SAFETY OF NER1006 IN ELDERLY: A POST-HOC ANALYSIS OF A PROSPECTIVE, MULTICENTER COHORT

Aims This study aimed to assess the difference of NER1006 (Plenvu Norgine, Harefield, UK) safety profile in elderly compared to younger patients in a real-life setting.

Methods We performed a post-hoc analysis of data from a cohort of 1289 patients undergoing a colonoscopy after an afternoon-only or an afternoon-morning preparation with a 1, 2 or 4L PEG-based solution consecutively enrolled from September 2018 to February 2019 in 5 Italian centres. The elderly population was defined by an age ≥65 years. Safety was monitored through adverse events (AEs) reporting.

Results Among 1289 patients, 233 subjects undergoing a bowel preparation with NER1006 were included in the analysis. The mean age was 59.5±15.9 years, 52.4% of patients were male, and 43.5% were older than 65 years old. Prevalence of obesity, hypertension, diabetes and renal failure was 12.2 vs 13.9% (p=0.7), 13.7 vs 32.7% (p=0.03), 3.1 vs 9.9% (p=0.001) and 1.7 vs 2.5% (p=0.3) in the two groups, respectively. Overall incidence of AEs was 19.8% and 10.9% (p=0.06) in the group of patients aged < 65 and ≥65 years. Incidence of nausea, vomit, abdominal pain, dehydration and headache was 3.1 vs 3.0% (p=0.9), 9.9 vs 5.9% (p=0.2), 0.8 vs 0.0% (p=0.3) 2.3 vs 0.0% (p=0.1) and 2.3 vs 0.0% (p=0.1), in the group of patients aged < 65 and ≥65 years, respectively. No serious AE or deaths occurred in any of the two groups.

Conclusions In this post-hoc analysis, we did not find any substantial difference in the safety profile of NER1006 in the elderly compared to younger patients. Given the observational nature of our study, an assessment of blood electrolyte or creatinine was not feasible. Nevertheless, no clinical event attributable to electrolyte imbalance or dehydration was observed in any patient. These results confirm the safety of this product even in the elderly and in a real-life setting.