Information for healthcare professionals only. 

This supplement has been commissioned by Norgine Pharmaceuticals Limited and contains promotional information.

View prescribing information for PLENVU® (macrogol 3350, sodium ascorbate, ascorbic acid, sodium sulfate anhydrous, potassium chloride, sodium chloride).

View prescribing information for MOVIPREP® (macrogol 3350, sodium sulfate anhydrous, ascorbic acid, sodium ascorbate, sodium chloride, and potassium chloride)

View prescribing information for KLEAN-PREP (macrogol 3350, anhydrous sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride)

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KLEAN-PREP is a registered trademark of Helsinn Birex Pharmaceuticals Limited.

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Samantha Horley, Endoscopy Nurse Practitioner, Russell Hall Hospital, Dudley, West Midlands

Foreword

As an endoscopy nurse, I come into regular contact with patients who need to take oral bowel preparation for their colonoscopy or sigmoidoscopy procedures. Oral bowel preparation taken correctly is vital to ensure that a patient’s bowel is effectively prepared and clean enough for a thorough and high-quality examination. Therefore, patient compliance with taking the bowel preparation as prescribed is necessary.

In my experience many patients report that taking oral bowel preparation is the worst part of their endoscopy experience, stating it is worse than the actual endoscopic procedure itself. Some patients find that the volume of the preparation is difficult to manage, and they also complain about the flavour of the preparation. If a patient is unable to follow the oral bowel preparation regimen this can lead to an insufficiently cleansed bowel and the necessity of repeat or alternative investigations.

When I learnt about PLENVU®1 (macrogol 3350, sodium ascorbate, ascorbic acid, sodium sulfate anhydrous, potassium chloride, sodium chloride)—a bowel preparation that offers a lower volume than MOVIPREP®2 (macrogol 3350, sodium sulfate anhydrous, ascorbic acid, sodium ascorbate, sodium chloride, and potassium chloride) and KLEAN-PREP3 (macrogol 3350, anhydrous sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride), and with new flavours—I could see that there may be greater patient compliance, which could lead to greater efficacy of preparation. Therefore, I arranged a 3-month trial in the endoscopy unit where I am based. An audit of this trial would determine if patients were more compliant with a treatment that offered less volume to be consumed and different flavours. Efficacy of this preparation would also be reviewed to determine if the treatment was as efficient as the existing preparation being used.

We used PLENVU® alongside the existing oral bowel preparation and each patient who had taken PLENVU® preparation was asked to complete a satisfaction survey including reactions to the volume, the taste, and comparison to other oral bowel preparations they may have used before. We also recorded the endoscopists’ opinion on the efficacy of the bowel preparation during the endoscopic procedures.

The importance of bowel cleansing for colonoscopy

Bowel cleansing is vital to ensure a good quality endoscopic examination of the bowel and identify any lesions and potential cancers, yet an audit carried out in the UK showed that 22.2% of poor bowel preparation was a reason for incomplete colonoscopies, which led to missing lesions and more repeat procedures.4 An adequate level of bowel cleansing is essential and important for the efficacy of colonoscopy. However, further costs and rescheduling/alternative procedures arise due to inadequate level of bowel cleansing.5 The European Society of Gastrointestinal Endoscopy (ESGE) has proposed a minimum rate of adequate bowel preparation of ≥90% and a target standard rate of ≥95%.6

Patient perspectives on bowel preparations 

Healthcare professionals working in the Colonoscopy Pre-Assessment Clinic will be well aware that, for patients scheduled to undergo colonoscopy, anxiety, and trepidation around the use of bowel preparation is commonplace. The taste and the volume of the bowel preparation treatments are two key concerns raised by patients. These issues may affect patients’ compliance with bowel cleansing regimen required prior to colonoscopy and compromise outcomes from the procedure.

Many patients struggle to tolerate the quantities of fluid involved in bowel preparation regimens, which can entail several litres of liquid consumed over a relatively short period of time. Some individuals complain that the taste of the bowel preparation itself is extremely unpalatable and will resort to strategies, such as flavouring with squash or drinking through a straw. The need to adhere to a low-residue diet can also have a negative impact on patients’ everyday life in the run up to the colonoscopy procedure.

Study and patient survey

PLENVU® is the first 1 litre PEG preparation to become available. It consists of a taste-optimised combination of two different formulations, designed to maximise adherence and to work synergistically for bowel cleansing. PLENVU® has two flavours—dose one is mango and dose two is fruit punch.7

This study at the Dudley Group NHS Foundation was undertaken to compare PLENVU® to MOVIPREP® in terms of both efficacy and patient satisfaction. The effectiveness of the two different bowel cleansing preparations was compared by the treating endoscopists and a patient survey carried out to gauge patients’ opinions of the new treatment.8

During this study, all non-bowel cancer screening programme (BCSP) patients were supplied with PLENVU® unless another preparation was specifically requested by the referrer; all BSCP colonoscopy patients used MOVIPREP® distributed by a specialist screening practitioner.8 Both PLENVU® and MOVIPREP® were prescribed and used in accordance with the recommendations laid out in their summaries of product characteristics.1,2

Efficacy

A Unisoft analysis was carried out over a 7-month period from 1 January 2019 onwards, looking at 544 cases where PLENVU® was used as bowel preparation, and 988 cases where MOVIPREP® was used. The efficacy of the bowel preparation was rated as excellent, good, fair, or inadequate by 15 endoscopists, using the standard endoscopy reporting tool. Of these 15 endoscopists; seven were gastroenterology consultants, one gastroenterology registrar, and seven colorectal surgical consultants.8

Overall, study results showed that both PLENVU® and MOVIPREP® performed similarly and were equally effective in preparing the bowel for colonoscopy (Figure 1). PLENVU® was rated as good or excellent by endoscopists in 66% (360/544) of cases, compared with 57% (567/988) for MOVIPREP®. In total, 27% (147/544) of endoscopists judged the bowel cleansing of PLENVU® as fair and only 6.8% (37/544) rated it as inadequate, which compares favourably to MOVIPREP®, which was rated fair in 35% (349/988) of cases and inadequate in 7.3% (72/988). Both PLENVU® (93.2%) and MOVIPREP® (92.7%) achieved the ESGE minimum rate of ≥90% adequate bowel preparation.6

Figure 1: Showing the study results for both PLENVU® and MOVIPREP®

 

Patient survey

The patient satisfaction survey provided a snapshot of opinion from 33 patients who received PLENVU® for bowel preparation prior to colonoscopy. The patients were asked some questions:6

  • Question 1: did you follow the 3-day low-residue diet plan?
  • Question 2: did you take all of the PLENVU®?
  • Question 3: did you find the instructions for taking the preparation easy?
  • Question 4: did you like the flavour of the PLENVU®?

Out of 33 patients, 30 patients (91%) adhered to the low-residue diet required prior to colonoscopy. In the three cases (9%) where patients did not, this was due to short-notice appointments and only one of those patients failed to achieve a good bowel preparation.8

The vast majority of patients successfully completed dosing of the PLENVU® bowel preparation prior to their colonoscopy. Overall, 31 out of 33 patients (94%) took all of the preparation as required. One patient (3%) left half of the second dose and the preparation was inadequate and required rebooking. Thirty patients (>90%) found the instructions for taking the PLENVU® preparation easy to understand.8

When directly questioned about whether they liked the flavour of PLENVU®, 19 patients (58%) answered no. Despite the negative feedback on taste expressed by some patients, it is important to note that around half of those questioned (the remaining 42% of patients) were satisfied with the flavour of PLENVU®.

Adverse events

Of the 33 patients surveyed, specific complaints reported by patients included isolated incidents of nausea, vomiting, and heaving. One patient (3%) was sick after completing both doses and one patient (3%) left 200 ml due to heaving, however, both preparations were rated ‘fair’ and the procedure was complete. 

Comparing with the clinical trial data

Overall, results from this study correspond closely with findings from Phase III trials of PLENVU®. Phase III clinical studies have evaluated PLENVU® using both the Harefield Cleansing Scale (HCS) and Boston Bowel Preparation Study (BBPS), and these studies have shown that it is effective for overall bowel and right-sided colon cleansing.9,10 In the MORA study, a randomised, blinded, multicentre, parallel-group trial, PLENVU® was directly compared with the standard PEG-based bowel preparation with ascorbate (2LPEG) in 849 patients undergoing colonoscopy. PLENVU® demonstrated superior colon cleansing efficacy—achieving overall cleansing success rates of 97.3% when given as an evening/morning regimen and 92.7% when used morning-only in the per protocol population.7

Results from the MORA Phase III trial looking at patient perceptions and opinions of PLENVU® also align with those reported in this study. Based on patient diary responses in the MORA trial, the overall tolerability and acceptability of PLENVU® was similar to the 2LPEG bowel preparation with self-reported adherence rates of around 90% across all treatment groups. The vast majority of patients in the Phase III trial (92–94%) said that PLENVU® was not very difficult to drink and almost all (97–99%) found the product instructions easy to follow. On the issue of taste, approximately 95% of patients in the Phase III study rated the taste of PLENVU® as ‘not very unacceptable’ and the same proportion felt that taking the same bowel preparation again would be acceptable. Overall, 93% of patients on the split-dosing PLENVU® regimen and 90% on the morning-only dose managed to complete their bowel preparation process without significant interference with normal daily activities, compared with 88.5% of patients in the 2LPEG group.7

In the Phase III study, the overall safety profile of PLENVU® was also comparable to that of 2LPEG. Treatment-related adverse events were mostly gastrointestinal, but were typically mild or moderate in severity and only transient.7

Most patients regard bowel preparation as an extremely unpleasant part of the overall colonoscopy experience. Both patients’ satisfaction and their compliance with the prescribed bowel preparation regimen may, therefore, be improved by availability of a lower volume and more palatable oral cleansing treatment. Compliance with the bowel cleansing preparation is crucial in order to ensure the diagnostic success of the colonoscopy. In this real-world study, PLENVU® showed equivalent, if not slightly better, bowel cleansing efficacy to MOVIPREP® as assessed by endoscopists, with 66% classing it as good or excellent compared with 57% for MOVIPREP®.

Key points

  • Effective bowel preparation is vital for a good quality endoscopic procedure
  • Poor bowel preparation may mean pathology and lesions are missed
  • Poor bowel preparation will require either repeat procedures or alternative investigations
  • Full patient compliance with a low-residue diet is necessary for maximum effectiveness of oral bowel cleansing
  • Full patient compliance with oral bowel cleansing preparation is needed to ensure the bowel is optimally cleansed
  • Patients should seek advice from a healthcare professional if they experience problems or have any questions with the low‑residue diet or bowel cleansing preparation.

References

  1. PLENVU® UK Summary of Product Characteristics. Available in the UK from www.medicines.org.uk
  2. MOVIPREP®  UK Summary of Product Characteristics. Available in the UK from www.medicines.org.uk
  3. KLEAN PREP UK Summary of Product Characteristics. Available in the UK from www.medicines.org.uk
  4. Gavin D, Valori R, Anderson J et al. The national colonoscopy audit: a nationwide assessment of the quality and safety of colonoscopy in the UK. Endoscopy. 2013; 62: 242–249.
  5. Hassan C, Bretthauer M, Kaminski M et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2013; 45: 142–150.
  6. Kaminski M, Thomas-Gibson S, Bugajski M et al. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2017; 49: 378–397.
  7. Bisschops R, Manning J, Clayton L et al. Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial. Endoscopy. 2019; 51 (01): 60–72.
  8. Horley S. Data on File. 2019.
  9. DeMicco M, Clayton L, Pilot J et al. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointestinal endoscopy. 2018; 87 (3): 677–687.
  10. Schreiber S, Baumgart D, Drenth J et al. Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial. Endoscopy. 2019; 51 (1): 73–84.

Conflicts of interest

Samantha Horley received an honorarium from Norgine Pharmaceuticals Limited.

This supplement has been commissioned and funded by Norgine Pharmaceuticals Limited and developed in partnership with Guidelines in Practice. Norgine Pharmaceuticals Limited suggested the topic and author, and carried out full medical approval on all materials to ensure compliance with regulations. The sponsorship fee included an honorarium for the author. The views and opinions of the author are not necessarily those of Norgine Pharmaceuticals Limited, or of Guidelines in Practice, its publisher, advisers, or advertisers. No part of this publication may be reproduced in any form without the permission of the publisher. 

UK-GE-PLV-2000026

Date of preparation: January 2021