Tu1096 COMPARISION OF THE EFFICACY AND SAFETY OF ORAL TRISULPHATE SOLUTION(OTS) AND POLYETHYLENE GLYOL ELECTROLYTE(PGE-E) AS BOWEL CLEANSING AGENT

Abstract

Polyethylene Glycol Electrolyte (PEG-E) is the primary recommended bowel cleansing agent in current Chinese bowel preparation guidelines. Patient compliance might be influenced by poor taste and large volume (3-4L), which can impact on the clinical outcome. Oral Trisulphate Solution (OTS) is a bowel cleansing agent with fruit favor and lower volume (3L) required. To compare the efficacy and safety of OTS and PGE-E on bowel cleansing before routine colonoscopy. This was a Phase III, multicenter, randomized, controlled, non-inferiority, investigator/assessor-blinded trial (NCT03562884). 294 subjects were included and randomized and 283 subjects (mITT, figure 1) received OTS (Eziclen®, n=143) or PEG-E (Fortrans®, n=140) via 2-days split-dosing regimen. The primary outcome was the proportion of subjects with successful preparation (global BBPS score ≥ 6 by central assessment). The secondary outcomes included BBPS global score, BBPS score by segment, lesion detection rate, proportion of fully compliant, patient satisfaction (6-questions questionnaire, lower score indicated better satisfaction) investigator satisfaction score (5-point Likert scale score) and safety evaluations. Farrington-Manning method was used to comparison the difference between groups. The proportion of subjects with successful cleansing was 100% for OTS and 99.3% for PEG-E (adjusted difference 0.7% (-5.3%, 6.7%), p<0.0001 for non-inferiority). The BBPS global score by central assessment was significantly higher in OTS than PEG-E (8.1(7.9,8.3) vs 7.7(7.5,7.9), p<0.0001) and by investigator higher for OTS (OTS :7.1(6.9,7.4) vs PEG-E: 6.6(6.4,6.9), p<0.0001). The BBPS score by segment was also significantly higher in OTS than PEG-E for all 3 segments by central assessment (p=0.0022, 0.0177, 0.0067 for right, transverse, left colon) and by investigator (p=0.0001, 0.0085, 0.0281 for right, transverse, left colon). OTS’s investigators satisfaction score was significantly higher than PEG-E (2.6 (2.5,2.8) vs 2.3 (2.2,2.5), P=0.0005). No significant difference between groups on patient satisfaction score (p=0.1848), compliance (p=0.2252), lesion detection rate (including adenomas, p=0.5787 and polyps, p=0.1832). Detailed results are shown in Table 1. Most drug-related AEs were mild to moderate and no significant differences between groups. There were no SAEs. OTS had at least equal efficacy to PEG-E and higher BBPs score overall and in all 3 segments. Investigator satisfaction was also significantly higher with OTS. Patient compliance, satisfaction and safety were similar. OTS improved bowel preparation outcomes with comparative safety profile to PEG-E.View Large Image Figure ViewerDownload Hi-res image Download (PPT)