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Different effects of basal insulin peglispro and insulin glargine on liver enzymes and liver fat content in patients with type 1 and type 2 diabetes.
Cusi, K, Sanyal, AJ, Zhang, S, Hoogwerf, BJ, Chang, AM, Jacober, SJ, Bue-Valleskey, JM, Higdon, AN, Bastyr, EJ, Haupt, A, et al
Diabetes, obesity & metabolism. 2016;:50-58
Abstract
AIMS: To compare effects of basal insulin peglispro (BIL), a hepatopreferential insulin, to insulin glargine (glargine) on aminotransferases and liver fat content (LFC) in patients with type 1 and type 2 diabetes (T1D, T2D). MATERIALS AND METHODS Data from two Phase 2 and five Phase 3 randomized trials comparing BIL and glargine in 1709 T1D and 3662 T2D patients were integrated for analysis of liver laboratory tests. LFC, measured by magnetic resonance imaging (MRI) at baseline, 26 and 52 weeks, was analyzed in 182 T1D patients, 176 insulin-naïve T2D patients and 163 T2D patients previously treated with basal insulin. RESULTS Alanine aminotransferase (ALT) increased in patients treated with BIL, was higher than in glargine-treated patients at 4-78 weeks (difference at 52 weeks in both T1D and T2D: 7 international units/litre (IU/L), P < .001), and decreased after discontinuation of BIL. More BIL patients had ALT ≥3× upper limit of normal (ULN) than glargine. No patient had ALT ≥3× ULN with bilirubin ≥2× ULN that was considered causally related to BIL. In insulin-naїve T2D patients, LFC decreased with glargine but was unchanged with BIL. In T1D and T2D patients previously treated with basal insulin, LFC was unchanged with glargine but increased with BIL. In all three populations, LFC was higher after treatment with BIL vs glargine (difference at 52 weeks: 2.2% to 5.3%, all P < .01). CONCLUSIONS Compared to glargine, patients treated with BIL had higher ALT and LFC at 52-78 weeks. No severe drug-induced liver injury was apparent with BIL treatment for up to 78 weeks.
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3-L split-dose is superior to 2-L polyethylene glycol in bowel cleansing in Chinese population: a multicenter randomized, controlled trial.
Zhang, S, Li, M, Zhao, Y, Lv, T, Shu, Q, Zhi, F, Cui, Y, Chen, M
Medicine. 2015;(4):e472
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Abstract
Large volume (4 L) of polyethylene glycol (PEG) solution would ensure a better quality of bowel cleansing but might be poorly tolerated. Due to the smaller body size, lower body weight, and different diet habits, the large volume of 4-L PEG might be poorly tolerated by the Chinese population. In view of this, a balance should be made between the volume and effectiveness. This study aimed to compare the effectiveness, compliance, and safety between 3-L split-dose and 2-L PEG in Chinese population. Consecutive patients scheduled for colonoscopy were recruited from 5 tertiary medical centers in South China between April and July, 2014. Patients were prospectively randomized into 2 groups: 3-L split-dose PEG (3L-group) and 2 L PEG (2L-group). The primary endpoint was bowel cleansing and was defined according to Ottawa Bowel Preparation Scale (OBPS). The safety and compliance were also evaluated. A total of 318 patients were included in the analysis. The mean total OBPS score was significantly higher in 2L-group than in 3L-group (4.4 ± 2.7 vs 2.9 ± 2.4, P < 0.001). Both the intention-to-treat and per-protocol analysis found that rates of successful and excellent bowel preparation were much higher in 3L-group (89.9% and 78.0%) than 2L-group (79.2% and 48.4%), respectively (P < 0.001). The average cecum intubation time was significantly shorter in 3L-group (8.2 ± 3.7 min) than in 2L-group (10.3 ± 4.2 min) (P = 0.04). Adenoma detection rate in right colon was slightly higher in 3L-group than in 2L-group (17.6% vs 12.6%, P = 0.21). The safety and compliance including the taste, smell, and dosage of PEG were similar between 2 groups (P > 0.05). 3-L split-dose PEG is superior to 2-L PEG by better bowel cleansing, improved safety and compliance, shorter cecum intubation time, and potentially higher adenoma detection rate in rightward colon in Chinese population.