High-quality colon cleansing and multiple neoplasia detection with 1L NER1006 versus mid-volume options: Post hoc analysis of phase 3 clinical trials

Abstract

Background and study aims Multiple neoplasia increase the risk of colorectal cancer. High-quality cleansing may improve adenoma detection. We assessed whether a new bowel preparation can improve colon cleansing and multiple lesion detection. Patients and methods This post hoc analysis of two randomized clinical trials in Europe and the US assessed the per study and combined cleansing efficacy of overnight split dosing with (preparation + clear fluids) 1 + 1 L polyethylene glycol (PEG) NER1006 versus 2 + 1 L PEG + ascorbate (2LPEG) or 1 + 2 L oral sulfate solution (OSS) combined. Treatment-blinded central readers assessed cleansing quality using the Harefield Cleansing Scale (HCS). Patients with full segmental scoring were included. HCS segmental scores 0–4 (high-quality = HCS 3–4) were analyzed for NER1006 versus 2LPEG/OSS. Mean number of polyps or adenomas per patient (MPP/MAP) was calculated for treatments in patients with at least one polyp or adenoma. Results In 1037 patients, NER1006 attained a greater rate of HCS 3 scores (29 % vs. 20 %; P < 0.001) and HCS 4 scores (20 % vs. 17 %; P = 0.007) versus 2LPEG/OSS. More polyps (678 versus 585) and adenomas (397 versus 331) were detected with NER1006 (N = 517) versus 2LPEG/OSS (N = 520). In all neoplasia-positive patients, with increasing minimal per-patient neoplasia multiplicity from 1 to 10, NER1006 numerically improved MPP (difference ± SE: 0.48 ± 0.24 to 3.89 ± 3.37) and MAP (0.47 ± 0.26 to 7.50 ± 9.00) versus 2LPEG/OSS. Conclusions Low-volume NER1006 enhances high-quality cleansing versus medium-volume 2LPEG or OSS, individually and when combined. NER1006 may consequently facilitate the detection of multiple neoplasia in patients.

Bowel-cleansing efficacy of the 1L polyethylene glycol-based bowel preparation NER1006 (PLENVU) in patient subgroups in two phase III trials

“…Patient characteristics for the individual and combined treatment groups have been described elsewhere. 25 , 26 , 32 Overall successful bowel cleansing on the HCS in each of the subgroups is presented in Figure 1 . Split-dose NER1006 was associated with high levels of cleansing across all patient types, ranging between 87.0% and 94.0% of patients.…”

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

“…The further analysis of two highly similarly-designed phase 3 randomized clinical trials, MORA and NOCT, investigated the clinical benefits of bowel preparation with overnight split dosing from combined NER1006 arms versus combined 2 L PEG or OSS, mostly beyond the attained cleansing benefits that have been reported before 15 16 17 18 19 . MORA and NOCT are near-identical study designs, and the variance of the observed effects are likely to be similar across the trials.…”

“…We studied the comparative detection rates of colorectal polyps or adenomas in the overall colon and the right colon 16 . The right colon cleansing quality was an alternative primary endpoint in these trials.…”

“…Improvements with NER1006 Original article ▶ Table 3 Lesion detection in all male patients, per trial, and in the combined treatment groups. Since combined cleansing data have already been published for NER1006 versus OSS/2 L PEG [15,16], the cleansing outcomes were only assessed per trial.…”

“…With an estimated use of 1-liter polyethylene glycol (1LPEG) NER1006 (PLENVU ® ) in over 3.5 million patients worldwide 14 , NER1006 has been shown to provide superior HQ (e. g., stool-free score before any suction) colon cleansing efficacy versus combined oral sulfate solution or 2 L PEG + ascorbate (OSS/2 L PEG) and an improved cleansing quality versus 4 L PEG 15 16 17 .…”