PLENVU® is generally well-tolerated1-3
REAL-WORLD-EVIDENCE
PLENVU® was significantly better tolerated than 2L and 4L PEG7
Study design: Maida M, et al. 20207
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.
Mean tolerability score from 0 to 10*7
Adapted from Maida M, et al. 20207
96.5% of patients
thought the tolerability of
PLENVU® was acceptable7
81.1% and 86.3%
treated with 2L and 4L PEG,
respectively†7
*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).
†Sufficient tolerability was defined as a score ≥6.
All treatments were administered using afternoon/afternoon dosing or afternoon/morning dosing.
AE: adverse event.
PLENVU® has a comparable safety profile to other PEG bowel preparations1,4-6
The common adverse events associated with PLENVU® are vomiting, nausea and dehydration4
Please refer to the Summary of Product Characteristics for further information on the safety profile of PLENVU®
Clinical trials
In total,
5 in 6 patients had
no treatment-related
AEs when treated
with PLENVU®
(n=1028)1–3
There were
no serious
treatment-related
AEs1–3
Most reported
AEs were mild
to moderate1–3
Rates of treatment-related AEs in the safety populations from the MORA, DAYB and NOCT clinical trials1–3
MORA1
- 11.5% with PLENVU® evening/morning dosing (30 out of 262 patients)
- 14.9% with PLENVU® morning/morning dosing (40 out of 269 patients)
- 7.6% with MOVIPREP® (PEG 3350 + sodium ascorbate + ascorbic acid +sodium sulfate + electrolytes) evening/morning dosing (20 out of 263 patients)
DAYB2
- 11.9% with PLENVU® evening/evening dosing (28 out of 235 patients)
- 4.1% with NaPic + MgCit morning/afternoon dosing (10 out of 241 patients)
NOCT3
- 14.9% with PLENVU® evening/morning dosing (39 out of 262 patients)
- 9.4% with trisulfate evening/morning dosing (25 out of 265 patients)
AE: Adverse event.
Who can you prescribe PLENVU® for?
PLENVU® can be used without dose adjustments in a wide range of patients4
PLENVU® is indicated in adults for bowel cleansing prior to any procedure requiring a clean bowel4
Patients with IBD can receive PLENVU® but it should be used with caution with severe acute IBD4
No special dosage adjustment is deemed necessary in patients with mild to moderate renal impairment. Patients with mild to moderate renal impairment were included in clinical studies. PLENVU® should be used with caution in patients with severe renal impairment4
No special dosage adjustment is deemed necessary in patients with mild to moderate hepatic impairment. Patients with elevated liver function tests were included in clinical studies4
ESGE recommendation
The ESGE strongly recommend using high volume or low volume PEG-based bowel preparations in patients with IBD.8
ESGE: European Society of Gastrointestinal Endoscopy, IBD: inflammatory bowel disease.
References
- Bisschops R, et al. Endoscopy 2019; 51(1): 60-72.
- Schreiber S, et al. Endoscopy 2019; 51(1): 73-84.
- DeMicco MP, et al. Gastrointest Endosc 2018; 87(3): 677-687.
- PLENVU® UK Summary of Product Characteristics. October 2020.
- MOVIPREP® UK Summary of Product Characteristics. October 2020.
- KLEAN-PREP® UK Summary of Product Characteristics. September 2020.
- Maida M, et al. World J Gastroenterol 2020; 26(16): 1950-1961.
- Hassan C, et al. Endoscopy 2019; 51(8): 775-794.
