Microcrystalline Cellulose-Free NaP Tablets (INKP-102) Achieve Comparable Overall and Superior Ascending Colon Cleansing Rates Versus Visicol Tablets: A Pooled Analysis of Phase II and III Trials Douglas Rex Background: Visicol (Salix Pharmaceuticals, Inc, Morrisville, NC) contains 13% microcrystalline cellulose (MCC), an excipient which can leave a residue, usually in the ascending colon, and impair full visibility during a colonoscopy. A new MCC-free sodium phosphate (NaP) tablet formulation, INKP-102, has been developed as an alternative bowel purgative to Visicol. Prior data have shown 32 tablets of INKP-102 to be preferred by patients and better tolerated than 40 Visicol tablets. To fully evaluate the efficacy of INKP-102 versus Visicol, a pooled efficacy analysis of phase 2 and phase 3 randomized, clinical trials was conducted. Methods: Patients received INKP-102 40 (60 g) or 32 tablets (48 g), 4 tablets at a time, or Visicol 40 tablets (60 g), 3 tablets at a time. Overall colon cleansing (OCC) and ascending colon cleansing (ACC) were assessed by a physician questionnaire using a 4-point scale, based on colonic contents. Patients were considered responders if they achieved a rating of ‘‘excellent’’ (O90% of mucosa observed, mostly liquid colonic contents, minimal suctioning required) or ‘‘good’’ (O90% of mucosa observed, mostly liquid stool, significant suctioning required) colon cleansing. Results: All randomized patients who received at least 1 dose of study medication and underwent a colonoscopy were included: 262, 269, and 264 patients treated with INKP-102 40 tablets, INKP102 32 tablets, and Visicol 40 tablets, respectively. A large, comparable percentage of OCC responders was reported in all groups; 97% and 96% for INKP-102 40 and 32 tablets, respectively, compared with 94% for Visicol 40 tablets. However, a significantly larger number of ACC responders was observed with INKP-102 40 (96%) and 32 tablets (94%) compared with Visicol 40 tablets (88%; P Z 0.0006 and P Z 0.0090 versus INKP-102 40 and 32 tablets, respectively). Of these responses, 74% and 76% were rated as excellent with INKP-102 40 and 32 tablets, respectively, compared with 51% with Visicol 40 tablets. Conclusion: This pooled analysis demonstrates that patients treated with 32 tablets of INKP-102 achieve a comparable OCC response and a superior ACC response compared with patients receiving 40 tablets of Visicol. The absence of MCC in INKP-102 may account for the differences in ACC response observed. The benefits of this new tablet NaP formulation suggest INKP-102 will be the first choice for tablet bowel purgatives. T1393 Association of Obesity, Serum Glucose and Lipids with the Risk of Advanced Colorectal Adenoma and Cancer: A Case-Control Study in Korea Yong Woo Chung, Dong Soo Han, Yoon Kyung Park, Byoung Kwan Son, Chang Hee Paik, Yong Cheol Jeon, Joo Hyun Sohn Background: Previous studies on life style for colon cancer risk suggest that obesity, serum lipids and glucose might be related to colorectal adenomas as well as to colorectal carcinogenesis. This case-control study was conducted to investigate the association between obesity, serum lipids and glucose, and the risk of advanced colorectal adenoma and cancer. Methods: Patients with histologically confirmed colorectal cancers (n Z 105), same number of patients with advanced colorectal adenomas matched by age and sex, and the same number of controls matched by age and sex were selected in Hanyang University Guri Hospital between January 2002 and June 2004. Results: Adenoma group showed significantly higher levels of mean BMI (p ! 0.01), serum glucose (p ! 0.01) and triglyceride (p ! 0.05). In cancer group, mean BMI and serum lipids levels were significantly lower than adenoma group (p ! 0.01), but mean serum glucose level was higher than adenoma group (p Z 0.19). In logistic regression analysis, there was a significant trend of increasing advanced colorectal adenoma risk with the rise in BMI (ptrend ! 0.001). Increasing trend for the risk with fasting serum glucose was also seen (ptrend Z 0.08). Both triglyceride and cholesterol were not stastically significant. Conclusions: Obesity and hyperglycemia are positively related to the increased risk of advanced colorectal adenomas. In this regard, insulin resistance associated with glucose intolerance is thought to play a role in colorectal carcinogenesis. Lower levels of BMI and serum lipids in patients with colon cancer may be the results of nutritional and metabolic changes in advanced cancer patients, not the direct causes of colon cancer.