@article{ZinmanInzucchiLachinetal.2014, author = {Zinman, Bernard and Inzucchi, Silvio E. and Lachin, John M. and Wanner, Christoph and Ferrari, Roberto and Fitchett, David and Bluhmki, Erich and Hantel, Stefan and Kempthorne-Rawson, Joan and Newman, Jennifer and Johansen, Odd Erik and Woerle, Hans-Juergen and Broedl, Uli C.}, title = {Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME (TM))}, series = {Cardiovascular Diabetology}, volume = {13}, journal = {Cardiovascular Diabetology}, number = {102}, issn = {1475-2840}, doi = {10.1186/1475-2840-13-102}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-116036}, year = {2014}, abstract = {Background: Evidence concerning the importance of glucose lowering in the prevention of cardiovascular (CV) outcomes remains controversial. Given the multi-faceted pathogenesis of atherosclerosis in diabetes, it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone. The SGLT-2 inhibitor empagliflozin improves glucose control, body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes. The aim of the ongoing EMPA-REG OUTCOME (TM) trial is to determine the long-term CV safety of empagliflozin, as well as investigating potential benefits on macro-/microvascular outcomes. Methods: Patients who were drug naive (HbA(1c) >= 7.0\% and <= 9.0\%), or on background glucose-lowering therapy (HbA(1c) >= 7.0\% and <= 10.0\%), and were at high risk of CV events, were randomized (1:1:1) and treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo (double blind, double dummy) superimposed upon the standard of care. The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. CV events will be prospectively adjudicated by an independent Clinical Events Committee. The trial will continue until >= 691 confirmed primary outcome events have occurred, providing a power of 90\% to yield an upper limit of the adjusted 95\% CI for a hazard ratio of <1.3 with a one-sided a of 0.025, assuming equal risks between placebo and empagliflozin (both doses pooled). Hierarchical testing for superiority will follow for the primary outcome and key secondary outcomes (time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina pectoris) where non-inferiority is achieved. Results: Between Sept 2010 and April 2013, 592 clinical sites randomized and treated 7034 patients (41\% from Europe, 20\% from North America, and 19\% from Asia). At baseline, the mean age was 63 +/- 9 years, BMI 30.6 +/- 5.3 kg/m(2), HbA1c 8.1 +/- 0.8\%, and eGFR 74 +/- 21 ml/min/1.73 m(2). The study is expected to report in 2015. Discussion: EMPA REG OUTCOME (TM) will determine the CV safety of empagliflozin in a cohort of patients with type 2 diabetes and high CV risk, with the potential to show cardioprotection.}, language = {en} } @article{RoseDammGreineretal.2014, author = {Rose, Markus A. and Damm, Oliver and Greiner, Wolfgang and Knuf, Markus and Wutzler, Peter and Liese, Johannes G. and Kr{\"u}ger, Hagen and Wahn, Ulrich and Schaberg, Tom and Schwehm, Markus and Kochmann, Thomas F. and Eichner, Martin}, title = {The epidemiological impact of childhood influenza vaccination using live-attenuated influenza vaccine (LAIV) in Germany: predictions of a simulation study}, series = {BMC Infectious Diseases}, volume = {14}, journal = {BMC Infectious Diseases}, number = {40}, issn = {1471-2334}, doi = {10.1186/1471-2334-14-40}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-117563}, year = {2014}, abstract = {Background: Routine annual influenza vaccination is primarily recommended for all persons aged 60 and above and for people with underlying chronic conditions in Germany. Other countries have already adopted additional childhood influenza immunisation programmes. The objective of this study is to determine the potential epidemiological impact of implementing paediatric influenza vaccination using intranasally administered live-attenuated influenza vaccine (LAIV) in Germany. Methods: A deterministic age-structured model is used to simulate the population-level impact of different vaccination strategies on the transmission dynamics of seasonal influenza in Germany. In our base-case analysis, we estimate the effects of adding a LAIV-based immunisation programme targeting children 2 to 17 years of age to the existing influenza vaccination policy. The data used in the model is based on published evidence complemented by expert opinion. Results: In our model, additional vaccination of children 2 to 17 years of age with LAIV leads to the prevention of 23.9 million influenza infections and nearly 16 million symptomatic influenza cases within 10 years. This reduction in burden of disease is not restricted to children. About one third of all adult cases can indirectly be prevented by LAIV immunisation of children. Conclusions: Our results demonstrate that vaccinating children 2-17 years of age is likely associated with a significant reduction in the burden of paediatric influenza. Furthermore, annual routine childhood vaccination against seasonal influenza is expected to decrease the incidence of influenza among adults and older people due to indirect effects of herd protection. In summary, our model provides data supporting the introduction of a paediatric influenza immunisation programme in Germany.}, language = {en} } @article{SauerbreiLangenhanBrandstaedtetal.2014, author = {Sauerbrei, A. and Langenhan, T. and Brandst{\"a}dt, A. and Schmidt-Ott, R. and Krumbholz, A. and Girschick, H. and Huppertz, H. and Kaiser, P. and Liese, J. and Streng, A. and Niehues, T. and Peters, J. and Sauerbrey, A. and Schroten, H. and Tenenbaum, T. and Wirth, S. and Wutzler, P.}, title = {Prevalence of antibodies against influenza A and B viruses in children in Germany, 2008 to 2010}, series = {Eurosurveillance}, volume = {19}, journal = {Eurosurveillance}, number = {5}, issn = {1560-7917}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-117347}, pages = {20687}, year = {2014}, abstract = {The prevalence of influenza A and B virus-specific IgG was determined in sera taken between 2008 and 2010 from 1,665 children aged 0-17 years and 400 blood donors in Germany. ELISA on the basis of whole virus antigens was applied. Nearly all children aged nine years and older had antibodies against influenza A. In contrast, 40\% of children aged 0-4 years did not have any influenza A virus-specific IgG antibodies. Eighty-six percent of 0-6 year-olds, 47\% of 7-12 year-olds and 20\% of 13-17 year-olds were serologically naive to influenza B viruses. By the age of 18 years, influenza B seroprevalence reached approximately 90\%. There were obvious regional differences in the seroprevalence of influenza B in Germany. In conclusion, seroprevalences of influenza A and influenza B increase gradually during childhood. The majority of children older than eight years have basal immunity to influenza A, while comparable immunity against influenza B is only acquired at the age of 18 years. Children aged 0-6 years, showing an overall seroprevalence of 67\% for influenza A and of 14\% for influenza B, are especially at risk for primary infections during influenza B seasons.}, language = {en} }