Dabigatran – a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs

Malmström, R. E., Godman, B. B., Diogene, E., Baumgärtel, C., Bennie, M., Bishop, I., Brzezinska, A., Bucsics, A., Campbell, S., Ferrario, A., +37 more...Finlayson, A. E., Fürst, J., Garuoliene, K., Gomes, M., Gutiérrez-Ibarluzea, I., Haycox, A., Hviding, K., Herholz, H., Hoffmann, M., Jan, S., Jones, J., Joppi, R., Kalaba, M., Kvalheim, C., Laius, O., Langner, I., Lonsdale, J., Lööv, S., Malinowska, K., McCullagh, L., Paterson, K., Markovic-Pekovic, V., Martin, A., Piessnegger, J., Selke, G., Sermet, C., Simoens, S., Tulunay, C., Tomek, D., Vončina, L., Vlahovic-Palcevski, V., Wale, J., Wilcock, M., Wladysiuk, M., Woerkom, M. v., Zara, C. & Gustafsson, L. L. (2013). Dabigatran – a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs. Frontiers in Pharmacology, 4(39). https://doi.org/10.3389/fphar.2013.00039
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There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use.

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