Michael Epstein, MD, AGAF, FACG
president
Digestive Disorders Associates
Annapolis, Maryland
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: Interval cancers may occur due to missed neoplasia during colonoscopy. ‘Adequate’ cleansing quality permits stool presence in the colon, however high-quality (stool-free) cleansing is now known to improve polyp detection. The 1 L polyethylene glycol (PEG) NER1006 improves high-quality colon cleansing, but whether it primarily reduces stool or liquid is unknown. We characterized the segmental high-quality cleansing with NER1006 versus two comparators, and its effect on mean polyp detection per patient.
Methods: A post hoc analysis of two similarly designed phase 3 clinical trials NOCT and MORA examined overnight split-dosing regimens. NER1006 was compared with oral sulfate solution (OSS; NOCT) and 2 L polyethylene glycol + ascorbate (2LPEG; MORA). Treatment-blinded central readers assessed colon cleansing quality using the Harefield Cleansing Scale (HCS) with segmental scores 0-1 (failures; irremovable stool), 2 (adequate; removable stool), 3 (high-quality; clear liquid) or 4 (high-quality; liquid-free). Site endoscopists detected polyps. Patients with full segmental scoring were included. The segmental scores distribution and mean number of polyps per patient (MPP; in patients with at least 1 to 10 polyps) were analysed per treatment group. MPP was also assessed in pooled NER1006 versus pooled OSS and 2LPEG. One-sided t-tests assessed potential differences between groups.
Results: Totally 1037/1103 patients were included (94% primary analysis set = 5185 segments). NER1006 attained more stool-free segments (HCS 3) than OSS (30% [388/1275] vs 25% [331/1300]; P=0.002) [Figure 1] or 2LPEG (28% [368/1310] vs 15% [191/1300]; P< 0.001) [Figure 2]. NER1006 attained more liquid-free segments (HCS 4) than 2LPEG (22% [285/1310] vs 17% [220/1300]; P=0.001), and less stool-containing segments (HCS 2) than OSS (48% [612/1275] vs 53% [687/1300]; P=0.007 or 2LPEG (49% [641/1310] vs 66% [854/1300]; P< 0.001). Pooled NER1006 showed a higher MPP than pooled OSS and 2LPEG for at least 1 (2.8 vs 2.3; P=0.036), 2 (4.4 vs 3.5; P=0.020), 3 (5.7 vs 4.5; P=0.033), 4 (7.3 vs 5.8; P=0.049), 5 (9.7 vs 6.8; P=0.017) and 6 polyps per patient (10.9 vs 7.5; P=0.020) [Figure 3]. In all other patients NER1006 had a numerically higher MPP per trial and when pooled.
Discussion: Finding multiple polyps in a patient is difficult. NER1006 improves high-quality cleansing over OSS or 2LPEG primarily by delivering more stool-free segments. This improved high-quality cleansing enables detection of more polyps per patient.
Citation: Michael S. Epstein, MD, FACG; Juha Halonen, PhD; Bharat Amlani, PharmD; Cesare Hassan, MD, PhD. P2030 - 1 L NER1006 IMPROVES HIGH-QUALITY COLON CLEANSING AND MEAN POLYP DETECTION VERSUS ORAL SULFATE SOLUTION AND 2 L POLYETHYLENE GLYCOL PLUS ASCORBATE. Program No. P2030. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.