Safety and Biological Tolerability of a New 2-Litre Gut Cleansing Solution Containing PEG+E in Patient Risk Groups Undergoing Colonoscopy

Abstract

Aim: To demonstrate that a new oral 2L gut cleansing solution PEG+E plus ascorbate (2L PEG+E) is as safe and well tolerated as the standard 4L PEG+E bowel preparation in risk group patients undergoing colonoscopy. Methods: A randomised, single-blind, multicentre study with two parallel treatment groups (2L PEG+E/Sol.A versus 4L standard PEG+E/Sol.B) included inpatients (aged: 18-85 years) undergoing routine colonoscopy. Both gut lavage solutions were taken as half the dose the evening before followed by the other half on the morning of the colonoscopy. Several subgroups were included: elderly, patients with inflammatory bowel disease (IBD), patients with concomitant cardiovascular (CV) disease and patients with impaired kidney function (creatinine clearance <80 mL/min). The laboratory results were summarised for changes from baseline or clinical significance. Endpoints of the analysis were the rate of adverse events, biological safety, patient acceptance and tolerance in relation to the observed gut cleansing quality. Results: 359 inpatients (180 with Sol.A and 179 with Sol.B) were included in the study. 87 patients (36 with Sol.A/51 with Sol.B) had an age between 65 and 75 years and 53 patients (26 with Sol.A/27 with Sol.B) an age above 75 years. 26 patients (17 with Sol.A/9 with Sol.B) had IBD, 75 patients (41 with Sol.A/34 with Sol.B) had a concomitant CV disease and 147 patients (68 Sol.A/79 Sol.B) an impaired kidney function. None of the risk factors, including age, concomitant CV disease and/or impaired renal function influenced the rate of effective gut cleansing. The observed frequency of adverse events was not different from the gereral population or the established safety profile of standard PEG+E. No clinically relevant differences were observed for the laboratory results. In terms of patient satisfaction, acceptability and taste, patients consistently preferred Sol.A over Sol.B., independent of the presence of risk factors. Similarly, the rating for “no problem” to drink the entire gut cleansing solution was in favour of the 2L Sol.A without any effects of age, CV conditions or impaired kidney function. Conclusion: The analysis has confirmed that the new 2L PEG+E solution is as safe as the well established 4-litre PEG+E solution, including patient subgroups with risk factors, undergoing routine colonoscopies. All patient groups can be prepared with the improved 2L PEG+E solution to enhance the patient acceptance for the colonoscopy procedure. Aim: To demonstrate that a new oral 2L gut cleansing solution PEG+E plus ascorbate (2L PEG+E) is as safe and well tolerated as the standard 4L PEG+E bowel preparation in risk group patients undergoing colonoscopy. Methods: A randomised, single-blind, multicentre study with two parallel treatment groups (2L PEG+E/Sol.A versus 4L standard PEG+E/Sol.B) included inpatients (aged: 18-85 years) undergoing routine colonoscopy. Both gut lavage solutions were taken as half the dose the evening before followed by the other half on the morning of the colonoscopy. Several subgroups were included: elderly, patients with inflammatory bowel disease (IBD), patients with concomitant cardiovascular (CV) disease and patients with impaired kidney function (creatinine clearance <80 mL/min). The laboratory results were summarised for changes from baseline or clinical significance. Endpoints of the analysis were the rate of adverse events, biological safety, patient acceptance and tolerance in relation to the observed gut cleansing quality. Results: 359 inpatients (180 with Sol.A and 179 with Sol.B) were included in the study. 87 patients (36 with Sol.A/51 with Sol.B) had an age between 65 and 75 years and 53 patients (26 with Sol.A/27 with Sol.B) an age above 75 years. 26 patients (17 with Sol.A/9 with Sol.B) had IBD, 75 patients (41 with Sol.A/34 with Sol.B) had a concomitant CV disease and 147 patients (68 Sol.A/79 Sol.B) an impaired kidney function. None of the risk factors, including age, concomitant CV disease and/or impaired renal function influenced the rate of effective gut cleansing. The observed frequency of adverse events was not different from the gereral population or the established safety profile of standard PEG+E. No clinically relevant differences were observed for the laboratory results. In terms of patient satisfaction, acceptability and taste, patients consistently preferred Sol.A over Sol.B., independent of the presence of risk factors. Similarly, the rating for “no problem” to drink the entire gut cleansing solution was in favour of the 2L Sol.A without any effects of age, CV conditions or impaired kidney function. Conclusion: The analysis has confirmed that the new 2L PEG+E solution is as safe as the well established 4-litre PEG+E solution, including patient subgroups with risk factors, undergoing routine colonoscopies. All patient groups can be prepared with the improved 2L PEG+E solution to enhance the patient acceptance for the colonoscopy procedure.