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Abstract: Antibiotic therapy improves the outcome of severe sepsis and septic shock, however pharmacokinetic properties are altered in this scenario. Amikacin (AMK) is an option to treat community or nosocomial infections, although standard doses might be insufficient in critically ill patients. The aim of this study was to evaluate two AMK dosage regimens in comparison with standard therapy with regard to efficacy in achieving adequate plasma levels as well as safety. In total, 99 patients with severe sepsis or septic shock were randomised to different AMK dose protocols: Group 1, 25mg/kg/day; Group 2, 30mg/kg/day; and Group 3, historical standard dose (15mg/kg/day). Peak plasma concentrations at 1h (C max) were determined. Pharmacokinetics was determined and renal function was monitored to evaluate toxicity. Groups were compared using bilateral T-test. Demographic characteristics of the three groups were comparable. AMK C max values were 57.4±9.8, 72.1±18.4 and 35.2±9.4μg/mL, respectively (P <0.001 between Groups 1 and 2 versus Group 3, and P <0.01 between Group 1 versus Group 2). A C max >60μg/mL was reached by 39%, 76% and 0% of patients in Groups 1, 2 and 3, respectively (P <0.001) and creatinine clearance at Day 28 was 95.6±47.4, 89.7±26.6 and 56.4±18.4mL/min, respectively. In conclusion, a 30mg/kg daily dose of AMK presents significantly higher C max compared with the other groups, with 76% of patients reaching recommended peak plasma levels with no association with higher nephrotoxicity. Standard doses are insufficient in critically ill patients to reach the recommended C max. [Copyright &y& Elsevier]

Abstract: Objectives: INCA (Intelligent Control Assistant for Diabetes) is an EU funded project aimed at improving diabetes therapy by creating a personal closed-loop system interacting with telemedical remote control. This study aims at identifying and applying suitable methods for a cost–benefit analysis from the perspective of the payor for health services. Methods: For cost analysis MOSAIK-M was used, a method and tool for health information systems analysis and design. Two MOSAIK-M models were created describing conventional insulin pump based diabetes care (CSII), and INCA based diabetes care. Both models were parameterised with costs and simulated to determine yearly costs of diabetes management and treatment for a patient with no diabetes related complications. Probability of developing complications and their duration were determined based on the Archimedes model. It was parameterised with results of a clinical study concerning HbA1c-value changes using the INCA system compared with conventional CSII. The simulation results in form of years of disease within a 30-year time frame were multiplied with corresponding treatment costs. Results: Yearly costs of conventional insulin CSII for a diabetes type 1 patient are €5908 (German health care system). Using INCA based on the clinical study setting would raise yearly costs by €2233. 24% of the INCA costs are generated by the continuous blood glucose measurement device, 5% by IT devices and services. Considering also diabetes related complications in a 30-year time frame and HbA1c value reductions from 7.9 and 7.6% (conventional CSII) to 7.5 and 7.3% (INCA) reduces the additional costs of INCA to €2102 and €2162. Conclusions: The approach produces an estimation of a lower bound for cost savings concerning the treatment of diabetes related complications in a 30-year time frame. These savings alone do not prove cost efficiency of the INCA approach. Further work is needed to improve the approximation and to include indirect and intangible costs. [Copyright &y& Elsevier]