PMID- 32095161
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220413
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: 
      subanalysis by age from a phase III, assessor-blinded study.
PG  - 1756284820902878
LID - 10.1177/1756284820902878 [doi]
LID - 1756284820902878
AB  - BACKGROUND: The incidence and mortality of colorectal cancer (CRC) increase with 
      age and, therefore, it is recommended that adults undergo regular CRC screening, 
      ideally by colonoscopy, with some new guidelines recommending screening begin at 
      45 years. Effective bowel preparation is a critical step to a successful 
      colonoscopy. Of concern is that older adults may have poorer quality of bowel 
      preparation or reduced tolerability for the bowel preparation. Here, we performed 
      a post hoc secondary analysis for the effect of age 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, non-inferiority study was conducted 
      comparing split-dose, low-volume SPMC oral solution with split-dose, low-volume 
      sodium picosulfate, magnesium oxide, and citric acid powder for oral solution. A 
      post hoc secondary analysis was performed to assess efficacy, safety, and 
      tolerability of SPMC oral solution by age group (<50 years, 50-64 years, 
      ⩾65 years). The 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: Within age groups, at least 83.9% of participants were 
      responders by the AS, and at least 91.1% of participants were responders by the 
      BBPS in the right colon. On both scales, responder rates were highest in the 
      youngest age group and decreased with increasing age. Greater than 88% of 
      participants in any age group found the preparation 'easy' or 'acceptable' to 
      ingest, with rates of 'easy' being highest in the oldest age group. No new safety 
      signals were seen in any age group. The most commonly reported drug-related, 
      treatment-emergent AEs were, by ascending age group, nausea (7.0%, 3.2%, 0.8%), 
      headache (4.2%, 2.8%, 1.6%) and vomiting (2.8%, 1.2%, 0.8%). CONCLUSION: 
      Ready-to-drink SPMC oral solution showed good efficacy of overall colon cleansing 
      and tolerability in adults across different age groups, including those 
      ⩾65 years.ClinicalTrials.gov identifier: NCT03017235.
CI  - (c) The Author(s), 2020.
FAU - Hookey, Lawrence
AU  - Hookey L
AD  - 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, Bldg C-300, Flourtown, PA 19031, USA.
FAU - Johnson, Kenneth Lee
AU  - Johnson KL
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 - 20200207
PL  - England
TA  - Therap Adv Gastroenterol
JT  - Therapeutic advances in gastroenterology
JID - 101478893
PMC - PMC7011337
OTO - NOTNLM
OT  - bowel preparation
OT  - colon cleansing
OT  - elderly
OT  - inadequate bowel preparation
OT  - older adults
OT  - oral solution
OT  - screening colonoscopy
COIS- Conflict of interest statement: Dr Hookey has participated in the speaker's 
      bureau for Ferring Pharmaceuticals Inc. Dr Bertiger 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. Dr Johnson was an investigator on clinical trials sponsored 
      by Ferring Pharmaceuticals Inc. Drs Boules, Ando, and Dahdal are employees of 
      Ferring Pharmaceuticals Inc.
EDAT- 2020/02/26 06:00
MHDA- 2020/02/26 06:01
PMCR- 2020/02/07
CRDT- 2020/02/26 06:00
PHST- 2019/09/16 00:00 [received]
PHST- 2019/12/04 00:00 [accepted]
PHST- 2020/02/26 06:00 [entrez]
PHST- 2020/02/26 06:00 [pubmed]
PHST- 2020/02/26 06:01 [medline]
PHST- 2020/02/07 00:00 [pmc-release]
AID - 10.1177_1756284820902878 [pii]
AID - 10.1177/1756284820902878 [doi]
PST - epublish
SO  - Therap Adv Gastroenterol. 2020 Feb 7;13:1756284820902878. doi: 
      10.1177/1756284820902878. eCollection 2020.