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Should recent experiences with CVOTs for oral hypoglycemic drugs allow us to rethink the regulatory paradigm?
Author(s) -
Meyer RJ
Publication year - 2015
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.193
Subject(s) - food and drug administration , rosiglitazone , medicine , drug approval , drug , clinical trial , regulatory science , drug labeling , drug trial , intensive care medicine , diabetes mellitus , pharmacology , pathology , endocrinology
In response to a meta‐analysis raising significant concerns over the cardiovascular safety of rosiglitazone, the US Food and Drug Administration (FDA) issued a draft guidance directing sponsors of novel diabetes drugs to address cardiovascular risk, including large outcomes trials. Regulatory experience supports that outcomes trials, absent a clear signal of risk, may add reassurance, but also have significant consequences. The FDA should finalize this guidance, taking into account the regulatory experience since 2008.