Summary Background Patient acceptance of bowel preparation can affect colon cancer screening compliance. Aim To compare patient acceptance, preference and tolerability of 32‐sodium phosphate tablets vs. 2L polyethylene glycol solution plus 4 bisacodyl tablets for bowel preparation. Methods A prospective, randomized, investigator‐blinded, multicentre trial was performed. Results were based on responses to a patient questionnaire. Results 411 patients (205 sodium phosphate; 206 polyethylene glycol plus bisacodyl) completed the study preparation and patient questionnaire prior to colonoscopy. More patients receiving sodium phosphate vs. polyethylene glycol plus bisacodyl found it easy to take (77% vs. 42%), reported it to be without taste (47% vs. 6%), found it easy to take with respect to volume of liquid prescribed (72% vs. 27%) and indicated they would take the same preparation again in the future (96% vs. 74%, P < 0.0001 for all). Fewer patients receiving sodium phosphate vs. polyethylene glycol plus bisacodyl had to take time off work or change ordinary activities to take the study preparation (18% vs. 52%, P < 0.0001). Nausea, vomiting, bloating and abdominal pain were reported less frequently with sodium phosphate ( P < 0.0013). Conclusion The 32‐tablet sodium phosphate dosing regimen was easier to take and better tolerated, when compared to 2L polyethylene glycol plus bisacodyl tablets for bowel preparation.
Purpose: The management of polypoid dysplasia in ulcerative colitis (UC) is evolving. There are at least 3 reports of polypectomy as a safe alternative to colectomy in pts with adenoma-like mass lesions (ALMs) (Rubin, et al Gastro 1999;117:1295 [n = 30]; Odze, et al Clinical Gastro Hep. 2004;2:534 [n = 24]; Kundu et al. Gastro 2005; S128(4): A579 [n = 30]). The management of high grade dysplasia (HGD) in ALMs is not well characterized. Aim of this study was to ascertain the course of pts with HGD in ALMs in the absence of any synchronous flat dysplasia. We hypothesize that colectomy is not mandated in pts after complete excision of ALMs with HGD. Methods: Pathology/clinical databases were systematically searched for dysplastic lesions in inflammatory bowel disease from 1997–2004. Pts were identified with UC who had ALM lesions, and a subset with high-grade dysplastic polyps were defined as our study cohort. Pt demographics, disease characteristics, surveillance protocol, histopathology of biopsies and colectomy specimens were evaluated. Results: 113 pts were identified with dysplastic lesions .102 (90%) of these had UC, 5(4%) had Crohn's disease and 6(6%) had indeterminate colitis. 30 of the 102 (29%) pts with UC had ALMs in the absence of synchronous flat dysplasia; of which 9(30%) had HGD in these polyps. The mean age of cohort was 61 yrs (28–75 yrs); 6/9(66%) were male. The mean duration of disease was 16.3 yrs (6–26 yrs). 7/9 (77%) pts had pancolitis .9 pts had 10 ALMs with HGD. 9/10 (90%) of these polyps were within the area of colitis. The polyps were found in: 1(10%) in cecum, 3(30%) in ascending colon, 1(10%) in descending colon, 3(30%) in sigmoid colon, and 2(20%) in rectum. Most polyps (8/10) were adenomatous and 2/10 were villous. The mean polyp size was 5.4 mm (2–12mm). 32 surveillance colonoscopies were performed (mean 3.6 colonoscopies/pt). The pts were followed for a mean of 64.5 mos (40–87 mos). 3/9 pts (33%) had colectomy. No pts in this cohort were detected to have carcinoma in surveillance biopsies and/or in their resection specimens. Conclusions: Our data suggests that the presence of high grade dysplasia in ALMs does not mandate colectomy. Continued close observation is suggested in this pt cohort after complete excision of polyps. Further prospective evaluation of this pt population is merited.
Purpose: Sedation improves patient acceptance of colonoscopy (COY), but accounts for 90% of complications [1]. Propofol reduces recovery time and improves patient satisfaction relative to benzodiazepines. Use of propofol by non-anesthesiologists is controversial, as is reimbursement for routine colonoscopy with anesthesia providers. Patient-controlled sedation (PCS) has been investigated for COY [2], but previous studies utilized suboptimal doses of narcotics, and were not blinded. We undertook a prospective, randomized, double-blind comparison of PCS for COY with propofol/remifentanil vs. midazolam/fentanyl. Methods: Sedation was provided via a Graseby 3400 PCA pump with a 60 cc syringe containing either propofol 10 mg/ml + remifentanil 10 μg/ml (group PR) or midazolam 0.5 mg/ml + fentanyl 12.5 μg/ml (group MF). The syringe and tubing were shrouded. Initial bolus was 2.5 ml with demand of 0.75 ml at zero lockout (PR) or 4 ml with 1 ml demand at 1' lockout (MF). An unblinded anesthesiologist was present to intervene. The 1° safety endpoint was SaO2<85% for 60.” Endoscopist, RN, and patient were blinded; satisfaction was assessed by Likert scale. Ambulation without assistance was assessed by a blinded observer. Comparison of times was by 2 sided t-test. Results: As shown in Table 1, time to sedation and to ambulation were significantly lower for group PR. Time to ambulation for group PR was less than procedure time (p < 0.0001). The study was underpowered for the safety endpoint, but PR patients were more likely to require stimulation to maintain SaO2 > 85%. Only one patient in group PR required intervention by the anesthesiologist (two breaths of 100% O2), but completed the procedure without sequelae. Satisfaction of patients, RN, and endoscopist were high in both groups.Table: Times (min) (mean ± SE)Conclusions: PCS with PR significantly reduces sedation and recovery times, improving throughput and permitting reduction in PACU capacity. Respiratory depression was more common in group PR, but was generally managed by low-skill interventions. These results may impact the debate on staffing of sedation for COY and economic viability of such practices. Gastrointest Endosc. 2001; 53(6):620–7. Endoscopy 2003; 35(8):683–7.
Purpose: Multiple meta-analyses (Kandiel 2005, Kotlyar 2011) have shown thiopurine use increases the risk of lymphoma. There is no meta-analysis specifically comparing the risk in patients (pts) who were active users of thiopurines as compared to past users. We aim to compare the SIR between pts actively using thiopurines to pts with past use. Methods: We searched MEDLINE for “lymphoproliferative and thiopurines” and “azathioprine and lymphoma.” Included citations were pop-based cohort studies examining IBD, evaluated cancer as an outcome, pts were prescribed AZA/6-MP, and studies which segregated active use of thiopurine data from past use or had data on the risk of lymphoma in patients who have never been on thiopurines. Pooled SIRs and 95% confidence intervals (CIs) were estimated. A look at meetings from 2005-2012 with keywords of “lymphoma” and “IBD” found one referral-based study (Peyrin-Biroulet). CIs assumed a Poisson distribution. Three population (pop)-based studies (Herrinton/Kaiser 2012, Beaugerie 2010, Peyrin-Biroulet 2010) separated data based on active vs. past use of thiopurines. One study (Armstrong 2010) only reported data for patients never on thiopurines. Peyrin-Biroulet did not report data on neverusers of thiopurines. Results: There were 484 citations; four were included. The incidence rate ratio (IRR) between active users and never-users was 3.73 (95% CI 2.15-6.27), p<0.0001. When comparing current use to past use, again the IRR was significantly elevated at 2.96 (95% CI 1.09-10.0), p=0.0095. Past use of thiopurines was not associated with an increased incidence of lymphoma when comparing past use with never-users. The IRR was found to be 1.26 (95% CI 0.39-3.14), p=0.30 (Figure 1).FigureConclusion: Past users of thiopurines do not have elevated SIRs as compared to IBD pts who have never used thiopurines. Previous studies (Beaugerie 2010, Loftus 2000) discussed how IBD alone is not a risk factor for lymphoma; those never using thiopurines or have had past use are not at a higher risk for lymphoma. Anti-TNF use may also be associated with lymphoma, but is not studied here. Pts without anti-TNF exposure and who have had thiopurines in the past may be counseled that they do not have an elevated risk of lymphoma. These data imply that increased risk of lymphoma with current use of thiopurines does not appear to continue after stopping therapy. Disclosure - Conflicts of Interest: Gary Lichtenstein Other financial benefit not in list, Grant/Research Support, Abbott Laboratories, Other financial benefit not in list, Grant/ Research Support, Abbott Laboratories, Other financial benefit not in list, Consulting, Bristol-MyersSquibb Co., Other financial benefit not in list, Grant/Research Support, Centocor/Orthobiotech, Inc., Other financial benefit not in list, Consulting, Centocor/Orthobiotech, Inc., Other financial benefit not in list, Grant/Research Support, ElanPharmaceuticals, Inc., Other financial benefit not in list, Consulting, Ferring Pharmaceuticals Inc, Other financial benefit not in list, Consulting, MillenniumResearch Group, Other financial benefit not in list, Consulting, Procter & Gamble Pharmaceuticals, Other financial benefit not in list, Grant/Research Support, Procter & Gamble Pharmaceuticals, Other financial benefit not in list, Consulting, Procter & Gamble Pharmaceuticals, Other financial benefit not in list, Grant/Research Support, Prometheus Laboratories Inc., Other financial benefit not in list, Consulting, PrometheusLaboratories Inc., Other financial benefit not in list, Grant/Research Support, Salix Pharmaceuticals, Inc., Other financial benefit not in list, Grant/ResearchSupport, Salix Pharmaceuticals, Inc., Other financial benefit not in list, Consulting, SalixPharmaceuticals, Inc., Other financial benefit not in list, Consulting, Warner Chilcotte, Other financial benefit not in list, Consulting, Schering-Plough Corp., Other financial benefit not in list, Consulting, Shire Pharmaceuticals Inc., Other financial benefit not in list, Grant/Research Support, Shire Pharmaceuticals Inc., Other financial benefit not in list, Consulting, WyethPharmaceuticals, Otherfinancial benefit not in list, Consulting, UCB, Inc., Otherfinancial benefit not in list, Consulting, Warner Chilcotte, Other financial benefit not in list, Grant/Research Support, Warner Chilcotte, Otherfinancial benefit not in list, Consulting James Lewis Self: Consulting fee, Consulting, Pfizer Inc, Self: Consulting fee, Advisory Committees or Review Panels, Centocor, Other financial benefit not in list, Grant/ Research Support, Allos Therapeutics, Self: Consulting fee, Consulting, Shire Pharmaceuticals Group, Other financial benefit not in list, Grant/Research Support, Takeda Pharmaceutical, Other financial benefit not in list, Grant/Research Support, Amgen, Self: Consulting fee, Consulting, Millennium Pharmaceuticals, Self: Consulting fee, Consulting, AstraZeneca, Self: Consulting fee, Consulting, GlaxoSmithKline, Self Consulting fee, Consulting, Dark Canyon Laboratories, Self: Consulting fee, Consulting, Roche Pharma AG, Self: Consulting fee, Other Activities Not in List Laurent Beaugerie: Self: Salary, Speaking and Teaching, Ferring Pharmaceuticals Inc, Self: Salary, Speaking and Teaching, Schering-Plough Corp., Self: Salary, Speaking and Teaching, Merck, Self: Salary, Speaking and Teaching Edward V. Loftus Self: Consulting fee, Advisory Committees or Review Panels, Pfizer Inc, Other financial benefit not in list, Grant/ Research Support, Genentech Inc., Other financial benefit not in List, Grant/Research Support, Braintree Laboratories Inc., Other financial benefit not in list, Grant/Research Support, Abbott, Self: Consulting fee, Advisory Committees or Review Panels, Abbott, Other financial benefit not in list, Grant/Research Support, UCB Pharma, Self: Consulting fee, Advisory Committees or Review Panels, UCB Pharma, Other financial benefit not in list, Grant/Research Support, Bristol-Myers Squibb Co., Other financial benefit not in list, Grant/Research Support, Bristol-Myers Squibb Co., Self: Consulting fee, Advisory Committees or Review Panels, Shire Pharmaceuticals Inc., Other financial benefit not in list, Grant/Research Support, Centocor, Inc., Other financial benefit not in list, Grant/ Research Support, Takeda Pharmaceutical Company Ltd, Other financial benefit not in list, Grant/Research Support, Amgen, Other financial benefit not in list, Grant/ Research Support The other coauthors have no other conflict of interest.
Determine the effect of delayed-release oral mesalamine 4.8 g/day (investigational 800mg tablet) vs 2.4 g/day (marketed 400mg tablet) on endoscopically measured mucosal healing in patients with moderately active ulcerative colitis (UC). Data from two Phase III, multi-center, randomized, double-blind, 6-week, controlled studies of similar design (ASCEND I&II) were pooled and analyzed. Mucosal healing was defined as endoscopy subscore of 0 or 1. Patients with moderately active UC (defined as a baseline Physician's Global Assessment score of 2) and baseline endoscopy subscore ≥ 2 were included in this analysis. A total of 423 analyzable patients with moderate UC were randomized in the two studies, of which 391 patients met criteria for this analysis. The two treatment groups were balanced with regard to baseline and demographic characteristics, disease history, and baseline disease state characteristics. In the population of patients with moderately active UC and baseline endoscopy subscore ≥ 2, the percentage of patients achieving mucosal healing is shown in the table below: MUCOSAL HEALING IN MODERATE UC PATIENTS MUCOSAL HEALING IN MODERATE UC PATIENTS The 4.8g/day dose of mesalamine was well tolerated, with adverse events comparable to 2.4g/day. Regardless of dose and as early as 3 weeks, delayed-release oral mesalamine induces endoscopically measured mucosal healing in >50% of patients. Compared to 2.4g/day, initiating therapy with 4.8g/day significantly improves endoscopic measured mucosal healing in patients with moderately active UC.
