TY - GEN
T1 - Cardiovascular outcome trials in type 2 diabetes – 2015
AU - Day, Caroline
AU - Bailey, Clifford J.
PY - 2015
Y1 - 2015
N2 - In December 2008 the US Food and Drug Administration (FDA) required that new drug applications for glucose-lowering agents must include a meta-analysis of all cardiovascular (CV) events during phase 2 and 3 trials (FDA, 2008). The level of relative risk would then be used to determine the need, or otherwise, for post-marketing studies (Table 1). This action was spurred by controversy about rosiglitazone, which raised the possibility that an anti-diabetic drug might exacerbate CV risk in people with type 2 diabetes. Thus the so-called CV outcome (or safety) trials were born. Although these safety trials are a “must do” if …
AB - In December 2008 the US Food and Drug Administration (FDA) required that new drug applications for glucose-lowering agents must include a meta-analysis of all cardiovascular (CV) events during phase 2 and 3 trials (FDA, 2008). The level of relative risk would then be used to determine the need, or otherwise, for post-marketing studies (Table 1). This action was spurred by controversy about rosiglitazone, which raised the possibility that an anti-diabetic drug might exacerbate CV risk in people with type 2 diabetes. Thus the so-called CV outcome (or safety) trials were born. Although these safety trials are a “must do” if …
UR - http://www.diabesityinpractice.co.uk/journal-content/view/cardiovascular-outcome-trials-in-type-2-diabetes-2015
M3 - Book/Film/Article review
SN - 2049-6257
VL - 4
SP - 131
EP - 133
JO - Diabesity in practice
JF - Diabesity in practice
ER -