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Landoni G.,Vita-Salute San Raffaele University | Biondi-Zoccai G.,University of Turin | Greco M.,Vita-Salute San Raffaele University | Greco T.,Vita-Salute San Raffaele University | And 4 more authors.
Critical Care Medicine | Year: 2012

Objective: Catecholaminergic inotropes have a place in the management of low output syndrome and decompensated heart failure but their effect on mortality is debated. Levosimendan is a calcium sensitizer that enhances myocardial contractility without increasing myocardial oxygen use. A meta-analysis was conducted to determine the impact of levosimendan on mortality and hospital stay. Data Sources: BioMedCentral, PubMed, Embase, and the Cochrane Central Register of clinical trials were searched for pertinent studies. International experts and the manufacturer were contacted. Study Selection: Articles were assessed by four trained investigators, with divergences resolved by consensus. Inclusion criteria were random allocation to treatment and comparison of levosimendan vs. control. There were no restrictions on dose or time of levosimendan administration or on language. Exclusion criteria were: duplicate publications, nonadult studies, oral administration of levosimendan, and no data on main outcomes. Data Extraction: Study end points, main outcomes, study design, population, clinical setting, levosimendan dosage, and treatment duration were extracted. Data Synthesis: Data from 5,480 patients in 45 randomized clinical trials were analyzed. The overall mortality rate was 17.4% (507 of 2,915) among levosimendan-treated patients and 23.3% (598 of 2,565) in the control group (risk ratio 0.80 [0.72; 0.89], p for effect <.001, number needed to treat = 17 with 45 studies included). Reduction in mortality was confirmed in studies with placebo (risk ratio 0.82 [0.69; 0.97], p = .02) or dobutamine (risk ratio 0.68 [0.52-0.88]; p = .003) as comparator and in studies performed in cardiac surgery (risk ratio 0.52 [0.35; 0.76] p = .001) or cardiology (risk ratio 0.75 [0.63; 0.91], p = .003) settings. Length of hospital stay was reduced in the levosimendan group (weighted mean difference = -1.31 [-1.95; -0.31], p for effect = .007, with 17 studies included). A trend toward a higher percentage of patients experiencing hypotension was noted in levosimendan vs. control (risk ratio 1.39 [0.97-1.94], p = .053). Conclusions: Levosimendan might reduce mortality in cardiac surgery and cardiology settings of adult patients. Copyright © 2012 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins.


Menichetti F.,Azienda Ospedaliera Universitaria Pisana
Internal and Emergency Medicine | Year: 2010

Cancer patients are at risk of infectious complications due to neutropenia following chemotherapy or early post-HSCT (Hemato Stem Cell Transplantation). The first episode of fever during recent onset neutropenia is caused mostly by bacteria, while subsequent episodes are mainly fungal in nature. Proper management of infectious complications in neutropenic cancer patients requires classification into the appropriate risk category and knowledge of the local epidemiology of infections, of the causative organisms and their resistance phenotype. © 2010 SIMI.


Falcone M.,University of Rome La Sapienza | Blasi F.,University of Milan | Menichetti F.,Azienda Ospedaliera Universitaria Pisana | Pea F.,Istituto di Farmacologia Clinica e Tossicologia | Violi F.,University of Rome La Sapienza
Internal and Emergency Medicine | Year: 2012

Despite advances in diagnosis, antimicrobial therapy and supportive care modalities, community-acquired pneumonia (CAP) remains an important cause of morbidity and mortality, especially in patients who require hospitalization. Elderly patients with poor functional status are characterized by a higher risk of developing severe CAP, due to the frequent presence of underlying respiratory and cardiac diseases, alteration of mental status, and immunosuppression. In recent years, changes in the healthcare system have shifted a considerable part of older patient care from hospitals to the community, and the traditional distinction between community- and hospital-acquired infections has become less clear. Pneumonia occurring among outpatients in contact with the healthcare system has been termed healthcare-associated pneumonia. Older frail patients have a high frequency of aspiration pneumonia and pneumonia due to gram-negative bacilli and other multidrug resistant pathogens. The contemporary presence of renal impairment usually requires specific dose adjustment of antibiotic therapy, which may be toxic in this specific patient population. This review produces a summary of therapeutic recommendations on the basis of the most updated clinical and pharmacological data. © 2012 SIMI.


Breugom A.J.,Leiden University | Swets M.,Leiden University | Bosset J.-F.,Besancon University Hospital njoz | Collette L.,European Organisation for Research | And 9 more authors.
The Lancet Oncology | Year: 2015

Background: The role of adjuvant chemotherapy for patients with rectal cancer after preoperative (chemo)radiotherapy and surgery is uncertain. We did a meta-analysis of individual patient data to compare adjuvant chemotherapy with observation for patients with rectal cancer. Methods: We searched PubMed, Medline, Embase, Web of Science, the Cochrane Library, CENTRAL, and conference abstracts to identify European randomised, controlled, phase 3 trials comparing observation with adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery for patients with non-metastatic rectal cancer. The primary endpoint of interest was overall survival. Findings: We analysed data from four eligible trials, including data from 1196 patients with (y)pTNM stage II or III disease, who had an R0 resection, had a low anterior resection or an abdominoperineal resection, and had a tumour located within 15 cm of the anal verge. We found no significant differences in overall survival between patients who received adjuvant chemotherapy and those who underwent observation (hazard ratio [HR] 0.97, 95% CI 0.81-1.17; p=0.775); there were no significant differences in overall survival in subgroup analyses. Overall, adjuvant chemotherapy did not significantly improve disease-free survival (HR 0.91, 95% CI 0.77-1.07; p=0.230) or distant recurrences (0.94, 0.78-1.14; p=0.523) compared with observation. However, in subgroup analyses, patients with a tumour 10-15 cm from the anal verge had improved disease-free survival (0.59, 0.40-0.85; p=0.005, pinteraction=0.107) and fewer distant recurrences (0.61, 0.40-0.94; p=0.025, pinteraction=0.126) when treated with adjuvant chemotherapy compared with patients undergoing observation. Interpretation: Overall, adjuvant fluorouracil-based chemotherapy did not improve overall survival, disease-free survival, or distant recurrences. However, adjuvant chemotherapy might benefit patients with a tumour 10-15 cm from the anal verge in terms of disease-free survival and distant recurrence. Further studies of preoperative and postoperative treatment for this subgroup of patients are warranted. Funding: None. © 2015 Elsevier Ltd.


Nannipieri M.,University of Pisa | Baldi S.,University of Pisa | Mari A.,National Research Council Italy | Colligiani D.,University of Pisa | And 8 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2013

Context: In obese patients with type 2 diabetes (T2DM), Roux-en-Y-gastric-bypass (RYGB) and sleeve gastrectomy (SLG) improve glycemic control. Objective: The objective of this study was to investigate the mechanisms of surgery-induced T2DM improvement and role of gastrointestinal hormones. Patients, Setting, and Intervention: In 35 patients with T2DM, we performed a mixed-meal test before and 15 days and 1 year after surgery (23 RYGB and 12 SLG). Main Outcome Measures: Insulin sensitivity, β-cell function, and amylin, ghrelin, PYY, pancreatic polypeptide (PP), glucagon, and glucagon-like peptide-1 (GLP-1) responses to the meal were measured. Results: T2DM remission occurred in 13 patients undergoing RYGB and in 7 patients undergoing SLG. Similarly in the RYGB and SLG groups, β-cell glucose sensitivity improved both early and long term (P < .005), whereas insulin sensitivity improved long term only (P < .006), in proportion to body mass index changes (P < .001). Early after RYGB, glucagon and GLP-1 responses to the meal increased, whereas the PP response decreased. At 1 year, PYY was increased, and PP, amylin, ghrelin, and GLP-1 were reduced. After SLG, hormonal responses were similar to those with RYGB except that PP was increased, whereas amylin was unchanged. In remitters, fasting GLP-1 was higher (P = .04), but its meal response was flat compared with that of nonremitters; postsurgery, however, the GLP-1 response was higher. Other hormone responses were similar between the 2 groups. In logistic regression, presurgery β-cell glucose sensitivity (positive, P < .0001) and mealstimulated GLP-1 response (negative, P = .004) were the only predictors of remission. Conclusions: RYGB and SLG have a similar impact on diabetes remission, of which baseline β-cell glucose sensitivity and a restored GLP-1 response are the chief determinants. Other hormonal responses are the consequences of the altered gastrointestinal anatomy. Copyright © 2013 by The Endocrine Society.

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