Background and Aims
The 1-L polyethylene glycol (PEG)-based bowel preparation agent NER1006 (Plenvu; Norgine,
Harefield, UK) has shown high cleansing efficacy and tolerability in clinical trials
in Europe and North America. However, no clinical trials have yet been reported in
Asia. Therefore, the aim of this study was to evaluate the efficacy and safety of
1L PEG-based bowel preparation with Plenvu compared with 2L PEG plus ascorbate bowel
preparation in a Korean population.
Methods
In this multicenter, endoscopist-blinded, randomized study, patients at 9 hospitals
in South Korea undergoing colonoscopy received either Plenvu or 2L PEG + ascorbate
(2L PEG) with a split dose. The primary endpoint was overall bowel cleansing success
(Boston Bowel Preparation Scale [BBPS] score ≥2 for all segments of the colon). Secondary
endpoints were high-quality bowel cleansing success (overall, BBPS score = 9; segmental
colon, BPPS score = 3), polyp detection rate (PDR), and adenoma detection rate (ADR).
Results
Of 360 included patients, cleansing efficacy was analyzed in 346 (Plenvu, 174; 2L
PEG, 172). The Plenvu group showed noninferior bowel cleansing success rates compared
with 2L PEG (93.10% vs 91.86%; difference, 1.24%; 1-sided 97.5% lower confidence limit,
–4.31%; Pnoninferiority < .0001; Psuperiority = .661). The Plenvu group had higher high-quality bowel cleansing success rates for
overall and right-sided colon segments than the 2L PEG group (49.43% vs 37.79% [P = .029] and 60.92% vs 48.84% [P = .024], respectively). The PDR was greater with Plenvu than with 2L PEG (48.85%
vs 37.79%, P = .038). However, ADR did not differ between the 2 groups (24.71% vs 20.35%, P = .331). Although treatment-emergent adverse events (TEAEs) were slightly higher
in the Plenvu group than in the 2L PEG group (65.71% vs 52.91%, P = .015), most TEAEs were mild (85.55%) and most patients recovered without any management
(99.23%).
Conclusions
Plenvu showed noninferior overall bowel cleansing success rates comparable with 2L
PEG but greater high-quality bowel cleansing in overall and right-sided colon, which
might help improve the PDR in the Asian population. (Clinical trial registration number:
KCT0005894.)
Graphical abstract
Graphical Abstract
Abbreviations:
2L PEG (2 L polyethylene glycol + ascorbate), ADR (adenoma detection rate), BBPS (Boston Bowel Preparation Scale), LCL (lower confidence limit), mITT (modified intention-to-treat), PDR (polyp detection rate), PEG (polyethylene glycol), PP (per-protocol), TEAE (treatment-emergent adverse event)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: October 12, 2021
Accepted:
September 27,
2021
Received:
June 5,
2021
Footnotes
DISCLOSURE: The following author disclosed financial relationships: S. N. Hong: Speaker and advisory board for KoreaPharm. All other authors disclosed no financial relationships. Research support for this study was provided by KoreaPharma Co, Ltd, Seoul, Korea.
DIVERSITY, EQUITY, AND INCLUSION: We worked to ensure ethnic or other types of diversity in the recruitment of human subjects. One or more of the authors of this article self-identifies as an under-represented ethnic minority in science.
If you would like to chat with an author of this article, you may contact Dr Jeen at [email protected]
Identification
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© 2022 by the American Society for Gastrointestinal Endoscopy
