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Resolor safely improved chronic constipation in men
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Results from a recent phase 3 study showed that Resolor is a safe, effective and well-tolerated treatment for men with chronic constipation.
Resolor (prucalopride, Johnson & Johnson) is a 5-hydroxytryptamine receptor-4 agonist that stimulates intestinal motility. Previous phase 3 trials showed positive results, but their cohorts were composed of less than 10% men.
Yan Yiannakou
“Prucalopride has become an important option in the treatment of patients with chronic constipation refractory to dietary and laxative therapy, but has to date been licensed for use only in women,” Yan Yiannakou, MD, from University Hospital of North Durham, United Kingdom, told Healio Gastroenterology. “This gender inequality was the result of an unforeseen consequence of the heavy preponderance of females who attend doctors for constipation, leading to an inadequate dataset of males to prove effect. It was important to address this so a study was set up to look specifically at male patients.”
To evaluate the efficacy of once-daily 1 mg to 2 mg prucalopride vs. placebo in men with chronic constipation, Yiannakou and colleagues performed a stratified, randomized, parallel-group, double blind trial involving 374 patients enrolled at 66 sites across Europe from September 2010 to October 2013.
The primary endpoint was the proportion of patients with a mean of three or more spontaneous complete bowel movements per week throughout the 12-week treatment period. This and other secondary points were assessed with daily electronic diaries, global assessment of illness severity and treatment efficacy, and patient questionnaires.
Overall, 37.9% of patients in the treatment group achieved the primary endpoint compared with 17.7% of the placebo group (P < .0001), and the number needed to treat was five (95% CI, 4-10). In the treatment group, 46.7% of patients rated treatment “quite a bit” to “extremely” effective at final treatment visit compared with 30.4% in the placebo group (P < .0001). Quality-of-life questionnaire scores improved by at least one point in 52.7% of the treatment group compared with 38.8% of the placebo group (P = .0035). Prucalopride also was well tolerated and had a good safety profile.
“This has shown treatment effects that are statistically significant and comparable to those seen in female cohorts,” Yiannakou said. “It is hoped this study will allow male patients to benefit from this treatment as well.”
Prucalopride is approved in the European Union as Resolor and in Canada as Resotran, but it is not yet approved in the United States. – by Adam Leitenberger
Disclosure: Yiannakou reports he has received lecture fees, travel and educational grants from Shire. Please see the study for a full list of all other authors’ relevant financial disclosures.
Editor’s Note: This article was updated on May 5 to reflect additional information.
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