PLENVU® consistently delivers highly effective cleansing with 1L of bowel preparation1,2
Clinical Trials
PLENVU® achieved superior colon cleansing compared to MOVIPREP® using evening/morning dosing1
Rate of successful overall bowel preparation in the per protocol population*1
Adapted from Bisschops R, et al. 20191
PLENVU® doubled high-quality cleansing rates in the right colon vs MOVIPREP® (p<0.001)1,4
Rate of high-quality and adequate cleansing in the right colon in the mFAS population4
Adapted from DOF-PLENV-001. July 20194
ESGE recommendation
The ESGE strongly recommend using high- or low-volume PEG regimens or non-PEG-based regimens that have been clinically validated.†5
*Successful overall bowel preparation was defined as grade A or B using the Harefield Cleansing Scale.
†In patients at high risk for hydroelectrolyte disturbances, the choice of laxative should be individualised.
: evening/morning dosing, : morning/morning dosing, ESGE: European Society of Gastrointestinal Endoscopy, LCL: lower confidence limit, mFAS: modified full analysis set.
Study design: Bisschops R, et al. 20191
Phase III, randomised, multicentre, colonoscopist-blinded and central reader-blinded, non-inferiority study
Aim
To assess the efficacy, safety and tolerability of PLENVU®
Treatments
In total, 849 patients received either:
PLENVU®
administered using
evening/morning dosing
(n=283)
PLENVU®
administered using
morning/morning dosing
(n=283)
MOVIPREP®
administered using
evening/morning dosing
(n=283)
Assessments
- The Harefield Cleansing Scale was used to evaluate two alternative primary endpoints:
- Successful overall bowel preparation
- High-quality cleansing in the right colon*†
- The threshold for significance was split across the two primary endpoints and was set at p<0.025
- Both non-inferiority and pre-planned superiority analyses were carried out
Populations
- Per protocol – all patients without major protocol deviations, who met eligibility criteria, took ≥75% of each dose, and had available data for at least one of the primary endpoints (n=670)
- mFAS – all patients randomised to receive treatment, excluding patients who failed screening and did not take any study drug according to the patient diary (n=822)
*High-quality cleansing was defined as ‘Excellent’ or ‘Good’ bowel preparation (scores 4 and 3) using the Harefield Cleansing scale.
†The right colon was defined as the ascending colon and caecum.
mFAS: modified full analysis set.
Real-world evidence
PLENVU® was significantly more effective than 2L and 4L PEG2
Rate of successful bowel preparation2
Adapted from Maida M, et al. 20202
PLENVU® doubled the high-quality cleansing rate in the right colon vs 2L and 4L PEG2
Rate of high-quality cleansing in the right colon2
Adapted from Maida M, et al. 20202
*Cleansing data were not available for 41 patients across the treatment arms.
All treatments were administered using afternoon/afternoon or afternoon/morning dosing.
Study design: Maida M, et al. 20203
Prospective, multicentre, observational study
Aim
To assess the real-world effectiveness and tolerability of PLENVU® compared to 2L PEG and 4L PEG
Treatments
In total, 1,289 patients received either:
PLENVU®
(N=233)
2L PEG
(N=566)
4L PEG
(N=490)
Bowel preparations were taken in the afternoon before colonoscopy (62.5%), or the afternoon and morning before colonoscopy (37.5%). Baseline characteristics were well balanced between the treatment groups.
Assessments
- The BBPS was used to evaluate two primary endpoints:
- Successful overall bowel preparation*
- High-quality cleansing in the right colon†‡
- Adherence was defined as taking ≥75% of each dose of bowel preparation
- Tolerability was evaluated using a semi-quantitative scale with a score ranging from 0 to 10 (0 represented the worst level of tolerability, and 10 represented the best level of tolerability)
*Successful overall bowel preparation was defined as a total BBPS score ≥6 and a partial score ≥2 in each colon segment.
†High-quality cleansing was defined as a BBPS score of 3.
‡The right colon was defined as the ascending colon and caecum.
BBPS: Boston Bowel Preparation Scale. PEG: polyethylene glycol.
References
- Bisschops R, et al. Endoscopy 2019; 51(1): 60-72.
- Maida M, et al. World J Gastroenterol 2020; 26(16): 1950-1961.
- Kamiński MF, et al. United European Gastroenterol J 2017; 5(3): 309-334.
- Norgine Ltd. DOF-PLENV-001. July 2019.
- Hassan C, et al. Endoscopy 2019; 51(8): 775-794.
