Efficacy and safety of oral sodium sulfate tablet compared with 1‐L polyethylene glycol plus ascorbate: a prospective, randomized, endoscopist‐blinded trial

Article

Author: Myung, Seung‐Jae ; Ye, Byong Duk ; Hwang, Sung Wook ; Byeon, Jeong‐Sik ; Park, Jin Hwa ; Hong, Seung Wook ; Yang, Dong‐Hoon ; Yang, Suk‐Kyun ; Park, Sang Hyoung

AbstractBackground and AimLow‐volume bowel preparation solutions, including 1‐L polyethylene glycol plus ascorbate (PEG‐A), have been developed to improve tolerability. The oral sodium sulfate tablet (OST) is a new agent with simethicone as a preloaded component. We investigated the efficacy, safety, and tolerability of OST compared to 1‐L PEG‐A.MethodsA single‐center, prospective, controlled study was performed with randomization into the OST (group A) and 1‐L PEG‐A (group B) groups. Bowel preparation efficacy was assessed on the Boston Bowel Preparation Scale (BBPS) and Bubble Scale. Safety and tolerability were evaluated using a questionnaire and laboratory examination.ResultsFinal analysis was performed on 171 patients (group A: 87, group B: 84). The proportion of bowel preparation success (BBPS ≥ 2 for each colonic segment) in group A was not inferior compared to group B (95.4%vs96.4%,P = 0.736, 1‐sided 97.5% lower confidence limit −7.0%). The adenoma detection rate was not different (59.6%vs41.9%;P = 0.087). The bubble scale was better in group A (0.2 ± 0.9vs1.9 ± 1.7,P < 0.001). All adverse events were mild in both groups. Nausea was less frequent in group A (14.9%vs38.1%,P = 0.001). Overall satisfaction was better in group A (8.1 ± 2.1vs6.4 ± 2.8,P < 0.001). No clinically significant laboratory abnormality developed in both groups. These findings were similarly shown in old patients ≥65 years.ConclusionsBoth OST and 1‐L PEG‐A were efficacious, safe, and tolerable for bowel preparation of colonoscopy. The OST showed fewer bubbles and slightly better tolerability.

01 Apr 2023·CardioVascular and Interventional Radiology

Transarterial Chemoembolization with Anthracyclines-Loaded Polyethylene Glycol Drug Eluting Microspheres for the Treatment of Hepatocellular Carcinoma: A Pooled Multicentric Analysis of Survival in 580 Patients

Article

Author: Bruix, Jordi ; Malagari, Katerina ; Veloso Gomes, Filipe ; de Baère, Thierry ; Verset, Gontran ; Coimbra, Élia ; Tovar-Felice, Gerardo

AbstractPurposeTo evaluate survival, efficacy and safety of transarterial chemoembolization (TACE) in the treatment of patients with hepatocellular carcinoma (HCC), through a pooled analysis of patients with BCLC 0, A and B HCC stages, treated with polyethylene glycol drug eluting microspheres (PEG-DEM) TACE. Materials and MethodsPatients from 3 retrospective and 2 prospective registries were included. Overall survival (OS), progression-free survival (PFS), tumour response and safety were evaluated. Multivariate Cox regression analysis was performed to evaluate predictors of OS. ResultsA total of 580 patients (72.1% males, mean age 66.9 ± 10.3 years) were included. 43.5% had BCLC A, and 41.0% BCLC B disease stage, and 85.8% were Child–Pugh class A. Complete and partial response (mRECIST or RECIST1.1) were achieved in 60.14% and 27.11% of patients, with overall response and disease control rates of 87.30% and 94.60%, respectively. Median OS was 50.8 months for the total population, and 61.2 and 38.1 months for BCLC 0 + A and BCLC B patients, respectively. Median PFS for the total population, BCLC 0 + A and BCLC B groups was 15.6, 21.6 and 12.7 months, respectively.ConclusionsThis multicentric pooled analysis confirmed efficacy and safety of PEG-DEM TACE, with a median OS of 50.8 months.

01 Mar 2023·Journal of Gastroenterology and Hepatology

Efficacy of oral sulfate tablets for bowel preparation and adenoma detection rate

Article

Author: Yim, Jeong Yoon ; Song, Ji Hyun ; Bae, Jung Ho

AbstractBackground and AimThe adenoma detection rate (ADR), which is closely related to bowel preparation, is the most important factor for colonoscopy quality assessment. New oral sulfate tablets (OSTs) have been developed to improve bowel preparation compliance. This study evaluated the efficacy of OSTs in terms of the ADR and bowel preparation status.MethodsMedical records of subjects under the age of 65 who underwent colonoscopy from March 2019 to February 2021 were retrospectively reviewed. Polyethylene glycol with ascorbic acid (PEG‐A) was used as a bowel preparation for the first half of the study period, and OSTs were used for the second half. In total, 16 971 subjects were included in the study: 9199 (54.2%) used PEG‐A, and 7772 (45.8%) used OSTs. Bowel cleansing quality was assessed by the Boston Bowel Preparation Scale (BBPS).ResultsThe average age was 50 years. The rate of adequate bowel preparation was higher in the OST group than in the PEG‐A group (97.2% vs 95.0%, P < 0.001). The mean BBPS was also higher in the OST group (8.02 vs 7.75, P < 0.001). The adenomas per colonoscopy (APC), the ADR and the sessile serrated polyp detection rate (SSPDR) were higher in the OST group than in the PEG‐A group (APC 0.56 ± 1.01 vs 0.48 ± 0.91, P < 0.001; ADR 34.5% vs 30.7%, P < 0.001; SSPDR 5.2% vs 3.3%, P < 0.001).ConclusionsCompared with PEG‐A, OSTs yielded superior APC, ADRs, SSPDRs, and better bowel cleanliness. Therefore, OSTs are a good alternative for patients who have difficulty taking large‐volume bowel preparation formulations.

100 Deals associated with TNF-PEG 20

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Preclinical	-	Polaris Pharmaceuticals, Inc.	16 Sep 2016

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