Endoscopy 2022; 54(S 01): S19-S20
DOI: 10.1055/s-0042-1744594
Abstracts | ESGE Days 2022
ESGE Days 2022 Oral presentations
11:00–12:00 Thursday, 28 April 2022 Club H. Optimizing bowel preparation and your service's quality

1L NER1006 DEMONSTRATES FAVOURABLE ADHERENCE RATES IN BOTH CLINICAL TRIALS AND THE REAL WORLD

R. Bisschops
1   University Hospitals Leuven, Department of Gastroenterology and Hepatology, Leuven, Belgium
,
H. Neumann
2   University Medical Center Mainz, Department of Medicine 1, Mainz, Germany
3   GastroZentrum Lippe, Bad Salzuflen, Germany
,
C. Allen
4   Salix Pharmaceuticals, Bridgewater, United States
,
A. Repici
5   Humanitas University, Department of Biomedical Sciences, Milan, Italy
6   Humanitas Research Hospital – IRCCS, Department of Gastroenterology, Milan, Italy
› Author Affiliations
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Aims 1L NER1006 is an ultra-low-volume bowel preparation with high-quality cleansing efficacy and a favourable safety profile. Since the introduction of 1L NER1006, it is estimated that it has been used in at least 5.9 million procedures. To understand the patient experience with 1L NER1006, we conducted a systematic literature search for all reported data on patient adherence with 1L NER1006 from clinical trials and real-world studies.

Methods Adherence was defined as the volume of preparation consumed and patient compliance with treatment. We identified five clinical trials and four real-world studies.

Results 1L NER1006 demonstrated significantly better adherence, across both doses of bowel preparation, compared with 4LPEG in a randomised Phase IV clinical trial ([Table 1]; dose one: p=0.03; dose two: p=0.006) (1). In a Phase III randomised clinical trial comparing 1L NER1006 and 2LPEG there was no significant difference in patient adherence to either dose of bowel preparation (dose one: p=0.214; dose two: p=0.183) (2). Similar results were seen in real-world studies. A large multicentre, US real-world non-comparative study, showed 87.1% of patients completed the 1L NER1006 bowel preparation (3). Moreover, in a real-world study involving five Italian centres, adherence rates were found to be comparable for 1L NER1006 (230/233 [98.7%]), 4LPEG (456/490 [93.1%], p=0.078) and 2LPEG (543/566 [95.9%], p=0.357) (4) ([Table 1]).

Tab. 1 Adherence reported in selected clinical trials and real-world studies.

Study

Comparator

Patients adhering to treatment, n/N (%)

1L NER1006

Comparator

p-value

Phase III MORA clinical trial

2LPEG

Dose 1: 242/262 (92.4)

Dose 1: 250/263 (95.1)

0.214

Dose 2: 239/262 (91.2)

Dose 2: 248/263 (94.3)

0.183

Phase IV clinical trial

4LPEG

Dose 1: 192/192 (100)

Dose 1: 185/190 (97.4)

0.030

Dose 2: 190/192 (99.0)

Dose 2: 177/190 (93.2)

0.006

Real-world observational US study

–

1392/1598 (87.1)

–

–

Real-world observational Italian study

2LPEG

230/233 (98.7)

543/566 (95.9)

0.357

4LPEG

456/490 (93.1)

0.078

Conclusions Patient experience with 1L NER1006 was overall favourable in both clinical and real-world settings, with high adherence.



Publication History

Article published online:
14 April 2022

© 2022. European Society of Gastrointestinal Endoscopy. All rights reserved.

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  • References

  • 1 Repici et al 2021,S0016-5107(21)01318-3,
    PubMed
  • 2 Bisschops et al 2019; 51: 60–72
    PubMed
  • 3 Cash et al 2021; 21: 70
    PubMed
  • 4 Maida et al 2020; 26: 1950–61
    PubMed