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

BACKGROUND Contradictory results are available about the effect of magnesium citrate plus sodium picosulfate bowel cleansing agents on the fluid and electrolyte balance, therefore, we 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. Effectiveness of bowel cleansing was assessed using Boston Bowel Preparation Scale (BBPS). Adequate cleansing was defined BBPS ≥ 6, and excellent cleansing as BBPS > 7. Tolerability was examined using standardized questionnaire. In safety analysis, the change of serum electrolytes levels of and renal function during bowel cleansing was assessed. RESULTS Adequate and excellent bowel cleansing were achieved 94.85% and 72.96% of cases. None or very mild symptoms were reported in 47.21% of cases. Statistically significant change 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, but rate of patients with values out of the normal range elevated significantly only in case of serum urea (3.95% vs. 26.97%, p < 0.0001). CONCLUSION Magnesium citrate with sodium picosulfate is outstandingly effective and well tolerated agent in colonoscopy preparation. It caused significant, but not clinically relevant changes in serum electrolytes levels and renal function.