Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
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SHR Neuro Krebs Kardio Lipid Stoffw Microb
Zannad, F; Stough, WG; Lipicky, RJ; Tamargo, J; Bakris, GL; Borer, JS; Alonso García, Mde L; Hadjadj, S; Koenig, W; Kupfer, S; McCullough, PA; Mosenzon, O; Pocock, S; Scheen, AJ; Sourij, H; Van der Schueren, B; Stahre, C; White, WB; Calvo, G.
Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion.
Eur Heart J Cardiovasc Pharmacother. 2016; 2(3):200-205
Doi: 10.1093/ehjcvp/pvw007
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- Co-Autor*innen der Med Uni Graz
- Sourij Harald
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- Abstract:
- The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i.e. to determine the efficacy of a drug over placebo or standard care) rather than demonstrating that risk is not increased by a pre-specified safety margin. All stakeholders are responsible for ensuring that new drug approvals occur under conditions of appropriate safety and effectiveness. It is also a shared responsibility to avoid unnecessary hurdles that may compromise access to useful drugs and threaten the sustainability of health systems. It is critical to renew this debate so that stakeholders can collectively determine the optimal approach for developing new drugs to treat type 2 diabetes mellitus. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.
- Find related publications in this database (using NLM MeSH Indexing)
- Animals -
- Cardiovascular Diseases - chemically induced
- Cardiovascular Diseases - epidemiology
- Diabetes Mellitus - drug therapy
- Guidelines as Topic -
- Humans -
- Hypoglycemic Agents - adverse effects
- Hypoglycemic Agents - therapeutic use
- Risk Assessment -
- Risk Management -
- United States -
- United States Food and Drug Administration -
- Find related publications in this database (Keywords)
- Diabetes mellitus
- Clinical trials
- Cardiovascular disease