Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints

Figure 1

CSBM and SBM response rates using different time intervals. Abbreviations: CIC, chronic idiopathic constipation; CMH, Cochran–Mantel–Haenszel; CSBM, complete spontaneous bowel movement; FDA, US Food and Drug Administration; PEG, polyethylene glycol; SBM, spontaneous bowel movement. ^†FDA CIC endpoint: weekly responder for ≥9 weeks out of the 12-week treatment period including 3 of the last 4 weeks of the period. for PEG 3350 vs placebo for all CSBM/SBM responder definitions. P value obtained from CMH chi-squared test, adjusting for pooled study sites, to ensure homogeneity/consistency across the treatment arms. A weekly CSBM/SBM responder is a patient who has at least three CSBMs/SBMs and at least one CSBM/SBM more than baseline in a week, and data are available on at least 4 days in a respective week. A continuous CSBM/SBM responder is a responder for ≥9 out of the first 12 weeks and ≥9 out of the last 12 weeks.