PMID- 32313553
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220414
IS  - 1756-283X (Print)
IS  - 1756-2848 (Electronic)
IS  - 1756-283X (Linking)
VI  - 13
DP  - 2020
TI  - Efficacy, safety, and tolerability of a ready-to-drink bowel preparation in 
      overweight and obese adults: subanalysis by body mass index from a phase III, 
      assessor-blinded study.
PG  - 1756284820910050
LID - 10.1177/1756284820910050 [doi]
LID - 1756284820910050
AB  - BACKGROUND: We performed a post hoc secondary analysis for the effect of body 
      mass index (BMI) on the efficacy, tolerability, and safety of ready-to-drink 
      sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) bowel 
      preparation. METHODS: A phase III, randomized, assessor-blinded, multicenter, 
      noninferiority study was conducted comparing split-dose, low-volume SPMC oral 
      solution with a powder formulation for oral solution. A post hoc secondary 
      analysis assessed efficacy, safety, and tolerability of SPMC oral solution 
      stratified by BMI. BMI was classified by Centers for Disease Control and 
      Prevention definitions (underweight and normal weight: BMI < 25 kg/m(2); 
      overweight: BMI 25-29.9 kg/m(2); class I obesity: BMI 30-34.9 kg/m(2); class II 
      obesity: BMI 35-39.9 kg/m(2); class III/severe obesity: BMI ⩾40 kg/m(2)). 
      Prespecified primary efficacy endpoint ('responders') was the proportion of 
      participants with 'excellent' or 'good' ratings on a modified Aronchick Scale 
      (AS). Secondary efficacy outcomes were the quality of cleansing of the right 
      colon as assessed by the Boston Bowel Preparation Scale (BBPS); as well as 
      selected findings from the Mayo Clinic Bowel Prep Tolerability Questionnaire. 
      Safety assessments included adverse events (AEs) and laboratory evaluations. 
      RESULTS: Between 82.8% and 92.5% of participants in any BMI group were responders 
      by AS, and between 91.3% and 100% were responders by BBPS in the right colon. 
      Efficacy was consistent across BMI groups, with no clear trends. Greater than 83% 
      of participants in any BMI group found the preparation 'easy' or 'acceptable' to 
      ingest, and the majority (>58%) rated SPMC oral solution as 'better' than a prior 
      bowel preparation. In all BMI groups, safety data were similar to the overall 
      cohort. Commonly reported, drug-related, treatment-emergent AEs were, by 
      ascending BMI group, nausea (1.1%, 5.3%, 1.0%, 5.7%, and 0%) and headache (1.1%, 
      4.1%, 1.0%, 5.7%, and 0%). CONCLUSIONS: Ready-to-drink SPMC oral solution had 
      consistent, good quality colon cleansing, and favorable tolerability among 
      participants of all BMI groups. CLINICALTRIALSGOV REGISTRATION: NCT03017235.
CI  - (c) The Author(s), 2020.
FAU - Hookey, Lawrence
AU  - Hookey L
AD  - Gastrointestinal Disease Research Unit, Department of Medicine, Queen's 
      University, Kingston, ON, Canada.
FAU - Bertiger, Gerald
AU  - Bertiger G
AUID- ORCID: 0000-0003-4731-2362
AD  - Hillmont GI, 1811 Bethlehem Pike, Building C-300, Flourtown, PA 19031, USA.
FAU - Johnson, Kenneth Lee 2nd
AU  - Johnson KL 2nd
AD  - Vidant Medical Group, Kinston, NC, USA.
FAU - Boules, Mena
AU  - Boules M
AD  - Ferring Pharmaceuticals, Inc., Parsippany, NJ, USA.
FAU - Ando, Masakazu
AU  - Ando M
AD  - Ferring Pharmaceuticals, Inc., Parsippany, NJ, USA.
FAU - Dahdal, David N
AU  - Dahdal DN
AD  - Ferring Pharmaceuticals, Inc., Parsippany, NJ, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03017235
PT  - Journal Article
DEP - 20200409
PL  - England
TA  - Therap Adv Gastroenterol
JT  - Therapeutic advances in gastroenterology
JID - 101478893
PMC - PMC7153178
OTO - NOTNLM
OT  - BMI
OT  - bowel preparation
OT  - colon cleansing
OT  - inadequate bowel preparation
OT  - obesity
OT  - oral solution
OT  - overweight
OT  - screening colonoscopy
COIS- Conflict of interest statement: LH has participated in the speaker's bureau for 
      Ferring Pharmaceuticals Inc. GB was an investigator for clinical trials sponsored 
      by Ferring Pharmaceuticals Inc. and has served as a consultant and has 
      participated in the speaker's bureau for Ferring Pharmaceuticals Inc. KLJ is an 
      investigator on clinical trials sponsored by Ferring Pharmaceuticals Inc. MB, MA, 
      and DND are employees of Ferring Pharmaceuticals Inc.
EDAT- 2020/04/22 06:00
MHDA- 2020/04/22 06:01
PMCR- 2020/04/09
CRDT- 2020/04/22 06:00
PHST- 2019/10/08 00:00 [received]
PHST- 2020/02/05 00:00 [accepted]
PHST- 2020/04/22 06:00 [entrez]
PHST- 2020/04/22 06:00 [pubmed]
PHST- 2020/04/22 06:01 [medline]
PHST- 2020/04/09 00:00 [pmc-release]
AID - 10.1177_1756284820910050 [pii]
AID - 10.1177/1756284820910050 [doi]
PST - epublish
SO  - Therap Adv Gastroenterol. 2020 Apr 9;13:1756284820910050. doi: 
      10.1177/1756284820910050. eCollection 2020.