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Background: In patients with mesalazine-refractory ulcerative colitis, systemic corticosteroids are the treatment of choice., Objective: To evaluate the efficacy and safety of prolonged release budesonide granules for the induction of remission in patients with mesalazine-refractory ulcerative colitis., Methods: Patients with mesalazine-refractory ulcerative colitis discontinued mesalazine at baseline and received 9 mg prolonged release budesonide granules daily for 8 weeks in this open-label, phase IIa study, followed by a 2-week follow-up phase wherein patients continued treatment on alternate days (EudraCT number 2014-005635-14; ClinicalTrials.gov identifier NCT02550418). The primary endpoint was clinical remission (Clinical Activity Index ≤4; stool frequency <18 per week; absence of rectal bleeding) at Week 8. Secondary endpoints included clinical, endoscopic and histological measures of disease at Week 8. A post hoc analysis assessed histo-endoscopic mucosal healing. Treatment-emergent adverse events and morning cortisol levels were assessed throughout the treatment and follow-up phases., Results: A total of 61 patients were included in the intention-to-treat population; 50 were included in the follow-up analysis set. Clinical remission was achieved in 29 patients (47.5%; 95% confidence interval: 34.6-60.7%) by Week 8. Mean stool and bloody stool frequency decreased significantly from 32.5 to 22.9 per week ( p <0.0001) and from 17.6 to 8.1 per week ( p <0.0001), respectively. Rates of mucosal healing, endoscopic remission and histological remission were 58.0%, 54.0% and 36.0%, respectively. Histo-endoscopic mucosal healing was achieved by 34.0% of patients. Twenty-four patients (39.3%) experienced treatment-emergent adverse events, of which gastrointestinal disorders (16.4%) were the most common. Mean morning cortisol levels were not significantly suppressed by Week 8., Conclusions: Treatment with prolonged release budesonide granules for 8 weeks was associated with clinical, endoscopic and histological remission and demonstrated a favourable safety profile in patients with mesalazine-refractory ulcerative colitis. These results warrant further investigation into the potential of prolonged release budesonide granules as an alternative treatment for this patient population.

Background: Adherence to mesalazine treatment is essential for the successful treatment of ulcerative colitis., Objective: The objective of this study was to compare the efficacy, safety and preference of a novel high-dose 1000 mg mesalazine tablet versus conventional treatment for ulcerative colitis remission., Methods: This pivotal phase III trial compared one 1000 mg mesalazine tablet (M1000 group) versus two registered 500 mg mesalazine tablets (M2x500 group), both taken three times daily, in patients with mild to moderately active ulcerative colitis. The primary efficacy variable was clinical remission at week 8., Results: A total of 306 patients were considered for intent-to-treat analysis. Clinical remission was achieved in 45.0% of the patients in the M1000 group versus 41.9% in the M2x500 group ( P  < 0.001 for non-inferiority). Mucosal healing was achieved by 68.9% of the patients in the M1000 group and 68.4% in the M2x500 group. The majority of patients preferred the intake of one high-dose tablet (47.7%) over two low-dose tablets (10.5%). Oral treatment with high-dose 1000 mg mesalazine tablets was well tolerated without new safety signals., Conclusions: The novel high-dose 1000 mg mesalazine tablet is effective, non-inferior to the registered 500 mg mesalazine tablet, and safe for ulcerative colitis treatment. It was preferred by a majority of patients and may improve ulcerative colitis treatment adherence.

Introduction: Video capsule endoscopy (VCE) is relatively new, informative and minimally invasive endoscopic diagnostic method for assessment of the small bowel mucosa., Objective: To evaluate the clinical significance of ten years' experience of VCE in Latvia., Materials and Methods: A retrospective review of patients who underwent VCE between July 2006 and July 2016 was conducted. All patients had undergone previous negative endoscopic examinations before VCE. Special original study protocol with more than 370 parameters was fulfilled for each patient. All the data was entered into the database with consecutive statistical analysis using SPSS ver.19., Results: In total out of 530 VCE were performed, due to technical reasons 421 patients' data were entered into the database. Out of these, 245 (58,2%) patients were females and 176 (41,8%) - males. Patients' age was varied from 13 to 82 (mean 44.39 ± 16.36) years. VCE most common indications were: Crohn's disease (26.1%), unclear iron deficiency anemia (22.8%), chronic unexplained abdominal pain (20.4%) and obscure bleeding from the digestive tract (17.1%). VCE findings were justified as clinically significant in 255 (60.57%) of cases. In 152 (36.10%) - findings were doubtful, and in 14 (3.33%) - clinically insignificant. Bowel preparation prior to capsule endoscopy was performed using one of the four schemes. Bowel cleanliness was statistically significantly better (p = 0.03) using 2 liters or 4 liters of polyethylene glycol-based electrolyte solution. Regional transit abnormalities (RTA) in 55 (13.1%) cases. Positive statistically significant correlation was observed between presence of RTA without changes / defects in the small bowel mucosa and patients age (p = 0.028)., Conclusions: 1. VCE is clinically significant examination in patients with Crohn's disease, obscure bleeding from the digestive tract, unexplained anemia and chronic unexplained abdominal pain, which also allows changing the patient's further treatment tactics. 2. 2 liters and 4 liters of polyethylene glycol-based electrolyte solution are by far the most efficient bowel preparation schemes prior VCE. 3. RTA is more common in the elderly patients.

Background and Aims: Budesonide may be an effective therapy for mild-to-moderately active ulcerative colitis (UC). This study aimed to demonstrate non-inferiority for oral 9mg budesonide once daily (OD) versus 3g mesalazine granules OD., Methods: This was an eight-week randomised, double-blind, double-dummy, multicentre study in which patients with mild-to-moderately active UC, defined as Clinical Activity Index (CAI) ≥6 and Endoscopic Index (EI) ≥4, received budesonide (Budenofalk® 3mg capsules×3) or mesalazine (Salofalk® 1000mg granules×3). The primary endpoint was clinical remission at week 8 (CAI ≤4 with stool frequency and rectal bleeding subscores of "0")., Results: 343 patients were randomised (177 budesonide, 166 mesalazine). Fewer patients achieved the primary endpoint with budesonide versus mesalazine (70/177 [39.5%] versus 91/166 [54.8%]) with a difference in proportions of -15.3% (95% CI [-25.7%, -4.8%]; p=0.520 for non-inferiority). The median time to first resolution of symptoms was 14.0 days (budesonide) and 11.0 days (mesalazine) (hazard ratio 1.19; 95% CI [0.94, 1.51]). Mucosal healing was observed in 54/177 (30.5%) budesonide patients versus 65/166 (39.2%) mesalazine patients, a difference of -8.6% (95% CI [-18.7%, 1.4%]; p=0.093). The incidences of adverse events (budesonide 26.6%, mesalazine 25.3%) and serious adverse events (budesonide 1.7%, mesalazine 1.2%) were similar., Conclusions: Once-daily 3g mesalazine administered as granules is superior to 9mg budesonide OD administered as capsules for achieving remission in mild-to-moderately active UC. However, it is noteworthy that remission of UC was attained in about 40% of budesonide-treated patients with a rapid onset of resolution., (Copyright © 2010. Published by Elsevier B.V.)