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Introduction: Meta-analyses are useful to increase knowledge and strengthen evidence about antidepressant treatment supplementary to individual studies.Methods: A pooled analysis of four multicenter, open-label, prospective, non-interventional studies (2009-2013) was performed to provide further evidence about the antidepressant effectiveness and tolerability of agomelatine (25-50 mg/day) in a large number of non-selected German outpatients with major depressive disorder. The main analysis was performed after 12 weeks (n = 9601) and in subpopulations after 24 and 52 weeks by descriptive statistical methods.Results: Overall, 60.1% of patients were pretreated with antidepressants. Concomitant psychiatric diseases (71.9%), co-medication with antidepressants (18.9%) and/or psychotropic medication (31.9%) were observed. Depressive symptoms improved according to the Clinical Global Impression (CGI) in 81% after 12 weeks, a response was observed in 78.7% (CGI-I ≤2), and remission in 34.5% of patients (CGI-S = 1 or 2). In subpopulations, response was documented in 79.3% (W24) and 75.9% (W52) and remission in 38.1% (W24) and 47.5% (W52), respectively. Over 12 weeks, adverse drug reactions (ADRs) were reported for 511 patients (5.32%), most frequently headache (0.92%) and nausea (0.75%), and serious adverse drug reactions (sADR) for 18 patients (0.19%). Between W12-W24 and W24-W52, ADRs were reported for 0.49%/0.99% and sADRs for 0.05%/0%, respectively. Overall, 49 patients (0.5%) showed clinically relevant transaminase elevations (AST/ALT >3 times upper normal value), with 19 patients (0.2%) showing preexisting elevations at the study start. One patient (0.03%) developed hepatitis with reversible symptoms after treatment discontinuation. ADR predominantly occurred within the first weeks of treatment. Mean weight and body mass index (BMI) remained unchanged over 24 weeks.Conclusion: In this pooled data analysis, 9601 depressed patients of clinical practice were evaluated over 12 weeks and subpopulations were also analyzed over 24 and 52 weeks. Agomelatine effectively reduced depressive symptoms (CGI-response and remission) with good general tolerability. [ABSTRACT FROM AUTHOR]

Introduction: Despite of advances in modern surgical and intensive care treatment, perioperative mortality remains high in patients with liver cirrhosis undergoing nonhepatic general surgery. In the few existing articles, mortality was reported to be as high as 70% in patients with poor liver function (high Child or model for end-stage liver disease (MELD) score). Since data are limited, we analyzed our recent experience with cirrhotic patients undergoing emergent or elective nonhepatic general surgery at a German university hospital.Methods: Since 2000, 138 nonhepatic general surgical procedures (99 intra-abdominal, 39 abdominal wall) were performed in patients with liver cirrhosis. Liver cirrhosis was preoperatively classified according to the Child (41 Child A, 59 B, 38 C) and the MELD score (MELD median 13). Sixty-eight (49%) of the patients underwent emergent operations. Most abdominal wall operations were for hernias. Intra-abdominal operations consisted of GI tract procedures (n=53), cholecystectomies (n=15), and various others (n=31). Perioperative data were gained by retrospective analysis.Results: Overall perioperative mortality in all 138 cases was 28% (9% in elective surgery, 47% in emergent surgery; p<0.001). Perioperative mortality was higher after intra-abdominal than after abdominal wall operations (35% vs. 8%; p=0.001) or in patients requiring transfusions (43% vs. 5% without transfusions; p<0.001). Perioperative mortality increased with the Child score (10% Child A, 17% Child B, 63% Child C; p<0.01) and the MELD score (9% MELD <10, 19% MELD 10–15, 54% MELD >15; p<0.001). Univariately, further factors like American Society of Anesthesiologists (ASA) score and various preoperative laboratory values were also associated with perioperative mortality. By multivariate analysis of all 138 operations, the Child and ASA classifications, intraoperative transfusions, and a preoperative sodium <130 mmol/l, but not the MELD score, were independent prognostic factors. Analysis of elective operations revealed only a preoperatively increased creatinine as risk factor for perioperative mortality. In emergent operations again, Child class, blood transfusions, and low sodium level, but not the MELD score, predicted postoperative mortality.Conclusions: Our results demonstrate that perioperative mortality remains high in patients with liver cirrhosisundergoing general surgery, especially in emergent situations. Patients with poor liver function and/or need for blood transfusions even had a very high mortality. In our experience, the Child score (together with other variables) independently correlates with perioperative mortality in emergent operations whereas the MELD score was inferior in predicting the outcome. [ABSTRACT FROM AUTHOR]

Introduction: Nivolumab is the first checkpoint-inhibitor approved for the treatment of advanced HCC patients. Real-life experience data of nivolumab treatment in HCC patients, especially those with advanced liver disease, is scarce., Materials and Methods: All patients with confirmed advanced HCC and nivolumab treatment from three large German centers were retrospectively analyzed. Clinical parameters and outcome were assessed., Results: A total of 34 patients were included. At the time of treatment initiation 5 patients (14.7%) were classified as stage BCLC B and 29 (85.3%) BCLC C, respectively. 25 (73.5) patients had received prior sorafenib treatment. All patients presented with cirrhosis, namely Child-Pugh stages A (56%) or B (41%), respectively. At time of patient's assessment, 20 out of 34 (58.8%) patients had died. Grade 3 toxicities occurred in two patients (5.9%). Best overall responses were partial response in four patients (11.8%) and stable disease in eight patients (23.5%). The median overall survival of the whole cohort was 7.5 weeks (range 0-46). Child-Pugh B stage disease at treatment start was significantly associated with poor outcome., Discussion: Nivolumab treatment seems safe and clinical efficacious. Patients with advanced liver disease require further prospective evaluation due to probable limited efficacy of nivolumab.