Safety and Adverse Event Profiles of Oral Prucalopride Are Similar in Elderly and Adult Patients With Chronic Constipation

Abstract

• Adverse events from Phase II/III double-blind placebo-controlled studies with a duration of 4 to 12 weeks were pooled. • Patients received placebo or prucalopride for the treatment of chronic constipation at a once-daily dose of 0.5, 1, 2 or 4 mg. • Adverse events reported in elderly (≥65 years) patients were compared to those reported in adult (18-65 years) patients included in the studies. • Three elderly patients died during the studies (versus no patients in the younger age group): − Two who received prucalopride died from pneumonia or bronchitis, both considered not related to study treatment by the investigator. − One who received placebo died from arrhythmia and myocardial infarction. • Prucalopride is a selective, high-affinity 5-HT4 receptor agonist with enterokinetic activities. The high affinity and selectivity for 5-HT4 receptors differentiates prucalopride from older-generation compounds such as cisapride and tegaserod, by minimizing the potential for target-unrelated side effects.1-3 • In the European Union, prucalopride is approved for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. The recommended dose is 2 mg once daily for adults and 1 mg once daily (with an increase to 2 mg once daily, if needed) for elderly patients.4