Prucalopride was originally approved for use only in women, as almost 90% of participants in the pivotal trials of the drug were female - reflecting the smaller number of men who seek medical care for chronic constipation.
Now, a randomised, placebo-controlled, double-blind study has confirmed the safety and efficacy of the drug in men with chronic constipation.
Comparable efficacy in men and women
Investigators enrolled 374 men with chronic constipation, defined as two or fewer spontaneous complete bowel movements (SCBMs) per week, as well as one or more of the following for at least 6 months:
- at least 25% of stools being very hard or hard
- sensation of incomplete evacuation following at least 25% of defaecations
- straining at defaecation for at least 25% of the time.
Prucalopride was significantly more effective than placebo at increasing the number of bowel movements, with 37.9% of patients in the prucalopride group and 17.7% of those in the placebo group achieving a mean of 3 or more SCBMs per week over the 12-week treatment period (p<0.0001).
Quality of life benefit
Prucalopride also improved health-related quality of life. The mean change from baseline in Patient Assessment of Constipation—Quality of Life (PAC-QOL) questionnaire score was significantly greater in the men treated with prucalopride than in those who received placebo (–0.79 vs –0.59, p=0.0158).
The proportion of patients with an improvement of at least 1 point in PAC-QOL satisfaction subscale score was 52.7% in the prucalopride group compared with 38.8% in the placebo group (p=0.0035).
Prucalopride was well tolerated in men, with no significant difference in the rate of treatment-emergent adverse events compared with placebo.
The most common treatment-emergent adverse events seen with prucalopride were diarrhoea, nausea, abdominal pain and headache.