Lubiprostone a promising treatment for chronic idiopathic constipation.
One of the most common gastrointestinal (GI) symptoms in patients with diabetes is constipation. However, there are few effective therapies or data available that evaluate treating constipation in patients withdiabetes.
In a randomized, double-blind, placebo-controlled clinical trial, investigators wanted to examine the efficacy of lubiprostone (Amitiza) on constipation symptoms and colon transit time (CTT) in patients with diabetes. The findings were published in theAmerican Journal of Gastroenterology.
Thestudyincluded patients with diabetes who had chronic idiopathic constipation (CIC) and who were recruited from outpatient clinics at a tertiary-care center and a Veterans Administration Hospital. There was a total of 76 participants, of which, 62% were female. There was a mean age of 56.9±9.1 years.
The investigators obtained demographic data, baseline stool patterns, and the survey Patient Assessment of Constipation Quality of Life (PAC-QOL).
CIC was defined by Rome III criteria, and baseline CTT was evaluated using the wireless motility capsule.
The patients were randomized to receive either 48 mcg lubiprostone per day or placebo for 8 weeks. According to the study, the primary endpoint measured was the difference in the number of spontaneous bowel movements (SBMs) per week versus baseline, for each group, at each week after therapy initiation.
The secondary endpoints included changes in CTT after 4 weeks of treatment, PAC-QOL after 8 weeks of treatment, and changes from baseline in associated GI symptoms, as well as need for rescue medication at 2, 4, and 8 weeks, the study reported.
The results of the study showed no significant differences between the 2 groups’ baseline data or demographics.
During the 8-week treatment period, patients in the lubiprostone arm had an average of 1.83±0.80 (P= 0.02) more SBMs per week than those in the placebo group as compared with the baseline, according to the study.
At week 4, the duration of CTT was shorter by an average of 13 hours compared with the baseline in the lubiprostone arm. Furthermore, it was prolonged an average of 7 hours compared with the baseline in the placebo arm, resulting in a treatment effect of 20.3±7.3 h (P= 0.006).
PAC-QOL improved in both groups, although no significant difference was observed between the 2. After 8 weeks, there was no difference in associated GI symptoms and need for rescue medication between the 2 groups.
No serious adverse events were recorded during the study.
The findings suggest that lubiprostone is a safe and effective treatment for increasing weekly SBMs and decreasing CTTs in patients with diabetes who have CIC, the study concluded.