Efficacy and safety of sodium phosphate tablets compared with PEG solutionin colon cleansing: two identically designed, randomized, controlled, parallel group, multicenter phase III trials

Background: Liquid purgatives for cleansing before colonoscopy often are po orly tolerated. A sodium phosphate tablet has been developed to! provide eq uivalent efficacy with better patient tolerance. These 2 studies compare th e safety, efficacy, and patient acceptance of the tablet (Visicol) to a pol yethylene glycol (PEG) solution in adults undergoing colonoscopy. Methods: Two identically designed, randomized, investigator-blinded, multic enter trials:were performed. The primary efficacy variable was the overall quality of colon cleansing. Patient tolerance was assessed in terms of comp liance with, the dosing regimen. Safety assessments included recording of a dverse events and changes in biochemical tests, electrocardiogram, and vita l signs. Results: Eight hundred forty-five patients participated in the studies; 420 took sodium phosphate tablets and 425 took a PEG solution. The 2 methods o f preparation were equivalent in the overall quality of colon cleansing, cl eansing in the right colon, and the frequency of inadequate preparation. Ov erall cleansing was excellent or good in 84.3% of patients in the tablet gr oup and in 76.7% in the PEG group. Patient compliance was greater in the ta blet group. There were also significantly fewer GI side effects in this gro up. Conclusions: Sodium phosphate tablets, compared with PEG solution, produce equivalent colon cleansing, are associated with fewer GI side effects, and are better tolerated by patients.