Bowel preparation with 1L polyethylene glycol and ascorbate NER1006 doubles the chance to detect three or more adenomas in overweight or obese males

Abstract

Background and study aims Men have more colon cleansing failures, colorectal adenomas, and colorectal cancers than women. We analyzed whether 1-liter (1 L) polyethylene glycol (PEG) NER1006 improves high-quality (HQ) colon cleansing and adenoma detection in males versus two mid-volume alternatives. Patients and methods The analysis of 1028 adult patients in two randomized clinical trials was performed. Adenoma detection and HQ cleansing were compared for overnight split dosing regimens with NER1006 (n = 513) versus combined oral sulfate solution or 2 L PEG + ascorbate (OSS/2 L PEG) (n = 515). Analyses included males versus females, overweight or obese (OO) males versus lean males, and NER1006 versus OSS/2 L PEG. In male patients, the adenoma detection rate of at least 3 (ADR3 +) was predicted with multiple logistic regression and statistical comparisons used the two-sided t-test. Results ADR3 + was greater in males versus females (10.7 % [56/524] versus 5.8 % [29/504]; P = 0.004) despite comparable adequate cleansing success rates (93.2 % [479/514] versus 93.0 % [466/501]; P = 0.912) and more HQ-scores in females (41.6 % [1069/2570] versus 45.3 % [1134/2505]; P = 0.008). ADR was almost twice as high in OO versus lean males (43.4 % [184/424] versus 23.1 % [21/91]; P < 0.001). Multivariate logistic regression predicted ADR3 + detection to be twice as likely in OO males using NER1006 versus OSS/2 L PEG (odds ratio (95 % confidence interval [CI]) = 2.049 (1.082–3.973); P = 0.030) and 90 % more likely in all males (1.902 (1.045–3.526); P = 0.037). In males, including OO males, NER1006 attained more HQ-scores per trial than OSS or 2 L PEG (P ≤ 0.017 for all comparisons). Conclusions NER1006 predicted the detection of more males for frequent surveillance than OSS/2 L PEG.

1L NER1006 can improve rates of adequate and high-quality bowel cleansing in the right colon: a post hoc analysis of two randomised clinical trials

“…Similar findings were observed in the 2LPEG/OSS group; however, a numerically higher rate was reported in patients treated with NER1006. The superior overall high-quality cleansing efficacy of NER1006 versus 2LPEG/OSS in overweight men and, separately, in obese male patients older than 60 years, has been reported previously [ 30 , 31 ]. In the current study, NER1006 maintained its high-quality cleansing superiority versus 2LPEG/OSS in the right colon of hard-to-cleanse patients.…”

“…This increases the osmotic activity of the preparation relative to 2LPEG and also enables delivery in a total preparation volume of 1L [ 14 ]. This enhanced osmotic activity may contribute to improved cleansing of the right colon, as seen in the original studies and detailed in these post hoc analyses [ 14 – 16 , 27 , 29 – 31 ].…”

“…Several risk factors contributing to inadequate bowel cleansing have been identified in the literature, and overweight men are regarded as being at high risk [ 30 ]. This specific category of patients is also considered to be at increased risk of CRC, with a high prevalence of colorectal adenomas and polyps in this population [ 31 ]. In line with previous studies on cleansing efficacy in high-risk patients, in this study, NER1006 effectively delivered comparable levels of right colon adequate cleansing in both overweight males and all other patients [ 30 ].…”

The effectiveness of a very low-volume compared to high-volume laxative in colon capsule endoscopy

“…The recent European introduction of a very low-volume PEG bowel preparation for OC prompted comparisons to established low-and high-volume regimens. So far, the very low-volume preparation shows to be at least non-inferior to both 2 L PEG-ASC and 4 L PEG solutions, with favorable patient experience, tolerability, and high adherence [22][23][24][25][26].…”

“…A very low-volume laxative was developed to pursue a more tolerable cleansing regimen. So far, this regimen was only studied for bowel preparation before colonoscopy [22][23][24][25][26]. Therefore, this study aimed to investigate the CR, ACR, and diagnostic yield (DY) of a very low-volume PEG-based laxative compared to a conventional high-volume laxative.…”