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.
OBJECTIVE
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.


CONCLUSIONS
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.
Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von- Guericke-University of Magdeburg, Magdeburg, Germany. christian.schulz@med.ovgu.de.
Christian
C
Schulz
Praxiszentrum Schweinfurt, Schweinfurt, Germany.
Joachim
J
Müller
Praxis Dr. Sauter. Wangen, Germany.
Joachim
J
Sauter
Center for Digestive Diseases, Internal Medicine Center, Eppendorf, Hamburg, Germany.
Stephan
S
Miehlke
Department of Internal Medicine I, Sana-Klinikum Lichtenberg, Berlin, Germany.
Christoph
C
Schmöcker
Department of Internal Medicine I, Sana-Klinikum Lichtenberg, Berlin, Germany.
Dirk
D
Hartmann
Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von- Guericke-University of Magdeburg, Magdeburg, Germany.
Peter
P
Malfertheiner
Medical Department, Casen Recordati, Spain.
Carlos
C
Badiola
D018256:Adenomatous Polyps / Q000175:diagnosis* / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002400:Cathartics / Q000008:administration & dosage* / Q000009:adverse effects; D002951:Citrates / Q000008:administration & dosage* / Q000009:adverse effects; D019343:Citric Acid / Q000008:administration & dosage* / Q000009:adverse effects; D003110:Colonic Neoplasms / Q000175:diagnosis* / Q000473:pathology; D003111:Colonic Polyps / Q000175:diagnosis* / Q000473:pathology; D003113:Colonoscopy; D003672:Defecation / Q000187:drug effects*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D010847:Picolines / Q000008:administration & dosage* / Q000009:adverse effects; D011237:Predictive Value of Tests; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D002400:Cathartics; D002951:Citrates; D004338:Drug Combinations; D009942:Organometallic Compounds; D010847:Picolines; D019343:Citric Acid; C005701:picosulfate sodium; C110422:magnesium citrate