Introduction Chronic constipation (CC) is a prevalent disorder that has a significant negative impact on quality of life. Traditional management has focused on lifestyle measures and laxative. Prucalopride, a selective high affinity 5-HT4 receptor agonist, has been demonstrated to an effective treatment of severe CC. However, its efficacy in secondary care and factors that predict clinical response are incompletely understood. Our aim was thus to identify baseline factors that may predict positive clinical outcomes in patients taking prucalopride for CC.
Methods A single centre, prospective open label trial was undertaken in patients with primary and secondary CC, defined as less than 2 spontaneous complete bowel movements (SCBM) per week, who were commenced on prucalopride. Validated questionnaires were used to assess the severity of symptoms (patient assessment of constipation symptoms (PAC-SYM)), somatic symptoms (patient health questionnaire (PHQ-12-SS)) and the personality trait of neuroticism (big five inventory-neuroticism scale (BFI-N)). At follow up, clinical response was defined as the proportion of patients achieving 3 or more SCBM per week.
Results 64 patients (59 female, mean age 48.3 years, range 19–83) had a mean SCBM per week of 1.6 (range 0.5–2). At a mean follow up of 4.6 weeks (range 4–8) 40/64 (62.5%) patients achieved clinical response. 8/64 (12.5%) did not tolerate treatment due to side effects. In an intention to treat analysis, mean SCBM per week increased from 1.6 to 3.2 (p = 0.01) with mean PAC-SYM scores reducing from 27.7 to 20 (p = 0.001). Logistic regression analysis demonstrated that BFI-N (odds ratio 8.7, 95% confidence interval (CI), 1.99–64, p < 0.01) and slow transit constipation (STC) (odds ratio 1.4, 95% CI, 1.20–2.1, p < 0.01) were independently associated with positive treatment outcomes.
Conclusion Prucalopride is a useful, generally well tolerated, treatment for the management of CC in secondary care. These data suggest that efficacy could be enhanced by targeting patients with STC and in those who are more neurotic. Further work is now warranted to confirm these findings in a larger cohort of patients.
Disclosure of Interest A. Farmer Paid Instructor for: Shire Pharmaceuticals, P. Harvey: None Declared, D. Haldar: None Declared, N. Quraishi: None Declared, Q. Aziz: None Declared