PMID- 34262611
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220424
IS  - 1756-283X (Print)
IS  - 1756-2848 (Electronic)
IS  - 1756-283X (Linking)
VI  - 14
DP  - 2021
TI  - Safety and efficacy of sodium picosulfate, magnesium oxide, and citric acid bowel 
      preparation in patients with baseline renal impairment or diabetes: subanalysis 
      of a randomized, controlled trial.
PG  - 17562848211024458
LID - 10.1177/17562848211024458 [doi]
LID - 17562848211024458
AB  - BACKGROUND: Selecting a bowel preparation for patients with renal impairment or 
      diabetes requires special consideration. We aimed to describe the effect of 
      baseline renal impairment or diabetes on the safety, efficacy, and tolerability 
      of low-volume sodium picosulfate, magnesium oxide, and citric acid (SPMC) 
      ready-to-drink oral solution bowel preparation. METHODS: A post hoc secondary 
      analysis was performed from a randomized, assessor-blinded study of SPMC oral 
      solution bowel preparation in participants with mild or moderate baseline renal 
      impairment or diabetes. 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 ascending 
      colon cleansing from the Boston Bowel Preparation Scale (BBPS), and selected 
      results from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety 
      assessments included adverse events (AEs), adenoma detection, and laboratory 
      evaluations. RESULTS: Similar overall colon cleansing was demonstrated in the 
      subgroups, with >85% of participants in any subgroup rated as responders by the 
      AS, and >92% of participant responders by the BBPS. Most participants reported a 
      tolerable bowel preparation, regardless of baseline renal impairment or diabetes 
      history. Safety of SPMC oral solution was similar between all subgroups and the 
      overall cohort. For the mild renal impairment, moderate renal impairment, and 
      diabetes subgroups, respectively, commonly reported, drug-related AEs were nausea 
      (2.6%, 5.3%, 1.4%) and headache (2.2%, 2.6%, 4.3%). CONCLUSIONS: Ready-to-drink 
      SPMC oral solution demonstrated efficacious colon cleansing in patients with 
      baseline mild/moderate renal impairment or diabetes, with a tolerable bowel 
      preparation reported by most. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov 
      identifier: NCT03017235.
CI  - (c) The Author(s), 2021.
FAU - Mankaney, Gautam N
AU  - Mankaney GN
AD  - Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, 
      Cleveland, OH, 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.
FAU - Burke, Carol A
AU  - Burke CA
AUID- ORCID: 0000-0002-7225-0696
AD  - Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, 9500 
      Euclid Avenue, Cleveland, OH 44195, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03017235
PT  - Journal Article
DEP - 20210628
PL  - England
TA  - Therap Adv Gastroenterol
JT  - Therapeutic advances in gastroenterology
JID - 101478893
PMC - PMC8243104
OTO - NOTNLM
OT  - bowel cleansing
OT  - colon cleansing
OT  - colonoscopy
OT  - diabetes
OT  - renal impairment
COIS- Conflict of interest statement: Dr Burke has received research support and 
      consultant fees from Ferring Pharmaceuticals Inc. Dr Mankaney has received 
      research support from Ferring Pharmaceuticals Inc. Drs Ando and Dahdal are 
      employees of Ferring Pharmaceuticals Inc.
EDAT- 2021/07/16 06:00
MHDA- 2021/07/16 06:01
PMCR- 2021/06/28
CRDT- 2021/07/15 06:20
PHST- 2020/12/24 00:00 [received]
PHST- 2021/05/24 00:00 [accepted]
PHST- 2021/07/15 06:20 [entrez]
PHST- 2021/07/16 06:00 [pubmed]
PHST- 2021/07/16 06:01 [medline]
PHST- 2021/06/28 00:00 [pmc-release]
AID - 10.1177_17562848211024458 [pii]
AID - 10.1177/17562848211024458 [doi]
PST - epublish
SO  - Therap Adv Gastroenterol. 2021 Jun 28;14:17562848211024458. doi: 
      10.1177/17562848211024458. eCollection 2021.