Lubiprostone Treatment in Patients With Irritable Bowel Syndrome With Constipation for up to 16 Weeks Duration

controlled trials (duration 4-12 weeks; PRU dose 0.5-4mg q.d.) in patients with CC were pooled, and different AE categories were compared between elderly and adults. RESULTS: 2717 patients were treated with PRU (exposure: 406 patient-yrs), of which 564 were ≥65 yrs (exposure: 63 patient-yrs). Exposure time to 2mg (recommended dose for adults) was 165 pt-yrs (n=938); exposure to 1mg (recommended dose for elderly) was 8 pt-yrs (n= 113). In the elderly, the incidence of the different AE categories was comparable between PRU and PLA, and comparable to those seen in adults except for serious AEs (SAEs). SAEs were reported at a higher rate in elderly (most commonly infections, infestations or respiratory disorders), with no difference observed between PRU and PLA (Table). Three elderly patients died, 2 on PRU, due to pneumonia or bronchitis (not considered related to study medication) and 1 on PLA due to arrhythmia/myocardial infarction. Most common AEs with PRU in both age groups were gastrointestinal symptoms (nausea, diarrhea, abdominal pain) and headache. Results in subgroups of patients 65-75 yrs and patients ≥75 yrs were similar to those observed in the whole group of elderly patients. The proportion of patients on PRU discontinuing therapy among the elderly and adults was similar. The incidence of cardiovascular AEs of interest (palpitations, corrected QT interval-related AEs, and ventricular arrhythmias) was comparable in both age groups, as well as for PRU and PLA. Cardiac ischemia and atrial arrhythmia-related AEs were more common in elderly, but their incidence was not different for PRU and PLA. The majority of ischemic and atrial rhythm-related AEs were reported by the investigator as unrelated to the study medication or doubtful. CONCLUSIONS: In 14 double-blind, PLA-controlled, Phase II/III trials of PRU, the safety and AE profiles were similar relative to PLA in adult and elderly patients with CC.