A European, multicentre, observational, post-authorisation safety study of oral sulphate solution: compliance and safety

Abstract

Background and study aims Oral sulphate solution (OSS) is a sulphate-based, low-volume bowel cleansing preparation taken in two doses of 500 mL, each followed by 1000mL of water or clear liquid. The primary objective of this observational study was to document compliance with the recommended hydration guidelines in a representative sample of the European population.

Patients and methods Prospective, non-interventional, multicentre study (NCT02630680, EUPAS9361) in patients prescribed OSS for colonoscopy preparation in routine clinical practice in Europe. Patients were included according to pre-agreed consecutive enrolment rules. Patients recorded the volume of OSS and water or clear liquid intake, and occurrence of adverse events (AEs). Compliance with hydration was calculated as a ratio of actual volume of water/clear liquid taken versus prescribed 2,000 mL, and non-compliance defined as < 75 % intake. Colon cleansing level was assessed on a 4-point scale.

Results Between October 2015 and January 2017, 1,281 patients were recruited in 16 centres in four European countries (safety population n = 1,206; registry population n = 1,177). Of patients, 94.5 % were ≥ 75 % and 86.8 % 100 % compliant with hydration guidelines. Patients took an average of 96.8 % of the recommended OSS volume; 46 patients (3.9 %) were non-compliant. Colon cleansing levels were good-to-excellent in 87.6 % of patients. Three hundred and twenty-nine patients (27.3 %) experienced 758 treatment-related AEs, mostly gastrointestinal (82.9 %), all were mild-to-moderate. Non-compliant patients had no AEs suggestive of dehydration.

Conclusion In this non-interventional study in a real-life setting, treatment compliance with hydration guidelines was good-to-excellent in 94.5 % of patients receiving OSS. The safety profile of OSS was similar to the prescribing information.

TRIAL REGISTRATION: Observational study EUPAS9361 at www.encepp.eu

Publication History

Received: 08 July 2019

Accepted: 15 October 2019

Article published online:
21 February 2020

• References

• 1 Hassan C, Bretthauer M, Kaminski MF. et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2013; 45: 142-150
• 2 Menees SB, Kim HM, Wren P. et al. Patient compliance and suboptimal bowel preparation with split-dose bowel regimen in average-risk screening colonoscopy. Gastrointest Endosc 2014; 79: 811-820 e813
• 3 Beck DE. Bowel preparation for colonoscopy. Clin Colon Rectal Surg 2010; 23: 10-13
• 4 American Society of Colon Rectal Surgeons, American Society for Gastrointestinal Endoscopy, Society of American Gastrointestinal Endoscopic Surgeons. et al. A consensus document on bowel preparation before colonoscopy: prepared by a Task Force from the American Society of Colon and Rectal Surgeons (ASCRS), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Surg Endosc 2006; 20: 1161
• 5 Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc 2003; 58: 76-79
• 6 Lebwohl B, Kastrinos F, Glick M. et al. The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc 2011; 73: 1207-1214
• 7 Ness RM, Manam R, Hoen H. et al. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol 2001; 96: 1797-1802
• 8 Chung YW, Han DS, Park KH. et al. Patient factors predictive of inadequate bowel preparation using polyethylene glycol: a prospective study in Korea. J Clin Gastroenterol 2009; 43: 448-452
• 9 Govani SM, Elliott EE, Menees SB. et al. Predictors of suboptimal bowel preparation in asymptomatic patients undergoing average-risk screening colonoscopy. World J Gastrointest Endosc 2016; 8: 616-622
• 10 Harewood GC, Wiersema MJ, Melton LJ. et al. A prospective, controlled assessment of factors influencing acceptance of screening colonoscopy. Am J Gastroenterol 2002; 97: 3186-3194
• 11 Kilgore TW, Abdinoor AA, Szary NM. et al. Bowel preparation with split-dose polyethylene glycol before colonoscopy: a meta-analysis of randomized controlled trials. Gastrointest Endosc 2011; 73: 1240-1245
• 12 Seo EH, Kim TO, Park MJ. et al. Optimal preparation-to-colonoscopy interval in split-dose PEG bowel preparation determines satisfactory bowel preparation quality: an observational prospective study. Gastrointest Endosc 2012; 75: 583-590
• 13 Marmo R, Rotondano G, Riccio G. et al. Effective bowel cleansing before colonoscopy: a randomized study of split-dosage versus non-split dosage regimens of high-volume versus low-volume polyethylene glycol solutions. Gastrointest Endosc 2010; 72: 313-320
• 14 World Health Organization. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Bulletin of the World Health Organization 2001; 79: 373-374
• 15 Izinova concentrate for oral solution. Summary of Product Characteristics. 2015
• 16 Di Palma JA, Rodriguez R, McGowan J. et al. A randomized clinical study evaluating the safety and efficacy of a new, reduced-volume, oral sulfate colon-cleansing preparation for colonoscopy. Am J Gastroenterol 2009; 104: 2275-2284
• 17 Di Palma JA, Wolff BG, Meagher A. et al. Comparison of reduced volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy colon cleansing. Am J Gastroenterol 2003; 98: 2187-2191
• 18 Di Palma JA, McGowan J, Cleveland MV. Clinical trial: an efficacy evaluation of reduced bisacodyl given as part of a polyethylene glycol electrolyte solution preparation prior to colonoscopy. Aliment Pharmacol Ther 2007; 26: 1113-1119
• 19 Rex DK, DiPalma JA, McGowan J. et al. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc 2014; 80: 1113-1123
• 20 Rex DK, Di Palma JA, Rodriguez R. et al. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc 2010; 72: 328-336
• 21 Hill NR, Fatoba ST, Oke JL. et al. Global Prevalence of Chronic Kidney Disease - A Systematic Review and Meta-Analysis. PLoS One 2016; 11: e0158765
• 22 Pimpin L, Cortez-Pinto H, Negro F. et al. Burden of liver disease in Europe: Epidemiology and analysis of risk factors to identify prevention policies. J Hepatol 2018; 69: 718-735
• 23 Blachier M, Leleu H, Peck-Radosavljevic M. et al. The burden of liver disease in Europe: a review of available epidemiological data. J Hepatol 2013; 58: 593-608
• 24 Sarin S, Maiwall R. Global burden of liver disease: a true burden on health sciences and economies. World Gastroenterology Organanisation 2012 17.
• 25 Holt EW, Yimam KK, Ma H. et al. Patient tolerability of bowel preparation is associated with polyp detection rate during colonoscopy. J Gastrointestin Liver Dis 2014; 23: 135-140
• 26 Lawrance IC, Willert RP, Murray K. A validated bowel-preparation tolerability questionnaire and assessment of three commonly used bowel-cleansing agents. Dig Dis Sci 2013; 58: 926-935
• 27 Anastassopoulos K, Farraye FA, Knight T. et al. A comparative study of treatment-emergent adverse events following use of common bowel preparations among a colonoscopy screening population: results from a post-marketing observational study. Dig Dis Sci 2016; 61: 2993-3006