530 Electrolyte Shifts of NER1006 Bowel Preparation for Colonoscopy in the Elderly Are Transient and Well-Tolerated

Abstract

INTRODUCTION: Bowel preparation safety is important, especially in the elderly. The 1L PEG-based bowel preparation NER1006 is indicated for colon cleansing in preparation for colonoscopy in adults. An analysis of data from a phase 3 randomized study was conducted, subgrouping patients by age (≤65 and >65 y). METHODS: Adults undergoing colonoscopy were randomly assigned to receive NER1006 or oral sodium sulfate (OSS; evening/morning split-dosing) with total minimum volume requirements of 64 oz (NER1006) and 96 oz (OSS). Safety assessments included monitoring adverse events (AEs) and clinical laboratory testing. Plasma electrolyte levels were measured at baseline, Day 2 (day of colonoscopy), Day 4 ± 1, and Day 9 ± 1. The safety population included all patients who received ≥1 study dose. Upper limit of normal cut-off values were 145 mmol/L (sodium), 105 mmol/L (chloride), and 5 mmol/L (potassium). RESULTS: The safety population included 262 (NER1006) and 265 (OSS) patients. Most patients were aged ≤65 y (NER1006, n=214; OSS, n = 217). In patients >65 y, the most common AEs were nausea (10.4%) and vomiting (8.3%) with NER1006 and decreased glomerular filtration rate (6.3%) with OSS. Mean baseline sodium levels were similar for NER1006 and OSS in patients ≤65 y (141 mmol/L) and >65 y (140 mmol/L). A greater percentage of patients >65 y with normal baseline sodium levels had high sodium levels ( >145 mmol/L) on Day 2 with NER1006 (48.9%) vs OSS (6.5%); shifts were transient and 93.5% of NER1006-treated patients had normal sodium levels by Day 4 (mean, 141 mmol/L). In patients ≤65 y in NER1006 group, 37.6% had a shift in sodium levels from normal at baseline to high at Day 2 (mean, 144.5 mmol/L) vs 3.7% with OSS; 90.9% of NER1006-treated patients had normal sodium levels by Day 4 (mean, 141.3 mmol/L). Chloride levels transiently increased from baseline in 27.7% (>65 y) and 19.2% (≤65 y) of patients at Day 2 with NER1006; 84.8% and 83.8% had normal levels by Day 4. At least 95% of NER1006-treated patients in both age groups had normal potassium levels from baseline through Day 9. Hyperuricemia was not reported in either age or treatment group. No electrolyte shifts resulted in clinical sequelae. CONCLUSION: NER1006 was generally well tolerated regardless of age. Transient increases in sodium and chloride levels were observed on the day of colonoscopy, but changes were not clinically meaningful and levels returned to normal in most patients by Day 4. Funding: Norgine BV/Salix Pharmaceuticals.