PMID- 21039673
OWN - NLM
STAT- MEDLINE
DCOM- 20110224
LR  - 20121115
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Linking)
VI  - 32
IP  - 9
DP  - 2010 Nov
TI  - Clinical trial: the efficacy of open-label prucalopride treatment in patients 
      with chronic constipation - follow-up of patients from the pivotal studies.
PG  - 1113-23
LID - 10.1111/j.1365-2036.2010.04455.x [doi]
AB  - BACKGROUND: Prucalopride is approved in Europe for symptomatic treatment of 
      chronic constipation in women with inadequate relief from laxatives. AIM: To 
      evaluate efficacy of prucalopride during long-term treatment of patients with 
      chronic constipation. METHODS: Patients from three pivotal double-blind, 
      placebo-controlled, 12-week studies with prucalopride could continue treatment in 
      open-label studies up to 24 months. Efficacy was evaluated every 3 months using 
      the Patient Assessment of Constipation-Quality of Life (PAC-QOL) satisfaction 
      scale. Laxative use and reasons for study discontinuation were recorded. RESULTS: 
      Eighty-six percent of patients who completed the pivotal studies continued 
      prucalopride treatment in the open-label studies (n = 1455, 90% female). 
      Improvement in average PAC-QOL satisfaction score observed after 12-week, 
      double-blind prucalopride was maintained during open-label treatment for up to 18 
      months; in each 3 month period, 40-50% of patients did not use any laxatives. 
      Most frequent adverse events (AEs) resulting in discontinuation were 
      gastrointestinal events (3.3%) and headache (1.0%). Only 10% of patients who had 
      normalized bowel function on prucalopride at the end of pivotal trials 
      discontinued due to insufficient response during open-label treatment. 
      CONCLUSION: Satisfaction with bowel function is maintained for up to 18 months of 
      treatment with prucalopride. Gastrointestinal events and headache cause 
      discontinuation of prucalopride treatment in  approximately 5% of patients (ClinicalTrials.gov 
      identifiers: NCT01070615 and NCT00987844).
CI  - (c) 2010 Mayo Foundation for Medical Education and Research.
FAU - Camilleri, M
AU  - Camilleri M
AD  - Mayo Clinic, Rochester, MN 55905, USA. camilleri.michael@mayo.edu
FAU - Van Outryve, M J
AU  - Van Outryve MJ
FAU - Beyens, G
AU  - Beyens G
FAU - Kerstens, R
AU  - Kerstens R
FAU - Robinson, P
AU  - Robinson P
FAU - Vandeplassche, L
AU  - Vandeplassche L
LA  - eng
SI  - ClinicalTrials.gov/NCT00987844
SI  - ClinicalTrials.gov/NCT01070615
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20100916
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Benzofurans)
RN  - 0 (Laxatives)
RN  - 0 (Serotonin 5-HT4 Receptor Agonists)
RN  - 0A09IUW5TP (prucalopride)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Benzofurans/*therapeutic use
MH  - Chronic Disease
MH  - Constipation/*drug therapy
MH  - Defecation/*drug effects
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Laxatives/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Serotonin 5-HT4 Receptor Agonists/*therapeutic use
MH  - Statistics as Topic
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2010/11/03 06:00
MHDA- 2011/02/25 06:00
CRDT- 2010/11/03 06:00
PHST- 2010/11/03 06:00 [entrez]
PHST- 2010/11/03 06:00 [pubmed]
PHST- 2011/02/25 06:00 [medline]
AID - 10.1111/j.1365-2036.2010.04455.x [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2010 Nov;32(9):1113-23. doi: 
      10.1111/j.1365-2036.2010.04455.x. Epub 2010 Sep 16.