Literature DB >> 33371690

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

Renáta Bor1, Mária Matuz2, Anna Fabián3, Zoltán Szepes3, Kata Szántó3, Klaudia Farkas3, Mariann Rutka3, Ágnes Milassin3, Daniella Pigniczki3, Anita Bálint3, Tibor Tóth3, Tamás Molnár3.   

Abstract

BACKGROUND: There are contradictory results about the effect of magnesium citrate plus sodium picosulfate bowel cleansing agents on the fluid and electrolyte balance. Therefore, this study aimed to determine the efficacy, tolerability and safety of this medication in colonoscopy preparation.
METHODS: 233 patients were enrolled in this phase IV prospective observational study. The effectiveness of bowel cleansing was assessed using the Boston Bowel Preparation Scale (BBPS). Adequate cleansing was defined as BBPS ≥ 6 and excellent cleansing as BBPS > 7. Tolerability was examined using a standardized questionnaire. In the safety analysis, the change of serum electrolytes levels and renal function during bowel cleansing was assessed.
RESULTS: Adequate and excellent bowel cleansing were achieved 94.85% and 72.96% of cases, respectively. None or very mild symptoms were reported in 47.21% of cases. Statistically significant changes occurred in serum potassium (4.38±0.43 vs. 4.25±0.43 mmol/L, p<0.0001), urea (4.86±1.37 vs. 3.84±1.43 mmol/L, p<0.0001) and creatinine (male: 81.07±16.02 vs. 84.54±15.11 μmol/L; female: 69.32±12.22 vs. 72.96±12.11 μmol/L, p<0.0001) levels during the colonoscopy preparation. However, the number of patients with values outside of the normal range increased significantly only in the case of serum urea (3.95% vs. 26.97%, p<0.0001).
CONCLUSION: Magnesium citrate with sodium picosulfate is outstandingly effective, well tolerated and a safe agent in colonoscopy preparation. It caused significant, but non-clinically relevant changes in serum electrolytes levels and renal function.

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Year:  2021        PMID: 33371690     DOI: 10.17235/reed.2020.7073/2020

Source DB:  PubMed          Journal:  Rev Esp Enferm Dig        ISSN: 1130-0108            Impact factor:   2.086


  1 in total

1.  Bowel preparation prior to colonoscopy with a new colonic irrigation device: Results of a prospective observational study.

Authors:  Niels Teich; Chris Klecker; Tobias Klugmann; Peter Dietel
Journal:  Endosc Int Open       Date:  2022-07-15
  1 in total

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