Comparative Evaluation of the Efficacy of Polyethylene Glycol With Ascorbic Acid and an Oral Sulfate Solution in a Split Method for Bowel Preparation: A Randomized, Multicenter Phase III Clinical Trial

Kim, Bun; Lee, Seong Dae; Han, Kyung Su; Kim, Jae Hak; Youk, Eui-Gon; Nam, Myung Jin; Lee, Dong Hoon; Sohn, Dae Kyung

doi:10.1097/dcr.0000000000000759

Cited by 25 publications

(40 citation statements)

References 33 publications

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“…This paper focused on the effectiveness of the formulation, not the safety. This study supports previous studies [13][14][15]28 that showed the non-inferiority of OSS compared with PEG-AA. Interestingly, OSS may be of benefit for older patients and female patients.…”

Section: Discussionsupporting

confidence: 92%

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Comparison of Oral Sulfate Solution and Polyethylene Glycol Plus Ascorbic Acid on the Efficacy of Bowel Preparation

et al. 2020

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Background/Aims: The quality of bowel preparation is one of the quality indicators for colonoscopy. The aim of this study was to compare the efficacy of oral sulfate solution (OSS) and polyethylene glycol plus ascorbic acid (PEG-AA) for bowel preparation. Methods: The study involved 167 patients who underwent diagnostic colonoscopies. Inadequate bowel preparation was defined as any score of ≤1 in each colon section based on the Boston Bowel Preparation Scale. Multivariate logistic regression was used to compare the efficacy of OSS and PEG-AA. Subgroup analyses were performed based on patient characteristics. Results: Overall, 106 (63.5%) patients received OSS, and 61 (36.5%) patients received PEG-AA. The rate of inadequate bowel preparation was 12.3% in patients receiving OSS and 32.8% in patients receiving PEG-AA (p=0.001). OSS (odds ratio [OR] = 0.26; p=0.003) and morning examination (OR=0.11; p=0.038) were significantly associated with efficient bowel preparation. The efficacy of OSS compared with PEG-AA was only significant in patients ≥50 years of age vs. <50 years of age (OR=0.13; p=0.001 vs. OR=0.96; p=0.959) and female vs. male patients (OR=0.06; p=0.002 vs. OR=0.58; p=0.339). Conclusions: OSS was significantly more efficient for bowel preparation than PEG-AA, especially in patients ≥50 years of age and female patients. Morning examination led to a good quality of bowel preparation, irrespective of the preparation regimen. Clin Endosc 2020 Apr 24.

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Section: Discussionsupporting

confidence: 92%

“…Concurrently, several randomized clinical trials have shown that OSS has comparable or better outcomes than PEG formulations and has acceptable safety. [14][15][16] Thus, this observational study aimed to compare the efficacy of OSS and PEG-AA and to identify the patient characteristics that were favorable to certain formulations.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Oral Sulfate Solution and Polyethylene Glycol Plus Ascorbic Acid on the Efficacy of Bowel Preparation

et al. 2020

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“…This analysis better reflects the real-world cleansing performance of NER1006 versus current alternatives such as 2LPEG (MOVIPREP ® , Norgine Ltd, Harefield, UK; assessed in the MORA trial) and oral sulfate solution (OSS; SUPREP ® , Braintree Laboratories, Braintree, MA, USA; assessed in the NOCT trial). These two comparators are both widely used and known for their high cleansing efficacy [23][24][25][26][27]. For a robust assessment of comparative cleansing efficacy, three complementary efficacy measures were analyzed: first, the patient-level rates of standard HCS overall colon cleansing success; then, the patient-level rate of overall high-quality cleansing; finally, the rate of segments cleansed at high-quality across the patient population ('population-level').…”

Section: Introductionmentioning

confidence: 99%

Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution

Repici

Coron

Spada

et al. 2019

Digestive and Liver Disease

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a b s t r a c tBackground & aims: Colonoscopy requires bowel cleansing for gut mucosa visualization; high-quality cleansing facilitates lesion detection. NER1006 is a 1L polyethylene glycol (PEG) bowel preparation. This post hoc analysis of two randomized trials investigated cleansing efficacy assessed, as in clinical practice, by site endoscopists. Methods: Patients received NER1006, 2L PEG + ascorbate (2LPEG), or oral sulfate solution (OSS) as a 2day evening/morning regimen (N2D) or NER1006 morning-only dosing (N1D). Treatment-blinded site endoscopists assessed cleansing using the Harefield Cleansing Scale (HCS). Analyses were conducted in a modified full analysis set, including (mFAS; n = 1378) or excluding (mFAS2; n = 1319) imputed failures, and in patients with 100% treatment adherence (mFAS100; n = 1047). Overall cleansing success (HCS grade A/B), overall high-quality cleansing (HCS grade A), and high-quality segments (HCS 3-4) per treatment population were analyzed. Results: Overall cleansing success was higher with N2D than 2LPEG (92.7-97.5% vs. 87.9-93.0%), and more patients had overall high-quality cleansing with N2D and N1D than 2LPEG (68.0-72.1% and 64.0-68.4% vs. 50.7-56.0%). Without imputed failures, N2D delivered more overall high-quality cleansing than ). More high-quality segments were demonstrated with N2D and N1D versus 2 LPEG (82.5-87.1% and 79.4-84.4% vs. 70.4-76.3%) and with N2D versus OSS (82.7-89.5% vs. 78.1-84.4%). Conclusion: When assessed by site endoscopists, NER1006 delivers greater high-quality cleansing than 2LPEG or OSS.

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“…The analysis was performed by study. Because 2LPEG and OSS have between them shown a comparable cleansing efficacy in two recent randomized controlled trials, the NOCT and MORA data sets were combined for an analysis of combined NER1006 versus combined 2LPEG/OSS [31,32]. Hereafter, combined NER1006 and combined 2LPEG/OSS will simply be referred to as NER1006 and 2LPEG/ OSS, respectively.…”

Section: Assessmentsmentioning

confidence: 99%

High-quality colon cleansing and multiple neoplasia detection with 1L NER1006 versus mid-volume options: Post hoc analysis of phase 3 clinical trials

Epstein¹,

Bénamouzig

Halonen

et al. 2020

Endosc Int Open

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Background and study aims Multiple neoplasia increase the risk of colorectal cancer. High-quality cleansing may improve adenoma detection. We assessed whether a new bowel preparation can improve colon cleansing and multiple lesion detection. Patients and methods This post hoc analysis of two randomized clinical trials in Europe and the US assessed the per study and combined cleansing efficacy of overnight split dosing with (preparation + clear fluids) 1 + 1 L polyethylene glycol (PEG) NER1006 versus 2 + 1 L PEG + ascorbate (2LPEG) or 1 + 2 L oral sulfate solution (OSS) combined. Treatment-blinded central readers assessed cleansing quality using the Harefield Cleansing Scale (HCS). Patients with full segmental scoring were included. HCS segmental scores 0–4 (high-quality = HCS 3–4) were analyzed for NER1006 versus 2LPEG/OSS. Mean number of polyps or adenomas per patient (MPP/MAP) was calculated for treatments in patients with at least one polyp or adenoma. Results In 1037 patients, NER1006 attained a greater rate of HCS 3 scores (29 % vs. 20 %; P < 0.001) and HCS 4 scores (20 % vs. 17 %; P = 0.007) versus 2LPEG/OSS. More polyps (678 versus 585) and adenomas (397 versus 331) were detected with NER1006 (N = 517) versus 2LPEG/OSS (N = 520). In all neoplasia-positive patients, with increasing minimal per-patient neoplasia multiplicity from 1 to 10, NER1006 numerically improved MPP (difference ± SE: 0.48 ± 0.24 to 3.89 ± 3.37) and MAP (0.47 ± 0.26 to 7.50 ± 9.00) versus 2LPEG/OSS. Conclusions Low-volume NER1006 enhances high-quality cleansing versus medium-volume 2LPEG or OSS, individually and when combined. NER1006 may consequently facilitate the detection of multiple neoplasia in patients.

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Comparative Evaluation of the Efficacy of Polyethylene Glycol With Ascorbic Acid and an Oral Sulfate Solution in a Split Method for Bowel Preparation: A Randomized, Multicenter Phase III Clinical Trial

Abstract: Oral sulfate solution is effective at colonoscopy cleansing and has acceptable tolerability when it is compared with polyethylene glycol with ascorbic acid. The taste and flavor of oral sulfate solution still need to be improved to enhance tolerability.

Cited by 25 publications

References 33 publications

Comparison of Oral Sulfate Solution and Polyethylene Glycol Plus Ascorbic Acid on the Efficacy of Bowel Preparation

Comparison of Oral Sulfate Solution and Polyethylene Glycol Plus Ascorbic Acid on the Efficacy of Bowel Preparation

Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution

High-quality colon cleansing and multiple neoplasia detection with 1L NER1006 versus mid-volume options: Post hoc analysis of phase 3 clinical trials

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Comparative Evaluation of the Efficacy of Polyethylene Glycol With Ascorbic Acid and an Oral Sulfate Solution in a Split Method for Bowel Preparation: A Randomized, Multicenter Phase III Clinical Trial

Abstract: Oral sulfate solution is effective at colonoscopy cleansing and has acceptable tolerability when it is compared with polyethylene glycol with ascorbic acid. The taste and flavor of oral sulfate solution still need to be improved to enhance tolerability.

Cited by 25 publications

References 33 publications

Comparison of Oral Sulfate Solution and Polyethylene Glycol Plus Ascorbic Acid on the Efficacy of Bowel Preparation

Comparison of Oral Sulfate Solution and Polyethylene Glycol Plus Ascorbic Acid on the Efficacy of Bowel Preparation

Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution

High-quality colon cleansing and multiple neoplasia detection with 1L NER1006 versus mid-volume options: Post hoc analysis of phase 3 clinical trials

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Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution