Introduction: Prucalopride is a selective, high-affinity 5-HT4 receptor agonist for the treatment of chronic constipation (CC) in women in whom laxatives fail to provide adequate relief. The recommended once-daily starting dose is 2 mg for adults (18–65 years), but 1 mg for elderly (>65 years) patients. This study aimed to compare the adverse event (AE) profiles of prucalopride in adults and elderly patients with CC.
Methods: Data were integrated from all 14 phase 2 of 3 double-blind, placebo-controlled trials of prucalopride in patients with CC (4–12 weeks' duration; prucalopride 0.5–4 mg once daily). AEs, serious AEs and AEs of particular interest were compared in adults and elderly patients with CC.
Results: In total, 1,369 patients were treated with placebo and 2,717 with prucalopride. Of patients taking prucalopride, 564 (20.8%) were elderly, 938 (34.5%) were exposed to prucalopride 2 mg [203 (21.6%) elderly] and 308 (11.3%) were exposed to prucalopride 1 mg [113 (37%) elderly]. The most common AEs with prucalopride, for elderly and adult patients, were gastrointestinal symptoms and headache, which usually occurred on the first treatment day. Elderly patients more commonly had a history of cardiac ischaemia and atrial arrhythmia, and these AEs (mostly considered unrelated to study medication) were more frequent in elderly patients than in adults. Serious AEs were more frequent in elderly patients [placebo: 9 (4.2%); prucalopride: 18 (3.2%)] than in adults (placebo: 17 (1.5%); prucalopride: 40 (1.9%)] but comparable in placebo- and prucalopride-treated groups. Three elderly patients died, one placebo and two prucalopride treated (considered unrelated to study medication). Overall, in elderly patients AE incidence was similar in placebo- [113 (52.8%)] and prucalopride-treated [331 (58.7%)] groups, and lower than in adults [placebo: 712 (61.6%); prucalopride: 1,534 (71.2%)].
Conclusions: This analysis shows that prucalopride AE profiles are similar in adult and elderly patients with CC.