More Adult Male Patients Detected with 5+ Adenomas after Bowel Preparation with 1L Polyethylene Glycol Ner1006 Versus 2L Polyethylene Glycol or Oral Sulfate Solution

Aims Male gender is more susceptible to develop colorectal adenomas and colorectal cancer. Both European and US clinical guidelines recommend a 3-year post-polypectomy surveillance period for patients with five or more colorectal adenomas [ ¹ ] ^, [ ² ]. We examined whether 1L polyethylene glycol (PEG)-based NER1006 can allow endoscopists to detect more adenomas in male patients versus 2LPEG/OSS.

Methods Analysis of the combined overnight split-dosing arms (NER1006/NER1006 versus 2LPEG/OSS) of the phase 3 clinical trials MORA and NOCT [ ³ ] ^, [ ⁴ ]. Included patients were males with documented polyp and adenoma counts in the overall colon, assessed by the site endoscopists. Patients with at least three (ADR3+) and five adenomas (ADR5+) were assessed per combined treatment. Similarly, the mean overall number of polyps (MPP) and adenomas (MAP) per patient were also analysed. Statistical comparisons used the 1-sided t-test.

Results A total of 524 male patients (NER1006: 241 and 2LPEG/OSS: 283) were included. The proportion of male patients detected with at least three adenomas was greater with NER1006 than with 2LPEG/OSS (13.7 % [33/241] versus 8.1 % [23/283]; P = 0.020) (Table). With NER1006, a significant proportion of male patients were identified with at least five adenomas (5.0 % [12/241] versus 2.1 % (6/283); P = 0.037) than 2LPEG/OSS. NER1006 also enabled detection of more polyps per male patient (1.75 (1.28, 2.21) versus 1.3 (1.08, 1.52); P = 0.036) and more adenomas per male patient (1.14 (0.77, 1.51) versus 0.76 (0.60, 0.92); P = 0.024) than 2LPEG/OSS.

Conclusions In adult male patients, bowel preparation with NER1006 enabled detection of more patients with either at least three or five adenomas, compared to 2LPEG/OSS. NER1006 also helped in detecting more polyps or adenomas per patient.

Table 1 Polyp and adenoma detection in male patients.

	NER1006	2LPEG/OSS	1-sided p-value
ADR5+: Patients with at least five adenomas,% (n/N)	5.0 % (12/241)	2.1 % (6/283)	0.037
ADR3+: Patients with at least three adenomas,% (n/N)	13.7 % (33/241)	8.1 % (23/283)	0.020
MPP: Number of polyps per patient, mean (95 % Confidence Interval)	1.75 (1.28, 2.21)	1.3 (1.08, 1.52)	0.036
MAP: Number of adenomas per patient, mean (95 % Confidence Interval)	1.14 (0.77, 1.51)	0.76 (0.60, 0.92)	0.024

Citation: Álvarez-González MA, Halonen J eP200 MORE ADULT MALE PATIENTS DETECTED WITH 5+ ADENOMAS AFTER BOWEL PREPARATION WITH 1L POLYETHYLENE GLYCOL NER1006 VERSUS 2L POLYETHYLENE GLYCOL OR ORAL SULFATE SOLUTION. Endoscopy 2021; 53: S163.

Publication History

Article published online:
19 March 2021

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