Association between health-related quality of life and symptoms in patients with chronic constipation

An integrated analysis of three phase 3 trials of prucalopride

J. Tack, Michael Camilleri, D. Dubois, L. Vandeplassche, A. Joseph, R. Kerstens

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Background: Prucalopride is a high-affinity 5-HT4 receptor agonist for the treatment of chronic constipation. The aims of this study were to investigate the relationship between health-related quality of life (HRQoL) and symptoms of constipation, and to assess the response of HRQoL to treatment using integrated data from three phase III trials of prucalopride. Methods: This was an integrated analysis of data from three pivotal multicenter, double-blind, randomized, placebo-controlled, parallel-group trials (ClinicalTrials.gov Identifiers: NCT00488137, NCT00483886 and NCT00485940). Relationships were investigated between Patient Assessment of Constipation Quality of Life (PAC-QOL) scores, Patient Assessment of Constipation Symptoms (PAC-SYM) scores, bowel movement frequency (assessed using daily diaries), and treatment. Key Results: Patients treated with prucalopride 2 mg (n = 659) and placebo (n = 661) were included in the analysis. An improvement in PAC-SYM scores correlated well with an improvement in PAC-QOL overall score (r = 0.711) and satisfaction subscale score (r = 0.589). After 12 weeks, PAC-QOL overall score and satisfaction subscale score significantly (p <0.001) improved by ≥1 point (clinically relevant) in 36.5% and 44.1% of patients treated with prucalopride, compared with 18.5% and 22.4% with placebo respectively. Moreover, 39.0% of patients with an improvement in satisfaction of ≥1 point achieved ≥3 spontaneous complete bowel movements/week, compared with 7.4% of those with no improvement in satisfaction (

Original languageEnglish (US)
Pages (from-to)397-405
Number of pages9
JournalNeurogastroenterology and Motility
Volume27
Issue number3
DOIs
StatePublished - Mar 1 2015

Fingerprint

prucalopride
Constipation
Quality of Life
Symptom Assessment
Placebos
Serotonin 5-HT4 Receptor Agonists
Receptors, Serotonin, 5-HT4

Keywords

  • Chronic constipation
  • HRQoL
  • PAC-QOL
  • PAC-SYM
  • Prucalopride

ASJC Scopus subject areas

  • Endocrine and Autonomic Systems
  • Gastroenterology
  • Physiology

Cite this

Association between health-related quality of life and symptoms in patients with chronic constipation : An integrated analysis of three phase 3 trials of prucalopride. / Tack, J.; Camilleri, Michael; Dubois, D.; Vandeplassche, L.; Joseph, A.; Kerstens, R.

In: Neurogastroenterology and Motility, Vol. 27, No. 3, 01.03.2015, p. 397-405.

Research output: Contribution to journalArticle

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