Eluxadoline effectively treated a variety of patients that presented with irritable bowel syndrome with diarrhea (IBS-D), according to a subgroup analysis of two randomized clinical trials published in Therapeutic Advances in Gastroenterology.
“This analysis provides evidence that eluxadoline is an effective IBS-D therapy irrespective of age, sex, race, presence of comorbidities, or baseline disease characteristics,” reported Brian E. Lacy, of Mayo Clinic, Jacksonville, Fla., and colleagues.
Eluxadoline is a locally active mixed µ- and κ-opioid receptor agonist and δ-opioid receptor antagonist approved for the treatment of IBS-D in adults. Prior research has shown that eluxadoline can improve stool consistency and abdominal pain, and that treatment responses were maintained over six months.
In this study, Lacy and colleagues looked at data from two large double-blind trials (IBS-3001 and IBS-3002) that enrolled patients (n = 2,423) meeting criteria for IBS-D.
Patients were randomly assigned to treated with placebo, eluxadoline 75 mg, or eluxadoline 100 mg twice daily.
Eluxadoline improved symptoms of IBS-D across all age groups (< 65 years and ≥ 65 years).
“However, elderly patients demonstrated apparent increased sensitivity to eluxadoline treatment,” the researchers reported.
Among patients aged < 65 years, a slightly higher proportion of responders was seen in those assigned to 100 mg dose of eluxadoline. Among patients aged ≥ 65 years, a higher proportion of patients were composite responders among those on the 75 mg dose. Among this age group, a greater proportion of patients assigned the 75 mg dose were also abdominal pain and stool consistency responders compared with those receiving the 100 mg dose.
Overall, patient sex did not appear to affect the efficacy of eluxadoline. More male and female patients who received eluxadoline were composite responders compared with those who received placebo.
Similarly, among all races, composite response was greater among patients assigned eluxadoline. However, the researchers did not that the majority (86.05%) of the patients were white.
Finally, the proportion of composite responders was higher among patients assigned 75 mg or 100 mg eluxadoline compared with placebo among patients with a BMI less than 30. Among patients with a BMI of 30 or greater, the proportion of responders was lower than that of patients with a lower BMI, but still higher compared with placebo.
“Overall, there were no new safety signals in any of the analyzed subgroups, with a similar safety profile across age and sex subgroups when comparing eluxadoline and placebo treatment groups,” the researchers wrote.
However, the proportion of patients with at least one adverse event was slightly higher among patients aged ≥ 65 years and female patients, the study found.
The researchers noted that although these data are “meaningful,” many of the subgroups had small population sizes, making it uncertain if the research is translatable to the population at large.