Marcello Maida, MD1, Sandro Sferrazza, MD2, Emanuele Sinagra, MD3, Gaetano Morreale, MD1, Michele Manganaro, MD1, Giuseppe Scalisi, MD4, Dario Schillaci, MD5, Giovanni Vettori, MD2, Giuseppe Conoscenti, MD3, Concetta Di Bartolo, MD4, Serena Garufi, MD1, Clara Maria Virgilio, MD4, Salvatore Camilleri, MD1
1S. Elia-Raimondi Hospital, Caltanissetta, Sicilia, Italy; 2Santa Chiara Hospital, Trento, Trentino-Alto Adige, Italy; 3Fondazione Istituto San Raffaele Giglio, Cefalù, Sicilia, Italy; 4ARNAS Garibaldi, Catania, Sicilia, Italy; 5Basarocco Hospital, Niscemi, Sicilia, Italy
Introduction: The effectiveness of bowel cleansing is a key element for a quality colonoscopy since it affects diagnostic accuracy and adenoma detection rate. A very-low-volume 1L PEG solution (NER1006) has been recently introduced after the publication of three phase 3 randomized controlled trials showing non-inferiority respect to comparators. Despite its proven effectiveness, the safety of NER1006 in the elderly has never been assessed in a real-life setting.
Methods: This study aimed to assess the safety profile of NER1006 in the elderly compared to younger patients in a real-life setting. We performed a post-hoc analysis of data from a cohort of 1289 patients undergoing a colonoscopy after a afternoon-only or a afternoon-morning preparation with a 1, 2 or 4L PEG-based solution consecutively enrolled from September 2018 to February 2019 in 5 Italian centers. The elderly population was defined by an age ≥65 years. Safety was monitored through adverse events 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. Mean age was 48.6±11.9 years (range 18-64) in the group of patients aged < 65 years, and 73.7±6.3 years (range 65-91) in the group of patients aged ≥65 years, while prevalence of hypertension, diabetes, and obesity was 13.7 vs. 32.7% (p=0.03), 3.1 vs. 9.9% (p=0.001) and 12.2 vs. 13.9% (p=0.7) in the two groups, respectively. Overall incidence of adverse events 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 adverse events or deaths occurred in any of the two groups.
Discussion: 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.
Citation: Marcello Maida, MD; Sandro Sferrazza, MD; Emanuele Sinagra, MD; Gaetano Morreale, MD; Michele Manganaro, MD; Giuseppe Scalisi, MD; Dario Schillaci, MD; Giovanni Vettori, MD; Giuseppe Conoscenti, MD; Concetta Di Bartolo, MD; Serena Garufi, MD; Clara Maria Virgilio, MD; Salvatore Camilleri, MD. P0125 - SAFETY OF NER1006 IN THE ELDERLY: A POST-HOC ANALYSIS OF A PROSPECTIVE, MULTICENTER COHORT. Program No. P0125. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.