The trial involved 38 medical centers and was led by Michael Camilleri, M.D., a Mayo Clinic gastroenterologist. Patients who met the study criteria were randomly assigned to receive either of two dosage levels of prucalopride, a medication that stimulates protein receptors involved in contraction of the colon, or a placebo.
“The 620 patients studied in this trial were severely constipated, averaging only one bowel movement during the two weeks before entering treatment, and most had struggled with the problem for several years, not merely months.“ The two milligram (mg) and four mg doses of prucalopride appeared roughly equal in benefit, with about 30 percent of patients averaging three bowel movements per week during the 12-week study.
Only 12 percent of patients on placebo averaged three bowel movements per week. Nearly half (47.3 and 46.6 percent, respectively) of the patients taking prucalopride increased their bowel movements by at least one per week, while about a quarter (25.8 percent) of those on placebo had a similar improvement. The most common adverse effect from the drug was diarrhea. Camilleri says the cardiac risk issues that have been raised about related drugs for constipation including tegaserod, appear to be less of a concern for prucalopride.
The results from other studies will need to be compiled and published, and safety and efficacy data submitted to the Food and Drug Administration for review, before it can be approved in the United States as a treatment for chronic constipation, he says.
MEDICA.de; Source: Mayo Clinic