Bowel cleansing efficacy of 1 L NER1006 versus macrogol and 3 L polyethylene glycol using split-dose administration

JGH Open. 2022 Nov 5;6(12):824-832. doi: 10.1002/jgh3.12816. eCollection 2022 Dec.

Abstract

Background and aim: Colonoscopies are an important diagnostic technique in the detection of colorectal cancer and colonic disease. Adequate examination is dependent on the degree of mucosal visibility, with poor cleansing impeding the detection of neoplasms. These patients require shorter colonoscopy surveillance intervals, longer hospital stays, and increased healthcare costs-rendering a screening colonoscopy cost-ineffective. In Australia and the Gold Coast Hospital and Health Service (GCHHS), macrogol and 3 L of polyethylene glycol are the preferred regimen given its safety profile and efficacy. Yet, little is known locally about the use of the new low-volume bowel preparation NER1006 (Plenvu) given its recent registration with the Therapeutic Goods of Australia (TGA). The primary outcome assessed the bowel cleansing efficacy of NER1006 compared with 7 days of macrogol and 3 L of polyethylene glycol using the Boston Bowel Preparation Scale (BBPS), while also assessing the influence of notable patient characteristics such as age, gender, body mass index (BMI), and the patients Charlson comorbidity index (CCI). Secondary outcomes assessed the polyp detection rate and procedural factors including cecal intubation, scope withdrawal time, and rebooking rates.

Methods: Data from all patients who underwent an outpatient colonoscopy procedure at GCHHS between 1 July 2020 and 30 September 2020 were analyzed. Patients were aged 50-74 years of age and were referred for a screening colonoscopy due to a positive fecal occult blood test (FOBT) result from the National Bowel Cancer Screening Program.

Results: Of the 238 patients who met the inclusion criteria, 108 patients received NER1006 and 130 patients received macrogol and 3 L polyethylene glycol. NER1006 achieved superior overall (P < 0.001) and right-sided colon cleansing (P = 0.016). There was an even distribution of males and females (P = 0.118), the mean age of both cohorts was <65 years of age. The macrogol and 3 L polyethylene glycol group had a statistically higher BMI (P < 0.001) and CCI (P < 0.001). Cecal intubation success was achieved in both cohorts (≥95%) and scope withdrawal time was ≥6 min, polyp detection was non-superior (P = 0.824), but superior in NER1006 when BBPS ≥6 (P = 0.002). Rebooking rates were significantly lower in the NER1006 group (P = 0.013).

Conclusion: This study demonstrated that NER1006 was superior in terms of overall and right-sided bowel cleansing as a primary endpoint. Patient factors demonstrated to be independent predictors of inadequate bowel preparation. Future studies should aim to explore the safety and tolerability of NER1006 while also assessing the bowel cleansing effectiveness in patients with a high BMI and comorbidity index.

Keywords: NER1006; bowel cancer screening; bowel preparation; colonoscopy; colorectal cancer; macrogol; macrogol and polyethylene glycol; polyethylene glycol; polyethylene glycol plus ascorbate; polyp detection rate.