Safety and colon-cleansing efficacy of a new residue-free formulation of sodium phosphate tablets.
OBJECTIVE
A residue-free sodium phosphate tablet (RF-NaP) was formulated that lacks microcrystalline cellulose, which can appear as a whitish residue in the colon. A multicenter, randomized, investigator-blinded study was conducted to compare the colon-cleansing efficacy of 40 or 32 tablets of RF-NaP with the marketed 40-tablet NaP treatment regimen.


METHODS
Eight hundred sixteen patients were randomized prior to colonoscopy to receive either 40 tablets (60 g) of NaP or RF-NaP or 32 tablets (48 g) of RF-NaP. Colon cleansing was assessed using a 4-point scale based on retained "colonic contents." The primary end point was overall colon-cleansing response rate to treatment (score of excellent/good) versus nonresponse (fair/inadequate).


RESULTS
Seven hundred four patients were included in the efficacy analysis. The overall colon-cleansing response rates were comparable among treatment arms (94.5%, 97.0%, and 95.3% for NaP, RF-NaP 40, and RF-NaP 32 tablets, respectively). Ascending colon-cleansing response rates for RF-NaP 40 (95.7%) and 32 tablets (93.6%) were significantly better than for NaP tablets (88.5%, p < 0.03 for both). Patients treated with RF-NaP 32 tablets experienced less pronounced changes in electrolyte levels and fewer adverse events (138/239, 58%) compared with patients receiving NaP (161/238, 68%, p= 0.07) and RF-NaP 40 tablets (156/236, 66%, p= 0.03). The most common adverse events reported were abdominal distention, nausea, abdominal pain, and vomiting.


CONCLUSIONS
Based on the safety, efficacy, and patient preferences, the 32-tablet RF-NaP regimen was superior to the 40-tablet RF-NaP and NaP regimen for colon cleansing prior to colonoscopy.
Rex
Douglas K
DK
Indiana University Medical Center, Indianapolis, Indiana 46202, USA.
Schwartz
Howard
H
Goldstein
Michael
M
Popp
John
J
Katz
Seymour
S
Barish
Charles
C
Karlstadt
Robyn G
RG
Rose
Martin
M
Walker
Kelli
K
Lottes
Sandra
S
Ettinger
Nancy
N
Zhang
Bing
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D002400:Cathartics / Q000008:administration & dosage* / Q000009:adverse effects; D003113:Colonoscopy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010710:Phosphates / Q000008:administration & dosage* / Q000009:adverse effects; D013607:Tablets
D002400:Cathartics; D010710:Phosphates; D013607:Tablets; C018279:sodium phosphate