M Maida1, F S Macaluso2, S Sferrazza3, M Ventimiglia2, E Sinagra4. 1. Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy. Electronic address: marcello.maida@hotmail.it. 2. IBD Unit, Villa Sofia-Cervello Hospital, Palermo, Italy. 3. Gastroenterology and Endoscopy Unit, Santa Chiara Hospital, Trento, Italy. 4. Gastroenterology and Endoscopy Unit, Fondazione Istituto San Raffaele Giglio, Cefalù, Italy.
Abstract
BACKGROUND: A 1 L PEG-based preparation for colonoscopy (NER1006) has been recently developed. AIMS: We conducted a meta-analysis of randomized controlled trials (RCTs) to explore the effectiveness and safety of NER1006 versus traditional preparations. METHODS: PubMed/Medline and Embase were systematically searched through January 2020 for phase-3 RCTs comparing NER1006 versus standard preparations. RESULTS: Three RCTs (1879 participants) met the inclusion criteria and were included. The analysis showed a higher cleansing success for NER1006 compared standard preparations (OR=1.28; 95% CI 1.00-1.62; p = 0.047, I2=0%) as well as a greater high-quality cleansing of the right colon (OR=2.13; 95% CI 1.16-3.94; p = 0.015, I2=76.0%) when assessed by the Harefield Cleansing Scale (HCS). The pooled estimate of the NER1006 effect on ADR showed a higher, although not significant, ADR of the right colon (OR=1.19; 95% CI 0.73-1.92; p = 0.485, I2=53%). When considering the impact of NER1006 on mild to moderate treatment-emergent adverse events (TEAEs), we observed a significant pooled estimate of TEAEs (OR=2.31; 95% CI 1.82-2.94; p<0.001, I2=0%). CONCLUSIONS: When compared to traditional preparations, NER1006 showed a better overall cleansing of the colon as well as a greater high-quality cleansing of the right colon, with comparable ADR. A higher incidence of mild to moderate TEAEs was observed for NER1006, in the absence of serious adverse events.
BACKGROUND: A 1 L PEG-based preparation for colonoscopy (NER1006) has been recently developed. AIMS: We conducted a meta-analysis of randomized controlled trials (RCTs) to explore the effectiveness and safety of NER1006 versus traditional preparations. METHODS: PubMed/Medline and Embase were systematically searched through January 2020 for phase-3 RCTs comparing NER1006 versus standard preparations. RESULTS: Three RCTs (1879 participants) met the inclusion criteria and were included. The analysis showed a higher cleansing success for NER1006 compared standard preparations (OR=1.28; 95% CI 1.00-1.62; p = 0.047, I2=0%) as well as a greater high-quality cleansing of the right colon (OR=2.13; 95% CI 1.16-3.94; p = 0.015, I2=76.0%) when assessed by the Harefield Cleansing Scale (HCS). The pooled estimate of the NER1006 effect on ADR showed a higher, although not significant, ADR of the right colon (OR=1.19; 95% CI 0.73-1.92; p = 0.485, I2=53%). When considering the impact of NER1006 on mild to moderate treatment-emergent adverse events (TEAEs), we observed a significant pooled estimate of TEAEs (OR=2.31; 95% CI 1.82-2.94; p<0.001, I2=0%). CONCLUSIONS: When compared to traditional preparations, NER1006 showed a better overall cleansing of the colon as well as a greater high-quality cleansing of the right colon, with comparable ADR. A higher incidence of mild to moderate TEAEs was observed for NER1006, in the absence of serious adverse events.
Authors: F Panzuto; M Maccauro; D Campana; A Faggiano; S Massironi; S Pusceddu; F Spada; D Ferone; R Modica; C M Grana; P Ferolla; M Rinzivillo; G Badalamenti; M C Zatelli; F Gelsomino; E De Carlo; M Bartolomei; M P Brizzi; S Cingarlini; A Versari; G Fanciulli; E Arvat; E Merola; M Cives; S Tafuto; S Baldari; M Falconi Journal: J Endocrinol Invest Date: 2020-08-16 Impact factor: 4.256