Michael S. Epstein, MD, FACG1, Juha Halonen, PhD2, Bharat Amlani, PharmD2, Cesare Hassan, MD, PhD3
1Investigative Clinical Research, Annapolis, MD; 2Norgine, Ltd., Harefield, England, United Kingdom; 3Ospedale Nuovo Regina Margherita, Roma, Lazio, Italy
Introduction: In pre-colonoscopy colon cleansing, the presence of removable stool is currently considered a success for reliable adenoma detection. The phase 3 trials of 1L polyethylene glycol (PEG) NER1006 (trials DAYB, MORA and NOCT) are the largest to date joint prospective study on colon cleansing quality. Split dosing with NER1006 achieved a higher or at least as high cleansing success as sodium picosulfate/magnesium citrate (SPMC), 2L PEG + ascorbate (2LPEG), or oral sulfate solution (OSS). NER1006 also improves high-quality (HQ) cleansing in whole treatment groups, but patient level benefits are unclear.
Methods: This post hoc analysis of DAYB, MORA and NOCT examined if NER1006 increases the number of HQ segments per patient vs SPMC, 2LPEG or OSS, and if that could improve the adenoma detection rate (ADR) or mean number of adenomas per patient (MAP). Treatment-blinded central readers used the Harefield Cleansing Scale (HCS) to assess cleansing quality. Site endoscopists detected polyps; adenomas were confirmed by histology. Patients with full HCS scoring and adenoma counts were included. In overall cleansing successes, (HCS Grades A-B; have segments with removable stool), the number of HQ segments (HCS scores 3-4; stool-free) per patient was assessed. One-sided t-tests compared treatments. Per-patient regression analyses assessed whether HQ segments per patient improves ADR (logistic; LogR) or MAP (linear; LinR), in all patients and in cleansing successes. Odds ratios or average increments are presented with 95% CI. Trend curves were plotted with data points for group means ± SD.
Results: A total of 1749 patients were included, 1471 (84%) with overall cleansing success (Fig 1). In cleansing successes, NER1006 achieved more HQ segments per patient than SPMC (1.13±1.29 vs 0.76±1.07; P=0.005), 2LPEG: (2.52±1.76 and 2.65±1.81 vs 1.65±1.71; P< 0.001 for both) and OSS (2.61±1.8 vs 2.30±1.81; P=0.032). More HQ segments per patient showed positive odds for ADR in all (OR 1.09 [1.03-1.16]; Ptrend=0.003) and successfully cleansed patients (OR 1.11 [1.04-1.18]; Ptrend=0.001) [Fig 2]. With LinR, more HQ segments per patient increased MAP in all (average increment 0.05 [0.01-0.09]; Ptrend=0.012) and successfully cleansed patients (average increment 0.05 [0.01-0.10]; Ptrend=0.025) [Fig 3].
Discussion: NER1006 delivered more HQ segments per patient than SPMC, 2LPEG or OSS. More HQ segments per patient may increase ADR and MAP and thus protect patients against colorectal cancer.
Citation: Michael S. Epstein, MD, FACG; Juha Halonen, PhD; Bharat Amlani, PharmD; Cesare Hassan, MD, PhD. P2031 - IN PATIENTS WITH AN OVERALL CLEANSING SUCCESS THE 1L POLYETHYLENE GLYCOL NER1006 ACHIEVES MORE HIGH-QUALITY CLEANSED SEGMENTS PER PATIENT THAN THREE STANDARD BOWEL PREPARATIONS. Program No. P2031. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.