scholarly journals Efficacy, tolerability and safety of split-dose bowel cleansing regimen of magnesium citrate with sodium picosulfate � a phase IV clinical observational study

Author(s):  
Renáta Bor ◽  
Maria Matuz ◽  
Anna Fabian ◽  
Zoltan Szepes ◽  
Kata Szántó ◽  
...  
2016 ◽  
Vol 25 (3) ◽  
pp. 295-302 ◽  
Author(s):  
Christian Schulz ◽  
Joachim Müller ◽  
Joachim Sauter ◽  
Stephan Miehlke ◽  
Christoph Schmöcker ◽  
...  

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. 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.


2009 ◽  
Vol 23 (10) ◽  
pp. 706-710 ◽  
Author(s):  
Jonathan Love ◽  
Edmond-Jean Bernard ◽  
Alan Cockeram ◽  
Lawrence Cohen ◽  
Martin Fishman ◽  
...  

BACKGROUND: Sodium picosulfate with magnesium citrate (PSMC) has been available as a precolonoscopy bowel preparation in Canada since 2005. A high patient acceptability and preference appears to have contributed to its wide adoption across the country. Despite its frequent use, there are relatively few published studies of this product, especially reports regarding its use in routine clinical practice. Moreover, to date, there have been no Canadian studies of any kind.OBJECTIVE: To conduct a preliminary evaluation of PSMC by prospectively collecting data describing its effectiveness.METHODS: In the present multicentre, observational study, sequential patients used PSMC according to each institution’s standard colonoscopy protocol. Differences in bowel cleansing protocols included dose timing, fluid intake, dietary restrictions and administration of bisacodyl. During colonoscopy, preparation quality was rated separately for the right and left sides of the colon.RESULTS: Of the 613 patients entered, 606 were evaluable for efficacy. For the right and left colon, respectively, 93.0% and 96.2% of preparations were rated either ‘excellent’ or ‘adequate’. In the 334 patients who received adjunctive bisacodyl and the 272 patients who did not, the results were similar: for the right and left colon, 92.3% and 97.1% of those who did not, and 93.4% and 95.7% of those who did receive bisacodyl, respectively, were rated either ‘excellent’ or ‘adequate’.CONCLUSIONS: Despite the differences in bowel cleansing protocols used at each hospital (including an additional laxative), PSMC consistently yielded a high percentage of positive ratings for efficacy.


2014 ◽  
Vol 79 (5) ◽  
pp. AB318
Author(s):  
CéSar Prieto ◽  
RAMóN AngóS ◽  
María Teresa BetéS ◽  
Susana De La Riva ◽  
Iago RodríGuez Lago ◽  
...  

2020 ◽  
Vol Volume 13 ◽  
pp. 449-457
Author(s):  
Antonio Afonso de Miranda Neto ◽  
Diogo Turiani Hourneaux de Moura ◽  
Kelly E Hathorn ◽  
Francisco Tustumi ◽  
Eduardo Guimarães Hourneaux de Moura ◽  
...  

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