1.
Fat-Modified Enteral Formula Improves Feeding Tolerance in Critically Ill Patients: A Multicenter, Single-Blind, Randomized Controlled Trial.
Qiu, C, Chen, C, Zhang, W, Kou, Q, Wu, S, Zhou, L, Liu, J, Ma, G, Chen, J, Chen, M, et al
JPEN. Journal of parenteral and enteral nutrition. 2017;(5):785-795
Abstract
BACKGROUND Improvement of fat digestion and absorption was supposed to relieve feeding intolerance. This trial aimed to evaluate the effect of a fat-modified enteral formula on feeding tolerance in critically ill patients. MATERIALS AND METHODS This trial was conducted in 7 hospitals in China. In total, 144 intensive care unit (ICU) patients with estimated need of enteral nutrition (EN) for at least 5 days were randomly given fat-modified enteral formula containing medium-chain triglycerides (MCT), carnitine, and taurine (interventional feed group, n = 71) or standard enteral formula (control feed group, n = 73). EN intake, feeding intolerance (diarrhea, vomiting, gastric retention, and abdominal distension) and outcomes (mechanical ventilator-free days of 28 days, length of ICU stay, length of hospital stay, and in-hospital mortality) were collected. RESULTS Daily calories and protein intake were increased in the interventional feed group compared with the control feed group ( P < .01). Total incidence of feeding intolerance was 42.3% in the interventional feed group and 65.7% in the control feed group ( P < .001). Daily incidence of feeding intolerance was 11.3%, 18.3%, 14.1%, 25.4%, and 26.1% in the interventional feed group and 31.5%, 32.9%, 34.2%, 34.2%, and 30.4% in the control feed group from study days 1-5 ( P = .0083). Incidence of feeding intolerance without abdominal distention was 32.9% in the interventional feed group and 49.3% in the control feed group ( P = .047), while the incidence of abdominal distension was 26.8% in the interventional feed group and 43.8% in the control feed group ( P = .03). No significant differences existed in outcomes between the 2 groups. CONCLUSIONS The fat-modified enteral formula containing MCT, carnitine, and taurine may improve feeding tolerance in critically ill patients.
2.
Evaluation of food effect on the oral bioavailability of pradigastat, a diacylglycerol acyltransferase 1 inhibitor.
Ayalasomayajula, SP, Meyers, CD, Yu, J, Kagan, M, Matott, R, Pal, P, Majumdar, T, Su, Z, Crissey, A, Rebello, S, et al
Biopharmaceutics & drug disposition. 2015;(7):452-61
Abstract
Pradigastat, a diacylglycerol acyltransferase 1 inhibitor, is being developed for the treatment of familial chylomicronemia syndrome. The results of two studies that evaluated the effect of food on the oral bioavailability of pradigastat using randomized, open-label, parallel group designs in healthy subjects (n=24/treatment/study) are presented. In study 1, a single dose of 20 mg pradigastat was administered under the fasted condition or with a high-fat meal. In study 2, a single dose of 40 mg pradigastat was administered under the fasted condition or with a low- or high-fat meal. At the 20 mg dose, the pradigastat Cmax and AUClast increased by 38% and 41%, respectively, with a high-fat meal. When 40 mg pradigastat was administered with a low-fat meal, the Cmax and AUClast increased by 8% and 18%, respectively, whereas with a high-fat meal the increase was 20% and 18%, respectively. The population pharmacokinetic analysis with the pooled data from 13 studies indicated that administration of pradigastat with a meal resulted in an increase of 30% in both the Cmax and AUC parameters. Based on these results, food overall increased pradigastat exposure in the range of less than 40%, which is not considered clinically significant. Both 20 and 40 mg doses of pradigastat were well tolerated under fasted or fed conditions.