title: Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study.
abstract: Background and study aimsThe success of any colonoscopy procedure depends upon the quality of bowel preparation. We evaluated the efficacy and safety of a new tailored dosing (TD) regimen compared with the approved PICOPREP day-before dosing regimen (DBD) in the European Union.Patient and methodsPatients (≥ 18 years) undergoing colonoscopy were randomised (2:1) to TD (Dose 1, 10 - 18 hours; Dose 2, 4 - 6 hours before colonoscopy) or DBD (Dose 1 before 8:00AM on the day before colonoscopy; Dose 2, 6 - 8 hours after Dose 1). The primary endpoint of overall colon cleansing efficacy was based on total Ottawa Scale (OS) scores (0 - 14, excellent-worst). The key secondary endpoint was a binary endpoint based on the ascending colon OS (success 0 or 1, failure [≥ 2]). Convenience and satisfaction were evaluated similar to the primary and key secondary endpoints. Safety and tolerability were also evaluated.ResultsUse of the PICOPREP TD regimen resulted in a statistically significant reduction in the mean total Ottawa Scale score compared to the PICOPREP DBD regimen (-3.93, 95 % confidence intervals [CI]: - 4.99, - 2.97;P< 0.0001) in the intent-to-treat analysis set. The PICOPREP TD regimen also resulted in a statistically significant increase in the odds of achieving an ascending colon OS score ≤ 1, compared to the PICOPREP DBD regimen (estimated odds ratio 9.18, 95 % CI: 4.36, 19.32;P< 0.0001). There was no statistically significant difference in the overall rate of treatment-emergent adverse events (12 % (TD) and 5.7 % (DBD), respectively,P= 0.2988). The convenience and satisfaction were comparable in the two groups.ConclusionThe TD regimen was superior to the DBD regimen for overall and ascending colon cleansing efficacy. ClinicalTrials.gov Identifier: NCT02239692.
authors.affiliation: Klinikdirektor ZIM II, Sprecher ZIM (Zentrum für Innere Medizin), Helios Dr. Horst Schmidt Kliniken Wiesbaden, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Kiesslich
authors.affiliation: Gastroenterologie am Bayerischen Platz, Berlin, Germany.
authors.forename: Stefan
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authors.lastname: Schubert
authors.affiliation: Praxis Dr. med. Michael R Mross, Berlin, Germany.
authors.forename: Michael
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authors.lastname: Mross
authors.affiliation: Internistische Gemeinschaftspraxis, Leipzig, Germany.
authors.forename: Tobias
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authors.lastname: Klugmann
authors.affiliation: Medisch Centrum, Alkmaar, the Netherlands.
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authors.affiliation: Internistisches Facharztzentrum Dr M Scholz, Langen, Germany.
authors.forename: Imke
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authors.affiliation: Clinique des Cèdres, Blagnac, France.
authors.forename: Gillaume
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authors.lastname: Bonnaud
authors.affiliation: Orbis Medisch Centrum, Sittard, the Netherlands.
authors.forename: Eric
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authors.affiliation: Rijnstate Arnhem, Wagnerlaan, the Netherlands.
authors.forename: Marcel
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authors.lastname: Groenen
authors.affiliation: Gastroenterologie Eppendorfer Baum, Hamburg, Germany.
authors.forename: Michael
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authors.lastname: Blaker
authors.affiliation: Ed Herriot Hopìtal, Lyon, France.
authors.forename: Thierry
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authors.lastname: Ponchon
authors.affiliation: MVZ Dachau, Dachau, Germany.
authors.forename: Wilfred
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authors.lastname: Landry
authors.affiliation: Ferring Pharmaceuticals, Kay Fiskers Plads 11 Copenhagen S, Denmark.
authors.forename: Meredin
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authors.lastname: Stoltenberg