Prucalopride still effective in CIC despite older age, unhealthy BMI or renal impairment
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Key takeaways:
- Prucalopride was efficacious, regardless of a patient’s age, BMI or renal function.
- Patients with obesity or moderate renal impairment experienced improvement, but it did not reach statistical significance.
Prucalopride was safe and effective in increasing the frequency of complete spontaneous bowel movements in patients with chronic idiopathic constipation, regardless of age, BMI or renal function, according to data.
“Prucalopride (1 or 2 mg once daily) has been demonstrated to improve the number of complete spontaneous bowel movements in patients with CIC over a 12-week treatment period as part of an integrated analysis of six phase 3 and 4 clinical trials,” Anthony Lembo, MD, director of research at the Digestive Disease Institute at Cleveland Clinic, and colleagues wrote in Therapeutic Advances in Gastroenterology.
They continued, “A pharmacokinetic analysis of prucalopride showed that there are no clinically significant differences in its pharmacokinetic profile based on age (17-95 years) or BMI (14-57 kg/m²) after accounting for the effect of renal function. However, efficacy and safety endpoints were not analyzed. This information would help to improve clinical understanding and enable health care professionals to tailor therapies based on individual patients’ characteristics.”
To examine the impact of age, BMI and renal function on the efficacy and safety of prucalopride (Motegrity, Shire) in patients with chronic idiopathic constipation (CIC), Lembo and colleagues performed a post-hoc analysis of data from six phase 3 and 4 clinical trials, which assessed use of prucalopride 1 mg or 2 mg daily over 12 weeks in patients with CIC.
Patients were stratified into subgroups based on age (< 50 years; 50-64 years; 65 years), BMI (underweight/healthy weight, < 25 kg/m²; overweight, 25 to < 30 kg/m²; obese, 30 kg/m²) and renal function (normal renal function, estimated glomerular filtration rate [eGFR]: 90 mL/min/1.73 m²; mild renal impairment, eGFR: 60 to < 90 mL/min/1.73 m²; moderate renal impairment, eGFR: 30 to < 60 mL/min/1.73 m²).
The primary endpoint was the proportion of patients who achieved a mean of at least three complete spontaneous bowel movements (CSBMs) per week over 12 weeks.
Of the patients included in analysis, 2,484 were stratified by age (prucalopride, n = 1,237; placebo, n = 1,247), 2,482 by BMI (prucalopride, n = 1,237; placebo, n = 1,245) and 2,474 by renal function (prucalopride, n = 1,233; placebo, n = 1,241).
According to data from each age subgroup, the primary endpoint was achieved by a “significantly greater proportion” of patients receiving prucalopride vs. placebo.
Based on BMI, more patients treated with prucalopride who were underweight or healthy weight (24.8% vs. 10.9%; P < .001) or overweight (34.6% vs. 15.4%, P < .001) achieved at least three CSBMs weekly. However, the difference was not statistically significant among patients with obesity (25.1% vs. 19.1%).
Further, the primary endpoint was achieved by more patients with normal renal function (29.8% vs. 13.7%; P < .001) or mildly impaired renal function (26.2% vs. 12.8%, P < .001) when treated with prucalopride vs. placebo, although the difference did not reach statistical significance among those with moderate renal impairment (17.7% vs. 12.2%).
The researchers noted patients who received prucalopride reported more treated-related adverse events, although no “unexpected” safety concerns were observed.
“These findings suggest slight differences in the efficacy profile of prucalopride in patients with CIC by BMI and renal function,” Lembo and colleagues wrote.
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