Tolerability and patient acceptance of sodium phosphate tablets compared with 4-L PEG solution in colon cleansing: combined results of 2 identically designed, randomized, controlled, parallel group, multicenter phase 3 trials.
OBJECTIVE
Evaluate patient tolerance and acceptance of a sodium phosphate (NaP) tablet purgative compared with a 4-L polyethylene glycol (PEG) solution.


BACKGROUND
Characteristics and side effects of bowel purgatives deter patients from undergoing screening colonoscopy. Published data demonstrated comparable bowel cleansing with NaP tablets and a 4-L PEG solution in 2 phase for 3 studies. This report presents data on patient tolerability and acceptance.


METHODS
Two identically designed, randomized, investigator-blinded, and multicenter trials were performed. Tolerability and patient acceptance were based on purgative regimen compliance, incidence of gastrointestinal adverse events, and patient responses to questionnaires.


RESULTS
Eight hundred forty-five patients were assessed (420 and 425 in the tablet and PEG solution groups, respectively). Patient compliance with the tablet regimen was greater: 94% of patients took all the tablets compared with 57% completing the PEG solution regimen (P<0.0001). Nausea, vomiting, and bloating occurred significantly less often in patients taking NaP tablets (P<0.0001). Among patients taking tablets, 88.4% rated them "easy" or "slightly difficult" to take, compared with 60.6% of patients taking the PEG solution. The preparation's taste was rated "barely tolerable" or "not tolerable" by 1% of patients treated with NaP tablets and 23.6% treated with PEG solution. Drinking the required volume of clear liquid for the tablet or PEG preparation was rated "easy" or "slightly difficult" by 92.2% and 66.9% of patients, respectively. Almost all (90.7%) patients taking the tablets indicated they would take the same preparation in the future, compared with 67.1% of patients taking the PEG solution (P<0.0001 for each comparison).


CONCLUSIONS
Tolerability and patient acceptance of a NaP tablet purgative were superior to 4-L PEG solution.
Kastenberg
David
D
Thomas Jefferson University, Philadelphia, PA 19107, USA. david.kastenberg@jefferson.edu
Barish
Charles
C
Burack
Harry
H
Dalke
Douglas Dean
DD
Duckor
Steven
S
Putnam
William
W
Valenzuela
Gregg
G
D000284:Administration, Oral; D000368:Aged; D002400:Cathartics / Q000008:administration & dosage*; D003108:Colonic Diseases / Q000175:diagnosis*; D003113:Colonoscopy / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004337:Drug Carriers / Q000008:administration & dosage*; D004733:Enema / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D010710:Phosphates / Q000008:administration & dosage*; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D016037:Single-Blind Method; D011795:Surveys and Questionnaires
D002400:Cathartics; D004337:Drug Carriers; D010710:Phosphates; D011092:Polyethylene Glycols; C018279:sodium phosphate