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DOI: 10.1055/s-0038-1637289
HIGHER MEAN HAREFIELD CLEANSING SCALE SCORES WITH 1L PEG-BASED NER1006 VERSUS 2L PEG + ASCORBATE: POST HOC ANALYSIS OF A RANDOMISED PHASE 3 CLINICAL TRIAL
Publikationsverlauf
Publikationsdatum:
27. März 2018 (online)
Aims:
The cleansing efficacy and safety of NER1006 (PLENVU®), a novel 1L polyethylene glycol (PEG)-based bowel preparation, were assessed versus standard 2L PEG + Ascorbate in the randomised phase 3 clinical trial MORA. This post hoc analysis of MORA assessed cleansing efficacy as the mean segmental cleansing scores using the Harefield Cleansing Scale (HCS).
Methods:
Patients (n = 849) aged 18 – 85 years were randomised to split-dosing bowel preparation with NER1006 evening/morning (NER1006 PM/AM), NER1006 morning only (NER1006 AM/AM), or 2L PEG + ascorbate (2L PEG + Ascorbate PM/AM).
Cleansing quality was assessed by treatment-blinded central readers using the HCS and scored 0 – 4 in each of the five HCS colon segments. Mean scores were calculated.
Results:
792 patients were analysed (Table 1). In all five segments, NER1006 PM/AM attained higher mean segmental HCS scores than 2L PEG + Ascorbate PM/AM (2.4 vs. 2.1, P < 0.0001; 2.6 vs. 2.3 vs. P < 0.0001; 2.6 vs. 2.4, P = 0.0006; 2.80 vs. 2.6, P = 0.0071; and 3.1 vs. 2.8, P < 0.0001). NER1006 AM/AM achieved higher mean segmental scores in the ascending colon plus caecum, transverse colon, descending colon, and rectum (2.4 vs. 2.1, P < 0.0001; 2.5 vs. 2.3, P < 0.0001; 2.6 vs. 2.4, P < 0.0001; 2.9 vs. 2.8, P = 0.0293).
HCS cleansing scores, mean (SD) [P-value vs. 2L PEG + Ascorbate PM/AM] |
NER1006 PM/AM, N = 262 |
NER1006 AM/AM, N = 270 |
2L PEG + Ascorbate PM/AM, N = 260 |
HCS Ascending colon |
2.4 (0.74) [P < 0.0001] |
2.4 (0.79) [P < 0.0001] |
2.1 (0.70) |
HCS Transverse colon |
2.6 (0.73) [P < 0.0001] |
2.5 (0.83) [P < 0.0001] |
2.3 (0.73) |
HCS Descending colon |
2.6 (0.78) [P = 0.0006] |
2.6 (0.83) [P < 0.0001] |
2.4 (0.75) |
HCS Sigmoid colon |
2.8 (0.87) [P = 0.0071] |
2.7 (0.93) [P = 0.0892 |
2.6 (0.88) |
HCS Rectum |
3.1 (0.86) [P < 0.0001 |
2.9 (0.93) [P = 0.0293] |
2.8 (0.90) |
Conclusions:
Both NER1006 dosing regimens, NER1006 PM/AM and NER1006 AM/AM, are more effective bowel preparations than 2L PEG + Ascorbate. NER1006 is the first low volume bowel preparation to demonstrate higher cleansing efficacy than standard 2L PEG + Ascorbate.