HIGH CLEANSING EFFICACY WITH OVERNIGHT SPLIT DOSING 1 L NER1006 IN BOTH MEN AND WOMEN: POST HOC ANALYSIS OF TWO RANDOMISED PHASE 3 CLINICAL TRIALS

Aims We compared, per gender, 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 colon cleansing efficacy of pooled PLENVU versus pooled 2L polyethylene glycol plus ascorbate (2LPEG) or oral sulfate solution (OSS) using overnight-split dosing. Pooling of arms increased the sample size for subgroup analyses. 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 gender (males and females).

Results A total of 1103 patients were included. The pooled PLENVU arm (N = 551) achieved a numerically higher overall cleansing success than the pooled 2LPEG/OSS arm (N = 552) (88.6% vs 86.2%; P = 0.328)([Table]). Overall cleansing success rates were high for NER1006 across gender (86.7%-90.2%), and, versus 2LPEG/OSS, were comparable in men (86.7% vs 88.9%; P = 0.7238) and significantly higher in women (90.2% vs 83.2%; P = 0.0071). The mean number of high-quality cleansed segments per patient was significantly greater with NER1006 than 2LPEG/OSS in all performed comparisons (P < 0.001).

Tab. 1 Overall success rates and high-quality segments per patient in all patients and by gender

	All patients	Male	Female
Overall cleansing success rate (Pooled PLENVU vs 2LPEG/OSS), % (n/N)	88.6%(488/551) vs 86.2%(476/552)	86.7%(221/255) vs 88.9%(263/296)	90.2%(267/296) vs 83.2%(213/256)
1-sided P-value	0.328	0.7238	0.0071
High-quality cleansed segments per patient (Pooled PLENVU vs 2LPEG/OSS), mean ± SD	2.3 ± 1.8 vs 1.8 ± 1.8	2.2 ± 1.8 vs 1.7 ± 1.7	2.4 ± 1.8 vs 1.8 ± 1.9
1-sided P-value	< 0.0001	0.0006	0.0005

Conclusions PLENVU achieved overall cleansing success rates in men and women of similar high magnitude as the overall population. While comparable in men, in women PLENVU achieved a greater overall cleansing success rate versus 2LPEG/OSS. The greater segmental high-quality cleansing with PLENVU is consistent with previous reports on trial-specific assessments.