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In adult subjects undergoing colonoscopy, the novel oral
sulfate bowel preparation offered equivalent colon cleansing compared to
polyethylene glycol and ascorbate (PEG-EA) preparation.
As per the study published in “The American Journal of Gastroenterology”, the oral sulfate tablets attained a high level of cleansing (92%) in outpatients undergoing colonoscopy. These tablets demonstrated noninferiority to PEG3350, electrolytes, and ascorbate [PEG-EA] and attained considerably more excellent preparations overall and in the proximal colon. Di Palma et al. undertook this multicenter, single-blind, noninferiority study to investigate the efficacy and safety of the oral sulfate tablets compared with the traditional United States Food and Drug Administration-approved bowel preparation solution containing PEG-EA in 620 adult patients which were randomized into two arms.
Participants (mean years 57 years) were allocated either to PEG-EA (n=306) group or the oral sulfate tablets (n=314) group. Both preparations were administered according to the split-dose regimen initiating the evening prior to colonoscopy. The colonoscopies were carried out by blinded investigators.
Utilizing a 4-point scale, the cleansing efficacy was evaluated segmentally and globally. The scores of excellent or good were considered to be a success. Safety was determined by spontaneously reported adverse events, lab testing, and solicited ratings of anticipated preparation symptoms.
An elevated rate of cleansing success was witnessed with oral sulfate tablets (92%) that displayed noninferiority to PEG-EA (89%). A small percentage of participants rated their anticipated gastrointestinal symptoms as serious (<5% for both preparations).
No clinically vital differences were witnessed between preparations for chemistry and hematology parameters. With oral sulfate tablets, there were no severe adverse experiences. The oral sulfate tablets preparation showed good tolerability, with a comparable rate of spontaneously reported adverse experiences to PEG-EA and a minimized rate of serious anticipated gastrointestinal symptoms.
Thus, the oral sulfate tablets are safe and effective
therapeutic choices that may be well-received by individuals undergoing
colonoscopy.
The American Journal of Gastroenterology
https://journals.lww.com/ajg/Fulltext/2021/02000/A_Safety_and_Efficacy_Comparison_of_a_New.23.aspx
A Safety and Efficacy Comparison of a New Sulfate-Based Tablet Bowel Preparation Versus a PEG and Ascorbate Comparator in Adult Subjects Undergoing Colonoscopy
Di Palma et al.
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