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      Ceftolozane/tazobactam: place in therapy

      1 , 2 , 3 , 1 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 1 , on behalf of ISGRI-SITA (Italian Study Group on Resistant Infections of the Società Italiana Terapia Antinfettiva)
      Expert Review of Anti-infective Therapy
      Informa UK Limited

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          Extended-spectrum beta-lactamase-producing Enterobacteriaceae: an emerging public-health concern.

          The medical community relies on clinical expertise and published guidelines to assist physicians with choices in empirical therapy for system-based infectious syndromes, such as community-acquired pneumonia and urinary-tract infections (UTIs). From the late 1990s, multidrug-resistant Enterobacteriaceae (mostly Escherichia coli) that produce extended-spectrum beta lactamases (ESBLs), such as the CTX-M enzymes, have emerged within the community setting as an important cause of UTIs. Recent reports have also described ESBL-producing E coli as a cause of bloodstream infections associated with these community-onset UTIs. The carbapenems are widely regarded as the drugs of choice for the treatment of severe infections caused by ESBL-producing Enterobacteriaceae, although comparative clinical trials are scarce. Thus, more rapid diagnostic testing of ESBL-producing bacteria and the possible modification of guidelines for community-onset bacteraemia associated with UTIs are required.
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            Is Open Access

            Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

            Objective To determine the availability of data on overall survival and quality of life benefits of cancer drugs approved in Europe. Design Retrospective cohort study. Setting Publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013. Main outcome measures Pivotal and postmarketing trials of cancer drugs according to their design features (randomisation, crossover, blinding), comparators, and endpoints. Availability and magnitude of benefit on overall survival or quality of life determined at time of approval and after market entry. Validated European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) used to assess the clinical value of the reported gains in published studies of cancer drugs. Results From 2009 to 2013, the EMA approved the use of 48 cancer drugs for 68 indications. Of these, eight indications (12%) were approved on the basis of a single arm study. At the time of market approval, there was significant prolongation of survival in 24 of the 68 (35%). The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months (median 2.7 months). At the time of market approval, there was an improvement in quality of life in seven of 68 indications (10%). Out of 44 indications for which there was no evidence of a survival gain at the time of market authorisation, in the subsequent postmarketing period there was evidence for extension of life in three (7%) and reported benefit on quality of life in five (11%). Of the 68 cancer indications with EMA approval, and with a median of 5.4 years’ follow-up (minimum 3.3 years, maximum 8.1 years), only 35 (51%) had shown a significant improvement in survival or quality of life, while 33 (49%) remained uncertain. Of 23 indications associated with a survival benefit that could be scored with the ESMO-MCBS tool, the benefit was judged to be clinically meaningful in less than half (11/23, 48%). Conclusions This systematic evaluation of oncology approvals by the EMA in 2009-13 shows that most drugs entered the market without evidence of benefit on survival or quality of life. At a minimum of 3.3 years after market entry, there was still no conclusive evidence that these drugs either extended or improved life for most cancer indications. When there were survival gains over existing treatment options or placebo, they were often marginal.
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              Antimicrobial Resistance.

              The development of antibiotics is considered among the most important advances of modern science. Antibiotics have saved millions of lives. However, antimicrobial resistance (AMR) threatens this progress and presents significant risks to human health.
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                Author and article information

                Journal
                Expert Review of Anti-infective Therapy
                Expert Review of Anti-infective Therapy
                Informa UK Limited
                1478-7210
                1744-8336
                March 14 2018
                April 03 2018
                March 09 2018
                April 03 2018
                : 16
                : 4
                : 307-320
                Affiliations
                [1 ] Infectious Diseases Unit, Ospedale Policlinico San Martino – IRCCS per l’Oncologia and Department of Health Sciences, University of Genoa, Genoa, Italy
                [2 ] Infectious Diseases Clinic, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Integrata Presidio Ospedaliero Universitario Santa Maria della Misericordia, Udine, Italy
                [3 ] Department of Medical Sciences, University of Turin, Infectious Diseases, City of Health and Sciences, Turin, Italy
                [4 ] Department of Surgical and Morphological Sciences of Clinical Medicine, University of Insubria, Varese, Italy
                [5 ] Infectious Diseases Clinic, Nuovo Santa Chiara University Hospital, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy
                [6 ] Institute of Clinical Pharmacology, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Integrata Presidio Ospedaliero Universitario Santa Maria della Misericordia, Udine, Italy
                [7 ] Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy
                [8 ] Clinical Microbiology and Virology Unit, Florence Careggi University Hospital, Florence, Italy
                [9 ] Institute of Infectious Diseases, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy
                [10 ] Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
                Article
                10.1080/14787210.2018.1447381
                29493397
                8b205109-40f2-496a-9968-c4cf08700e75
                © 2018
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