Endoscopy 2019; 51(04): S70-S71
DOI: 10.1055/s-0039-1681378
ESGE Days 2019 oral presentations
Friday, April 5, 2019 17:00 – 18:30: Colon cleansing 1 Club D
Georg Thieme Verlag KG Stuttgart · New York

1L NER1006 IMPROVES HIGH-QUALITY COLON CLEANSING VERSUS STANDARD BOWEL PREPARATIONS: POST HOC ANALYSIS OF PHASE 3 CLINICAL TRIALS USING REAL-WORLD CLEANSING ASSESSMENT BY SITE ENDOSCOPISTS

J Gschossmann
1   Klinik für Innere Medizin, Klinikum Forchheim, Forchheim, Germany
,
C Noble
2   Western General Hospital, Edinburgh, United Kingdom
,
B Amlani
3   Medical Affairs, Norgine, Harefield, United Kingdom
,
A Repici
4   Humanitas Research Hospital & Humanitas University, Milano, Italy
› Institutsangaben
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Publikationsverlauf

Publikationsdatum:
18. März 2019 (online)

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    Aims:

    Colonoscopy requires bowel cleansing; high-quality cleansing facilitates lesion detection. NER1006 is a 1L polyethylene glycol (PEG) bowel preparation. This post hoc analysis of three randomised trials investigated cleansing efficacy assessed, as in clinical practice, by site endoscopists.

    Methods:

    Patients received either a 2-day evening/morning regimen of NER1006 (N2D), 2L PEG+ascorbate (2LPEG), or oral sulfate solution (OSS); or day-before NER1006 (NDB) or sodium picosulfate plus magnesium citrate (SPMC). Morning-only NER1006 (N1D) dosing was also evaluated. Cleansing was assessed by treatment-blinded site endoscopists using the Harefield Cleansing Scale (HCS). This analysis included only patients with self-reported 100% treatment adherence. Overall cleansing success (HCS grade A or B), overall high-quality cleansing success (HCS grade A), and the proportion of high-quality segments (HCS 3 – 4) per treatment population were analysed.

    Results:

    Among 1985 randomised patients, 1367 were included (Table). Overall cleansing success was higher with N2D than 2LPEG (97.5% vs. 93.0%) and more patients had overall high-quality cleansing with N2D and N1D than 2LPEG (72.1% and 68.4% vs. 56.0%). N2D delivered more overall high-quality cleansing than OSS (77.3% vs. 69.8%). Overall cleansing success was higher with NDB than SPMC (74.5% vs. 62.9%) and more patients achieved HCS Grade A with NDB than SPMC (29.0% vs. 12.0%). More high-quality segments were demonstrated with N2D and N1D versus 2LPEG (87.1% and 84.4% vs. 76.3%), with N2D versus OSS (89.5% vs. 84.4%) and with NDB than SPMC (60.3% vs. 47.0%).

    Tab. 1:

    High-quality colon cleansing as assessed by site endoscopists in patients with self-reported 100% treatment adherence

    Cleansing success

    N2D vs. 2LPEG

    N1D vs. 2LPEG

    N2D vs. OSS

    NDB vs. SPMC

    Sample size: NER1006 vs. comparator, N

    204 vs. 200

    193 vs. 200

    225 vs. 225

    145 vs. 175

    Overall cleansing success HCS Grades A+B, n/N (%); P-value

    199/204 (97.5) vs. 186/200 (93.0) P = 0.016

    180/193 (93.3) vs. 186/200 (93.0) P = 0.459

    211/225 (93.8) vs. 210/225 (93.3) P = 0.424

    108/145 (74.5) vs. 110/175 (62.9) P = 0.012

    Overall high-quality cleansing success HCS Grade A, n/N (%); P-value

    147/204 (72.1) vs. 112/200 (56.0) P < 0.001

    132/193 (68.4) vs. 112/200 (56.0) P = 0.006

    174/225 (77.3) vs. 157/225 (69.8) P = 0.035

    42/145 (29.0) vs. 21/175 (12.0) P < 0.001

    High-quality segments HCS 3 – 4, n/N (%); P-value

    888/1020 (87.1) vs. 763/1000 (76.3) P < 0.001

    814/965 (84.4) vs. 763/1000 (76.3) P < 0.001

    1007/1125 (89.5) vs. 950/1125 (84.4) P < 0.001

    437/725 (60.3) vs. 411/875 (47.0) P < 0.001

    Conclusions:

    When assessed by site-endoscopists NER1006 (PLENVU) delivers greater high-quality, HCS grade A, cleansing than 2LPEG, OSS, or SPMC.


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