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Lecumberri R.,Hematology Service | Panizo E.,Hematology Service | Gomez-Guiu A.,Clinical Pharmacology Service | Varea S.,Hematology Service | And 6 more authors.
Journal of Thrombosis and Haemostasis | Year: 2011

Objectives: The prevention of venous thromboembolism (VTE) is a priority for improved safety in hospitalised patients. Worldwide, there is growing concern over the undersuse of appropriate thromboprophylaxis. Computerised decision support improves the implementation of thromboprophylaxis and reduces inpatient VTE. However, an economic assessment of this approach has not yet been performed. Objectives:To evaluate the economic impact of an electronic alert (e-alert) system to prevent VTE in hospitalised patients over a 4year period. Patients/methods:All hospitalised patients at a single institution during the first semesters of 2005-2009 (n=32280) were included. All cases of VTE developed during hospitalisation were followed and direct costs of diagnosis and management collected. Results:E-alerts achieved a sustained reduction of the incidence of in-hospital VTE, OR 0.50 (95% CI, 0.29-0.84), the impact being especially significant in medical patients, OR 0.44 (95% CI, 0.22-0.86). No increase in prophylaxis-related bleeding was observed. In our setting, the mean direct cost (during hospitalisation and after discharge) of an in-hospital VTE episode is €7058. Direct costs per single hospitalised patient were reduced after e-alerts from €21.6 to €11.8, while the increased use of thromboprophylaxis and the development of e-alerts meant €3 and €0.35 per patient, respectively. Thus, the implementation of e-alerts led to a net cost saving of €6.5 per hospitalised patient. Should all hospitalised patients in Spain be considered, total yearly savings would approach €30million. Conclusions:E-alerts are useful and cost-effective tools for thromboprophylaxis strategy in hospitalised patients. Fewer thromboembolic complications and lower costs are achieved by its implementation. © 2011 International Society on Thrombosis and Haemostasis. Source

Cuesta-Gragera A.,University of Valencia | Navarro-Fontestad C.,University of Valencia | Mangas-Sanjuan V.,University Miguel Hernandez | Gonzalez-Alvarez I.,University Miguel Hernandez | And 4 more authors.
European Journal of Pharmaceutical Sciences | Year: 2015

The objective of this paper was to validate a previously developed semi physiological model to simulate bioequivalence trials of drug products. The aim of the model was to ascertain whether the measurement of the metabolite concentration-time profiles would provide any additional information in bioequivalence studies (Fernandez-Teruel et al., 2009a,b; Navarro-Fontestad et al., 2010). The semi-physiological model implemented in NONMEM VI was used to simulate caffeine and its main metabolite plasma levels using caffeine parameters from bibliography. Data from 3 bioequivalence studies in healthy subjects at 3 different doses (100, 175 and 400 mg of caffeine) and one study in cirrhotic patients (200 or 250 mg) were used. The first aim was to adapt the previous semi-physiological model for caffeine, showing the hepatic metabolism with one main metabolite, paraxanthine. The second aim was to validate the model by comparison of the simulated plasma levels of parent drug and metabolite to the experimental data. The simulations have shown that the proposed semi-physiological model was able to reproduce adequately the pharmacokinetic behavior of caffeine and paraxanthine in both healthy subjects and cirrhotic patients at all the assayed doses. Therefore, the model could be used to simulate plasma concentrations vs. time of drugs with the same pharmacokinetic scheme as caffeine, as long as their population parameters are known, and it could be useful for bioequivalence trial simulation of drugs that undergo hepatic metabolism with a single main metabolite. © 2015 Elsevier B.V. All rights reserved. Source

Gomez-Outes A.,Spanish Agency for Medicines and Health Care Products AEMPS | Suarez-Gea M.L.,Spanish Agency for Medicines and Health Care Products AEMPS | Lecumberri R.,University of Navarra | Rocha E.,University of Navarra | And 2 more authors.
Therapeutic Advances in Cardiovascular Disease | Year: 2011

The therapeutic armamentarium of parenteral anticoagulants available to clinicians is mainly composed by unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), fondaparinux, recombinant hirudins (i.e. bivalirudin, desirudin, lepirudin) and argatroban. These drugs are effective and safe for prevention and/or treatment of thromboembolic diseases but they have some drawbacks. Among other inconveniences, UFH requires regular anticoagulant monitoring as a result of variability in the anticoagulant response and there is a risk of serious heparin-induced thrombocytopaenia (HIT). LMWH, fondaparinux and recombinant hirudins are mainly cleared through the kidneys and their use in patients with severe renal insufficiency may be problematic. LMWH is only partially neutralized by protamine while fondaparinux and recombinant hirudins have no specific antidote. Novel anticoagulants in development for parenteral administration include new indirect activated factor Xa (FXa) inhibitors (idrabiotaparinux, ultra-low-molecular-weight heparins [semuloparin, RO-14], new LMWH [M118]), direct FXa inhibitors (otamixaban), direct FIIa inhibitors (flovagatran sodium, pegmusirudin, NU172, HD1-22), direct FXIa inhibitors (BMS-262084, antisense oligonucleotides targeting FXIa, clavatadine), direct FIXa inhibitors (RB-006), FVIIIa inhibitors (TB-402), FVIIa/tissue factor inhibitors (tifacogin, NAPc2, PCI-27483, BMS-593214), FVa inhibitors (drotrecogin alpha activated, ART-123) and dual thrombin/FXa inhibitors (EP217609, tanogitran). These new compounds have the potential to complement established parenteral anticoagulants. In the present review, we discuss the pharmacology of new parenteral anticoagulants, the results of clinical studies, the newly planned or ongoing clinical trials with these compounds, and their potential advantages and drawbacks over existing therapies. © 2011 The Author(s). Source

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