Aim: Perform a comparison between adalimumab (ADA) and infliximab (IFX) in treating post-operative recurrence of Crohn's disease (a comparative analysis of efficacy and safety).Methods: From the 267 patients treated with adalimumab or infliximab between January 2005 and June 2014 in Romania, 44 received anti-TNF (tumor necrosis factor) therapy for prevention of post-operative recurrence. A comparison between patients treated with IFX and ADA was made with the Chi-square and t-student test, with the aid of the statistical program Mini Tab 17.Results: Twenty-one patients received IFX and 23 ADA. This included 49% males (22/44), with a mean age of 41 years, mean disease duration of 6 years, and 84.1% had previously received azathioprine. The IFX group is comparable with the ADA group regarding most of the parameters, except for therapy duration. Mean duration of therapy was 33 months. The rate of complete response was comparable between the two groups: 67% in the IFX group vs. 78.3% in the ADA group, the same as the rate of reresection, 19.1% vs. 4.4% and the rate of endoscopic recurrence, 29 vs. 33% at 12 months. Risk factors for postoperative recurrence (POR) (male sex, younger age, ileocolonic location, stricturing or penetrating behaviour) were studied, only ileocolonic location was found to be associated with Crohn's disease recurrence in patients treated with ADA.Conclusions: Overall infliximab and aalimumab are equally efficient in patients with resected Crohn's disease (CD) with a complete response of 72.7%, a rate of re-resection of 11.4% and a rate of endoscopic recurrence of 35%. Ileocolonic location might be a predictive factor for loss of response to adalimumab in resected Crohn's disease patients.

Background: Heartburn occurs predominantly in the upper gastrointestinal tract and is associated with gastroesophageal reflux disease (GERD) and gastritis. Omeprazole is the most prescribed proton pump inhibitor class of medication to treat heartburn related clinical conditions. To compare the efficacy of omeprazole 40 mg (as a total daily dose) and 20 mg using patient-reported outcome measures (PROMs) in patients with heartburn due to various aetiologies like non-erosive reflux disease, GERD, gastritis, dyspepsia, functional heartburn, gastro-duodenal ulcer.Methods: Naïve patients presenting heartburn symptoms were treated with omeprazole. PROMs were assessed based on short-form-leeds dyspepsia questionnaires (SF-LDQ), work productivity activity impairment (WPAI), relief obtained using medication and, treatment satisfactory questionnaires (TSQ).Results: A total of 18,724 patients with heartburn (GERD and gastritis; n=10,509) were treated with omeprazole (Dr. Reddy’s omeprazole [DO]/generic omeprazole [GO]/branded omeprazole [BO]) 40 mg (as a total daily dose) and 20 mg. Statistical comparative analysis showed significant improvement with omeprazole 40 mg (as a total daily dose) compared to omeprazole 20 mg in SF-LDQ, relief obtained using medication among patients with heartburn. DO 20 mg showed a greater improvement under the ‘a lot’ and ‘complete’ relief category.Conclusions: Omeprazole 40 mg (as a total daily dose) presented better efficacy as compared to omeprazole 20 mg in patient reported outcomes. This study highlights omeprazole 40 mg as the preferred intervention for improving PROMs and quality of life in the treatment of heartburn related clinical conditions.

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Background: Adequate sedation is a prerequisite for quality endoscopic examination of the digestive tract. We aimed to evaluate the current practices and safety profile of sedation for gastrointestinal endoscopy in Romania and its impact on the technical success of the procedure and procedure-related adverse events. Methods: We conducted a prospective, multicentric, observational study including all patients undergoing digestive endoscopic procedures under various degrees of sedation. We collected data regarding the endoscopic procedure, type and degree of sedation, drug regimens, personnel in charge of sedation, and relevant patient related information. The main study outcome was the rate of sedation-related adverse events; secondary study outcomes included procedure-related adverse events and the impact of sedation on procedure success. Results: 1043 consecutive endoscopic procedures from eight Romanian endoscopy units were included in our study. Sedation regimens were highly variable between participating centers, with 566 (54%) of procedures being performed under sedation provided by an anaesthesiologist. Sedation-related adverse events occurred in 40 cases (3.8%), most of them were mild respiratory and cardiovascular events and all reversed spontaneously. On multivariate analysis, male gender, procedure type (endoscopic ultrasound and endoscopic retrograde cholangiopancreatography) and deep sedation were risk factors for complications. The endoscopy unit, ASA status, age and type of sedative did not influence the complication rate. Conclusion: In conclusion, sedation for endoscopic procedures is generally safe, despite a high variability in sedation practices between centres in Romania. Establishing a national guideline on sedation for gastrointestinal endoscopy will ensure consistent and safe practice for these procedures.