PMID- 37490604
OWN - NLM
STAT- MEDLINE
DCOM- 20230911
LR  - 20230914
IS  - 1539-2031 (Electronic)
IS  - 0192-0790 (Linking)
VI  - 57
IP  - 9
DP  - 2023 Oct 1
TI  - Comparison of a Novel, Flavor-optimized, Polyethylene Glycol and Sulfate Bowel 
      Preparation With Oral Sulfate Solution in Adults Undergoing Colonoscopy.
PG  - 920-927
LID - 10.1097/MCG.0000000000001894 [doi]
AB  - INTRODUCTION: A new bowel preparation for colonoscopy has been developed 
      containing poorly absorbed sulfate salts and polyethylene glycol 3350, which 
      retain water within the intestinal lumen resulting in copious diarrhea, thereby 
      cleansing the bowel. The product was formulated to be safe and effective with a 
      sports drink-like flavor. This study evaluated the new flavored polyethylene 
      glycol and sulfate solution (FPSS) compared with a Food and Drug 
      Administration-approved bowel preparation containing sulfate salts only [oral 
      sulfate solution (OSS)]. METHODS: Five hundred adults were enrolled in this 
      multicenter, noninferiority study. Subjects were assigned FPSS or OSS 
      administered in split-dose regimens (PM/AM). FPSS subjects took 2 L of the 
      flavored osmotic solution (1 L at night and 1 L in the morning). OSS was taken 
      according to its approved labeling. Colonoscopies were graded globally and 
      segmentally by blinded local investigators using a 4-point scale (excellent, 
      good, fair, and poor), with "good" and "excellent" considered successful. Safety 
      was assessed by adverse events (AEs) and laboratory testing. RESULTS: A high rate 
      of cleansing success was seen with FPSS (94%), which was noninferior to OSS 
      (94%). This conclusion was confirmed by blinded central readers. Segmental 
      success rates were >90% for both preparations, including the right colon. 
      Questionnaire ratings indicated the FPSS experience was preferred over OSS with 
      87% of FPSS subjects noting their preparation was "tolerable" to "very easy" to 
      consume versus 74% for OSS. The majority of FPSS subjects agreed their 
      preparation tasted like a sports drink. Gastrointestinal symptoms were the most 
      common AEs. There was no difference between preparations for any AE and no 
      clinically significant differences in laboratory parameters. CONCLUSIONS: The new 
      sports drink-like flavored preparation achieved a high level of cleansing in the 
      study, demonstrating noninferiority to OSS. FPSS was well-tolerated with low 
      rates of expected gastrointestinal symptoms. The optimized flavor of FPSS 
      resulted in significantly better acceptance ratings.
CI  - Copyright (c) 2023 Wolters Kluwer Health, Inc. All rights reserved.
FAU - Bhandari, Raj
AU  - Bhandari R
AD  - Delta Research Partners, Monroe, LA.
FAU - Goldstein, Michael
AU  - Goldstein M
AD  - Long Island GI Research Group, Great Neck, NY.
FAU - Mishkin, Daniel S
AU  - Mishkin DS
AD  - GI Reviewers, Brookline.
FAU - McGowan, John
AU  - McGowan J
AD  - Braintree Laboratories, Inc, Braintree, MA.
FAU - Cleveland, Mark vB
AU  - Cleveland MV
AD  - Braintree Laboratories, Inc, Braintree, MA.
FAU - Di Palma, Jack A
AU  - Di Palma JA
AD  - Braintree Laboratories, Inc, Braintree, MA.
AD  - Division of Gastroenterology, University of South Alabama College of Medicine, 
      Mobile, AL.
LA  - eng
SI  - ClinicalTrials.gov/NCT04446312
PT  - Journal Article
PT  - Multicenter Study
DEP - 20231001
PL  - United States
TA  - J Clin Gastroenterol
JT  - Journal of clinical gastroenterology
JID - 7910017
RN  - 0 (Sulfates)
RN  - 0 (Cathartics)
RN  - 0 (Salts)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 0 (Sulfur Compounds)
SB  - IM
MH  - Humans
MH  - Adult
MH  - *Sulfates/adverse effects
MH  - *Cathartics/adverse effects
MH  - Salts
MH  - Polyethylene Glycols/adverse effects
MH  - Colonoscopy/methods
MH  - Sulfur Compounds
EDAT- 2023/07/25 19:15
MHDA- 2023/09/11 06:42
CRDT- 2023/07/25 15:03
PHST- 2022/05/11 00:00 [received]
PHST- 2023/06/18 00:00 [accepted]
PHST- 2023/09/11 06:42 [medline]
PHST- 2023/07/25 19:15 [pubmed]
PHST- 2023/07/25 15:03 [entrez]
AID - 00004836-990000000-00188 [pii]
AID - 10.1097/MCG.0000000000001894 [doi]
PST - epublish
SO  - J Clin Gastroenterol. 2023 Oct 1;57(9):920-927. doi: 
      10.1097/MCG.0000000000001894.