Enhanced flat adenoma detection rate with high definition colonoscopy plus i-scan for average-risk colorectal cancer screening

Background and aim: The usefulness of high definition colonoscopy plus i-scan (HD+i-SCAN) for average-risk colorectal cancer screening has not been fully assessed. The detection rate of adenomas and other measurements such as the number of adenomas per colonoscopy and the flat adenoma detection rate have been recognized as markers of colonoscopy quality. The aim of the present study was to compare the diagnostic performance of an HD+i-SCAN with that of standard resolution white-light colonoscope. Methods: This is a retrospective analysis of a prospectively collected screening colonoscopy database. A comparative analysis of the diagnostic yield of an HD+i-SCAN or standard resolution colonoscopy for average-risk colorectal screening was conducted. Results: During the period of study, 155/163 (95.1%) patients met the inclusion criteria. The mean age was 56.9 years. Sixty of 155 (39%) colonoscopies were performed using a HD+i-SCAN. Adenoma-detection-rates during the withdrawal of the standard resolution versus HD+i-SCAN colonoscopies were 29.5% and 30% (p = n.s.). Adenoma/colonoscopy values for standard resolution versus HD+i-SCAN colonoscopies were 0.46 (SD = 0.9) and 0.72 (SD = 1.3) (p = n.s.). A greater number of flat adenomas were detected in the HD+i-SCAN group (6/60 vs. 2/95) (p < .05). Likewise, serrated adenomas/polyps per colonoscopy were also higher in the HD+i-SCAN group. Conclusions: A HD+i-SCAN colonoscopy increases the flat adenoma detection rate and serrated adenomas/polyps per colonoscopy compared to a standard colonoscopy in average-risk screening population. HD+i-SCAN is a simple, available procedure that can be helpful, even for experienced providers. The performance of HD+i-SCAN and substantial prevalence of flat lesions in our average-risk screening cohort support its usefulness in improving the efficacy of screening colonoscopies.

Initial experience with golimumab in clinical practice for ulcerative colitis

Background: Golimumab is a TNF-blocking agent indicated as a second-line therapy in ulcerative colitis. Purpose: To research the effectiveness and safety of golimumab in patients with ulcerative colitis in clinical practice. Methods: Retrospective study of the effectiveness and safety of golimumab in patients with ulcerative colitis. All patients received golimumab 200 mg subcutaneously at week 0, and golimumab 100 mg subcutaneously at week 2. After the induction treatment, each patient received 50 mg sc. every 4 weeks in patients with body weight less than 80 kg, and 100 mg every 4 weeks in patients with body weight greater than or equal to 80 kg. Results: Study of a group of 23 ulcerative colitis patients, 7 of whom were naive to any anti-TNF therapy, and 16 patients who had previously been treated with an anti-TNF agent other than golimumab (non-naive patients). The average treatment time with golimumab was 14.3 weeks. Globally, withdrawal of corticosteroids was observed in 74% of cases. Clinical response was observed in 85.5% of patients who had not received biological treatment previously, and in patients who had previously received biological treatment the response rate was 75%. Conclusions: In this short study, golimumab seems to be an alternative treatment in naive and non-naive anti-TNF ulcerative colitis patients. It is also a safe therapy, given that there were no adverse effects in the patients studied.

Clinical trial designs of new medicinal products for treating schizophrenia: discussion of EMA's Guideline and a Better Long Term Trial Design

Background and Objectives: Schizophrenia is a severe chronic disease. Endpoint variables lack objectivity and the diagnostic criteria have evolved with time. In order to guide the development of new drugs, European Medicines Agency (EMA) issued a guideline on the clinical investigation of medicinal products for the treatment of schizophrenia. Methods: Authors reviewed and discussed the efficacy trial part of the Guideline. Results: The Guideline divides clinical efficacy trials into short-term trials and long-term trials. The short-term three-arm trial is recommended to replace the short-term two-arm active-controlled non-inferiority trial because the latter has sensitivity issues. The Guideline ultimately makes that three-arm trial a superiority trial. The Guideline discusses four types of long-term trial designs. The randomized withdrawal trial design has some disadvantages. Long-term two-arm active-controlled non-inferiority trial is not recommended due to the sensitivity issue. Extension of the short-term trial is only suitable for extension of the short-term two-arm active-controlled superiority trial. The Guideline suggests that a hybrid design of a randomized withdrawal trial incorporated into a long-term parallel trial might be optimal. However, such a design has some disadvantages and might be too complex to be carried out. Authors suggest instead a three-group long-term trial design, which could provide comparison between test drug and active comparator along with comparison between the test drug and placebo. This alternative could arguably be much easier to carry out compared with the hybrid design. Conclusions: The three-group long-term design merits further discussion and evaluation.