Background & 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 2-day 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 OSS (74.5–77.3% vs. 67.8–69.8%). 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.

Repici, A., Coron, E., Sharma, P., Spada, C., Di Leo, M., Noble, C. L., Gschossmann, J., Bargallo Garcia, A., Baumgart, D. C., Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution, <<DIGESTIVE AND LIVER DISEASE>>, 2019; 51 (12): 1671-1677. [doi:10.1016/j.dld.2019.06.026] [https://hdl.handle.net/10807/250788]

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

Spada, Cristiano;Di Leo, Mauro;
2019

Abstract

Background & 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 2-day 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 OSS (74.5–77.3% vs. 67.8–69.8%). 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.
2019
Inglese
Repici, A., Coron, E., Sharma, P., Spada, C., Di Leo, M., Noble, C. L., Gschossmann, J., Bargallo Garcia, A., Baumgart, D. C., Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution, <<DIGESTIVE AND LIVER DISEASE>>, 2019; 51 (12): 1671-1677. [doi:10.1016/j.dld.2019.06.026] [https://hdl.handle.net/10807/250788]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/250788
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