THE IMPACT OF PLECANATIDE ON QUALITY OF LIFE FOR PATIENTS WITH CHRONIC IDIOPATHIC CONSTIPATION (CIC): RESULTS FROM TWO PHASE 3 CLINICAL STUDIES

OBJECTIVES: To investigate whether plecanatide, a uroguanylin analog, improved health-related quality of life (HRQoL) in 2 clinical trials of patients with chronic idiopathic constipation (CIC). METHODS: Patients meeting modified Rome III CIC criteria were randomized to placebo, plecanatide 3mg or 6mg daily for 12 weeks. The primary endpoint was the proportion of durable overall CSBM responders (≥3 CSBMs plus increase of ≥1 CSBM over baseline in the same week) for ≥9 of 12 treatment weeks, including ≥3 of the last 4 weeks. HRQpL assessments included: Patient Assessment of Constipation-Symptoms (PAC-SYM), PAC-Quality of life (PAC-QOL), and Treatment Satisfaction. Results are versus placebo. RESULTS: Patients (N=2683) had similar baseline characteristics. Pooled efficacy showed significantly greater overall durable CSBM responders with plecanatide 3mg (n=184,20.5%) and 6mg (n=176,19.8%) vs placebo (n=103,11.5%; P