PMID- 32140554
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2364-3722 (Print)
IS  - 2196-9736 (Electronic)
IS  - 2196-9736 (Linking)
VI  - 8
IP  - 3
DP  - 2020 Mar
TI  - A European, multicentre, observational, post-authorisation safety study of oral 
      sulphate solution: compliance and safety.
PG  - E247-E256
LID - 10.1055/a-1090-7289 [doi]
AB  - Background and study aims  Oral sulphate solution (OSS) is a sulphate-based, 
      low-volume bowel cleansing preparation taken in two doses of 500 mL, each 
      followed by 1000mL of water or clear liquid. The primary objective of this 
      observational study was to document compliance with the recommended hydration 
      guidelines in a representative sample of the European population. Patients and 
      methods  Prospective, non-interventional, multicentre study (NCT02630680, 
      EUPAS9361) in patients prescribed OSS for colonoscopy preparation in routine 
      clinical practice in Europe. Patients were included according to pre-agreed 
      consecutive enrolment rules. Patients recorded the volume of OSS and water or 
      clear liquid intake, and occurrence of adverse events (AEs). Compliance with 
      hydration was calculated as a ratio of actual volume of water/clear liquid taken 
      versus prescribed 2,000 mL, and non-compliance defined as < 75 % intake. Colon 
      cleansing level was assessed on a 4-point scale. Results  Between October 2015 
      and January 2017, 1,281 patients were recruited in 16 centres in four European 
      countries (safety population n = 1,206; registry population n = 1,177). Of 
      patients, 94.5 % were >/= 75 % and 86.8 % 100 % compliant with hydration 
      guidelines. Patients took an average of 96.8 % of the recommended OSS volume; 46 
      patients (3.9 %) were non-compliant. Colon cleansing levels were 
      good-to-excellent in 87.6 % of patients. Three hundred and twenty-nine patients 
      (27.3 %) experienced 758 treatment-related AEs, mostly gastrointestinal (82.9 %), 
      all were mild-to-moderate. Non-compliant patients had no AEs suggestive of 
      dehydration. Conclusion  In this non-interventional study in a real-life setting, 
      treatment compliance with hydration guidelines was good-to-excellent in 94.5 % of 
      patients receiving OSS. The safety profile of OSS was similar to the prescribing 
      information.
FAU - Regula, Jaroslaw
AU  - Regula J
AD  - Medical Centre for Postgraduate Education and Maria Sklodowska-Curie 
      Institute-Oncology Centre, Warsaw, Poland.
FAU - Spaander, Manon C W
AU  - Spaander MCW
AD  - Department of Gastroenterology and Hepatology, Erasmus MC Cancer Institute, 
      Rotterdam, The Netherlands.
FAU - Suchanek, Stepan
AU  - Suchanek S
AD  - Department of Internal Medicine, 1st Faculty of Medicine, Charles University, 
      Military University Hospital, Prague, Czech Republic.
FAU - Kornowski, Anne
AU  - Kornowski A
AD  - Ipsen Pharma, Boulogne-Billancourt, France.
FAU - Perrot, Valerie
AU  - Perrot V
AD  - Ipsen Pharma, Boulogne-Billancourt, France.
FAU - Fischbach, Wolfgang
AU  - Fischbach W
AD  - Medizinische Klinik II, Klinikum Aschaffenburg-Alzenau, Aschaffenburg, Germany.
CN  - DUS investigators
LA  - eng
PT  - Journal Article
DEP - 20200221
PL  - Germany
TA  - Endosc Int Open
JT  - Endoscopy international open
JID - 101639919
PMC - PMC7055619
COIS- Competing interests Dr. Regula has received travel grants from Abbvie and Alfa 
      Sigma, and honoraria/consultation fees from Ipsen, Polpharma, Takeda, Alfa Sigma, 
      Krka, and Promed. Dr. Kornowski and Dr. Perrot are employees of Ipsen Pharma. Dr. 
      Fischbach has received support for presentations from Abbott, AbbVie Deutschland, 
      BioMerieux, Falk, Kibion, Norgine, Pfizer and Reckitt Benckiser, and as acted in 
      an advisory role for Boehringer Ingelheim, Norgine and Pfizer.
EDAT- 2020/03/07 06:00
MHDA- 2020/03/07 06:01
PMCR- 2020/03/01
CRDT- 2020/03/07 06:00
PHST- 2019/07/08 00:00 [received]
PHST- 2019/10/15 00:00 [accepted]
PHST- 2020/03/07 06:00 [entrez]
PHST- 2020/03/07 06:00 [pubmed]
PHST- 2020/03/07 06:01 [medline]
PHST- 2020/03/01 00:00 [pmc-release]
AID - 10.1055/a-1090-7289 [doi]
PST - ppublish
SO  - Endosc Int Open. 2020 Mar;8(3):E247-E256. doi: 10.1055/a-1090-7289. Epub 2020 Feb 
      21.