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Article 8, 3/2016

ORIGINAL PAPER

Superiority of a Split-dose Regimen of Sodium Picosulfate/Magnesium Citrate (SPMC) in Comparison to a Prior-day Schedule (AM/PM) for Colonoscopy Preparation. A Randomized Single-blinded Study

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Christian Schulz1, Joachim Müller2, Joachim Sauter3, Stephan Miehlke4, Christoph Schmöcker5, Dirk Hartmann5, Peter Malfertheiner1, Carlos Badiola6

1) Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von- Guericke-University of Magdeburg, Magdeburg;
2) Praxiszentrum Schweinfurt, Schweinfurt;
3) Praxis Dr. Sauter. Wangen;
4) Center for Digestive Diseases, Internal Medicine Center, Eppendorf, Hamburg; 5) Department of Internal Medicine I, Sana-Klinikum Lichtenberg, Berlin, Germany 6) Medical Department, Casen Recordati, Spain

DOI: http://dx.doi.org/ 10.15403/jgld.2014.1121.253.mag

ABSTRACT
Background & Aims: Split-dose regimens are generally recommended for bowel cleansers. However, other regimens still remain in the summary of product characteristics of some bowel cleansers in Europe. The aim of this study is to compare the efficacy and safety of a split-dose regimen of sodium picosulfate/magnesium citrate (SPMC) with a prior-day schedule (AM/PM).

Methods: Multicenter, randomized (EudraCT no. 2013-001620-20), endoscopist-blinded, parallel study, carried out in subjects 18 years or older undergoing elective colonoscopy. The primary endpoint was the bowel cleansing assessment using a binary transformation (adequate/inadequate) of the Global Preparation Assessment (GPA) scale. Additional parameters analyzed were the segmental assessment of bowel cleansing (RSS), the adenoma detection rate and safety evaluations.

Results: 315 subjects comprised the ITT set. A significantly higher proportion of patients in the split-dose regimen had an adequate bowel preparation (AM/PM: 30.8% vs split-dose: 79.9%; p<0.0001). The mean global RSS was significantly lower in the split-dose group (AM/PM: 5.0 [SD: 2.91] vs split-dose: 2.6 [SD: 2.14]; p<0.0001). Flat polyps were detected in a higher proportion of subjects in the split-dose group compared with the AM/PM group (AM/PM: 16.0% vs split-dose: 22.0%). Both regimens were equally safe and well tolerated, with no serious treatment-emergent adverse events or discontinuations due to adverse events.

Conclusion: A split-dose regimen of SPMC is superior to the AM/PM regimen administered the day before colonoscopy. Split regimen of SPMC should be considered the standard of use.

Key words: sodium picosulfate magnesium citrate – colon cleansing – split regimen – colonoscopy – bowel preparation.

Abbreviations: CTCAE: Common Terminology Criteria for Adverse Events; eGFR: Glomerular filtration rate; mITT: modified intent-to-treat; RSS: Residual Stool Score; SA: safety analysis; SAE: serious adverse event; SmPC: summary of product characteristics; SPMC: sodium picosulfate-magnesium citrate.