Area Editoriale
OBJECTIVE: Aresidue-free sodium phosphate tablet (RF-NaP) was formulated that lacksmicrocrystalline cellulose, which can appear as a whitish residue in the colon.A multicenter, randomized, investigator-blinded study was conducted to comparethe colon-cleansing efficacy of 40 or 32 tablets of RF-NaP with the marketed40-tablet NaP treatment regimen. METHODS: Eight hundred sixteen patients wererandomized prior to colonoscopy to receive either 40 tablets (60 g) of NaP or RF-NaP or 32tablets (48 g)of RF-NaP. Coloncleansing was assessed using a 4-point scale based on retained "coloniccontents." The primary end point was overall colon-cleansing response rateto treatment (score of excellent/good) versus nonresponse (fair/inadequate).RESULTS: Seven hundred four patients were included in the efficacy analysis.The overall colon-cleansing response rates were comparable among treatment arms(94.5%, 97.0%, and 95.3% for NaP, RF-NaP 40, and RF-NaP 32 tablets,respectively). Ascending colon-cleansing response rates for RF-NaP 40 (95.7%)and 32 tablets (93.6%) were significantly better than for NaP tablets (88.5%, p< 0.03 for both). Patients treated with RF-NaP 32 tablets experienced lesspronounced changes in electrolyte levels and fewer adverse events (138/239,58%) compared with patients receiving NaP (161/238, 68%, p= 0.07) and RF-NaP 40tablets (156/236, 66%, p= 0.03). The most common adverse events reported wereabdominal distention, nausea, abdominal pain, and vomiting. CONCLUSIONS: Basedon the safety, efficacy, and patient preferences, the 32-tablet RF-NaP regimenwas superior to the 40-tablet RF-NaP and NaP regimen for colon cleansing priorto colonoscopy.Leggil'articolo