MORE DETECTED POLYPS PER PATIENT WITH 1L NER1006 VERSUS STANDARD BOWEL PREPARATIONS: META-ANALYSIS OF 1749 PATIENTS IN THREE RANDOMISED PHASE 3 CLINICAL TRIALS

Aims:

Effective colonoscopy requires adequate bowel cleansing to detect polyps of 5 mm or more in size. The 1L polyethylene glycol (PEG) NER1006 recently demonstrated superior high-quality colon cleansing efficacy over standard bowel preparations with, between them, comparable cleansing efficacies on validated cleansing scales. To explore the clinical value of improved high-quality cleansing, this meta-analysis of three randomised clinical trials assessed the mean lesion detection rates per patient for NER1006 versus standard treatments.

Methods:

Colon cleansing efficacy of split-dosing NER1006 was assessed as either overnight dosing (N2D) versus 2L PEG + ascorbate (2LPEG; MORA trial) or oral sulfate solution (OSS; NOCT trial), or as day before dosing (NDB) versus sodium picosulfate + magnesium citrate (SPMC; DAYB trial). Morning only dosing of NER1006 (N1D) was also assessed in MORA. Polyp- and adenoma detection were key secondary endpoints and these lesions were detected by site endoscopists as per usual clinical practice. Per-patient averages of overall colon polyps and adenomas were calculated for NER1006 versus comparators, per treatment and at an aggregate phase 3 level.

Results:

From 1985 randomised patients, 1749 with available lesion counts were included (Table). At the aggregate level, NER1006 demonstrated a significantly higher mean polyp detection per patient than the comparators (Mean [SD]: 1.23 [2.69] vs. 1.00 [1.73]; P = 0.014). Within each trial, NER1006 also demonstrated numerically higher mean polyp detection per patient than its comparator.

Tab. 1:

Mean number of overall colon polyps detected per patient with 1L PEG NER1006 versus older treatments.

Phase 3 trial	MORA	NOCT	DAYB	Phase 3 aggregate: DAYB+MORA+NOCT
Split-dosing bowel preparations	N2D (n = 256) or N1D (n = 266) vs. 2LPEG+Asc (n = 250)	N2D (n = 251) vs. OSS (n = 258)	NDB (n = 229) vs. SPMC (n = 239)	NDB, N2D or N1D (n = 1002) vs. SPMC, 2LPEG or OSS (n = 747)
Overall colon polyp count per patient, NER1006 vs. Comparator, mean ± SD; p-value	N2D: 1.35 ± 2.87 and N1D: 1.24 ± 2.23 vs. 1.08 ± 1.76; 0.103 and 0.181	1.27 ± 2.94 vs. 1.13 ± 1.82; 0.255	1.04 ± 2.68 vs. 0.77 ± 1.59; 0.094	1.23 ± 2.69 vs. 1.00 ± 1.73; 0.014
Overall colon adenoma count per patient, NER1006 vs. Comparator, mean ± SD; p-value	N2D: 0.62 ± 1.41 and N1D: 0.54 ± 1.18 vs. 0.55 ± 1.25; 0.280 and 0.540	0.95 ± 2.78 vs. 0.75 ± 1.42; 0.154	0.38 ± 0.84 vs. 0.35 ± 1.17; 0.363	0.63 ± 1.73 vs. 0.56 ± 1.29; 0.160

Conclusions:

Bowel preparation with the NER1006 (PLENVU) enables greater detection of overall colon polyps per patient than the pooled use of standard alternatives SPMC, 2LPEG or OSS.