Cardiovascular Outcomes Trials in Type 2 Diabetes Mellitus.
OBJECTIVE
To review the spectrum of contemporary cardiovascular outcomes trials (CVOTS) in type 2 diabetes mellitus (T2DM), spanning both the pre- and post-ACCORD eras.


METHODS
We reviewed a total of 12 CVOTs and delineated the two eras in accordance with the 2008 US Food and Drug Administration (FDA) mandate requiring completion of CVOTs prior the licensing of new glucose-lowering agents. The salient implications regarding macrovascular disease complications were summarized.


RESULTS
Five trials in the pre-ACCORD and 7 in the post-ACCORD era were identified. Heterogeneous results pertaining to the degree of glycemic control associated with optimal macrovascular disease risk reduction, as well as the safest pharmacologic means to do so, were observed.


CONCLUSIONS
The post-ACCORD era is representative of a significant shift in the landscape of CVOTs in T2DM, with an emphasis on safety of glucose-lowering agents. Recently completed and ongoing trials of dipeptidyl peptidase-4 inhibitors and sodium-glucose cotransporter 2 inhibitors will continue to inform clinical practice on safe and effective ways to reduce CV risk in T2DM.
Department of Internal Medicine, University of Maryland Medical Center, Baltimore, Md., USA.
Karan
K
Kapoor
Praveen
P
George
Michael
M
Miller
D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D003925:Diabetic Angiopathies / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D016896:Treatment Outcome
D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000077203:Sodium-Glucose Transporter 2 Inhibitors