HIGH CLEANSING EFFICACY WITH OVERNIGHT SPLIT DOSING 1 L NER1006 ACROSS BODY MASS INDEX RANGES: POST HOC ANALYSIS OF TWO RANDOMISED PHASE 3 CLINICAL TRIALS

Aims We compared, per body mass index (BMI) range, the cleansing performance of 1 L polyethylene glycol NER1006 (PLENVU) versus two preparations.

Methods This post hoc analysis of two phase 3 clinical trials compared the efficacy of pooled PLENVU versus pooled 2 L polyethylene glycol plus ascorbate (2 LPEG) or oral sulfate solution (OSS) using overnight split-dosing. Pooling increased subgroup sample sizes. The primary efficacy endpoint was the bowel cleansing success, assessed by treatment-blinded central readers using the Harefield Cleansing Scale (HCS). Patients with no primary efficacy data were imputed as failures; the resulting estimates of efficacy were therefore conservative. Overall cleansing success and the mean number of high-quality cleansed segments per patient were calculated per BMI subgroups < 25 (under- and normal weight), 25- < 30 (overweight), and > 30 (obese).

Results Among 1103 included patients, the pooled PLENVU arm (N = 551) achieved a numerically higher overall cleansing success than the pooled 2 LPEG/OSS arm (N = 552) (88.6% vs 86.2%; P = 0.328)(Table). Overall cleansing success rates were consistently high for PLENVU across BMI subgroups (range 88.2%-89.4%) and numerically higher for PLENVU versus comparator in two out of three subgroups: < 25 (89.4% vs 87.7%; P = 0.3573), 25- < 30 (88.2% vs 88.4%; P = 0.4207), or > 30 (88.4% vs 81.8%; P = 0.0535). The mean number of high-quality cleansed segments per patient was significantly greater with PLENVU than 2LPEG/OSS in all comparisons (P < 0.005).

Tab. 1 Overall success rates and high-quality segments per patient in all patients and by body mass index subgroup

	All patients	BMI < 25: Under- and normal weight	BMI 25–30: Overweight	BMI > 30: Obese
Overall cleansing success rate (Pooled PLENVU vs 2LPEG/OSS), % (n/N)	88.6% (488/551) vs 86.2% (476/552)	89.4% (135/151) vs 87.7% (143/163)	88.2% (186/211) vs 88.4% (198/224)	88.4% (167/189) vs 81.8% (135/165)
1-sidedP-value	0.328	0.3573	0.4207	0.0535
High-quality cleansed segments per patient (Pooled PLENVU vs 2LPEG/OSS), mean ± SD	2.3 ± 1.8 vs 1.8 ± 1.8	2.3 ± 1.8 vs 1.7 ± 1.8	2.3 ± 1.8 vs 1.8 ± 1.8	2.4 ± 1.9 vs 1.7 ± 1.8
1-sided P-value	< 0.0001	0.0013	0.0046	0.0013

Conclusions Across BMI ranges, PLENVU achieved high overall cleansing success rates similar to the overall population and comparable to 2LPEG/OSS. The greater segmental high-quality cleansing is consistent with previous reports on trial-specific assessments.