Endoscopy 2019; 51(04): S71-S72
DOI: 10.1055/s-0039-1681381
ESGE Days 2019 oral presentations
Friday, April 5, 2019 17:00 – 18:30: Colon cleansing 1 Club D
Georg Thieme Verlag KG Stuttgart · New York

PLASMA ELECTROLYTE CONCENTRATIONS AFTER THE USE OF 1L POLYETHYLENE GLYCOL BOWEL PREPARATION NER1006: POST HOC ANALYSIS OF RANDOMISED CLINICAL TRIALS

MA Alvarez-Gonzalez
1   Hospital del Mar, Barcelona, Spain
,
A Repici
2   Humanitas Research Hospital & Humanitas University, Milano, Italy
,
H Thompson
3   Medical Affairs, Norgine, Harefield, United Kingdom
,
S Mokashi
3   Medical Affairs, Norgine, Harefield, United Kingdom
,
C Hassan
4   Gastroenterology and Endoscopic Unit, Ospedale Nuovo Regina Margherita, Roma, Italy
› Author Affiliations
Further Information

Publication History

Publication Date:
18 March 2019 (online)

Also available at
 

Aims:

Bowel preparations contain electrolytes to maintain electrolyte homeostasis after diarrhoea. This post-hoc analysis of randomised, Phase 3 clinical trials assessed plasma sodium concentrations following treatment with the 1L NER1006.

Methods:

The safety of NER1006 was assessed in the studies NOCT, MORA and DAYB. This analysis included patients whose plasma sodium concentrations shifted from normal at baseline to above upper limit normal (ULN) at any subsequent visit. ULN was defined locally and ranged from 143 – 148mmol/L. Timing of blood sample collection was determined by the dosing schedule. Samples were collected at 4 visits: at baseline (1), day of colonoscopy (2), 1 – 4 days (3) and 8 – 10 days (4) post-colonoscopy.

Results:

Among 1134 randomised patients, 1028 had evaluable sodium data and 214 were included in this analysis (Table). A transient shift around 5mmol/L occurred predominantly at Visit 2, with 96.4 – 99.6% patients returning to normal levels by visit 3. More patients in NOCT compared to MORA and DAYB experienced elevated sodium levels. However, in NOCT the baseline value was high with > 50% patients at > 142mmol/L. For such patients, minor shifts of only 2 – 3mmol/L would exceed ULN. There were 4 reported cases of mild hypernatremia across the studies, all of which were considered treatment-related by investigator. No hyponatraemia was observed with NER1006. Across all three studies the median changes in plasma electrolyte levels were transient and not considered clinically significant.

Tab. 1:

Mean sodium plasma levels in NER1006 patients who were normal at baseline but above ULN at subsequent visit (safety set).

Study % patients with shift Normal baseline to ULN

Baseline Mean mmol/L (SD)

Visit 2 Mean mmol/L (SD)

Visit 3 Mean mmol/L (SD)

Visit 4 Mean mmol/L (SD)

MORA (n = 92) 17% (92/531)

142 (2.08)

148 (2.05)

142 (2.83)

143 (2.56)

DAYB (n = 17) 7% (17/235)

141 (1.87)

146 (2.26)

144 (2.68)

143 (2.62)

NOCT (n = 105) 40% (105/262)

141 (1.82)

147 (1.61)

142 (2.23)

142 (2.06)

Overall (n = 214)

142 (1.96)

147 (1.92)

142 (2.57)

142 (2.35)

Conclusions:

Mild, transient increases in plasma electrolyte levels were observed with NER1006 (PLENVU) on visit 2, these were not clinically significant.