influences on the mean number of de novo adhesions regardless of treatment, including surgery duration (P = 0.048), blood loss in myomectomy patients (P = 0.019), length of uterine incision in myomectomy patients (P < 0.001) and number of suture knots (P < 0.001). There were 15 adverse events considered treatment-related in the LRS patients (7.2%) and 18 in the Adept group (8.3%). Of 17 reported serious adverse events (9 LRS; 8 Adept) none were considered treatment-related. CONCLUSIONS The study confirmed the safety of Adept in laparoscopic surgery. The proportion of patients with de novo adhesion formation was considerably higher than previous literature suggested. Overall there was no evidence of a clinical effect but various surgical covariates including surgery duration, blood loss, number and size of incisions, suturing and number of knots were found to influence de novo adhesion formation. The study provides direction for future research into adhesion reduction strategies in site specific surgery.
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Icodextrin improves metabolic and fluid management in high and high-average transport diabetic patients.
Paniagua, R, Ventura, MD, Avila-Díaz, M, Cisneros, A, Vicenté-Martínez, M, Furlong, MD, García-González, Z, Villanueva, D, Orihuela, O, Prado-Uribe, MD, et al
Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis. 2009;(4):422-32
Abstract
BACKGROUND Icodextrin-based solutions (ICO) have clinical and theoretical advantages over glucose-based solutions (GLU) in fluid and metabolic management of diabetic peritoneal dialysis (PD) patients; however, these advantages have not yet been tested in a randomized fashion. OBJECTIVE To analyze the effects of ICO on metabolic and fluid control in high and high-average transport diabetic patients on continuous ambulatory PD (CAPD). PATIENTS AND METHODS A 12-month, multicenter, open-label, randomized controlled trial was conducted to compare ICO (n = 30) versus GLU (n = 29) in diabetic CAPD patients with high-average and high peritoneal transport characteristics. The basic daily schedule was 3 x 2 L GLU (1.5%) and either 1 x 2 L ICO (7.5%) or 1 x 2 L GLU (2.5%) for the long-dwell exchange, with substitution of 2.5% or 4.25% for 1.5% GLU being allowed when clinically necessary. Variables related to metabolic and fluid control were measured each month. RESULTS Groups were similar at baseline in all measured variables. More than 66% of the patients using GLU, but only 9% using ICO, needed prescriptions of higher glucose concentration solutions. Ultrafiltration (UF) was higher (198 +/- 101 mL/day, p < 0.05) in the ICO group than in the GLU group over time. Changes from baseline were more pronounced in the ICO group than in the GLU group for extracellular fluid volume (0.23 +/- 1.38 vs -1.0 +/- 1.48 L, p < 0.01) and blood pressure (systolic 1.5 +/- 24.0 vs -10.4 +/- 30.0 mmHg, p < 0.01; diastolic 1.5 +/- 13.5 vs -6.2 +/- 14.2 mmHg, p < 0.01). Compared to baseline, patients in the ICO group had better metabolic control than those in the GLU group: glucose absorption was more reduced (-17 +/- 44 vs -64 +/- 35 g/day) as were insulin needs (3.6 +/- 3.4 vs - 9.1 +/- 4.7 U/day, p < 0.01), fasting serum glucose (8.3 +/- 36.5 vs -37 +/- 25.8 mg/dL, p < 0.01), triglycerides (54.5 +/- 31.9 vs -54.7 +/- 39.9 mg/dL, p < 0.01), and glycated hemoglobin (0.79% +/- 0.79% vs -0.98% +/- 0.51%, p < 0.01). Patients in the ICO group had fewer adverse events related to fluid and glucose control than patients in the GLU group. CONCLUSION Icodextrin represents a significant advantage in the management of high transport diabetic patients on PD, improving peritoneal UF and fluid control and reducing the burden of glucose overexposure, thereby facilitating metabolic control.
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Echocardiographic, electrocardiographic and blood pressure changes induced by icodextrin solution in diabetic patients on peritoneal dialysis.
Paniagua, R, Orihuela, O, Ventura, MD, Avila-Díaz, M, Cisneros, A, Vicenté-Martínez, M, Furlong, MD, García-González, Z, Villanueva, D, Prado-Uribe, MD, et al
Kidney international. Supplement. 2008;(108):S125-30
Abstract
The use of icodextrin as an osmotic agent in solutions for peritoneal dialysis (PD) has important cardiovascular effects related with better control of extracellular volume. Among them, reduction of arterial pressure and an improvement in echocardiographic parameters stand out. In diabetic patients, icodextrin has additional potential advantages related with better metabolic control. In a multicenter, open-label randomized controlled trial, the effects of icodextrin solutions were compared to glucose solutions on echocardiographic, electrocardiographic, and blood pressure changes in diabetic patients on PD. Two phases were noted in the follow-up. In the early phase (6 months), reduction in ambulatory blood pressure (ABP) and left ventricular end diastolic diameter were found in the icodextrin group. These changes correlated with changes in body fluids. In the late phase (12 months), a trend towards baseline values in ABP was seen. Changes in inferior vena cava diameter and in low frequency R-R variability spectral analysis in the icodextrin group suggest that icodextrin increases circulating blood volume and sympathetic tone, probably by accumulation of icodextrin metabolites in the bloodstream and improvement in diabetic neuropathy as a result of lower peritoneal glucose absorption. The effects of icodextrin in diabetic patients were related to better fluid management and metabolic control.
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Icodextrin does not impact infectious and culture-negative peritonitis rates in peritoneal dialysis patients: a 2-year multicentre, comparative, prospective cohort study.
Vychytil, A, Remón, C, Michel, C, Williams, P, Rodríguez-Carmona, A, Marrón, B, Vonesh, E, van der Heyden, S, Divino Filho, JC, ,
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2008;(11):3711-9
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BACKGROUND Icodextrin is a glucose polymer derived by hydrolysis of cornstarch. The different biocompatibility profile of icodextrin-containing peritoneal dialysis (PD) solutions may have a positive influence on peritoneal host defence. Furthermore, cases of sterile peritonitis potentially associated with icodextrin have been reported. METHODS The primary objective of this multicentre, longitudinal, observational, non-interventional, prospective cohort study, which included 722 PD patients, was to evaluate the incidence of overall peritonitis in patients treated with icodextrin-containing PD solutions (Extraneal) used during one long-dwell exchange/day compared with those treated with non-icodextrin-containing PD solutions. The secondary objective was to determine if culture-negative peritonitis rates differed between patients treated with icodextrin from two independent manufacturers. All peritonitis episodes were assessed by a Steering Committee in a blind manner. RESULTS There was no significant difference between icodextrin-treated and control patients in the adjusted overall, culture-positive or culture-negative peritonitis rates. When stratified by the icodextrin supplier, there was no significant difference in the adjusted rate of culture-negative peritonitis episodes between groups. CONCLUSION Subjects receiving icodextrin as part of their PD regimen experienced neither a higher rate of culture-negative peritonitis nor a lower rate of infectious peritonitis compared with non-icodextrin users. There was no significant influence of the icodextrin raw material supplier on peritonitis rates.
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[Glucan solution nasal spray vs saline in the treatment of chronic rhinosinusitis: a multi-centric double blind randomised clinical trial].
Passali, D, Fiorella, R, Camaioni, A, Villari, G, Mora, E, Passali, GC, Passali, FM, Crisanti, A, Bellussi, L
La Clinica terapeutica. 2007;(2):139-45
Abstract
OBJECTIVES The aim of our study was to evaluate the efficacy of 30 days treatment with glucan solution nasal spray vs. saline in the treatment of signs and symptoms of chronic rhinosinusitis. MATERIALS AND METHODS 100 patients affected by chronic rhinosinusitis were enrolled. At the beginning and at the end of the study were evaluated: nasal congestion, headache, rhinorrea, facial pain, rhinopharyngeal exudate, inferior turbinate hypertrophy; a complete instrumental analysis of nasal functions by Active Anterior Rhinomanometry, nasal Muco-Ciliary Transport time and scraping of nasal mucosa was also performed. The patients were randomized 1:1 for receiving intranasal saline or intranasal glucan solution spray. Treatment was administered as follows: 2 puffs/nostril 3 times a day for 30 days. RESULTS The patients in therapy with the glucan solution showed a significant improvement concerning rhinorrea facial pain, intensity of headache, inferior turbinate hypertrophy, rhinopharyngeal exudates, inspiratory/expiratory nasal resistences, Muco-ciliary transport time, normalization of nasal mucosas and rhinocytogram; saline lavage didn't show this effects. Both treatment improved rhinorrea, instead both treatment didn't affect nasal congestion. CONCLUSIONS According to the results of our multicentric double blind randomized study, we suggest the use of glucan solution nasal spray as an efficacious therapeutic tool in the management of nasal symptoms in patients affected by chronic rhinosinusitis.